Natera, a cell-free DNA and precision medicine company, has acquired Foresight Diagnostics in an all-stock deal valued at up to $450 million. Foresight specializes in ultrasensitive molecular residual disease detection.

Freenome Holdings plans to go public through a $330 million SPAC merger with Perceptive Capital Solutions, with additional investments from RA Capital, Bain Capital Life Sciences and others. The funding will support the 2026 launch of Freenome's blood-based cancer screening tests.

Tagomics has received $1.15 million from Innovate UK to develop a diagnostic test for the early detection of colorectal cancer using its Interlace multiomic platform. The funding will support a 250-patient pilot study with the NHS to evaluate the test's performance in real-world settings.

The FDA generally will require randomized controlled trials for the approval of CAR T-cell therapies, except in cases involving rare or multiple relapsed or refractory populations, FDA Center for Biologics Evaluation and Research officials wrote in the Journal of the American Medical Association. While single-group trials have supported previous approvals, RCTs with survival or time-to-event endpoints will be preferred moving forward.

Roche has received a CE mark for its cobas bacterial vaginosis/candida vaginitis assay, which identifies bacteria and yeast associated with vaginitis. The assay uses PCR technology to provide precise results from a single vaginal swab, enabling targeted therapies and reducing treatment delays.

The FDA has approved Waskyra, the first gene therapy for Wiskott-Aldrich syndrome, a rare and serious immune disorder. Developed by the Italian nonprofit Fondazione Telethon ETS, the therapy modifies a patient’s blood stem cells to carry functional copies of the WAS gene.

The FDA has approved omidubicel-onlv (Omisirge), the first cell therapy for severe aplastic anemia. The approval followed data showing 95% of patients achieved rapid neutrophil recovery, and 94% had disease-free and overall survival.