NEW YORK – Consumer genomics firm 23andMe last week provided additional information on the court-supervised sale of its assets. The company will not accept bids from entities based in or with controlling investments from certain countries, including China, Cuba, Iran, North Korea, Russia, or Venezuela, out of concern for customer privacy and national security. Bidders will also be required to guarantee that they will comply with the company’s privacy policies and applicable law, and the company is asking bidders for detailed descriptions of their intended use of any purchased customer data.
OS Therapies will meet with the US Food and Drug Administration to discuss expedited approval of its OST-HER2 immunotherapy for fully resected lung metastatic osteosarcoma, the biopharmaceutical company said this week. The treatment uses listeria bacteria to initiate a strong immune response, which the company said improved 12-month event-free survival outcomes for patients in Phase IIb clinical trials. OS Therapies expects the FDA’s written response by June and said the treatment could be available to patients in early 2026 if it is granted breakthrough therapy designation and then approved.
Zai Lab said this week that China's National Medical Products Administration accepted its supplemental new drug application seeking approval for ROS1/TRK/ALK inhibitor Augtyro (repotrectinib) for the treatment of adult patients with previously treated advanced or metastatic solid tumors that harbor an NTRK gene fusion. Augtyro was already approved in China for ROS1-positive advanced or metastatic non-small cell lung cancer in May 2024. In the US, Augtyro is marketed by Bristol Myers Squibb and was approved in June 2024 for NTRK fusion-positive solid tumors. Zai Lab holds rights to develop and commercialize Augtyro in China, Hong Kong, Taiwan, and Macau.
Genetic Alliance said this week that Galatea Bio has joined the iHope Genetic Health (iGH) program, expanding access to no-cost genomic testing for underserved families around the world. Galatea Bio, based in Miami Lakes, Florida, plans to enroll millions of participants in Africa, Latin America, Asia, the Middle East, Southern Europe, Eastern Europe, and other regions that have been underrepresented in large-scale genomic studies to its Galatea Global Biobank (GGB). As part of iGH, it will provide diagnostic services to children with suspected rare genetic diseases in low- and middle-income communities who lack access to molecular testing.
Mursla Bio said this week that it has secured US Food and Drug Administration breakthrough device designation for its EvoLiver combination test for the detection of hepatocellular carcinoma. The test uses an immunoassay to isolate organ-specific extracellular vesicles and a qPCR test for the detection of miRNA targets, and it is intended for the surveillance of cirrhotic patients who are at elevated risk of liver cancer. Breakthrough device designation is used to hasten regulatory processes for devices that could improve the diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.
Baebies announced this week that its Anti-Factor Xa heparin monitoring test on its Finder platform has obtained breakthrough device designation from the US Food and Drug Administration, enabling access to priority review and dedicated regulatory guidance. The test is intended for use at the point of care and provides results in less than 15 minutes from 50 microliters of whole blood.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.