Blood-test results changed planned treatment for 1 in 3 patients in a colon cancer trial.

Natera Inc. (NTRA) and TransCode Therapeutics Inc. (RNAZ) announced a collaboration to enroll patients in a colorectal cancer clinical trial using Natera's Signatera test to identify eligible patients. The trial targets patients at risk of recurrence but with no approved therapies. TransCode's TTX-MC138 aims to inhibit a biomarker linked to metastatic cancers. The trial is part of the PRE-I-SPY program and is registered at clinicaltrials.gov.

TransCode Therapeutics and Natera are collaborating to identify colorectal cancer patients with molecular residual disease (MRD) for a Phase 2a trial of TTX-MC138. The trial, conducted under Quantum Leap Healthcare's PRE-I-SPY program, aims to address the unmet need for treating MRD-positive patients who are disease-free on imaging. TTX-MC138 targets microRNA-10b, a biomarker linked to metastatic cancers. Natera's Signatera test will help streamline patient enrollment.

Natera (NTRA) will use its Signatera MRD test to identify patients for TransCode's Phase 2a TTX-MC138 trial in the PRE-I-SPY program. The trial aims to extend the use of MRD beyond detection. Success depends on positive Phase 2a results and evidence of improved outcomes.

Natera's multi-cancer early detection assay received FDA Breakthrough Device designation. The blood-based test screens for multiple cancers using cell-free DNA, addressing gaps in current screening options. The FDA reviewed data from 12 cancer types, focusing on sensitivity, specificity, and signal origin. The designation accelerates development and review but does not permit marketing. Natera plans to continue collaborating with the FDA.

Natera (NTRA) received FDA Breakthrough Device designation for its multi-cancer early detection blood test. The company's share price has surged 75.10% year-to-date and 136.73% over one year. Analysts have mixed valuations, with some suggesting a 13% overvaluation, while a DCF model indicates a 33% undervaluation. Risks include reimbursement changes and high R&D spending.

Natera (NTRA) stock rose 2.2% after the FDA granted Breakthrough Device designation to its multi-cancer early detection assay. The assay showed promising performance data across 12 cancer types. The company's shares are up 74.9% year-to-date, trading near a 52-week high of $425.64. Natera plans a commercial launch in Japan in 2027 for its Signatera test, approved as a companion diagnostic for bladder cancer.