NOverview
Naveris develops and sells molecular diagnostic tests, including NavDx, a blood test that detects HPV-associated cancers (such as head and neck cancers) at an early stage, using blood and saliva samples for the detection of viral DNA/RNA linked to cancer. Its products are used by healthcare providers to aid early cancer detection and guide clinical management, and the company also pursues drug development and clinical trials as potential future revenue streams. Unlike some competitors that focus only on generic cancer screening, Naveris centers its offering on viral-associated cancers and leverages a noninvasive blood-based assay to identify cancer signal early, supporting oncologists and surgeons in decision-making. The company aims to transform cancer detection, drug development, and clinical trials by applying its diagnostic technology to improve patient outcomes and accelerate development pipelines.
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About Naveris
Industries
Company Size
51-200
Company Stage
Acquired
Total Funding
$69.9M
Headquarters
Waltham, MA
Founded
2017
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Simplify's take
What believers are saying
- CareDx said Specialty Oncology revenue reached $12.5 million in Q3 2026.
- NavDx volume grew 35% year over year in Q3 2026.
- Medicare pricing at $1,800 and expanded studies support reimbursement and adoption.
What critics are saying
- CareDx now owns Naveris; standalone control vanished after July 1, 2026.
- Epic Aura rollout and billing migration create integration risk through 2027.
- If future studies weaken MRD utility, NavDx loses pricing power and relevance.
What makes Naveris unique
- NavDx is the only Medicare-covered HPV-driven head and neck MRD assay.
- TTMV-HPV DNA detects recurrence earlier than scans; CareDx cited 332-patient evidence.
- July 2026 CareDx acquisition proves NavDx became strategic specialty oncology infrastructure.
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Funding
Total Funding
$69.9M
Above
Industry Average
Funded Over
4 Rounds
Benefits
- Remote Work Options
Growth & Insights and Company News
6 month growth
11%1 year growth
12%2 year growth
12%What CareDx (CDNA) said on its Q3 earnings call. CareDx (NASDAQ:CDNA) reported third-quarter 2026 revenue growth of 39% as testing volumes increased, driven by its transplant business and the addition of Specialty Oncology testing following the July acquisition of Naveris. Revenue for the quarter ended Sept. 30 was $139 million, up 39% from a year earlier and 6% sequentially. Testing-services revenue rose 65% year over year to $119 million and represented 86% of total revenue. The company reported 75,900 tests completed during the quarter, a 51% increase from the prior-year period. Adjusted EBITDA doubled year over year to $30 million, or 22% of revenue, from $15 million. Non-GAAP gross margin improved to 74% from 71%. CareDx ended the quarter with $250 million in cash and cash equivalents and no debt, while generating $13 million in operating cash flow. Transplant testing drives growth. Transplant testing volume totaled 50,750 tests, rising 21% year over year and 5% sequentially. Chief Executive Officer John Hanna said growth reflected clinical evidence, field execution, protocol adoption and workflow integration. "Kidney continued to grow well over 20% year over year," Hanna said during the company's earnings call. "Lung also had a very strong quarter, and heart continues to grow in the mid-teens." CareDx said its transplant revenue per test, excluding Specialty Oncology, was $1,514 in the third quarter, up 15% from a year earlier. The company's reported testing-services revenue included $15 million of out-of-period revenue, compared with $6 million in the prior-year quarter. Excluding out-of-period revenue, transplant revenue increased 39% year over year and 9% sequentially, according to the company. Hanna said the company continues to see opportunity both in surveillance testing and in testing used for clinical situations requiring additional assessment. He cited potential use cases including treatment monitoring following rejection, immunosuppression management, delayed graft function and reducing biopsies. CareDx said it has 21 transplant centers live on Epic Aura, an electronic medical record integration. The company expects half of transplant orders to flow through EMR integrations by year-end. The company also launched a patient website and portal during the quarter. More than 5,000 patients had registered for the