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Operator
Operator
Hello, everyone. Thank you for joining us, and welcome to the CareDx Q3 2026 earnings call. (Operator Instructions)
各位好。感謝各位加入,歡迎參加 CareDx 2026 年第三季財報電話會議。(接線員指示)
I will now hand the conference over to Nina Deka, CareDx Head of Investor Relations. Nina, please go ahead.
現在我將把會議交給 CareDx 投資人關係主管 Nina Deka。Nina,請開始。
Nina Deka - Head, Investor Relations
Nina Deka - Head, Investor Relations
Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the third quarter 2026 ending September 30, 2026. The results and our earnings presentation are available on the company's website at caredx.com.
謝謝,接線員。各位下午好。感謝各位今天加入我們。今天稍早,CareDx 公布了截至 2026 年 9 月 30 日止之 2026 年第三季財務結果。相關結果與我們的財報簡報可於公司網站 caredx.com 查閱。
Joining me on today's call are John Hanna, President and Chief Executive Officer; and Keith Kennedy, Chief Operating Officer and Chief Financial Officer.
今天與我一同出席電話會議的有總裁暨執行長 John Hanna,以及營運長兼財務長 Keith Kennedy。
Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that can cause actual results to differ materially from those anticipated or implied by these forward-looking statements.
在開始之前,我想提醒各位,管理團隊在本次電話會議中將發表包含前瞻性陳述的內容。本次電話會議中任何非歷史事實之陳述,均應視為前瞻性陳述。所有前瞻性陳述皆基於目前的估計與各項假設。這些陳述涉及重大風險與不確定性,可能導致實際結果與這些前瞻性陳述所預期或暗示者有重大差異。
Accordingly, you should not place undue reliance on these statements. Information concerning the risks, uncertainties, and other factors that could cause results to differ from these forward-looking statements is included in our filings with the Securities and Exchange Commission.
因此,您不應過度依賴這些陳述。有關可能導致結果與這些前瞻性陳述不同之風險、不確定性及其他因素的資訊,已載於我們向美國證券交易委員會提交的文件中。
The information provided in this conference call speaks only to the live broadcast today, October 29, 2026. We disclaim any intention or obligation, except as required by law, to update or authorize any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise.
本次電話會議所提供的資訊僅適用於今日(2026 年 10 月 29 日)的即時播出。除法律要求外,我們不承擔亦不意圖更新或使任何資訊、財務預測或其他前瞻性陳述生效之任何義務,不論係因新資訊、未來事件或其他原因。
This call will also include a discussion of certain non-GAAP financial measures. These non-GAAP financial measures should be considered in addition to, not as a substitute or in isolation from GAAP measures. Reconciliations of our non-GAAP financial measures to the most directly comparable GAAP financial measures may be found in today's earnings release or investor presentation, which are posted on our website.
本次電話會議亦將討論若干非 GAAP 財務衡量指標。這些非 GAAP 財務衡量指標應作為 GAAP 指標之補充,而非替代,亦不應單獨或孤立地解讀。我們的非 GAAP 財務衡量指標與最直接可比之 GAAP 財務衡量指標的調節表,可於今日的財報新聞稿或投資人簡報中查閱,相關文件已張貼於我們的網站。
With that, I will now turn the call over to John.
接下來,我將把電話會議交給 John。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Thank you, Nina. Good afternoon, everyone, and thank you, all, for joining us today.
謝謝你,Nina。各位下午好,也感謝各位今天加入我們。
We had another strong quarter of solid execution, extending our leadership in transplantation, expanding into specialty oncology, and preparing for our entrance into cell therapy.
我們又交出一個執行穩健的強勁季度,持續鞏固我們在移植領域的領導地位,拓展至專科腫瘤,並為進入細胞治療領域做好準備。
As a reminder, our strategy is to focus on markets where we believe our core competencies give us the right to win. Markets where patients face a high burden of disease and are managed by a concentrated group of subspecialty providers where the high cost of treatment and disease management warrants repeat molecular testing and where our solution selling approach, including integrated testing, digital solutions, and pharmacy can create a competitive advantage.
提醒各位,我們的策略是聚焦於我們相信自身核心能力能讓我們具備勝出條件的市場。也就是患者疾病負擔高、由相對集中的次專科醫療提供者管理的市場;在這些市場中,高昂的治療與疾病管理成本使得重複分子檢測具備合理性;同時,我們的解決方案式銷售方法(包含整合式檢測、數位解決方案與藥局服務)能創造競爭優勢。
In my conversations with clinicians across transplantation, oncology, and cell therapy over the past quarter, The feedback is consistent. Clinicians want actionable, precision molecular information about their patient's disease status and how it is changing over time to inform treatment decisions.
在過去一季我與移植、腫瘤以及細胞治療領域臨床醫師的交流中,回饋相當一致。臨床醫師希望取得可採取行動的精準分子資訊,以了解其病患的疾病狀態以及其隨時間的變化,從而協助治療決策。
Across these markets, our approach to driving growth is consistent: generate the evidence that builds clinical belief and make testing easier to integrate into practice workflows.
在這些市場中,我們推動成長的方法一致:產出能建立臨床信心的證據,並讓檢測更容易整合進臨床作業流程。
Today, I'll cover our progress across the growth drivers we use to execute this strategy, our pipeline, the evidence we're generating, and how we're executing in the market, including specialty oncology. I'm also excited to share later in my prepared remarks a new facet to our strategy and how we build meaningful connections with patients throughout their care journey.
今天,我將說明我們在用以執行此策略的各項成長驅動因素上的進展、我們的產品研發管線、我們正在產出的證據,以及我們在市場上的執行情況(包括專科腫瘤)。我也很期待在稍後的準備講稿中分享我們策略的一個新面向,以及我們如何在病患整個照護旅程中建立有意義的連結。
But first, let's talk about our pipeline. Innovation remains central to maintaining our leadership position, applying CareDx strengths in new markets and expanding our addressable market. Both of our organic pipeline programs are on track.
不過首先,先談談我們的研發管線。創新仍是維持我們領導地位的核心,能將 CareDx 的優勢應用到新市場並擴大我們的可服務市場規模。我們兩項自研管線計畫皆按進度推進。
For each pipeline program, we begin by generating evidence well before launch so clinicians have the data they need to evaluate the test and understand how it can inform patient care.
對於每一項管線計畫,我們都會在上市前很早就開始產出證據,讓臨床醫師擁有所需數據來評估檢測,並了解其如何為病患照護提供資訊。
Let me start with AlloHeme. We continue to advance AlloHeme, our recurrence monitoring test, for patients undergoing cell therapy to treat AML and MDS hematologic malignancies. Designed as a universal assay for cell therapy patients without reliance on a specific disease mutation, AlloHeme represents an organic expansion of our capabilities into a market where we believe we have the potential to establish a differentiated leadership position.
我先從 AlloHeme 談起。我們持續推進 AlloHeme——我們的復發監測檢測——用於接受細胞治療以治療 AML 與 MDS 血液惡性腫瘤的病患。AlloHeme 被設計為適用於細胞治療病患的通用型檢測,不依賴特定疾病突變;這代表我們能力的自研延伸,進入一個我們相信有機會建立差異化領導地位的市場。
The ACROBAT Clinical Validation Steering Committee has submitted the initial trial manuscript for peer review. Recall, at Tandem earlier this year, the authors demonstrated that AlloHeme identified molecular relapse a median of 41 days before clinical diagnosis. We remain on track to complete CLIA readiness activities before year-end, supporting a planned commercial launch in the first quarter of 2027.
ACROBAT 臨床驗證指導委員會已提交初始試驗論文稿供同儕審查。回顧今年稍早在 Tandem 會議上,作者團隊展示 AlloHeme 能在臨床診斷前中位數 41 天偵測到分子層級復發。我們仍按計畫在年底前完成 CLIA 就緒相關工作,以支持 2027 年第一季的商業化上市計畫。
HistoMap Kidney, which adds a layer of molecular insights to tissue biopsy assessment, complementing AlloSure Kidney blood-based monitoring, is also on track. This quarter, a second independent validation study performed in conjunction with investigators at the University of Wisconsin was published in the peer-reviewed journal, Transplantation.
HistoMap Kidney 亦按進度推進;該產品在組織切片評估上增加一層分子洞見,並與 AlloSure Kidney 以血液為基礎的監測相互補充。本季,與威斯康辛大學研究人員合作進行的第二項獨立驗證研究,已發表於同儕審查期刊《Transplantation》。
HistoMap's molecular classification exhibited robust concordance across established rejection categories. Importantly, the authors evaluated a subgroup of patients diagnosed with microvascular inflammation, or MVI. Previously, this pathology was often interpreted as no rejection. The clinical significance of this phenotype was elevated by a recent study published in the New England Journal of Medicine, which found that these patients had a significantly greater risk of graft loss than previously believed.
HistoMap 的分子分類在既有的排斥反應分類中展現出穩健的一致性。重要的是,作者評估了一個被診斷為微血管發炎(microvascular inflammation,MVI)的病患亞群。過去,這種病理表現常被解讀為沒有排斥反應。近期發表於《新英格蘭醫學期刊》的研究提升了此表型的臨床重要性;該研究發現,這些病患的移植物喪失風險顯著高於先前認知。
In the transplantation article, HistoMap was able to identify two subgroups of patients with MVI that had meaningfully different long-term graft outcomes. Over a follow-up of up to six years, 50% of patients molecularly classified by HistoMap as having a high risk of rejection experienced graft loss compared with 15% of those classified by HistoMap as having a low risk of rejection. This more than threefold difference demonstrates HistoMap's potential to identify clinically meaningful risk in the setting of MVI beyond conventional pathology.
在《Transplantation》這篇文章中,HistoMap 能夠辨識出兩個 MVI 病患亞群,其長期移植物結局存在顯著差異。在最長達六年的追蹤期間內,經 HistoMap 分子分類為高排斥風險的病患中,有 50% 發生移植物喪失;相較之下,經 HistoMap 分類為低排斥風險者為 15%。這超過三倍的差異顯示,HistoMap 在 MVI 情境下,除傳統病理之外,具備辨識具臨床意義風險的潛力。
We remain focused on completing HistoMap CLIA readiness activities before year-end in support of a broader commercial availability in 2027.
