Studie v JAMA Dermatology ukázala, že Signatera lépe než AMERK předpovídá návrat Merkelova karcinomu. Zachytila relaps častěji, se senzitivitou 90 % vs 55 % a dříve o 5,1 měsíce vs 2,1 měsíce.
Signatera outperformed AMERK, the current standard of care for prognosis and recurrence monitoring, across sensitivity, positive and negative predictive value, and lead time to recurrence
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of results from a prospective, multicenter study in Merkel cell carcinoma (MCC) published in JAMA Dermatology. The study evaluated the Signatera test against the Merkel cell polyomavirus antibody test (AMERK), finding Signatera to be a significantly stronger predictor of recurrence that also detected relapse earlier.
MCC is a rare but aggressive skin cancer that recurs in approximately 40% of patients.1 Despite its severity, clinicians have lacked a reliable, universal biomarker to guide surveillance. The AMERK test has been a widely used monitoring tool, but its utility is limited: it can only be used in the roughly 50% of MCC patients whose tumors are virus-positive, and its accuracy diminishes after immunotherapy exposure or multiple recurrences.2-3 Signatera’s clinical validation has been published across all MCC patients, irrespective of viral status, leading to inclusion in NCCN Guidelines as a recommendation for surveillance monitoring.
This published study is a retrospective analysis of a prospective, multicenter, head-to-head comparison of Signatera and AMERK testing in 169 patients with MCC. Key findings include:
Superior predictive power: The Signatera test was a significantly stronger predictor of recurrence than AMERK (HR difference = 6.6; p < 0.001), with higher hazard ratios, higher positive predictive value (PPV), and higher negative predictive value (NPV).Higher Sensitivity: Signatera detected recurrence more frequently than AMERK with a sensitivity of 90% vs 55%, respectively.Longer Lead Time: In patients where recurrence was detected by both tests, Signatera detected recurrence earlier than AMERK with a median lead time of 5.1 months vs. 2.1 months, respectively.“For years, AMERK had been our best available tool, but its inability to function in virus-negative patients and after immunotherapy has been a recognized limitation,” said Lisa Zaba, M.D., Ph.D., associate professor of dermatology and director of the Merkel cell carcinoma multidisciplinary clinic at the Stanford University School of Medicine, and corresponding author of the study. “These data demonstrate that Signatera can give clinicians a more precise and earlier signal across all patients, enabling more proactive management of this challenging disease.”
“Signatera MRD testing outperformed AMERK across every key measure in this study — sensitivity, hazard ratios, predictive values, and lead time to detection,” said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager, oncology, at Natera. “Signatera was shown to be a more universally reliable biomarker for MCC surveillance, particularly because it retains its accuracy in both virus-positive and virus-negative disease and after exposure to immunotherapy.”
References
McEvoy AM, Lachance K, Hippe DS, et al. Recurrence and mortality risk of Merkel cell carcinoma by cancer stage and time from diagnosis. JAMA Dermatol. 2022;158(4):382-389. doi:10.1001/jamadermatol.2021.6096Paulson KG, Lewis CW, Redman MW, et al. Viral oncoprotein antibodies as a marker for recurrence of Merkel cell carcinoma: a prospective validation study. Cancer. 2017;123(8):1464-1474. doi:10.1002/cncr.30475Miller DM, Shalhout SZ, Wright KM, et al. The prognostic value of the Merkel cell polyomavirus serum antibody test: a dual institutional observational study. Cancer. 2024;130(15):2670-2682. doi:10.1002/cncr.35314About Natera
Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Duquesne Family Office Stanleyho Druckenmillera měla v prvním čtvrtletí 2026 největší pozici v Naterě za těsně pod 613 miliony USD, což představovalo 18,1 % portfolia. Natera zároveň v 1. čtvrtletí 2026 zvýšila tržby o 39 % na 697 milionů USD.
He's a retired hedge fund manager, but people still want to know what billionaire Stanley Druckenmiller is doing with his money. The answer? Investing in the medical diagnostic company Natera (NTRA 0.31%).
