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NTRA 資訊
NTRA 事件
Natera and TransCode Collaborate on Colorectal Cancer Research
Natera (NTRA) and TransCode Therapeutics (RNAZ) announced a strategic collaboration in colorectal cancer, CRC. The collaboration will support enrollment for TransCode's Phase 2a trial evaluating TTX-MC138 in patients with CRC. Patients will be eligible for enrollment if they have completed curative-intent therapy and remain positive for molecular residual disease, as detected by Natera's Signatera test, with no radiographic evidence of disease. The collaboration aims to surface patient populations who meet the trial's MRD-positive eligibility criteria more efficiently, streamline site-level identification, and optimize the pace and quality of enrollment for the study.
Natera Receives FDA Breakthrough Device Designation
Natera 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. "Too many cancers are diagnosed after they've progressed, simply because limited screening options exist," said Alexey Aleshin, M.D., corporate chief medical officer and general manager, oncology and early cancer detection, Natera. "This designation underscores the rigor and promise of our MCED program, and we look forward to working with the FDA as we aim to detect cancer earlier, when it's easier to treat."
Natera Launches Signatera-Guided Melanoma Trial
Natera announced the enrollment of the first patients in a new Signatera-guided trial in melanoma, sponsored by NYU Langone Health. The study uses Signatera to guide treatment escalation for patients with advanced or metastatic melanoma, an aggressive form of skin cancer. The current standard of care for these patients is combination immunotherapy until clinical progression. This trial is designed to identify patients who may need earlier intervention by detecting persistent molecular residual disease prior to radiographic progression.
AFT and Natera Launch AFT-70 NAVIGATE Clinical Trial
Alliance Foundation Trials, AFT, and Natera (NTRA) announced the launch of AFT-70 NAVIGATE, a randomized phase III trial evaluating a novel molecular residual disease-guided treatment strategy for patients with intermediate and high-risk ER-positive/HER2-negative early breast cancer. The trial is sponsored and led by AFT, with collaboration and co-funding from Natera and Genentech, a member of the Roche (RHHBY).
BTIG Analyst Says Grail Cancer Test Received Positive FDA Vote
BTIG analyst Mark Massaro says following the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee for the Galleri cancer test from Grail (GRAL) that while the company "got a net positive vote," the panelist votes on effectiveness and benefit/risk was "closer than we expected" and "even closer when you listened to the expert's responses to their votes." The firm, which does not have a rating on Grail, thinks the panel "should most likely (but is not a lock to) bode well for the company's FDA approval prospects" and thinks "a rising tide is likely to lift many boats." The first FDA AdCom panel convened to discuss a multi-cancer early detection test will have direct readthroughs to other MCED tests either launched, or in development, from our Guardant Health (GH), Abbott's (ABT) Exact Sciences, Caris Life Sciences (CAI), Freenome (FRNM) and Natera (NTRA), the analyst added.
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