我們仍專注於在年底前完成 HistoMap 的 CLIA 就緒相關工作,以支持 2027 年更廣泛的商業供應。
And as a reminder, in liver transplantation, we continue to collect and analyze follow-up data from patients enrolled in MAPLE, our multicenter prospective clinical validation study. Evidence generation is central to how we advance our pipeline. We are building the evidence needed to demonstrate clinical value and support future adoption and coverage.
另外提醒各位,在肝臟移植方面,我們持續收集並分析納入 MAPLE(我們的多中心前瞻性臨床驗證研究)的病患追蹤資料。證據產出是我們推進研發管線的核心。我們正在建立所需證據,以證明臨床價值並支持未來的採用與給付涵蓋。
Turning now to evidence generation for our on-market products, evidence is how we build belief in molecular testing as standard of care. Our medical affairs team continues to strengthen the foundation for long-term growth by advancing clinical confidence in our testing portfolio and supporting the translation of evidence into clinical practice.
接著談我們已上市產品的證據產出;證據是我們建立分子檢測作為標準照護信念的方式。我們的醫學事務團隊持續透過提升對我們檢測產品組合的臨床信心,並支持將證據轉化到臨床實務中,來強化長期成長的基礎。
I'll start with specialty oncology and then turn to transplant.
我將先從專科腫瘤開始,接著再談移植。
In specialty oncology, NavDx is used for molecular residual disease or MRD testing in HPV-driven cancers with surveillance as its first established context of use. Investigators are now exploring additional context of use including radiation de-escalation in HPV-driven head and neck cancer. This is an important clinical question because the burden of radiation for head and neck cancer can be profound. Treatment typically lasts for six to seven weeks, and the cumulative effects can make it difficult for patients to swallow, maintain nutrition, and manage everyday life, with some effects persisting long after treatment ends.
在專科腫瘤領域,NavDx 用於 HPV 驅動型癌症的分子殘存病灶(molecular residual disease,MRD)檢測,其首個已確立的使用情境為監測(surveillance)。研究人員目前正探索其他使用情境,包括在 HPV 驅動型頭頸癌中進行放射治療降階(radiation de-escalation)。這是一個重要的臨床問題,因為頭頸癌放射治療帶來的負擔可能非常沉重。治療通常持續六到七週,累積效應可能使病患難以吞嚥、維持營養並應付日常生活,且部分影響在治療結束後仍可能持續很長一段時間。
If clinicians could safely reduce that burden for selected patients while maintaining disease control, even a shorter course or lower dose, that de-escalation could be meaningful.
如果臨床醫師能在維持疾病控制的同時,為特定患者安全地降低那樣的負擔,即便只是縮短療程或降低劑量,這種降階治療也可能具有重要意義。
At the American Society of Radiation Oncology Conference, or ASTRO, two independent Phase II studies utilizing NavDx in distinct radiation de-escalation settings were presented. The first evaluated radiation after surgery. In an independent prospective multicenter study, investigators at Emory and Vanderbilt used post-operative NavDx results to guide the subsequent radiation dose and treatment area.
在美國放射腫瘤學會年會(ASTRO)上,發表了兩項在不同放射治療降階情境中使用 NavDx 的獨立第二期研究。第一項評估術後放射治療。在一項獨立的前瞻性多中心研究中,Emory 與 Vanderbilt 的研究人員使用術後 NavDx 結果來指引後續的放射劑量與治療範圍。
Among 35 patients, the study reported 97% control of the cancer in the treated region at 12 and 24 months, along with favorable patient-reported swallowing function at one year. These findings are early, but they illustrate one potential context of use for precision molecular information following surgery.
在 35 名患者中,研究報告顯示於治療區域在 12 個月與 24 個月的癌症控制率為 97%,且一年時患者回報的吞嚥功能表現良好。這些發現仍屬早期,但它們說明了在手術後運用精準分子資訊的一種潛在使用情境。
The second study from Ohio State evaluated patients receiving radiation as their primary treatment. Investigators measured NavDx kinetics during treatment to determine which patients would receive a reduced radiation dose. In the first 15 patients, 12 had a greater than 95% decline in their NavDx score by week four and received a lower radiation dose than the current standard.
第二項來自俄亥俄州立大學的研究評估以放射治療作為主要治療的患者。研究人員在治療期間測量 NavDx 的動態變化(kinetics),以判定哪些患者可接受降低的放射劑量。在前 15 名患者中,有 12 名在第 4 週時其 NavDx 分數下降超過 95%,並接受了低於現行標準的放射劑量。
All 12 achieved a complete response at three months, with no cancer returning in the treated region at the interim analysis. Longer follow-up will be important, but the study demonstrates how NavDx is being evaluated to tailor radiation based on an individual patient's response.
這 12 名患者在 3 個月時皆達到完全反應(complete response),且在期中分析時治療區域未見癌症復發。更長期的追蹤將很重要,但該研究展示了如何根據個別患者的反應來評估以 NavDx 量身調整放射治療。
Together, these two Phase II trials evaluated two distinct contexts of use: guiding radiation after surgery and adapting definitive radiation during treatment to safely reduce the burden of radiation for selected patients while maintaining disease control.
綜合而言,這兩項第二期試驗評估了兩種不同的使用情境:在手術後指引放射治療,以及在治療期間調整根治性放射治療,以在維持疾病控制的同時,為特定患者安全地降低放射治療負擔。
At ASTRO, more than 20 trials were highlighted exploring radiation de-escalation in this setting, underscoring the level of clinical interest in determining which patients may safely receive a lower dosage.
在 ASTRO 上,重點介紹了超過 20 項在此情境中探索放射治療降階的試驗,凸顯臨床界對於判定哪些患者可安全接受較低劑量的高度關注。
A new study is also evaluating NavDx during the initial period after definitive radiation treatment and before the standard of care imaging assessment at month three. A newly published eight-center study in clinical cancer research led by investigators at Mount Sinai and Dana-Farber Cancer Institute evaluated 332 patients during this early post-treatment period.
另有一項新研究正在評估於根治性放射治療後的初期、以及標準照護在第 3 個月進行影像評估之前的期間使用 NavDx。一項新近發表於《Clinical Cancer Research》的八中心研究,由西奈山(Mount Sinai)與丹娜法伯癌症研究院(Dana-Farber Cancer Institute)的研究人員主導,於此治療後早期期間評估了 332 名患者。
Patients whose results remained positive faced a much greater risk of recurrence, while no recurrences were observed among those whose results later became negative. The findings highlight the potential prognostic value of molecular results before the standard three-month imaging assessment. This illustrates how the evidence could expand NavDx beyond established surveillance and into additional treatment decisions across the patient journey.
結果持續為陽性的患者面臨顯著更高的復發風險;而在那些之後轉為陰性的患者中,未觀察到復發。這些發現突顯在標準三個月影像評估之前,分子檢測結果可能具有預後價值。這也說明相關證據如何可能將 NavDx 的應用從既有的監測(surveillance)擴展到患者全病程中的更多治療決策。
Turning to solid organ transplant, this fall, both at the Banff Meeting on Transplant Pathology and the American Society of Nephrology Kidney Week, or ASN, we presented new evidence that further demonstrates how molecular testing can help clinicians assess rejection risk, inform monitoring, and navigate some of the most difficult decisions in kidney transplant care.
接著談實體器官移植。今年秋季,我們在移植病理學 Banff 會議以及美國腎臟學會腎臟週(ASN Kidney Week)上,發表了新的證據,進一步顯示分子檢測如何協助臨床醫師評估排斥風險、制定監測策略,並在腎臟移植照護中面對一些最艱難的決策時提供指引。
One of the key analyses comes from our KOAR registry and looks at a particularly challenging clinical scenario, patients with borderline changes or T-cell mediated rejection seen on biopsy, where histology alone does not always predict who is at risk.
其中一項關鍵分析來自我們的 KOAR 登錄研究(registry),聚焦於一個特別具挑戰性的臨床情境:活檢顯示邊緣性變化(borderline changes)或 T 細胞介導性排斥(T-cell mediated rejection)的患者;在這些情況下,僅靠組織學(histology)並不總能預測誰具有風險。
In 131 patients, an AlloSure Kidney result of 1% or higher around the time of biopsy was independently associated with a nearly threefold higher risk of graft loss or a decline in kidney function of 30% or more. This could help clinicians identify higher risk patients who may benefit from closer monitoring, reinforcing AlloSure's role in informing care beyond a signal diagnostic decision.
在 131 名患者中,於活檢前後時間點 AlloSure Kidney 結果達 1% 或以上,與移植物喪失或腎功能下降 30% 以上的風險近三倍增加呈獨立相關。這可協助臨床醫師辨識較高風險、可能需要更密切監測的患者,並強化 AlloSure 在不僅是單一診斷決策訊號之外、仍可用於指引照護的角色。
At ASN, investigators from the Paris Transplant Group presented results from a multinational randomized trial of 332 kidney transplant recipients. Patients monitored using an AlloSure-based monitoring strategy underwent 49% fewer biopsies between months 3 and 12 with similar rates of death, graft loss, and acute rejection and no statistically significant difference in kidney function at 12 months. This is important prospective evidence supporting the potential for molecular monitoring to reduce invasive procedures while maintaining comparable outcomes.
在 ASN 上,巴黎移植團隊(Paris Transplant Group)的研究人員發表了一項跨國隨機試驗結果,納入 332 名腎臟移植受者。採用以 AlloSure 為基礎的監測策略進行追蹤的患者,在第 3 至第 12 個月間接受的活檢數量減少 49%,同時死亡、移植物喪失與急性排斥的發生率相近,且在 12 個月時腎功能無統計上顯著差異。這是重要的前瞻性證據,支持分子監測在維持可比臨床結果的同時,有潛力降低侵入性處置。
Demonstrating that AlloSure-based monitoring strategy can reduce invasive biopsies while maintaining similar clinical outcomes strengthens the clinical and health economic rationale for broader protocol adoption and payer coverage.
