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.
The drugmaker is subsidizing the cost of BRCA testing for women diagnosed with ovarian cancers, for whom guidelines now recommend such testing for cancer therapy selection.
If approved, the companion test can be used to identify which metastatic breast cancer patients have mutations in BRCA1/2 genes and are likely to respond to Lynparza.