As of the first quarter of 2026, Natera was the top holding of the Duquesne Family Office, which manages Druckenmiller's private wealth. It accounted for 18.1% of the portfolio's holdings, and the stake was worth slightly under $613 million at the time.
The genetic testing company may not be as well known as Nvidia or get as much attention, but surprisingly, Natera has quietly returned three times more than the chipmaker over the past 12 months.
Stanley Druckenmiller. Image source: Getty Images.
Druckenmiller keeps betting big on Natera Duquesne provides quarterly filings showing what it bought and sold, but it isn't required to explain its investment decisions.
Still, as the medical testing market is rapidly growing, it makes sense as to why Druckenmiller and his family office have been aggressively building a position in Natera. According to Grand View Research, the global genetic testing market was valued at only $11.7 billion in 2024, but is expected to reach $39.3 billion by 2030. And the global cancer diagnostics market is even bigger, expected to climb from $119.8 billion in 2025 to $191.1 billion by 2033.
Natera has a lot of opportunities within those markets, as it specializes in cell-free DNA testing and has testing for oncology, organ health, and women's health. It also offers testing for rare diseases. One product growth source for the company, in particular, has been through oncology testing. Last year, Natera increased its processed oncology tests by 51.6% from over 528,000 in 2024 to more than 800,000 in 2025. In the first quarter of 2026, it also saw a 50%+ increase in processed oncology tests.
In addition, Natera offered its shareholders even more bullish news in June, as its Signatera test became the first approved molecular residual disease test approved for patients with colorectal cancer in Japan. Signatera is expected to launch in Japan by the end of 2026.
Strong results continue into 2026 In 2025, Natera generated $2.3 billion, which was a 35.9% increase from 2024. That's on the back of increased testing; Natera processed 3.5 million total tests in 2025, a 15% increase from the number of tests processed in 2024.
Thus far, Natera is continuing to ride that wave of momentum. In the first quarter of 2026, it exceeded one million processed tests in a quarter for the first time. It also reported revenue of $697 million, a 39% increase, and Natera also boosted the midpoint of its full-year sales guidance by $120 million.
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Should you follow Druckenmiller's lead into Natera? Natera continues to show that demand for its testing is increasing, and shareholders have been rewarded with a rising stock price. As of this writing, the Natera stock price is up over 19%, and while it may not make investing headlines like Nvidia, Natera is performing better than the chipmaker. Over the last 12 months, the Natera stock price has been up more than 72%, while the Nvidia stock price has climbed slightly above 24%.
It's also a company that analysts generally view favorably, with 19 out of 22 saying Natera is a buy.
That said, Natera is also an unprofitable company. In 2025, it reported a net loss of $208.2 million, up from a net loss of $190.4 million in 2024. It's also continuing to invest heavily in research and development (R&D), with its R&D costs climbing from $129.1 million in Q1 2025 to $210.7 million in Q1 2026.
Overall, Natera can reward shareholders who are comfortable with an investment with high-reward potential but also increased risk. It's a leader in the medical diagnostics space and continues to report impressive revenue growth.
But owning Natera also means accepting the company's unprofitability, which may continue for some time. Druckenmiller appears comfortable with the risk associated with his Natera investment, but that's not reason alone for retail investors to own the stock.
Natera oznámila, že Signatera získala certifikaci jako zařízení třídy C podle nařízení EU IVDR jako první personalizovaný MRD test pro solidní nádory v EU. Certifikace má usnadnit zavádění nových studií a udržet dostupnost v EU po roce 2028.
Signatera is the first personalized molecular residual disease (MRD) test for solid tumors to receive IVDR certification in the EU
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR).
The IVDR represents one of the world’s most rigorous regulatory frameworks for in vitro diagnostic medical devices, replacing the outgoing In Vitro Diagnostic Medical Devices Directive (IVDD). To obtain certification, the Signatera platform — including the assay, specimen collection kit, and associated software — underwent a comprehensive review against some of the most stringent standards in the medical industry, including evidence of analytical and clinical validity, as well as quality system management.
IVDR certification reduces the lead time and regulatory overhead for launching new clinical trials, and it ensures that Natera can continue offering Signatera to EU patients after the IVDD transition deadline in 2028.