證明以 AlloSure 為基礎的監測策略能在維持相似臨床結果的同時減少侵入性活檢,將強化更廣泛採用標準化流程(protocol)與保險支付方給付覆蓋的臨床與健康經濟學論述。
Together, these findings demonstrate the growing breadth of the AlloSure Kidney evidence base, helping clinicians assess risk when biopsy findings are ambiguous and informing monitoring strategies designed to reduce unnecessary procedures.
綜合而言,這些發現展現了 AlloSure Kidney 證據基礎的持續擴展,協助臨床醫師在活檢結果不明確時評估風險,並為旨在減少不必要處置的監測策略提供依據。
Across the solid organ transplant and specialty oncology portfolios, we are focused not only on demonstrating test performance but also on showing how our solutions can inform more clinical decisions and create value for patients, providers, and payers. That evidence is central to expanding use across our established portfolio and advancing our pipeline toward launch, reimbursement, and future coverage.
在實體器官移植與專科腫瘤兩大產品組合中,我們不僅著重於證明檢測效能,也致力於展示我們的解決方案如何支援更多臨床決策,並為患者、醫療提供者與支付方創造價值。這些證據是擴大既有產品組合使用、並推進我們的產品線(pipeline)邁向上市、取得報銷(reimbursement)與未來給付覆蓋的核心。
Turning now to go-to-market. Since we closed the acquisition of NavDx on July 1, we've been executing against the three specialty oncology integration priorities I outlined last quarter, and I want to update you on each.
接著談市場推進(go-to-market)。自我們於 7 月 1 日完成 NavDx 的收購以來,我們一直依照我在上季所概述的三項專科腫瘤整合優先事項推進執行,並希望逐一向各位更新。
First, we are leveraging our commercial capabilities to expand adoption of NavDx. We started the expansion of our field team to build belief in NavDx testing as a standard of care for HPV-driven cancers. That added commercial and medical presence is intended to drive deeper adoption of protocols for MRD surveillance. In addition, our customer service team is making it easier for patients to access NavDx testing through blood draw scheduling and our national mobile phlebotomy network.
第一,我們正運用商業化能力來擴大 NavDx 的採用。我們已開始擴編前線團隊,以建立將 NavDx 檢測視為 HPV 驅動癌症標準照護的臨床共識。新增的商業與醫學端人力,旨在推動 MRD 監測(surveillance)流程的更深度採用。此外,我們的客服團隊也透過安排抽血時程與全國行動抽血服務網路,讓患者更容易取得 NavDx 檢測。
Second, we are applying our clinical workflow optimization expertise to simplify the customer experience and support longitudinal testing. We have enabled electronic ordering through our care portal and see growing use of standard orders for surveillance testing and are integrating NavDx ordering into Epic Aura. We currently expect Epic-based ordering to begin by January 1, 2027.
第二,我們正運用臨床工作流程優化的專業,簡化客戶體驗並支援長期追蹤檢測。我們已透過照護入口網站(care portal)啟用電子下單,並看到監測檢測的標準化醫囑使用增加,同時也正將 NavDx 下單整合至 Epic Aura。我們目前預期以 Epic 為基礎的下單將於 2027 年 1 月 1 日前後開始。
Third, we are strengthening revenue cycle management execution. On October 1, we moved NavDx onto our CareDx billing platform and brought in-house 100% of our RCM workflows, creating a more scalable operational foundation. As Keith will review, we are already seeing RCM collections momentum with NavDx.
第三,我們正在強化收入循環管理(RCM)的執行。10 月 1 日,我們已將 NavDx 併入 CareDx 的帳務平台,並將 100% 的 RCM 工作流程收回內部執行,建立更具可擴展性的營運基礎。如 Keith 將會回顧的,我們已經看到 NavDx 在 RCM 收款(collections)方面的動能。
We believe these go-to-market workflow optimization and operational scale efforts position us to sustain NavDx growth through 2027, consistent with the guidance we shared when we announced the transaction.
我們相信,這些市場推進的工作流程優化與營運規模化措施,將使我們能在 2027 年前持續支撐 NavDx 的成長,與我們在宣布該交易時所分享的指引一致。
These are the same core capabilities that have made us the leader in solid organ transplant that we are now applying across specialty oncology. We have a repeatable model for translating differentiated science into clinically valuable solutions and bringing them to clinicians and patients at scale.
這些正是讓我們成為實體器官移植領導者的核心能力,而我們現在正將其應用到專科腫瘤領域。我們擁有可複製的模式,能將具差異化的科學轉化為具臨床價值的解決方案,並以規模化方式推廣至臨床醫師與患者。
Turning now to solid organ transplant go-to-market execution. First, I want to say that we are encouraged to see kidney disease elevated on the national agenda with the release of the new Health and Human Services Kidney Care National Plan. The scale of the need is profound.
接著談實體器官移植的市場推進執行。首先,我想說,我們很受鼓舞地看到,隨著新版衛生與公共服務部(HHS)《腎臟照護國家計畫》的發布,腎臟疾病已被提升至國家議程的重要位置。需求規模極為龐大。
An estimated 36 million American adults are living with chronic kidney disease, and most do not even know that they have it. More than 800,000 Americans are living with kidney failure, including approximately 0.5 million receiving dialysis and the hope of a transplant. More than 90,000 people remain on the kidney transplant wait list, while only approximately 28,000 kidney transplants are performed each year.
估計有 3,600 萬名美國成年人罹患慢性腎臟病,而多數人甚至不知道自己患病。超過 80 萬名美國人正處於腎衰竭狀態,其中約 50 萬人接受透析並期盼移植。仍有超過 9 萬人名列腎臟移植等候名單,但每年實際進行的腎臟移植僅約 2.8 萬例。
The asymmetry between the supply of transplantable organs and the demand is dramatic. Behind those numbers are patients and families living with the physical burden of dialysis and uncertainty of waiting and the hope that a transplant can offer a longer and fuller life.
可移植器官供給與需求之間的不對稱極為明顯。在這些數字背後,是患者與家庭承受透析的身體負擔、等待的不確定性,以及移植可能帶來更長且更充實人生的希望。
The Kidney Care National Plan recognizes the importance of preventing kidney failure where possible while expanding access to transplantation and encouraging innovation. We strongly share that goal: helping more patients who need a transplant receive one and supporting them throughout the transplant journey.
《腎臟照護國家計畫》認可在可行情況下預防腎衰竭的重要性,同時擴大移植可近性並鼓勵創新。我們強烈認同這個目標:協助更多需要移植的病患獲得移植,並在整個移植旅程中支持他們。
Against that backdrop, transplant testing grew 21% in the quarter. We believe that momentum reflects our differentiated clinical evidence and continued investments in field execution, protocol adoption, and workflow integration.
在此背景下,本季移植檢測量成長21%。我們相信,這股動能反映了我們具差異化的臨床證據,以及我們在前線執行、流程(protocol)採用與工作流程整合方面的持續投資。
We increased our engagement with transplant centers, supported broader implementation of testing protocols, particularly in kidney and lung, and continued to make our solutions easier to incorporate into clinical practice. We now have 21 centers live on Epic Aura, bringing ordering, results, and longitudinal testing history into existing clinical workflows. We anticipate that we will achieve our goal of half our transplant orders flowing through EMR integrations by year-end.
我們加強與移植中心的互動,支持更廣泛地落實檢測流程,特別是在腎臟與肺臟領域,並持續讓我們的解決方案更容易納入臨床實務。目前已有21家中心在 Epic Aura 上線,將開立檢驗、結果與縱向檢測歷史整合進既有臨床工作流程。我們預期在年底前達成目標:有一半的移植檢測訂單透過 EMR 整合流轉。
We are also building stronger connections with patients throughout their care journey with the goal of helping them remain informed, engaged, and connected to ongoing monitoring. In Q3, we launched our new patient website, www.caredx.com/patients, a home for kidney, heart, and lung transplant patients and caregivers. We want patients to feel supported long after surgery and to understand why ongoing monitoring matters. We believe greater engagement can support adherence and help patients stay connected to their care journey.
我們也在病患整個照護旅程中建立更緊密的連結,目標是協助他們保持知情、投入並與持續監測保持連結。在第三季,我們推出新的病患網站 www.caredx.com/patients,作為腎臟、心臟與肺臟移植病患及照護者的資訊平台。我們希望病患在手術後很長一段時間都能感受到支持,並理解為何持續監測很重要。我們相信,更高的參與度可支持依從性,並幫助病患持續連結其照護旅程。
Our new patient portal builds on that experience by connecting patients more directly to their AlloSure results. As of this week, more than 5,000 patients have already registered for the portal. It gives them a simple way to access their latest results, see how those results have changed over time, and find relevant information that can help them understand the results in context.
我們新的病患入口網站在此基礎上更進一步,讓病患能更直接連結到其 AlloSure 結果。截至本週,已有超過5,000名病患完成入口網站註冊。該入口網站提供簡便方式讓他們取得最新結果、查看結果隨時間的變化,並找到相關資訊以協助他們在脈絡中理解結果。
This addresses an important need for transplant patients who want to remain informed and connected to their care between visits. It is another way that we are differentiating, not only through our tests, but through the experience and support that we build around them.
這回應了移植病患在回診間隔期間希望保持知情並與照護保持連結的重要需求。這也是我們展現差異化的另一種方式:不僅在檢測本身,也在我們圍繞檢測所打造的體驗與支持。
Now, I'd like to turn it over to Keith to walk you through our financial results. Keith?
接下來,我想把時間交給 Keith,請他帶各位回顧我們的財務結果。Keith?
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Thank you, John. I plan to cover our third-quarter 2026 financial results and our updated 2026 guidance. We signed and closed the sale of our Lab Products business in the second quarter, so the first half of 2026 represents the full-year results for that business. Any transition services or other costs are included in our third-quarter results. We are substantially complete with transition services.
謝謝你,John。我將說明我們2026年第三季的財務結果,以及更新後的2026年財測指引。我們已於第二季簽署並完成出售實驗室產品(Lab Products)業務,因此2026年上半年反映該業務的全年結果。任何過渡服務或其他成本均已包含在第三季結果中。我們的過渡服務已大致完成。
On July 1, 2026, we closed the acquisition of our Specialty Oncology business, which is included in testing services. Please refer to our SEC disclosures and financial statements for unaudited pro forma financial information.
