Natera develops genetic tests for clinicians caring for people with cancer, inherited conditions, pregnancies, and organ transplants, using DNA analysis to inform medical decisions. Its portfolio includes Signatera for tracking residual cancer, Panorama for prenatal screening, and Prospera for assessing transplanted organ health. The company combines laboratory analysis with software that distinguishes DNA fragments in blood, and earns revenue mainly from diagnostic testing, alongside licensing and services for research partners. Clinicians use its portals to order tests, track samples, and review results, while patients have access to genetic information sessions. Natera was founded in 2004 and is headquartered in Austin, Texas.
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Austin, Texas
Founded
2004
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Natera, Inc. receives FDA Breakthrough Device designation for its multi-cancer early detection assay. Published on 10/09/2026 at 01:36 pm EDT S&P Capital IQ Natera, Inc. announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. Natera?s MCED assay analyzes cell-free DNA in the blood to screen for multiple cancers. In granting the BDD, the FDA assessed data from 12 cancer types and considered sensitivity, specificity, and cancer signal origin (CSO) performance. The test generated compelling results to support the designation. The Breakthrough Devices program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Devices must meet rigorous criteria to earn the designation. (C) S&P Capital IQ - 2026
Natera's Signatera test has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency as a companion diagnostic for muscle-invasive bladder cancer. The approval supports Signatera-guided decisions for adjuvant atezolizumab treatment and marks the company's second PMDA authorisation for Signatera in three months. Natera plans to commercially launch Signatera for MIBC in Japan in the first half of 2027. The regulatory approval was supported by data from the IMvigor011 Phase III clinical trial, which included more than 20 participating sites in Japan. Bladder cancer affects more than 34,000 people annually in Japan, with approximately 20-25% of newly diagnosed cases classified as MIBC. Following the announcement, Natera stock gained 5.5%.
Natera presents largest MRD dataset in lung cancer at IASLC 2026 world conference. Published on 09/18/2026 at 07:05 am EDT S&P Capital IQ Natera and its collaborators presented four abstracts, including two oral presentations. A mini-oral presentation featured the largest molecular residual disease (MRD) dataset ever presented in lung cancer. This analysis of 1,129 patients with resected stage 1-3 non-small cell lung cancer (NSCLC) spanned an observation period from 2016 to 2025. Signatera MRD detection was evaluated in the early post-surgical window and throughout surveillance, with the following key findings: Early post-surgical Signatera-status was strongly prognostic of recurrence-free survival. Signatera-positivity in the early post-surgical window (7?90 days after surgery) was associated with significantly worse recurrence-free survival (RFS), with a 25% higher absolute 3-year RFS for Signatera-negative patients. Signatera-positive patients had approximately 5X the risk of recurrence or death during surveillance. Findings were consistent across both the primary surgical and perioperative cohorts, supporting broad applicability of Signatera monitoring across resected stage 1-3 NSCLC. Full list of presentations at WCLC 2026 included: Abstract P2.192 Poster: ctDNA After Definitive Therapy +/- Immunotherapy and Association with Survival Outcomes in Locally Advanced Unresectable NSCLC. Abstract P2.200 Poster: ctDNA-based Molecular Residual Disease as a Predictive Biomarker for Treatment Stratification in Unresectable Stage 3 NSCLC. Abstract MO05.07 Mini Oral: KRAS G12C Predicts Superior Outcomes with 1L Cemiplimab for Non-Squamous aNSCLC With PD-L1 = 50%: Data From EMPOWER-Lung 1. Abstract MO11.09 Mini Oral: Post-Surgical Molecular Residual Disease Detection, Adjuvant Treatment Patterns, and Overall Survival in Resected Stage 1-3 NSCLC. (C) S&P Capital IQ - 2026
Natera teams with Angiex on cancer drug trial monitoring. * August 31, 2026 Natera inked a collaboration deal with biotech Angiex to assess the use of its Signatera blood test, which looks for small traces of cancer DNA in patients who have been diagnosed and treated for the disease.
Natera has partnered with Kupando Therapeutics to supply its Latitude tissue-free minimal residual disease (MRD) assay for a Phase 1 immunotherapy trial in multiple skin cancers. The assay will monitor disease and treatment response in patients receiving Kupando's investigational therapy. The collaboration extends Natera's MRD technology into early-stage drug development settings. Natera is a US-based molecular diagnostics company that develops and commercialises testing services. The partnership expands Natera's presence in oncology clinical trials and supports use of its MRD technology across different tumour types. However, the revenue impact from these early-stage trial deployments is likely modest at this stage. Investors will watch whether additional oncology trials adopt Natera's platforms and if the company begins disclosing trial counts or patient volumes linked to MRD collaborations.