portal as of the earnings call, according to Hanna. Specialty Oncology integration continues. Specialty Oncology revenue, which includes NavDx testing for HPV-driven cancers, was $12.5 million during the quarter. For comparison with Naveris' reported results before the acquisition, CareDx said Specialty Oncology revenue grew 37% year over year and 5% sequentially. Specialty Oncology test volume was 15,150 tests, representing 35% growth from Naveris' reported volume in the third quarter of 2025. Specialty Oncology revenue per test was $823, above the company's prior forecast of $775. Chief Operating Officer and Chief Financial Officer Keith Kennedy said CareDx moved NavDx onto its billing platform on Oct. 1 and brought revenue-cycle-management workflows in house. Kennedy said management believes NavDx pricing could rise over time as the company develops evidence and expands adoption. He said the Medicare price for the test is $1,800, while adding that the company expects to discuss its outlook further on its fourth-quarter call. CareDx is expanding its field team and medical presence for NavDx, enabling electronic orders through its Care portal and integrating NavDx ordering into Epic Aura. The company expects Epic-based ordering to begin by Jan. 1, 2027. Hanna also discussed research evaluating NavDx in radiation de-escalation for HPV-driven head and neck cancer. He said two independent phase II studies presented at the American Society for Radiation Oncology meeting evaluated use of the test in post-surgical radiation and during primary radiation treatment. He cautioned that longer follow-up and additional evidence will be important. Pipeline programs target 2027 launches. CareDx said its two organic pipeline programs remain on track. AlloHeme, a recurrence-monitoring test for patients receiving cell therapy for acute myeloid leukemia and myelodysplastic syndromes, is expected to complete CLIA readiness activities before year-end, supporting a planned first-quarter 2027 commercial launch. The company said an initial manuscript from the ACROBAT clinical-validation trial has been submitted for peer review. Hanna said results presented earlier this year showed that AlloHeme identified molecular relapse a median of 41 days before clinical diagnosis. Hanna said CareDx plans a targeted commercial launch for AlloHeme, initially focusing on leading stem-cell and bone-marrow transplant centers rather than building a large sales organization. He said the test is expected to be launched with native Epic Aura ordering capability. CareDx also expects to complete CLIA readiness activities for HistoMap Kidney before year-end, with broader commercial availability planned for 2027. HistoMap is designed to provide molecular information from kidney-biopsy tissue and complement AlloSure Kidney blood-based monitoring. The company cited an independent study published in Transplantation that evaluated patients with microvascular inflammation. According to Hanna, 50% of patients classified by HistoMap as high risk experienced graft loss over up to six years of follow-up, compared with 15% of patients classified as low risk. Guidance raised. CareDx raised its full-year 2026 revenue outlook by $30 million to a range of $520 million to $530 million. At the midpoint, the guidance implies $525 million in revenue and 38% year-over-year growth. The company increased full-year adjusted EBITDA guidance by $23 million to $90 million to $100 million. The midpoint of $95 million would represent 18% of revenue. For the fourth quarter, CareDx's implied guidance calls for total revenue of $131 million to $141 million and testing-services revenue of $112 million to $122 million. The company expects total testing volume of 76,000 to 80,000 tests, including 61,000 to 63,000 transplant tests and 15,000 to 17,000 Specialty Oncology tests. Kennedy said CareDx expects fourth-quarter non-GAAP gross margin of 71% to 72% and adjusted EBITDA of $16 million to $26 million. About CareDx (NASDAQ:CDNA). CareDx, Inc is a healthcare diagnostics company focused on improving the care of organ-transplant patients. The company develops and commercializes noninvasive tests and digital tools intended to help physicians assess transplant-organ health, identify potential rejection, and support long-term patient management. Its offerings include AlloSure donor-derived cell-free DNA tests for monitoring transplant recipients, AlloMap gene-expression testing for heart-transplant patients, and HeartCare, which combines AlloMap and AlloSure results.