2026年7月1日,我們完成對專科腫瘤(Specialty Oncology)業務的收購,該業務納入檢測服務(Testing Services)。請參閱我們的 SEC 揭露與財務報表,以取得未經審計的備考(pro forma)財務資訊。
To illustrate growth on a comparable basis or relative performance, I may present our results combined with Naveris' reported results from periods prior to the acquisition, which are not included in our reported results.
為了在可比基礎上說明成長或相對表現,我可能會呈現將收購前期間 Naveris 的已揭露結果與我們結果合併後的數據;該等期間的 Naveris 結果並未納入我們的已揭露結果中。
Turning to the financial highlights section of our earnings presentation on slide 12. For the third quarter of 2026 and our year-over-year results, revenue of $139 million increased 39%. Testing volume of 75,900 tests increased 51%. Non-GAAP gross margin of 74% increased from 71%. Adjusted EBITDA of $30 million or 22% of revenue doubled from $15 million, and we ended the quarter with $250 million in cash and cash equivalents and no debt.
接著看我們財報簡報第12頁的財務重點。2026年第三季及年對年結果方面,營收為1.39億美元,成長39%。檢測量為75,900次,成長51%。非 GAAP 毛利率為74%,高於71%。調整後 EBITDA 為3,000萬美元(占營收22%),較1,500萬美元倍增;本季末我們持有2.5億美元的現金及約當現金,且無負債。
We generated $13 million in cash flow from operations this quarter, including $11 million in seller funded transaction expenses that we paid post close and $1.5 million in option-related compensation paid post-close to our Specialty Oncology employees.
本季我們自營運產生1,300萬美元現金流,其中包含我們在交割後支付的1,100萬美元由賣方資助的交易費用,以及交割後支付給專科腫瘤員工的150萬美元與選擇權相關的薪酬。
Turning to slide 13, the chart on the left illustrates total reported revenue of $139 million or 39% increase year over year and 6% sequentially driven by higher-margin testing services. Total revenue this quarter includes $15 million in out-of-period revenue up from $6 million in the prior-year quarter. Excluding out-of-period revenue in both periods, total revenue grew 32% year over year and 7% sequentially.
接著看第13頁,左側圖表顯示已揭露總營收為1.39億美元,年增39%、季增6%,主要由高毛利的檢測服務帶動。本季總營收包含1,500萬美元的跨期(out-of-period)營收,高於去年同期的600萬美元。若在兩個期間皆排除跨期營收,總營收年增32%、季增7%。
The three charts on the right provide revenue by segment. Testing Services revenue, the next chart shows our third quarter revenue of $119 million, which increased 65% year over year and 19% sequentially, and now represents 86% of our revenue up from 72% in the prior-year quarter.
右側三張圖表按部門呈現營收。檢測服務營收方面,下一張圖顯示我們第三季營收為1.19億美元,年增65%、季增19%,目前占總營收86%,高於去年同期的72%。
Testing revenue of $119 million includes $15 million of out-of-period revenue ahead of our $8 million prior estimate and up from $6 million in the prior-year quarter. Excluding out-of-period revenue, Testing Services revenue increased 58% year over year and 24% sequentially and transplant revenue alone increased 39% year over year and 9% sequentially.
1.19億美元的檢測營收包含1,500萬美元的跨期營收,高於我們先前估計的800萬美元,也高於去年同期的600萬美元。若排除跨期營收,檢測服務營收年增58%、季增24%;其中僅移植營收年增39%、季增9%。
Testing Services revenue also includes Specialty Oncology revenue of $12.5 million. We do not record revenue prior to an acquisition, but for illustrative purposes compared to Naveris' reported results prior to this acquisition, Specialty Oncology revenue grew 37% year over year and 5% sequentially, which was at the higher end of our previously estimated range of 30% to 40%. As John previously stated, we are increasing our investment in the Specialty Oncology commercial organization to expand our reach and frequency in this market.
檢測服務營收亦包含1,250萬美元的專科腫瘤營收。我們不會在收購前認列營收,但為了說明之用,若與本次收購前 Naveris 已揭露結果相比,專科腫瘤營收年增37%、季增5%,落在我們先前估計30%至40%區間的高端。如 John 先前所述,我們正提高對專科腫瘤商業團隊的投資,以擴大我們在此市場的覆蓋與拜訪頻率。
The next chart on the right illustrates the growth in our Patient and Digital business, which grew 31% year over year and 5% sequentially. And the last chart shows the revenue from our Lab Products business prior to the sale on June 30.
右側下一張圖表顯示我們病患與數位(Patient and Digital)業務的成長,年增31%、季增5%。最後一張圖表則顯示我們在6月30日出售前的實驗室產品業務營收。
Turning to slide 14, testing volume continued to ramp with third-quarter volume of 75,900 tests, up 51% year over year and 31% sequentially. Transplant volume of 50,750 (sic - see slide 14, "60,750") tests increased 21% year over year and 5% sequentially above our historic Q2 to Q3 trend.
接著看第14頁,檢測量持續攀升,第三季檢測量為75,900次,年增51%、季增31%。移植檢測量為50,750(原文如此——見第14頁「60,750」)次,年增21%、季增5%,高於我們歷史上第二季到第三季的趨勢。
Specialty Oncology volume was 15,150 tests in the third quarter. For illustrative purposes, compared to Naveris' reported results for Q3 2020 -- sorry, 2025, prior to the acquisition, Specialty Oncology volumes grew 35% compared to the prior year.
第三季專科腫瘤檢測量為15,150次。為了說明之用,若與收購前 Naveris 在2020年第三季——抱歉,2025年第三季——的已揭露結果相比,專科腫瘤檢測量較前一年成長35%。
Turning to slide 15, our revenue per test for Testing Services including Specialty Oncology revenue grew 9% year over year, driven by 22% year-over-year improvement in Transplant revenue per test. Excluding out-of-period revenue, revenue per test of $1,377 grew 4% year over year, including the dilution from Specialty Oncology this quarter, excluding Specialty Oncology, transplant revenue per test of $1,514 grew 15% year over year.
接著看第15頁,包含專科腫瘤營收在內的檢測服務每次檢測營收年增9%,主要由移植每次檢測營收年增22%所帶動。若排除跨期營收,每次檢測營收為1,377美元,年增4%;本季包含專科腫瘤帶來的稀釋效應。若排除專科腫瘤,移植每次檢測營收為1,514美元,年增15%。
In the prior quarter, transplant represented 100% of our test volume mix. With the acquisition of our Specialty Oncology business, our mix in the third quarter was 80% transplant and 20% Specialty Oncology. Specialty Oncology revenue per test of $823 was 6% higher than our prior forecast of $775 for this quarter.
在上一季,移植占我們檢測量組合的100%。隨著收購專科腫瘤業務,我們第三季的組合為80%移植、20%專科腫瘤。專科腫瘤每次檢測營收為823美元,較我們先前對本季的預測775美元高出6%。
Turning to the next slide, our non-GAAP gross margins for the third quarter were 74%, increasing from 71% in the prior-year quarter and sequentially in line with our second-quarter gross margins, driven by a cost discipline coupled with a 9% increase in revenue per test. The chart on the right illustrates a doubling of our adjusted EBITDA from $15 million in the prior-year quarter to $30 million this quarter and the 23% sequential increase from the second quarter.
接著看下一頁,我們第三季非 GAAP 毛利率為74%,高於去年同期的71%,且與第二季毛利率季比大致持平;主要受惠於成本紀律,以及每次檢測營收提升9%。右側圖表顯示我們調整後 EBITDA 由去年同期的1,500萬美元倍增至本季的3,000萬美元,並較第二季季增23%。
Turning the guidance on slide 17, we are increasing our 2026 full-year revenue guidance by $30 million to $520 million to $530 million or $525 million and 38% year-over-year growth at the midpoint of the range and our full-year adjusted EBITDA guidance by $23 million to $90 million to $100 million or $95 million at the midpoint of the range and 18% of revenue. Given there is one quarter left in 2026 on the right-hand side of slide 17, we included the Q4 2026 implied model used to derive the midpoint of the 2026 guide.
回到第 17 張投影片的指引,我們將 2026 全年營收指引上調 3,000 萬美元至 5.20 億至 5.30 億美元(區間中點為 5.25 億美元),以中點計算年增 38%;同時將全年調整後 EBITDA 指引上調 2,300 萬美元至 9,000 萬至 1.00 億美元(區間中點為 9,500 萬美元),約占營收的 18%。鑑於 2026 年只剩下一個季度(見第 17 張投影片右側),我們納入了用以推導 2026 年指引中點的 2026 年第四季隱含模型。
For those without the presentation in front of them, let me restate the key Q4 assumptions. Total revenue range of $131 million to $141 million or 25% year-over-year growth at the $136 million midpoint of the range. Testing Services revenue of $112 million to $122 million or 50% year-over-year growth at the $117 million midpoint of the range, including $8 million in out-of-period revenue and $18.7 million in Patient and Digital revenue.
對於手邊沒有簡報的各位,我再重申第四季的關鍵假設。總營收區間為 1.31 億至 1.41 億美元,或以區間中點 1.36 億美元計算年增 25%。檢測服務(Testing Services)營收為 1.12 億至 1.22 億美元,或以區間中點 1.17 億美元計算年增 50%,其中包含 800 萬美元的跨期(out-of-period)營收,以及 1,870 萬美元的病患與數位(Patient and Digital)營收。
Moving to test volumes, Q4 test volume of 76,000 to 80,000 tests or 47% year-over-year growth at the 78,000 midpoint of the range. And test volume includes transplant volume range of 61,000 to 63,000 tests or 17% year-over-year growth at the 62,000 test midpoint of the range and 15,000 to 17,000 Specialty Oncology tests.
接著看檢測量,第四季檢測量為 76,000 至 80,000 次,或以區間中點 78,000 次計算年增 47%。檢測量包含移植(Transplant)檢測量區間 61,000 至 63,000 次,或以區間中點 62,000 次計算年增 17%,以及 15,000 至 17,000 次的腫瘤專科(Specialty Oncology)檢測。
Moving to revenue per test for testing services. Our Q4 2026 model assumes revenue per test, including the combined mix of Transplant and Specialty Oncology of approximately $1,500, comprised of $1,400 of accrued revenue per test and approximately $100 in out-of-period revenue per test.
