NTRA's Signatera Gains EU IVDR Certification for Multiple Cancers
Natera's Signatera became the first personalized MRD test for solid tumors to earn EU IVDR certification, supporting broader expansion across Europe.
Natera's Signatera became the first personalized MRD test for solid tumors to earn EU IVDR certification, supporting broader expansion across Europe.
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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 platf.
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of new data in JAMA Oncology, evaluating the utility of Signatera, its personalized molecular residual disease (MRD) test, in patients with resected colorectal liver metastases (CRLM). The data was also presented as an oral presentation at the 2026 European Society for Medical Oncology Gastrointestinal (ESMO GI) Congress. The liver is the most com.
Natera's Aveta partnership brings Signatera into a global Phase 3 head and neck cancer trial to assess MRD and treatment response.
Genetic testing firm Natera and cancer drug developer Aveta Biomics said on Monday they have partnered on a late-stage study of an experimental therapy for head and neck cancer, in a bid to improve how patients' response to treatment is monitored.
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.
Natera's Signatera gains Japan PMDA approval for CRC, marking the country's first approved MRD test and advancing its global expansion.
Natera (NTRA) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.
AUSTIN, Texas & IRVINE, Calif.--(BUSINESS WIRE)--Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN), a clinical stage biotechnology company developing immune-modulating therapies for the management and treatment of life-threatening conditions, today announced a strategic partnership to incorporate Natera's Prospera kidney transplant assessment test into Eledon's planned Phase 3 clinical trial of tegoprubart, an in.
Natera Inc. (NASDAQ:NTRA) said Japan's Ministry of Health, Labour and Welfare approved its Signatera molecular residual disease (MRD) test for patients with colorectal cancer in the adjuvant setting, making it the first PMDA-approved MRD test in the country.
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This approval supports the use of Signatera for patients with colorectal cancer (CRC) in the adjuvant setting and makes Signatera the first PMDA-approved MRD test in Japan. Natera expects to commercially launch Signatera for CRC in Japan by the end of 2.
Exelixis falls after STELLAR-303 misses statistical significance in overall survival for a key colorectal cancer subgroup, raising approval uncertainty.
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the National Comprehensive Cancer Network® (NCCN®) has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to include tumor-informed multiplex PCR circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing in the treatment algorithm for patients with MIBC.The updated guidelines state that the Panel “recommends the conside.
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced its robust scientific presence at the upcoming American Transplant Congress (ATC), taking place June 20-24, 2026. The company and its collaborators will share 21 presentations, including seven oral presentations, highlighting the utility of the Prospera test to inform risk assessment and long-term graft monitoring across kidney, heart, lung, and multi-organ transp.
Natera, Inc. (NTRA) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Natera teams with CytoDyn to track ctDNA in CLOVER Phase 2, using Signatera to map leronlimab response in metastatic colorectal cancer.
AUSTIN, Texas & VANCOUVER, Wash.--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn”), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, today announced a strategic collaboration to evaluate circulating tumor DNA (ctDNA) dynamics and generate real-world molecular insi.
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AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the appointments of Thomas Lynch, M.D., and Eric Rubin, M.D., to the Company's board of directors. “Tom and Eric have helped lead some of the most important advances in modern oncology, and we are thrilled to welcome them to the Board,” said Matthew Rabinowitz, Ph.D., co-founder of Natera and executive chairman of the board. “Their deep expertise across evidence.