CareDx acquires liquid biopsy firm Naveris for up to $260M. The deal comes on the heels of CareDx divesting its Lab Products business to EuroBio Scientific for $170 million. Omar Ford, Editor-in-Chief, MD+DI, Informa Markets - Engineering May 4, 2026 CareDx is diving deeper into the oncology space with the acquisition, nearly a month after the company shed its Lab Products business to EuroBio Scientific. The deal, which is expected to close in 3Q26, calls for an upfront cash payment of $160 million, with the potential for an additional $100 million in milestones. Waltham, MA-based Naveris has developed blood-based tests that monitor for signs of rejection after kidney, heart, and lung transplantation. The company has also developed NavDx, a liquid biopsy test that can detect human papillomavirus (HPV)-driven cancers earlier and with greater accuracy than scans or traditional biopsies. Benefits of acquiring Naveris. CareDX said Naveris had an estimated 2025 revenue of $34 million and is expected to grow 30% to 40% annually for the next three years, neutral to CareDx's FY2026 Adjusted EBITDA guidance. "Naveris extends our platform into a large specialty oncology market where our model already applies and where we can lead," said John Hanna, President and CEO of CareDx, according to a Seeking Alpha transcript of the call. "It allows us to stay disciplined about where we compete, focusing on indications where molecular monitoring is differentiated and scalable. As we evaluated this opportunity, we were particularly focused on the long-term impact of our growth and returns to shareholders, and we have a strong conviction that this investment can deliver both within the framework of our existing operating model." Naveris employs about 100 individuals and has performed more than 130,000 commercial tests to date. The test received Medicare coverage in 2023 and is a leading solution in Head & Neck and Anal cancer MRD surveillance. "Naveris has developed and commercialized a liquid biopsy monitoring platform proven to detect cancer earlier and with greater accuracy than conventional approaches," said James B. McNally, CEO of Naveris. "We are thrilled to be combining forces with CareDx to fulfill our mission of improving patient outcomes by delivering disruptive technology that transforms cancer care and expanding patient access to precision medicine." Editor-in-Chief, MD+DI, Informa Markets - Engineering Omar Ford is a seasoned journalist specializing in medical technology, healthcare innovation, and the medical device and diagnostics industry. As the editor-in-chief of Medical Device + Diagnostics Industry (MD+DI), he has earned a reputation as a leading authority in the field, offering in-depth insights into the latest trends, regulatory changes, and technological advancements shaping the future of healthcare. Omar has been a featured speaker at MD&M and MEDevice events. Omar has written for several publications prior to MD+DI. He is a former contributor at Bioworld Medtech, an online publication owned by Clarivate. He was a general assignment reporter for the Beaufort Gazette and an education and county reporter for the Griffin Daily News. He is the 2001 winner of the Judson Chapman Award from the South Carolina Press Association and the 2003 McClatchy President's Award recipient. Omar has a bachelor's degree in print journalism from the University of South Carolina. Throughout his tenure at MD+DI, Omar has covered a wide array of topics, including medical technology innovations, regulatory affairs, market dynamics, and the growing impact of artificial intelligence in healthcare. Omar is the host of the Let's Talk Medtech podcast.
Under the terms of the deal, CareDx will pay $160 million in upfront cash consideration, with up to an additional $100 million tied to future revenue milestones. The companies said they expect the transaction to close in the third quarter of 2026, subject to customary conditions.