接著看檢測服務的每次檢測營收。我們的 2026 年第四季模型假設每次檢測營收(包含移植與腫瘤專科的合併組合)約為 1,500 美元,其中包括每次檢測 1,400 美元的應計(accrued)營收,以及每次檢測約 100 美元的跨期營收。
For Transplant, our model assumes revenue per test of approximately $1,680 comprised of $1,550 of accrued revenue per test and $130 of out-of-period revenue per test.
就移植而言,我們的模型假設每次檢測營收約為 1,680 美元,其中包括每次檢測 1,550 美元的應計營收,以及每次檢測 130 美元的跨期營收。
For Specialty Oncology, our model assumes $825 of revenue per test and no out-of-period revenue. Our model also assumes 71% to 72% non-GAAP gross margins and non-GAAP operating expenses of approximately $79 million, including depreciation of $3 million plus or minus $2 million.
就腫瘤專科而言,我們的模型假設每次檢測營收為 825 美元,且沒有跨期營收。我們的模型亦假設非 GAAP 毛利率為 71% 至 72%,以及非 GAAP 營運費用約 7,900 萬美元,其中包含折舊 300 萬美元(上下浮動 200 萬美元)。
Our Q4 2026 implied adjusted EBITDA range is $16 million to $26 million or $21 million at the midpoint of the range representing approximately 15% of revenue or 3 times our prior-year results. Slide 18 and 19 charts our prior and current full-year 2026 guidance compared to our 2025 results.
我們 2026 年第四季隱含的調整後 EBITDA 區間為 1,600 萬至 2,600 萬美元(區間中點為 2,100 萬美元),約占營收的 15%,或約為前一年結果的 3 倍。第 18 與第 19 張投影片呈現我們先前與目前的 2026 全年指引,並與 2025 年結果對照。
And with that, I'll turn the call back over to John.
接下來我把電話交回給 John。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Thank you, Keith. Our strategy is clear, and we are executing with discipline. This quarter, our transplant franchise delivered strong growth. We continued to scale Specialty Oncology and we advanced our pipeline toward planned commercial launches in 2027.
謝謝你,Keith。我們的策略很清楚,而且我們正以紀律執行。本季,我們的移植業務平台(transplant franchise)交出強勁成長。我們持續擴大腫瘤專科規模,並推進產品管線,朝 2027 年規劃的商業化上市邁進。
Across each market, that business progress translates into something much more meaningful, reaching and supporting more patients at important moments in their care.
在每個市場中,這些業務進展都轉化為更有意義的成果:在病患照護的重要時刻,觸及並支持更多病患。
As our testing volume grows, so does the number of patients and families we have the opportunity to serve with precision molecular information that can help inform care decisions and provide greater clarity.
隨著我們的檢測量成長,我們也有機會服務更多病患與家庭,提供精準的分子資訊,協助形成照護決策並帶來更高的清晰度。
I want to close by thanking the entire CareDx team. Your commitment to patients is what makes this progress possible. Every test represents a patient, a family, and an opportunity to make a difference. I am grateful for the work you do every day to expand our impact.
最後我想感謝整個 CareDx 團隊。你們對病患的承諾,讓這些進展成為可能。每一次檢測都代表一位病患、一個家庭,以及一個帶來改變的機會。我很感謝你們每天所做的工作,持續擴大我們的影響力。
Thank you. And I would now like to ask the operator to open the line for questions.
謝謝。接下來我想請接線員開放提問。
Operator
Operator
(Operator Instructions) Kyle Mikson, Canaccord Genuity.
(接線員指示) Canaccord Genuity 的 Kyle Mikson。
Kyle Mikson - Equity Analyst
Kyle Mikson - Equity Analyst
Hey, guys. Thanks for the questions. Great quarter. I guess, John, on the final LCD from August. Could you just elaborate on how physician behavior has changed or could change as well as any change to testing frequency and patient penetration that you're seeing so far? And then how does that translate into the observable kind of volume revenue going forward, like in 2027, if you want to comment on next year possibly. Thanks.
嗨,各位。謝謝讓我提問。這一季表現很棒。我想問一下,John,關於 8 月最終版 LCD。你能否多談談醫師行為已經如何改變、或可能如何改變,以及你目前看到的檢測頻率與病患滲透率是否有任何變化?另外,這會如何轉化為未來可觀察到的量與營收,例如 2027 年;如果你願意,也可以談談明年可能的情況。謝謝。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Hi, Kyle. Thanks so much for the question and for joining us. We said all along that the LCD was a payment policy and really would not impact utilization in the field. And so as you've seen, we've continued to grow volume year over year, quarter over quarter without any hiccup.
嗨,Kyle。非常感謝你的提問,也謝謝你加入我們。我們一直以來都說 LCD 是一項給付政策,基本上不會影響前線的使用量(utilization)。因此如你所見,我們的量持續年增、季增成長,沒有任何卡頓。
I think if anything, as I've said previously, this is just an overhang that's been removed from the business and we can get back to focusing on clinical differentiation and workflow optimization.
我認為若真要說有什麼影響,正如我先前提過的,這只是移除了壓在業務上的一個不確定因素(overhang),讓我們可以回到聚焦臨床差異化與工作流程最佳化。
Kyle Mikson - Equity Analyst
Kyle Mikson - Equity Analyst
All right, perfect. Then for you or for Keith, on the NavDx ASP, so $823 in the quarter. I think the guidance was $770 or high $700s and then 4Q and then $820 range as well. So maybe just talk about further ASP sort of upside for NavDx next year, or is it just like kind of a volume growth story going forward?
好,完美。那再請教你或 Keith,關於 NavDx 的 ASP,本季是 823 美元。我記得指引是 770 美元或 700 多美元的高段,然後第四季也是大約 820 的區間。所以能否談談明年 NavDx 的 ASP 是否還有進一步上行空間,或接下來主要就是量成長的故事?
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
No, thank you, Kyle. We put it on our billing system on October 1, as John covered in his prepared remarks, and we're really excited about that. We think there's opportunity there.
不,謝謝你,Kyle。我們在 10 月 1 日把它放到我們的計費系統上,如同 John 在事先準備的發言中提到的,我們對此非常興奮。我們認為那裡有機會。
We do believe that we will be able to see price appreciation up to $1,000 or higher over time. And so the Medicare price for that test is $1,800. And so as we develop evidence and continue to increase adoption across the market, we'll see a lift on that. We hope to talk more about that when we do our Q4 call for next year.
我們確實相信,隨著時間推進,我們能看到價格提升到 1,000 美元或更高。而該檢測的 Medicare 價格是 1,800 美元。因此,隨著我們建立證據並持續提升在市場上的採用率,我們將會看到 ASP 上升。我們希望在明年進行第四季電話會議時,再多談一些。
Operator
Operator
Mark Massaro, BTIG.
BTIG 的 Mark Massaro。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Hey, John and Keith, thanks for taking the questions. This looks like the strongest volume quarter you've had in four years. And so what I'm trying to understand, you talked about protocol adoption and increase in kidney and lung. I would be curious about any changes in heart or maybe did kidney and lung just outperform heart?
嗨,John 和 Keith,謝謝回答問題。這看起來是你們四年來最強的一個量的季度。所以我想了解的是,你們談到方案(protocol)採用,以及腎臟與肺部的增加。我很好奇心臟是否有任何變化,或是腎臟與肺部只是表現優於心臟?
But maybe at a higher level, the 21% growth in the quarter is really an inflection point higher. So would be curious if you could just expand a little bit more about the protocols, how many transplant centers are now on the protocols? How are you doing in for-cause? And has there been any lift in surveillance testing?
但從更高層次來看,本季 21% 的成長確實是一個更高的拐點。所以也想請你們多展開談談這些方案:目前有多少移植中心已採用這些方案?你們在因故(for-cause)檢測方面表現如何?而監測(surveillance)檢測是否有任何提升?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Mark, thanks so much for joining and for the question. Yeah, we had a really strong quarter. The team is firing on all cylinders in the field, both the sales and the medical affairs team in really building belief in the use of this testing, both in surveillance, which we have seen continued growth in the adoption of kidney surveillance protocols, lung surveillance protocols, heart surveillance protocols and in the use of the tests in other contexts of care.
Mark,非常感謝你加入,也謝謝你的問題。是的,我們這一季非常強勁。前線團隊火力全開,銷售與醫療事務團隊都在努力建立對這項檢測使用的信心;不論是在監測情境(我們看到腎臟監測方案、肺部監測方案、心臟監測方案的採用持續成長),或是在其他照護情境中使用這些檢測。
And so this quarter, consistent with prior quarters, kidney continued to grow well over 20% year over year. Lung also had a very strong quarter, and heart continues to grow in the mid-teens, and that has been consistent for us. And we think that that's going to continue because the adoption of this testing is growing into a real standard of care in clinical practice for transplantation patients.
因此,本季與前幾季一致,腎臟年增持續成長超過 20%。肺部本季也非常強勁,而心臟則持續以 10% 中段的幅度成長,這對我們而言一直都很一致。我們認為這將會延續,因為這項檢測的採用正在臨床實務中成長為移植病患真正的照護標準(standard of care)。
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
And then I might add to that, we have 17% year over year at the midpoint growth in volumes for testing, which we think is really strong. We had a great fourth quarter as you'll remember last year, so the comp is really great. And then obviously, this quarter is an amazing quarter. The sequential comp is also really great, but we feel very good about it.
接著我可能還要補充一點,我們在檢測量方面,以中位數來看年增成長為 17%,我們認為這非常強勁。如你所記得的,去年第四季表現非常好,所以比較基期其實很高。而且很明顯地,本季也是一個非常出色的季度。季對季的比較也非常亮眼,因此我們對此感到非常有信心。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Okay, that's really helpful. Is there a reason why lung is performing so strong? I can -- I recognize that it's relatively early days in terms of penetration. I think some investors misunderstood your market as mature, but it sounds to me like your -- this is not very mature. Maybe could you speak a little bit about how much room there is left and maybe penetration rates by segment or at least in lung would be helpful.