Under this certification, Signatera is indicated for use in the adjuvant and surveillance settings across gastrointestinal malignancies, genitourinary malignancies, non-small cell lung cancer, head and neck cancer, breast cancer, skin cancer, gynecological malignancies, diffuse large B-cell lymphoma, indolent non-Hodgkin's lymphomas, and pan-cancer immunotherapy monitoring.
Certification was supported by extensive clinical and analytical evidence demonstrating Signatera’s performance across multiple tumor types and clinical settings. It follows two significant regulatory milestones for the Signatera portfolio: in June 2026, Signatera received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for patients with colorectal cancer; and in May 2026, the U.S. Food and Drug Administration approved Signatera™ CDx as a companion diagnostic for patients with muscle-invasive bladder cancer.
“MRD testing is redefining how we assess recurrence risk and guide treatment decisions for patients with cancer,” said Julien Taieb, M.D., Ph.D., head of the gastroenterology and gastrointestinal oncology department at the Université Paris-Cité. “This certification for Signatera is an important milestone as it will enhance access to personalized MRD testing for patients across Europe within a more rigorous regulatory framework.”
“Achieving IVDR certification is a key milestone in Natera’s plan to bring Signatera MRD testing to Europe,” said Solomon Moshkevich, president, clinical diagnostics at Natera. “Backed by extensive clinical evidence across multiple cancer types, this builds on our recent regulatory approvals in both the United States and Japan.”
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Natera se spojí s Aveta Biomics a do globální studie fáze 3 LA-HNSCC zapojí test Signatera pro sledování MRD a odpovědi na léčbu. Studie může zahrnout asi 826 pacientů.
Key Takeaways Natera partnered with Aveta to integrate Signatera into a global Phase 3 LA-HNSCC trial.Signatera will assess MRD and treatment response across neoadjuvant to follow-up care.The trial may enroll 826 patients globally, with enrollment expected in the second half of 2026. Natera (NTRA - Free Report) recently announced a partnership with Aveta Biomics to support AVTA 30-01, a global Phase 3 registrational trial of its oral immunotherapy, APG-157, in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Natera’s Signatera test will be integrated into the AVTA 30-01 Phase 3 study to assess molecular residual disease (MRD) and treatment response during neoadjuvant, induction, adjuvant and follow-up care.
Management noted that growing clinical evidence continues to demonstrate the value of Signatera for MRD detection in head and neck cancer. The company believes its collaboration with Aveta on the AVTA 30-01 trial will further demonstrate Signatera’s potential to advance the field and improve patient care.
Likely Trend of NTRA Stock Following the NewsShares of NTRA have lost 0.3% since the announcement on Monday. Year to date, the stock has gained 18.5% against the industry’s 2.3% decline. The S&P 500 has risen 9.7% in the same timeframe.
The partnership with Aveta Biomics is a positive development for Natera as it expands the clinical use of Signatera in a global Phase 3 registrational trial. Successful validation of Signatera for MRD monitoring and treatment response in head and neck cancer could strengthen its clinical evidence and support wider adoption. Over time, the collaboration could enhance Natera’s position in precision oncology while creating opportunities for biopharma partnerships centered on MRD-guided treatment strategies.
NTRA currently has a market capitalization of $39.00 billion.
Image Source: Zacks Investment Research
More on the NewsAPG-157 is Aveta’s first-in-class oral immunotherapy designed to benefit both immune-hot and immune-cold tumors in LA-HNSCC. The therapy has received FDA Fast Track and Orphan Drug Designations for this indication. The Phase 3 study builds on Phase 2 results that demonstrated favorable safety, evidence of tumor control, deep molecular responses and promising event-free survival outcomes.
The trial is expected to enroll approximately 826 patients across North America, Europe, Asia-Pacific and Australia, with patient enrollment to begin in the second half of 2026. It will include separate randomized cohorts for patients with resectable and unresectable locally advanced disease, with both treatment and control arms. Signatera will serve as a secondary endpoint to generate insights into disease recurrence and therapeutic response through circulating tumor DNA (ctDNA) monitoring to assess MRD.