CareDx announces agreement to acquire Naveris, A leader in viral-mediated cancer MRD surveillance testing. Transaction extends CareDx's Precision Medicine Testing Services strategy into specialty oncology with a Medicare-reimbursed commercial-stage MRD test and platform addressing a $4.5 Billion TAM Estimated 2025 Revenue of $34 Million is expected to grow 30-40% annually for the next three years and neutral to CareDx's FY2026 Adjusted EBITDA guidance BRISBANE, Calif.-(BUSINESS WIRE)-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced it has entered into a definitive agreement to acquire Naveris, a commercial stage precision oncology diagnostics company with a highly differentiated and Medicare-reimbursed, blood-based monitoring solution for viral-mediated cancers. The transaction is an extension of CareDx's strategy to focus on its U.S. Precision Medicine Testing Services and Patient and Digital Solutions. The definitive agreement provides for an up-front cash consideration of $160 million with up to an additional $100 million based on the achievement of revenue milestones. Naveris' highly differentiated liquid biopsy platform is based on Tumor Tissue Modified Viral (TTMV(R) DNA. The platform measures fragments of viral DNA released from tumor tissue into the bloodstream, serving as a highly accurate biomarker in human papillomavirus (HPV)-driven cancers. This tumor-naïve testing is designed to support the management of patients from diagnosis through post-treatment molecular residual disease (MRD) surveillance. Naveris reported unaudited revenue of $34 million in 2025, which we forecast to grow 30-40% annually for the next three years. For the first quarter of 2026, Naveris reported unaudited revenue of approximately $12 million, gross margins of 65% and net operating loss of $0.2 million. CareDx estimates the transaction will not impact its 2026 AEBITDA guidance and plans to provide further guidance following the close of the transaction. "Today's announcement accelerates our growth strategy in Precision Medicine Testing Services and Patient & Digital Solutions. We are focused on being a leader in concentrated specialty markets where a high burden of disease drives repeat testing. Naveris fits that profile with a differentiated technology that is early in its adoption," said John Hanna, President & CEO of CareDx. "Naveris is poised for strong growth, leveraging our core capabilities - building belief in molecular testing, simplifying clinical workflow, and generating evidence for coverage and reimbursement." Naveris employs approximately 100 individuals and has performed more than 130,000 commercial tests to date. The test received Medicare coverage in 2023 and is a leading solution in Head & Neck and Anal cancer MRD surveillance. "Naveris has developed and commercialized a liquid biopsy monitoring platform proven to detect cancer earlier and with greater accuracy than conventional approaches," said James B. McNally, Chief Executive Officer of Naveris. "We are thrilled to be combining forces with CareDx to fulfill our mission of improving patient outcomes by delivering disruptive technology that transforms cancer care and expanding patient access to precision medicine." The parties anticipate the transaction to close in the third quarter of 2026, subject to customary closing conditions. Goldman Sachs is acting as the exclusive financial advisor to CareDx in connection with the transaction. Fenwick & West is acting as legal advisor to CareDx. J.P. Morgan Securities LLC is acting as the exclusive financial advisor to Naveris in connection with the transaction. Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal advisor to Naveris. About CareDx CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company's integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com. About Naveris A portfolio company of B-FLEXION Life Sciences, Naveris is a privately held, commercial-stage precision oncology diagnostics company focused on improving outcomes for patients with viral-driven cancers. Founded in 2017, the Company develops and commercializes novel molecular diagnostics designed to enable earlier cancer detection and more personalized disease management. Naveris' proprietary NavDx(R) test is a clinically validated circulating tumor DNA blood test that detects tumor tissue-modified viral (TTMV(R) HPV DNA to support post-treatment surveillance and molecular residual disease (MRD) assessment in HPV-driven cancers. The Company operates high-complexity clinical laboratories in Massachusetts and North Carolina that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center and certified under CLIA. For more information, please visit www.naveris.com and www.NavDx.com. Forward Looking Statements This press release includes forward-looking statements related to CareDx including statements regarding the expected completion and timing of the acquisition, the anticipated impact of the transaction on CareDx's