好的,這真的很有幫助。肺臟為什麼表現得這麼強,有什麼原因嗎?我可以——我理解就滲透率而言目前仍算相對早期。我想有些投資人誤以為你們的市場已經成熟,但聽起來你們——這其實並不算很成熟。也許你能談談還剩下多少成長空間,以及按細分領域的滲透率,或至少肺臟的滲透率,會很有幫助。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Yeah, I think you're right there, Mark, and we saw you noted that in a document. And I think you're spot on that we've got a lot of runway to go in all three segments.
是的,我想你說得沒錯,Mark,我們也看到你在一份文件中提到這點。而且我認為你判斷得非常準確:我們在三個細分領域都還有很長的跑道。
Lung in particular, as you know, is a really complex organ, because you have environmental exposure as people breathe. And so there's a risk of infection. And lung transplantation is, I hate to say it, but like the least efficacious of the three. The average survival of a lung transplant patient is only five years. And so they surveil these patients very closely to monitor for both immunological rejection and any environmental allergen that can cause the lung to go bad.
特別是肺臟,如你所知,是一個非常複雜的器官,因為人們呼吸時會有環境暴露。因此存在感染風險。而肺移植——我不太想這麼說——但在三者之中算是療效最不理想的。肺移植病患的平均存活期只有五年。因此他們會非常密切地監測這些病患,以同時監控免疫性排斥反應,以及任何可能導致肺功能惡化的環境過敏原。
And so we're actually seeing a higher test per patient in year one in lung than in any other organ where the test is adopted in the center. And so the ability to sell deep into lung transplant centers coupled with our digital solutions, including our product, AlloHome, which is a remote patient monitoring solution for lung transplant patients that comes with a remote spirometry service that monitors the force of breathing in the lung like once that starts to dip, it's a signal that that patient is having a problem and needs to come in and be visited by the doctor.
因此我們實際上看到,在採用我們檢測的中心中,肺臟在第一年每位病患的檢測次數高於任何其他器官。所以,能夠在肺移植中心深度銷售,再加上我們的數位解決方案(包括我們的產品 AlloHome),這是一套針對肺移植病患的遠端病患監測方案,並搭配遠端肺量計(spirometry)服務,用來監測肺部呼吸的用力程度;一旦數值開始下降,就代表該病患可能出現問題,需要回診由醫師評估。
So that solution together has been really well received in the field by clinicians. And thus, we're seeing very strong growth in lung transplantation along with the fact that it's the most recent product to reach the market and has the lowest base of volume. And I think we expect that that's going to grow faster than the other two organs for some time to come.
因此,這套解決方案在臨床端獲得非常好的回饋。也因此,我們看到肺移植領域的成長非常強勁;再加上它是最新上市的產品,基礎量也最低。我想我們預期在接下來一段時間內,它的成長速度會快於另外兩個器官。
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
And Mark, I guess I would -- we talked historically about our mix and the analyst often asked us about the mix, and we've obviously seen very, very strong growth in lung and kidney, and heart has just been a solid performer. Obviously, it's been around on the market a lot longer.
另外 Mark,我想我會——我們過去談過我們的組合(mix),分析師也常問我們組合的問題;我們顯然看到肺臟與腎臟成長非常、非常強勁,而心臟一直是穩健的表現者。很明顯地,心臟產品在市場上已經存在更久。
Our mix currently is around 45% kidney, 45% heart, and 10% lung as people think through the mix of the organs.
我們目前的組合大約是:腎臟 45%、心臟 45%、肺臟 10%,供大家思考器官組合的分布。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Okay, that is really helpful. And if I can sneak one more in. Keith, your billing and collections team is doing a fantastic job. You continue to drive out performance there, recognizing that you're guiding for $8 million in Q4 for prior period collections. I'm not asking for '27 guidance, but is it fair to say that there are some additional claims to pursue in 2027?
好的,這真的很有幫助。如果我可以再偷偷問一個問題。Keith,你們的帳單與收款團隊做得非常出色。你們持續提升那邊的表現,也理解你們指引第四季前期期間(prior period)收款為 800 萬美元。我不是在問 2027 年的指引,但可以說 2027 年還有一些額外的理賠案件(claims)可以去追討嗎?
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Yeah, we do anticipate that going forward, we will have out-of-period revenue. What we've said historically is that we'd like to see where our accrual rates and everything merges to we end up around 2% of revenue is out-of-period quarterly. And so that's where I'm trying to land the aircraft. But this is just -- it's one of those kinds of things. Our performance is going great.
是的,我們確實預期未來仍會有跨期收入(out-of-period revenue)。我們過去的說法是,我們希望觀察我們的應計比率等最終會收斂到哪裡,目標是每季跨期金額約占營收的 2%。所以我想把飛機降落在那個位置。但這就是——這類事情之一。我們的表現進展得非常好。
Revenue cycle management is going great. This is a game where you're You just have to do 100 things every day, every test, and the payers just don't want to pay. So you're always constantly rewarded if you do it well, they'll use it against you if you don't. So we spent a lot of time making sure that we have the processes in place to make sure we have the right to win in all these cases. So we continue to work on it, and it's going well.
營收循環管理(revenue cycle management)做得很順。這是一場遊戲:你每天、每一個檢測都得把 100 件事做好,而付款方就是不想付錢。所以如果你做得好,會不斷得到回報;如果你做不好,他們就會拿來對付你。因此我們花很多時間確保流程到位,確保在所有這些案件中我們具備勝出的條件。所以我們會持續推進,進展也很順利。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Excellent. Congrats on the great quarter, guys.
太棒了。恭喜各位這麼出色的一季。
Operator
Operator
Tycho Peterson, Jefferies.
Tycho Peterson,Jefferies。
Unidentified Participant
Unidentified Participant
Hey, team. This is Noah on for Tycho. Congrats on the quarter. To start, I just wanted to discuss EBITDA and the margins a little bit. It looks like you had quite a step up in EBITDA margin, even on a sequential basis, and some leverage coming in on sales and marketing. So just wondering if there's any particular you can highlight that's driving that improvement there.
嗨,團隊好。我是 Noah,代 Tycho 發問。恭喜這一季的表現。首先,我想稍微討論一下 EBITDA 和利潤率。看起來你們的 EBITDA 利潤率大幅提升,即使以季對季來看也是如此,而且銷售與行銷費用也出現一些槓桿效益。想請問是否有任何特別因素可以指出,是什麼在推動這項改善?
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Well, as you see, our OpEx has dated around $75 million from Q2 to Q3, and we had about $1.5 million of spend in Q3 related to the transaction. And sometimes, they make us take things into operating expenses, even though it's transaction related. We will likely have up to about $1 million, $1.5 million of that over the next 1.5, 2 years, but it's declining at a rapid rate.
如你所見,我們的營業費用(OpEx)從第二季到第三季大致維持在約 7,500 萬美元,而第三季有約 150 萬美元的支出與該交易(transaction)相關。有時候,即便是交易相關,他們仍要求我們把某些項目列入營業費用。未來 1.5 到 2 年內,我們可能還會有最多約 100 萬到 150 萬美元的這類支出,但它正在快速下降。
But we feel like that expense control as margins went up, our expense control, the increase on the revenue cycle management is falling 100% down to investors. And as you'll see in our SEC filings, which may already be released, we have positive net income all three quarters this year. And we had positive net income in the third quarter of last year. And we're generating significant cash-off and operations. We're obviously disciplined. We think of ourselves as owners of the business and we're in here making sure we're being good stewards of your capital and our capital.
但我們認為,隨著毛利率上升,我們的費用控管——以及營收循環管理改善所帶來的增益——正 100% 反映到投資人身上。而且如你在我們的 SEC 申報文件中所見(可能已經發布),我們今年前三季都呈現淨利為正。去年第三季我們也有正的淨利。我們也正在產生顯著的營運現金流。我們顯然很自律。我們把自己視為企業的所有者,並在這裡確保我們善盡受託責任,妥善管理你們的資本與我們的資本。
Unidentified Participant
Unidentified Participant
Got it. And then maybe just one more on transplant ASPs. Obviously, quite a step up on a year-over-year basis. I know true ups are playing a part there. I'm curious how you're thinking about the longer-term runway, you how much ASP appreciation is left in a maturity state and what can you do in maybe the next couple of months, couple of quarters in the blocking and tackling to improve ASPs? Thanks.
了解。另外再問一個關於移植業務 ASP(平均售價)的問題。很明顯地,年對年有相當大的提升。我知道追溯調整(true ups)在其中扮演了一部分角色。我想了解你們如何看待較長期的成長跑道:在成熟狀態下,ASP 還剩多少上升空間?以及在接下來幾個月、幾個季度,你們在一些基本功(blocking and tackling)上可以做哪些事來提升 ASP?謝謝。
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Keith Kennedy - Chief Operating Officer, Chief Financial Officer
Thank you. And we will come out, obviously, in Q4 and give you thoughts around next year. But we do have internal, you know, we said we got here, we had a three-year target of $2,000 per test. We're at $1,550 in Q4, and we still have the team rolling on getting to $2,000 per test. And so we're really working on that. Again, let me differentiate when I say that, that is for solid organ transplant.
謝謝。我們當然會在第四季對明年提供一些看法。但我們內部確實——你知道,我們曾說過我們設定了一個三年目標:每次檢測 2,000 美元。我們在第四季是 1,550 美元,而團隊仍在持續推進,朝每次檢測 2,000 美元邁進。所以我們正在非常努力地做這件事。再次說明一下,我所指的是實體器官移植(solid organ transplant)。
And on the Naveris, we thought that originally coming out of the gate was going to be like $775 a test came in the low $800s. And we thought it was really important to put that on our billing system and leverage the workflows that we have in place, so we have the right to win there. So we do think that's an upward positive story and tailwind. We're just not prepared to (inaudible) at this point.
