Close Menu

Personal Genome Diagnostics

The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.

The partners will focus on optimizing technology and conducting clinical utility studies for liquid biopsy and tissue-based genomic applications.

The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.

The company said it has seen progress in efforts to get FDA approval for its tissue and liquid biopsy tests as data continues to accumulate for pan-cancer utility.