FDA clearance
FDA Clears Qiagen QiaStat-Dx Meningitis/Encephalitis Panel
The panel is the fourth FDA-cleared test on Qiagen's rapid syndromic QiaStat-Dx system.
Devyser Fetal Abnormality Test Nabs China Approval; Firm, Thermo Fisher Collaborate on FDA Approval
The fetal abnormality test measures the most common chromosomal abnormalities, including Down syndrome, via a single-tube PCR process.
FDA Approves Thermo Fisher Oncomine Dx Target Test as CDx for Servier's Voranigo Brain Cancer Drug
The approval expands the clinical indications for the test, which was previously approved as a CDx for non-small cell lung cancer, thyroid cancer, and bile duct cancer drugs.
FDA Approves Illumina Cancer Genomic Profiling Assay as CDx for Kinase Inhibitors From Bayer, Lilly
The test's first CDx approvals are for Bayer's Vitrakvi in solid tumors and for Lilly's Retevmo in non-small cell lung cancer.
Labcorp Receives FDA De Novo Authorization for Blood-Based Tumor Mutation Profiling Assay
The company's PGDx Elio plasma focus test is a next-generation sequencing assay that allows for mutation profiling of solid tumors from blood samples.