至於 Naveris,我們原先認為一開始推出時每次檢測大概會是 775 美元,但實際落在 800 多美元的低段。我們認為把它納入我們的計費系統、並運用我們既有的工作流程非常重要,如此一來我們在那裡就具備勝出的條件。所以我們確實認為這是一個向上、正面的故事與順風。只是目前我們還沒準備好(聽不清)到這個程度。
You have another question Noah?
Noah,你還有另一個問題嗎?
Operator
Operator
Bill Bonello, Craig-Hallum.
Craig-Hallum 的 Bill Bonello。
Bill Bonello - Analyst
Bill Bonello - Analyst
Hey, guys. Thanks a lot for taking my questions. I just wanted to circle back on the transplant volume. It just seems to me like measuring against a target protocol is maybe no longer the best way to think about where volume could go. I mean, I would imagine your team is more out promoting the expansion of use cases across the entire continuum than trying to get people to necessarily say, hey, we'll get as many people as possible to test six times a year. Is that kind of fair and is there as much for-cause opportunity because of the expanded testing reasons as there is surveillance opportunity.
嗨,各位。非常感謝讓我提問。我想再回到移植量的問題。在我看來,用目標化的 protocol 來衡量,可能已經不再是思考量能上升空間的最佳方式。我的意思是,我想你們團隊現在更是在推動整個照護連續體中使用情境的擴張,而不是一定要讓大家說:嘿,我們要讓盡可能多的人一年檢測六次。這樣理解是否合理?另外,因為檢測理由擴大,for-cause(因症/因事件)機會是否和 surveillance(例行監測)機會一樣大?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
That's a great question, Bill. I think that it's both. There are centers today in the United States that don't use molecular testing at all, surprisingly. And there are centers today that use it only in the for-cause setting and have no surveillance program. And we continue to try to build belief at those centers that this should be a part of their standard of care for transplantation patients.
這是個很好的問題,Bill。我認為兩者都有。目前美國有些中心竟然完全不使用分子檢測。也有一些中心只在 for-cause 的情境使用,完全沒有 surveillance 計畫。我們持續在這些中心建立共識:這應該成為移植病人的標準照護(standard of care)之一。
Certainly, I believe that the for-cause indication is large. We have talked about expanding that context of use, including looking at therapeutic efficacy in the setting of rejection, transitioning patients from dual therapy to monotherapy in the setting of immune suppression, the weaning of immune suppression, and then also supporting the management of patients that have delayed graft functions and trying to reduce biopsies in that setting.
我確實相信 for-cause 的適應症規模很大。我們也談過擴大其使用情境,包括:在排斥反應情境下評估治療效果、在免疫抑制治療情境下將病人從雙藥治療轉為單藥治療、免疫抑制的減量(weaning),以及支持延遲移植物功能(delayed graft function)病人的管理,並在該情境下嘗試減少切片(biopsy)。
So there's a lot of use cases for for-cause, but not every patient has rejection. There are a lot of patients that get a nice living donor organ and are at low risk for immunological rejection. So certainly, it's a large opportunity, continue to pursue, and we continue each of these use cases. And we think that -- this gives us a lot of room in each of our clinical indications in transplantation to continue to grow.
所以 for-cause 有很多使用案例,但不是每位病人都會發生排斥反應。有很多病人接受了很好的活體捐贈器官,免疫學排斥風險較低。因此這當然是一個很大的機會,我們會持續推進,也會持續拓展這些使用案例。我們認為——這讓我們在移植領域各項臨床適應症上都有很大的成長空間。
Bill Bonello - Analyst
Bill Bonello - Analyst
Okay, that's very helpful. And then just on AlloHeme, can you just tell us sort of the plan for pursuing coverage there and what some of the critical milestones we should be looking at or waiting for?
好的,這很有幫助。另外關於 AlloHeme,你們能否談談在那邊推動給付(coverage)的計畫,以及我們應該關注或等待哪些關鍵里程碑?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Absolutely. And thanks for the questions, Bill. First and foremost is publication of the clinical validation study, the ACROBAT trial. And as I shared in my prepared remarks, the steering committee, the PIs around the country that led that trial have drafted a manuscript and submitted that for peer review publication. So that's number one.
當然可以。也謝謝你的提問,Bill。第一也是最重要的是臨床驗證研究 ACROBAT 試驗的論文發表。如同我在事先準備的發言中提到的,該試驗的指導委員會以及全國各地帶領試驗的主要研究者(PI)已完成論文草稿並提交同儕審查發表。這是第一點。
Number two, as you know, the submission of your tech assessment data for coverage largely parallels the data that you need to generate for New York State Department of Health approval, like all of the guard band studies, the analytical verification studies, the reproducibility study. And so we continue to be on track to complete that CLIA readiness work in 2026, such that we are prepared in 2027 to submit that analytical verification data along with the clinical validation data for coverage.
第二,如你所知,為了取得給付而提交技術評估(tech assessment)資料,基本上與你為取得紐約州衛生部核准所需產出的資料是並行的,例如所有 guard band 研究、分析驗證(analytical verification)研究、再現性(reproducibility)研究。因此我們仍按計畫在 2026 年完成 CLIA 就緒(readiness)工作,讓我們在 2027 年能夠把分析驗證資料連同臨床驗證資料一起提交以爭取給付。
And when we had our investor call in February, we said that we would anticipate that coverage materializing likely in '28 and that the product delivering significant revenues in 2029.
而在我們 2 月的投資人電話會議上,我們也提到預期給付大概率會在 2028 年落地,並且產品在 2029 年帶來顯著營收。
Bill Bonello - Analyst
Bill Bonello - Analyst
Excellent. That's very helpful. Thank you.
太好了。這非常有幫助。謝謝。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Thank you.
謝謝。
Operator
Operator
Mason Carrico, Stephens, Inc.
Stephens, Inc. 的 Mason Carrico。
Mason Carrico - Equity Analyst
Mason Carrico - Equity Analyst
Hey, guys. I will just ask my two up front here. So on AlloHeme, recognizing it's early, I guess, how are you guys thinking about the volume ramp after you launched? Do you plan on gating volumes at all ahead of Medicare coverage?
嗨,各位。我先把兩個問題一起問。關於 AlloHeme,雖然還很早,但你們如何看待上市後的量能爬坡(volume ramp)?在取得 Medicare 給付之前,你們會在量能上做任何限制(gate volumes)嗎?
And then I guess as my follow-up there, on the workflow, will AlloHeme be orderable through Epic Aura at launch at centers where that's already live or does that integration come later?
接著我的追問是,關於工作流程(workflow),AlloHeme 在上市時,對於已經上線 Epic Aura 的中心,是否能直接透過 Epic Aura 下單?還是要等之後才會完成整合?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Yeah, thanks, Mason. Those are great questions. I don't think we're going to gate volume because for me, I believe this product will be a standard of care and is going to significantly change the way AML and MDS patients are monitored. And so this mark in a concerted way focusing on the top-tier KOL centers first and being fully integrated and getting the test adopted on protocol there. And that's what we're going to focus on next year with a limited team doing that, Mason.
是的,謝謝你,Mason。這些都是很好的問題。我不認為我們會限制量能,因為我相信這個產品會成為標準照護,並且會大幅改變 AML 與 MDS 病人的監測方式。因此我們會以有計畫、集中的方式,先聚焦在頂尖的 KOL 中心,並完成整合,讓檢測在那裡依照 protocol 被採用。這就是我們明年要專注的重點,Mason,我們會用一個精簡的團隊來做。
We're not going to hire a hundred people to do this. We'll have a limited team in the field focused and targeted on those top stem cell transplant centers, bone marrow centers.
我們不會為此招募一百個人。我們會有一個規模有限的前線團隊,聚焦並鎖定那些頂尖的幹細胞移植中心、骨髓中心。
And then as it relates to Epic, I love this question because this will be a product that we launch native on Epic Aura. So 100% of the ordering should go through EMR integration on day 1. And I am very excited to see what that ramp looks like because this is the first test that I'm aware of that I've ever launched that will be native on that platform. And so we're very excited about that.
至於 Epic,我很喜歡這個問題,因為這會是一個在 Epic Aura 平台上以原生(native)方式上線的產品。因此在第一天,100% 的下單都應該會透過 EMR 整合來完成。我非常期待看到那個爬坡曲線會是什麼樣子,因為就我所知,這是我推出過的第一個能在該平台上原生上線的檢測。所以我們對此非常興奮。
Mason Carrico - Equity Analyst
Mason Carrico - Equity Analyst
Got it. Thank you. I'll leave it at that.
了解。謝謝。我就先到這裡。
Operator
Operator
Matt Larew, William Blair.
William Blair 的 Matt Larew。
Matt Larew - Analyst
Matt Larew - Analyst
Yeah, good afternoon, and thanks for the question. I'm sort of going to piggyback on that one and John, you alluded to a focus team around AlloHeme at launch, in your initial prepared remarks, you described both HistoMap and AlloHeme sort of starting to build support activities and commercial infrastructure throughout 2027. Could you describe a little bit more what that will look like and how much you can just sort of leverage from the existing team versus people and other related resources that you're going to be layering on throughout the year?
是的,午安,謝謝讓我提問。我想延續剛才那題。John,你提到 AlloHeme 上市時會有一個聚焦型團隊;而在你一開始的事先準備發言中,你描述 HistoMap 與 AlloHeme 都會在 2027 年逐步建立支援活動與商業化基礎設施。你能否更具體說明那會是什麼樣子?以及你們能在多大程度上沿用既有團隊,相對於在一年中逐步增補的人力與其他相關資源?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Yeah, thanks for the question, Matt. HistoMap is a product that extends our solution for kidney transplantation. And so HistoMap is utilized on a tissue biopsy, presumably in a patient that has an elevated AlloSure score, and then goes on for a biopsy procedure.
好的,謝謝你的問題,Matt。HistoMap 是一個延伸我們腎臟移植解決方案的產品。因此 HistoMap 是用在組織切片上,通常是在病人的 AlloSure 分數升高後,接著進行切片檢查時使用。
And so our field team that markets and sells and does medical education around AlloSure Kidney today will all be the same team that promotes HistoMap Kidney. So no added resource there, really just adding another product to the bag to complete and round off our solution in kidney transplant management.
