The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.
Investigators from the pharma concluded that most liquid biopsy false positives and negatives could be traced to technical specifics of individual tests.
The BioFire FilmArray Pneumonia panel will be used to optimize clinical trial enrollment for an antibiotic to treat combat carbapenem-resistant A. baumannii infections.
Plans are in place for a Guardant360-based assay to predict response to AsztraZeneca's Tagrisso and for a blood-based TMB test using the larger GuardantOmni panel.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
Myriad Genetics' BRACAnalysis CDx can identify which metastatic patients have BRCA mutations and would likely benefit from treatment with AstraZeneca's Lynparza.
The drugmaker will use Myriad's expanded molecular diagnostic panel to evaluate best responders to a combination of Lynparza and Avastin in clinical trials.
Chembio said that under the agreement it will develop a quantitative, reader-based POC test that detects an undisclosed biomarker, and apply for FDA clearance.