Head and neck cancer affects roughly 950,000 people worldwide each year, and recurrence remains a significant cause of mortality despite advances in surgery, radiation and immunotherapy. This collaboration further expands Natera’s clinical evidence in head and neck cancer, following the positive results from the recently concluded Phase 2 SINERGY trial, which supported the use of Signatera MRD-guided monitoring in this disease setting.
Industry Prospects Favoring the MarketGoing by the data provided by Precedence Research, the minimal residual disease testing market was valued at $1.70 billion in 2025 and is expected to witness a CAGR of 12% through 2034.
Factors like the demand for highly sensitive technologies like next-generation sequencing and digital PCR, which accurately detect minimal residual cancer cells to guide treatment decisions and predict patient outcomes, are boosting the market’s growth.
Other NewsNatera recently announced a collaboration with CytoDyn to evaluate ctDNA dynamics and generate real-world molecular data in support of the latter’s metastatic colorectal cancer (mCRC) program.
In May, Natera announced a collaboration with Diakonos Oncology to incorporate its Signatera molecular residual disease test into Diakonos’ DOC-RM Phase I/II investigational immunotherapy trial for patients with refractory melanoma.
Natera received the FDA approval of Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab immunotherapy in patients with muscle-invasive bladder cancer.
NTRA’s Zacks Rank & Key PicksNatera currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are BrightSpring Health (BTSG - Free Report) , Globus Medical (GMED - Free Report) and West Pharmaceutical (WST - Free Report) .
BrightSpring Health, currently carrying a Zacks Rank #2 (Buy), reported first-quarter 2026 adjusted earnings per share (EPS) of 39 cents, which beat the Zacks Consensus Estimate by 34.5%. Revenues of $3.61 billion surpassed the Zacks Consensus Estimate by 8.35%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BrightSpring Health has an estimated long-term earnings growth rate of 46.5%. BTSG’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 14.6%.
Globus Medical, currently carrying a Zacks Rank #2, reported a first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
GMED has an estimated long-term earnings growth rate of 10.2%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
West Pharmaceutical, carrying a Zacks Rank #2 at present, reported first-quarter 2026 EPS of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%.
Natera a Aveta Biomics uzavřely partnerství pro globální fázi 3 registrační studii AVTA 30-01 s APG-157 u lokálně pokročilého spinocelulárního karcinomu hlavy a krku. Do studie se zapojí Signatera pro sledování molekulární odpovědi a minimální reziduální nemoci (MRD).
Signatera™ will be used to evaluate molecular response to APG-157 in the neoadjuvant, induction, and adjuvant settings
AUSTIN, Texas & BEDFORD, Mass.--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Aveta Biomics, Inc., a clinical-stage immuno-oncology company advancing first-in-class oral immunotherapies for solid tumors, today announced a strategic partnership supporting AVTA 30-01, Aveta’s global Phase 3 registrational clinical trial evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) (NCT07667296).
APG-157 is Aveta's first-in-class oral immunotherapy intended to expand the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC. APG-157 has received FDA Fast Track and Orphan Drug Designations for this indication.
AVTA 30-01 builds upon previously reported Phase 2 clinical data of APG-157 monotherapy in demonstrating favorable safety, evidence of tumor-control, deep molecular responses, and encouraging event-free survival outcomes. The trial will incorporate serial Signatera testing to assess molecular residual disease (MRD) and treatment response throughout therapy and follow-up. Circulating tumor DNA (ctDNA) has emerged as one of the most promising approaches for detecting MRD and identifying recurrence earlier than conventional imaging alone.
Approximately 826 patients are expected to be enrolled across North America, Europe, Asia-Pacific, and Australia. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms, and Signatera will be a secondary endpoint. The trial is expected to begin enrollment in 2H’26.
Global annual incidence of head and neck cancer is approximately 950,000,1 and disease recurrence remains a major cause of mortality despite advances in surgery, radiation therapy, and immunotherapy.
“Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment,” said Parag Mehta, Ph.D., founder and chief executive officer of Aveta Biomics. “We believe APG-157 has the potential to transform treatment by activating anti-tumor immunity in both immune-cold and immune-hot tumors. Incorporating serial Signatera testing into AVTA 30-01 will allow us to further validate the ctDNA findings observed in Phase 2 while generating molecular response data that will advance the understanding of treatment benefits for patients and strengthen the regulatory submission.”
This study adds to the evidence Natera continues to generate in head and neck cancer. The company recently announced a successful readout of the prospective Phase 2 SINERGY trial, supporting Signatera MRD-guided treatment in this histology.
“Growing evidence continues to demonstrate the value of Signatera MRD detection in head and neck cancer,” said Eric Matthews, general manager, biopharma, Natera. “We’re pleased to partner with Aveta on AVTA 30-01 to demonstrate how Signatera has the potential to advance the field and improve care for patients.”
References
Sun H, et al. Global burden of head and neck cancer: Epidemiological transitions, inequities, and projections to 2050. Front Oncol. 2025 Sep 25;15:1665019.About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
About Aveta Biomics
Aveta Biomics is a clinical-stage immuno-oncology company advancing first-in-class oral therapies designed to reprogram the tumor microenvironment and expand the benefits of immunotherapy to patients with immune-cold cancers. The company’s lead candidate, APG-157, has received FDA Fast Track and Orphan Drug Designations for head and neck squamous cell carcinoma and is in a global phase 3 registrational trial. APG-157 is also being evaluated across additional oncology indications including high-grade adult glioma and oral dysplasia. For more information, visit www.avetabiomics.com.
Forward-Looking Statements (for Natera)
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our or our partners’ efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Forward-Looking Statements (for Aveta)
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those regarding the impact of the Fast Track Designation, the progress of our clinical trials, potential regulatory approvals, the development and commercial success of our drug candidates, and our strategic goals, reflect our current expectations and involve risks and uncertainties. Actual results may differ materially due to factors such as our ability to advance drug candidates through development and regulatory approval, clinical trial outcomes, competition, and economic conditions. Words like “may,” “will,” “could,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. We caution you not to place undue reliance on these statements, which speak only as of the date they are made. As a private company, Aveta Biomics is under no obligation to publicly update or revise any forward-looking statements to reflect new information or future events, except as required by applicable law.
Natera získala v Japonsku schválení pro Signatera u kolorektálního karcinomu a plánuje komerční spuštění do konce roku 2026, pokud padne konečné rozhodnutí o cenách. O podporu prodeje se postará SRL Inc.
The precision medicine company expects to launch Signatera commercially in Japan by the end of 2026, pending final pricing decisions.
The approval marks a key milestone in Natera’s international oncology expansion.
More than 150,000 people are diagnosed with colorectal cancer each year in Japan, making it one of the country’s most common cancers and highlighting the need for personalized treatment strategies.
Clinical Evidence And Medical Society Support Back ApprovalThe cancer test company said findings from the GALAXY clinical trial supported regulatory clearance.
The study showed that patients who tested MRD-positive following surgery experienced substantial benefit from adjuvant chemotherapy, while MRD-negative patients did not appear to benefit from the treatment.
The GALAXY trial analyzed 2,240 samples, making it one of the largest prospective studies evaluating MRD testing in resectable colorectal cancer.
The study forms part of the broader CIRCULATE-Japan platform, which involves thousands of patients and more than 150 institutions across Japan.
SRL To Lead Commercialization Efforts Across JapanCommercial rollout of Signatera in Japan will be supported by SRL Inc., Japan’s largest reference laboratory and a member of H.U. Group Holdings.
As Natera’s exclusive business partner in Japan, SRL will help expand access to personalized MRD testing through its nationwide laboratory network.
On Tuesday, the National Comprehensive Cancer Network (NCCN) recognized Natera’s Signatera technology for muscle-invasive bladder cancer.
The recognition marks the third NCCN guideline recommendation for circulating tumor DNA (ctDNA) testing, which could enhance treatment protocols for patients, reflecting positively on Natera’s market position and growth potential.
NTRA Stock Price Activity: Natera shares were up 10.29% at $258.92 at the time of publication on Wednesday, according to Benzinga Pro data.
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