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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.

The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.

The agency recommended the combination for previously untreated CLL patients with certain genetic mutations, including those with a 17p deletion or TP53 mutation.

The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.

The combination treatment was approved for metastatic NSCLC patients without EGFR or ALK gene mutations and regardless of their PD-L1 status.