An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
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.
The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
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).