Natera, Inc. develops and commercializes cell-free DNA and genetic testing for oncology, women’s health and organ health. Company updates commonly cover financial results, revenue trends, laboratory operations and publications supporting tests such as Signatera, Prospera, Panorama and Horizon.
Recurring news also includes oncology molecular residual disease applications, clinical evidence presented at medical meetings, transplant rejection surveillance data, collaborations using Natera assays in drug trials, and patent or litigation developments tied to its MRD technology. The company reports through CLIA-certified and CAP-accredited laboratory operations and through Foresight Diagnostics, its subsidiary.
Natera (NTRA) and TransCode Therapeutics (RNAZ) announced a colorectal cancer collaboration supporting enrollment in TransCode’s Phase 2a trial of TTX-MC138.
TransCode will use Natera’s Signatera test to identify eligible patients who have completed curative-intent therapy but remain positive for molecular residual disease, meaning molecular evidence of remaining cancer, with no disease visible on imaging. The companies aim to improve patient identification and enrollment. Quantum Leap Healthcare Collaborative is conducting the study within its PRE-I-SPY program, marking the program’s first expansion beyond breast cancer into colorectal cancer.
Natera (NASDAQ: NTRA) received FDA Breakthrough Device designation for its blood-based assay intended to screen for multiple cancers. The multi-cancer early detection (MCED) assay analyzes cell-free DNA in blood. In granting the designation, the FDA assessed data from 12 cancer types and considered screening performance and how well the test identified where a cancer signal originated.
The Breakthrough Devices program is intended to speed development, assessment and review for premarket approval, 510(k) clearance and De Novo marketing authorization. These are routes for bringing medical devices to market; the announced milestone is designation, not marketing authorization. The program covers technologies intended to improve diagnosis or treatment of life-threatening or irreversibly debilitating conditions.
Natera (NTRA) announced enrollment of the first patients in a randomized, Signatera-guided trial for advanced or metastatic melanoma sponsored by NYU Langone Health.
The multi-center study tests whether detecting persistent molecular residual disease, cancer traces detected through DNA testing, can guide earlier treatment escalation. After six weeks of nivolumab plus relatlimab, Signatera-positive patients without progression on imaging will be randomized to continue that treatment until clinical progression or add ipilimumab. The primary endpoint is progression-free survival, the time patients live without their disease worsening. Natera hopes the study will improve patient selection for treatment escalation; a potential change in clinical practice depends on positive results.
Natera (NTRA) presented new Signatera clinical data across gastrointestinal and gynecologic cancers in four oral presentations at the ASTRO 2026 Annual Meeting.
In locally advanced rectal cancer, the test detected every instance of local cancer growth or recurrence, with 100% sensitivity and 97% specificity after neoadjuvant treatment. Sensitivity measures detection of affected patients; specificity measures correct identification of unaffected patients. In anal cancer, 18-month progression-free survival was 8% after a positive post-treatment result versus 97% among patients who remained negative. In vulvovaginal cancer, positive results preceded imaging-detected recurrence with a median lead time of 117 days. A preliminary cervical cancer report linked a positive mid-treatment result to one patient's subsequent recurrence.
Natera (NTRA) and Alliance Foundation Trials launched AFT-70 NAVIGATE, a randomized phase III breast cancer trial using Signatera-guided treatment decisions. AFT sponsors and leads the trial, with collaboration and co-funding from Natera and Genentech. AFT expects to enroll more than 2,000 patients with stage II-III ER-positive/HER2-negative breast cancer at approximately 200 U.S. and international sites.
Patients without detectable molecular residual disease (MRD), traces of cancer detected by Signatera, after standard treatment will be randomized. The control arm receives standard endocrine therapy plus upfront CDK4/6 inhibition. The investigational arm receives Genentech’s giredestrant alone, adding CDK4/6 inhibition only if Signatera becomes positive. The primary endpoint is non-inferiority in 4-year distant recurrence-free survival, testing whether the guided strategy is not worse than control within the trial’s allowed margin.
Natera (NTRA) received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency for its Signatera test as a companion diagnostic in muscle-invasive bladder cancer (MIBC).
The approval covers use of Signatera to guide adjuvant atezolizumab (Tecentriq) treatment decisions in patients with MIBC. It is Signatera’s second PMDA authorization in three months and the first PMDA-approved companion diagnostic in Japan for MRD-guided care. Commercial launch for MIBC in Japan is expected in the first half of 2027, pending final reimbursement, pricing, and PMDA approval of atezolizumab in MIBC. The authorization was supported by the IMvigor011 phase III trial, which involved more than 20 sites in Japan.
Natera (NTRA) reported new data from the largest molecular residual disease (MRD) study in lung cancer, covering 1,129 patients with resected stage 1–3 non-small cell lung cancer (NSCLC) observed from 2016 to 2025.
Early post-surgical Signatera MRD status (7–90 days after surgery) was strongly prognostic for recurrence-free survival, with Signatera-negative patients showing a 25% higher absolute 3-year recurrence-free survival than Signatera-positive patients. During surveillance, Signatera-positive patients had approximately 5 times the risk of recurrence or death. Results were consistent across primary surgical and perioperative cohorts, supporting broad applicability of Signatera monitoring in resected stage 1–3 NSCLC. Natera and collaborators presented four abstracts in total at WCLC 2026.
Natera (NASDAQ:NTRA) reported new real-world data in Blood Neoplasia validating its Signatera™ ctDNA-based MRD test in 144 patients with newly diagnosed or relapsed/refractory lymphoma, spanning 14 indolent and aggressive subtypes and 1,105 plasma samples collected from baseline through surveillance.
According to Natera, end-of-treatment Signatera-positivity was the strongest independent predictor of event-free survival (multivariate HR: 80.83 vs PET/CT HR: 5.18; p<0.001) and showed 100% positive predictive value vs 62% for PET/CT. During surveillance, Signatera achieved 91% sensitivity and 92% specificity and was strongly prognostic (HR: 33.74; p<0.0001). Signatera clearance during first-line therapy and after CAR-T in relapsed/refractory patients was associated with improved event-free survival and longer median durable treatment intervals (16.1 vs 1.97 months; p=0.0091), supporting earlier, more individualized lymphoma management.
Natera (NASDAQ: NTRA) announced a national partnership with Susan G. Komen to advance breast cancer awareness, education and understanding of personalized molecular residual disease (MRD) testing. The collaboration highlights Natera’s Signatera MRD test, which is supported by more than 185 peer‑reviewed publications across multiple cancer types, including breast cancer.
Under the agreement, Natera will be the 2026 Premier National Series Sponsor of Susan G. Komen’s Race for the Cure and MORE THAN PINK Walk events, and will support Komen’s “Know More” patient education series, aiming to enhance breast health awareness, patient support and advocacy nationwide.
Natera (NASDAQ: NTRA) announced a collaboration with privately held Angiex to use its personalized Signatera circulating tumor DNA (ctDNA) test in Angiex’s ongoing Phase I trial of AGX101, a TM4SF1-directed Nuclear-Delivered Antibody-Drug Conjugate™ for unresectable, locally advanced or metastatic solid tumors.
The partnership will apply longitudinal Signatera testing to monitor molecular treatment response and potentially complement imaging, aiming to better interpret radiologic changes and deepen understanding of this novel ND-ADC drug class.