The firm is also developing a methylated DNA biomarker test — called EsoCheck Dx — for Barrett's esophagus that uses samples collected with EsoCheck.
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
CPIC wants to issue guidelines for non-actionable genes, standardize PGx terms, and work with groups like ClinGen and ClinVar to expand use of its guidelines.
The draft guidance also provides recommendations about communicating the results of biotin interference testing to users of diagnostic tests.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
The collaboration between 15 federal and state groups used a workshop format originally developed by CDC to help other countries with their One Health issues.
The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.
The immunoassays are are indicated for the quantitative determination of IgM RF antibodies and the semi-quantitative determination of IgA RF antibodies.
The self-administered test is designed to detect human chorionic gonadotropin levels in women as early as six days before a first missed period.
The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.