The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
Caris will use its whole-transcriptome sequencing assay and Molecular Intelligence Trials service to identify patients for a phase II clinical trial.
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.
The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
The company announced agreements to use the Oncomine Dx Target Test in drug development programs with Daiichi Sankyo, Takeda, and Spectrum Pharmaceuticals.
The drugmaker will use Myriad's expanded molecular diagnostic panel to evaluate best responders to a combination of Lynparza and Avastin in clinical trials.