business, financial profile, and operating results, the benefits of the Naveris product, reimbursement coverage for the Naveris product, the achievement of CareDx's financial and operational goals and its expectations and prospects for 2026, the ability of CareDx to advance Naveris' platform technologies on a timely basis, if at all, the ability to satisfy all closing conditions and complete the transaction, difficulties or unanticipated expenses in connection with integrating the companies, and other statements that are not historical facts. These forward-looking statements are based on information currently available to CareDx and its current expectations, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the failure to obtain required regulatory approvals or satisfy closing conditions, delays in completing the transaction, general economic and market factors, and other risks discussed in CareDx's filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these risks may cause CareDx's actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx's forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. More News From CareDx, Inc. BRISBANE, Calif.-( BUSINESS WIRE )-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Financial Highlights Revenue of $118 million, an increase of 39% year-over-year Testing services revenue of $91 m... BRISBANE, Calif.-( BUSINESS WIRE )-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced its participation at the International Society of Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting, taking place April 22-25 in Toronto, Canada. The real-world clinical use and scient... BRISBANE, Calif.-( BUSINESS WIRE )-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today introduced AlloSeq Nano, a nanopore-based HLA (human leukocyte antigen) and ABO blood type genotyping solution, at the European Federation for Immunogenetics (EFI) Conference 2026. AlloSeq Nano is an inn... CareDx, Inc. NASDAQ:CDNA Release Versions
Naveris(R) to highlight new publications at the 44th Annual J.P. Morgan Healthcare Conference. DURHAM, N.C. - (BUSINESS WIRE) - Naveris, Inc., the leader in precision oncology diagnostics for viral-driven cancers, today announced that it will be highlighting new data supporting the use of blood-based ctDNA tests to improve post-treatment surveillance protocols in both head-and-neck and anal cancers at the 44th Annual J.P. Morgan Healthcare Conference, to be held January 12-15, 2026, in San Francisco, CA. Recent data published in Cancers reinforces the value of the Naveris Tumor Tissue Modified Viral (TTMV(R) HPV DNA technology in the surveillance of anal squamous cell carcinoma (ASCC). The Company's flagship NavDx(R) test demonstrated high per-test positive predictive value (PPV) of 98% and negative predictive value (NPV) of 95% for recurrence detection in the surveillance setting. Additionally, NavDx helped resolve 92% of clinically indeterminate findings (CIFs).[i] These results reinforce the clinical utility of NavDx testing as part of a comprehensive surveillance protocol and align with recently expanded Medicare coverage for the use of NavDx in ASCC molecular residual disease (MRD) testing. "We are pleased to share significant business updates at the J.P. Morgan Healthcare Conference including our recently expanded Medicare coverage for NavDx in anal cancer MRD, new clinical data that reinforces the clinical utility of NavDx in anal cancer surveillance, and the impactful clinical consensus statement that highlights the utility of ctHPVDNA in head and neck cancer surveillance," commented James McNally, Chief Executive Officer of Naveris. Naveris management will present these updates on Wednesday, January 14, 2026 at 2:30 p.m. PT at the 44th Annual J.P. Morgan Healthcare Conference. Naveris is a privately held, commercial-stage precision oncology diagnostics company focused on improving outcomes for patients with viral-driven cancers. Founded in 2017, the Company develops and commercializes novel molecular diagnostics designed to enable earlier cancer detection and more personalized disease management. Naveris' proprietary NavDx(R) test is a clinically validated circulating tumor DNA blood test that detects tumor tissue - modified viral (TTMV(R) HPV DNA to support post-treatment surveillance and molecular residual disease (MRD) assessment in HPV-driven cancers. The Company operates high-complexity clinical laboratories in Massachusetts and North Carolina that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center and certified under CLIA. For more information, please visit www.naveris.com and www.NavDx.com.
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About Naveris
Industries
Company Size
51-200
Company Stage
Acquired
Total Funding
$69.9M
Headquarters
Waltham, MA
Founded
2017
There are no jobs for Naveris right now.
Find jobs on Simplify and start your career today
We update Naveris's jobs every few hours, so check again soon!Browse all jobs