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) reported phase III VOLGA bladder cancer findings linking Signatera Genome blood-test results with event-free survival at ESMO 2026.
The analysis tracked circulating tumor DNA (ctDNA), tumor-derived DNA in blood, before bladder-removal surgery. 24-month event-free survival was 91% among persistently Signatera-negative patients, 81% among initially positive patients whose ctDNA cleared before surgery, and 55% among those remaining positive. Signatera has been evaluated in seven phase III bladder cancer trials.
In resectable stage 2B–3B non-small cell lung cancer, Clarity detected ctDNA in 99% of patients before treatment; clearance before surgery or chemoradiotherapy was associated with 100% one-year event-free survival. Other studies examined Signatera in endometrial and breast cancer, including serial monitoring of minimal residual disease (MRD), cancer traces remaining after treatment.
Natera (NTRA) announced new data presented at ASN Kidney Week 2026, including real-world analyses of chronic kidney disease (CKD). The presentations comprised 18 abstracts, including three oral presentations.
Among patients with newly occurring CKD, the median interval from the first abnormal kidney indicator to documented diagnosis was about 5.3 years. Median estimated kidney filtration rate fell from 75 to 66 mL/min/1.73 m² in the two years before diagnosis. Only one third of patients meeting KDIGO-aligned high-risk criteria had documented nephrology care; those who did waited a median of 149 days. Natera said its Renasight genetic test is designed to clarify the cause of kidney disease and support earlier, more targeted specialist referrals.
Natera (NTRA) will present clinical evidence across 20 abstracts at the ESMO Annual Congress, taking place October 23–26, 2026, in Madrid.
In the ICONIC gastroesophageal cancer trial, Signatera Genome detected all evaluable recurrences during surveillance, with a >7.3-month median lead time over standard imaging. In the phase III SAGITTARIUS colon cancer trial, Signatera results changed providers’ pre-planned treatment for one in three patients; 87% of those patients had treatment reduced based on negative molecular residual disease results, meaning no residual cancer DNA was detected. An analysis of exceptional responders with HER2-positive metastatic breast cancer found 81% had sustained negative results during serial monitoring. In a separate cohort, Signatera complemented by blood-based genomic profiling identified clinically relevant biomarkers in 18 of 50 patients.
Natera (NTRA) announced that its Signatera cancer-monitoring test was named to TIME’s Best Inventions of 2026 in the Medical & Healthcare category. Signatera is a personalized molecular residual disease (MRD) test that uses each patient’s tumor genetic signature to detect and measure fragments of tumor DNA in blood. It monitors disease recurrence and response to treatment across cancer types.
Natera was also named to Fortune’s Future 120 in October 2026. Signatera is supported by more than 200 peer-reviewed publications and used by more than 55% of U.S. oncologists.
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.