因此,我們目前在前線負責 AlloSure Kidney 的行銷、銷售與醫學教育的團隊,也會是同一個團隊來推廣 HistoMap Kidney。所以基本上不需要新增資源,只是把另一個產品加入產品組合,讓我們在腎移植管理的解決方案更完整、更到位。
That product, as I've said before, addresses not a huge market. I would say somewhere in the range of 2,500 to 5,000 kidney biopsies a year. And we will likely target a Medicare reimbursement for that product somewhere in the ballpark of $3,000 a test, which is consistent with other tissue-based gene expression molecular tests that are on market today.
如我之前所說,這個產品所面對的市場並不算大。我會說大約每年 2,500 到 5,000 例腎臟切片。我們很可能會把該產品的 Medicare 給付目標訂在每次檢測約 3,000 美元左右,這也與目前市面上其他以組織為基礎的基因表現分子檢測的水準一致。
In the AlloHeme setting, as I shared, that's really a new call point for us. This is for bone marrow transplant centers that are patients that have AML and MDS that are managed by a HemOnc. And we will have a very targeted team focused on that to begin with -- to start the journey of introduction of AlloHeme into the top centers that really drive standard of care, influence among other clinicians and guideline adoption.
在 AlloHeme 的情境下,如我先前分享的,這對我們而言確實是一個全新的切入點。這是針對骨髓移植中心,那些罹患 AML 與 MDS、並由血液腫瘤科(HemOnc)管理的病患。而我們一開始會有一支非常聚焦的團隊專注於此——啟動將 AlloHeme 導入真正引領照護標準、在其他臨床醫師間具影響力並推動指南採納的頂尖中心之旅。
Matt Larew - Analyst
Matt Larew - Analyst
Okay, that's great. Thank you. The second is on Naveris. Again, you highlighted up front some of the evidence that you started to generate there. As you think about expanding into other contexts of use, again, you talked through some of the Phase II studies today, what's 2027 going to look like in terms of further evidence generation, and what's maybe the timeline or key sort of flags in the ground as you work towards coverage and commercial launch?
好的,太好了。謝謝。第二個問題是關於 Naveris。同樣地,你一開始就強調了你們已開始在那裡產出的一些證據。當你們思考擴展到其他使用情境時——你們今天也談到一些第二期研究——就進一步的證據產出而言,2027 年會是什麼樣子?以及在你們朝向給付涵蓋與商業化上市推進時,時間表或關鍵里程碑大概會是什麼?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Right. So NavDx is commercially available. It's being utilized broadly in the head and neck cancer space. And there are a large number of ongoing clinical studies that we are supporting across the country to continue to generate the evidence to demonstrate the utility of NavDx, both in the surveillance setting and then in other contexts of use like treatment decision making such as radiation de-escalation as I outlined in my prepared remarks.
是的。所以 NavDx 已經商業化上市。它在頭頸癌領域被廣泛使用。而我們也在全國支持大量正在進行的臨床研究,持續產出證據以證明 NavDx 的效用——不論是在監測(surveillance)情境,或是在其他使用情境,例如我在事先準備的發言中提到的、用於治療決策(如放射治療降階)。
I think that this indication of radiation de-escalation is really interesting because it's really a difficult clinical decision to make. The morbidity of radiation is significant for patients.
我認為放射治療降階這個適應情境非常有意思,因為這確實是一個很難做的臨床決策。放射治療對病患造成的罹病負擔(morbidity)相當顯著。
I had one clinician at the ASTRO meeting that I attended tell me that the radiation de-escalation study that he is running at his center is the number one accruing trial in the entire medical center across every indication that that oncology center treats because patients want less radiation. It is significantly affecting their daily life.
我在參加 ASTRO 會議時,有一位臨床醫師告訴我,他們中心正在進行的放射治療降階研究,是整個醫學中心、跨所有適應症中收案(accruing)排名第一的試驗,因為病患希望接受更少的放射治療。這對他們的日常生活造成了非常大的影響。
And so, while it's not a lot of testing, you would only test each patient once. The way I think about this is that if you're using NavDx early in their care journey, your (inaudible) for patient with NavDx throughout their care journey in surveillance post-definitive treatment. And so it's a catalyst for us to drive more surveillance utilization and more tests per patient with NavDx.
因此,雖然檢測量不大——每位病患只需要檢測一次。但我的看法是,如果你在他們照護旅程的早期就使用 NavDx,你(聽不清)就能在他們完成根治性治療後的監測階段,於整個照護旅程中持續使用 NavDx 追蹤該病患。因此,這會成為我們推動更多監測端使用、並提升每位病患使用 NavDx 檢測次數的催化劑。
Now, both of these trials were Phase II trials. And so they're not definitive Phase III CTs, but I think the interest in this particular context of use so high in the clinical community that we will likely start to see in 2027 more clinicians utilizing NavDx to determine the extent of radiation in their patients.
另外,這兩項試驗都是第二期試驗。因此它們不是具決定性的第三期臨床試驗(CTs),但我認為臨床社群對這個特定使用情境的興趣非常高,因此我們很可能在 2027 年開始看到更多臨床醫師使用 NavDx 來決定病患放射治療的強度/範圍。
Matt Larew - Analyst
Matt Larew - Analyst
Okay. That's great. Thank you.
好的。太好了。謝謝。
Operator
Operator
(Operator Instructions) Yi Chen, H.C. Wainwright.
(接線生指示)易晨,H.C. Wainwright。
Unidentified Participant
Unidentified Participant
This is (inaudible) on for Yi. A quick one for you guys. Could you go through bridging the revenue guidance increase between transplant volume, current period reimbursement in the NavDx and kind of the prior period collections? Trying to figure out for 2027 modeling what current revenue per test assumptions we should carry forward and how we should think about the remaining pools.
我是(聽不清),代替易提問。快速問一題。你們能否說明一下,營收指引上調在移植量、NavDx 當期給付(reimbursement),以及某種程度上前期回收款(collections)之間,是如何銜接/橋接的?我想釐清在做 2027 年模型時,我們應該沿用哪些「每次檢測的當期營收」假設,以及該如何看待剩餘的資金池(remaining pools)。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Yeah, thanks for the question. We're not providing 2027 guidance today, but what I would point you to is previously in -- when we provided a three-year long range plan, we said that we would grow our solid organ transplant business by 15% year over year.
好的,謝謝你的問題。我們今天不提供 2027 年指引,但我想提醒你的是,先前——在我們提供三年期長程計畫時——我們曾表示,實體器官移植業務將以每年 15% 的年增率成長。
And so I think using that as the basis for '27 and then in NavDx we said at the time of the acquisition that we would grow that business 30% to 40% for the next two years, so through 2027 as well.
因此,我認為你可以把這個作為 2027 年的基礎;而在 NavDx 方面,我們在收購時也提到,未來兩年該業務將成長 30% 到 40%,也就是同樣延伸到 2027 年。
And I think for your modeling purposes, you can just use the Q4 ASP guidance for each product and hold that steady through 2027.
我想就你的建模目的而言,你可以直接採用第四季的各產品 ASP 指引,並在 2027 年前都維持不變。
Unidentified Participant
Unidentified Participant
Thank you very much.
非常感謝。
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Thank you for joining the call.
感謝各位加入本次電話會議。
Operator
Operator
Kyle Mikson, Canaccord Genuity.
Kyle Mikson,Canaccord Genuity。
Kyle Mikson - Equity Analyst
Kyle Mikson - Equity Analyst
Yeah, thanks. Just had a quick follow-up. Just one question. As these frontier labs and pharma kind of need more data to train these AI models, thinking about expanding outside oncology, just giving your guys role in transplant and then maybe partnerships like with 10x for the ImmuneScape, how could CareDx sort of have a role in that over time and what could that do for sort of the company outside of just traditional testing?
是的,謝謝。我有個簡短的追問。就一個問題。隨著這些前沿實驗室與藥廠需要更多資料來訓練這些 AI 模型,並思考擴展到腫瘤學以外的領域——考量你們在移植領域的角色,以及可能像與 10x 在 ImmuneScape 上的合作——CareDx 長期而言可能如何在其中扮演角色?而這對公司在傳統檢測之外,可能帶來什麼影響?
John Hanna - President, Chief Executive Officer, Director
John Hanna - President, Chief Executive Officer, Director
Yeah, thanks for the question, Kyle. We certainly have an extensive database in solid organ transplant, including molecular information on the tests that we performed. We have data on utilization from the EMR and software tools that we provide to our customers, and we have established a platform that we call VANTx that today, allows our medical team to support clinicians in the field in understanding utilization trends and running models on that data to predict what's going to happen with both cohorts and individual patients that those clinicians manage. And we continue to invest in that data platform, and we have a series of models within that platform that are both locked statistical models and then open learning models that we make accessible to those clinicians.
好的,謝謝你的問題,Kyle。我們在實體器官移植領域確實擁有龐大的資料庫,其中包含我們所執行檢測的分子層級資訊。我們也有來自 EMR 與我們提供給客戶之軟體工具的使用(utilization)資料;此外,我們建立了一個我們稱為 VANTx 的平台,目前可讓我們的醫療團隊在第一線協助臨床醫師理解使用趨勢,並在該資料上運行模型,以預測這些臨床醫師所管理之病患群體(cohorts)與個別病患的後續走向。我們也持續投資這個資料平台;平台內有一系列模型,包括封閉式的統計模型,以及我們提供給臨床醫師使用的開放式學習模型。
We're starting today to really chart our strategy in a Specialty Oncology on how we're going to utilize the data we're generating from HPV-driven cancers in a similar way and in a platform similar to VANTx or in the same platform.
我們目前也正開始在專科腫瘤(Specialty Oncology)領域規劃策略,思考要如何以類似方式運用我們在 HPV 驅動癌症所產生的資料——在一個類似 VANTx 的平台上,或是在同一個平台中。
And so I'd ask, just hold that question for some time in early '27, and we'll come back to you on that one. But thanks for the question, Kyle.
因此我想請你先把這個問題保留到 27 年初的一段時間後,我們會再回來跟你更新。不過仍謝謝你的提問,Kyle。
Operator
Operator
There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.
目前沒有其他問題。今天的電話會議到此結束。感謝各位出席。各位現在可以掛線。