Invivoscribe is excited to announce that the LeukoStrat CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib).

Tempus, a leader in artificial intelligence and precision medicine, today announced a new collaboration to develop a companion diagnostic (CDx) test with TScan Therapeutics, a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of cancer patients.

ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDx™ as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox).

In the decade since Foundation Medicine first launched its FoundationOne genomic profiling test to look for specific biomarkers in tumor tissue samples, it has racked up dozens of FDA approvals allowing the test to serve as a companion diagnostic for a broad spectrum of cancer drugs.

The US Food and Drug Administration (FDA) has granted approval for Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic for Takeda’s Exkivity (mobocertinib).

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved the AmoyDx Pan Lung Cancer PCR Panel as a companion diagnostic to direct the use of Eli Lilly's Retevmo (selpercatinib) in RET fusion-positive non-small cell lung cancer.