News and reporting on BRCA biomarkers.
The combination test will allow clinicians to analyze breast cancer patients for germline hereditary cancer markers at the same time as they search their blood for driver mutations.
FDA clearance of the first NGS companion diagnostic paves the way for other comprehensive genomic profiling tests, but Foundation will have to educate docs on the benefits of its test.
The test is approved to identify patients who harbor BRCA mutations and are therefore more likely to respond to Clovis Oncology's ovarian cancer drug Rubraca.
Invitae will test 1,000 breast cancer patients from TME practices using its hereditary cancer test, regardless of whether they meet current eligibility criteria.
Progression-free and overall survival seen in the veliparib arm weren't statistically significant, but were encouraging enough to move the drug to Phase III, AbbVie said.
The new assay, called the CellMax-DNA Genetic Cancer Risk Test, will complement CellMax Life's planned slate of liquid biopsy assays for early cancer detection.
The molecular diagnostics firm said it will submit its BRACAnalysis CDx alongside AstraZeneca's Lynparza to Japan's Pharmaceuticals and Medical Devices Agency.
Multiple variant databases are creating competition among groups that disagree on how to advance the most scientifically robust and sustainable sharing model.
A Counsyl study suggests that just half of individuals go through with insurance-mandated pretest genetic counseling, paying out of pocket or canceling the test instead.
The study showed an overall benefit regardless of BRCA mutation or HRD status, but some analysts believe the FDA still might require a CDx for niraparib.