The serum-based proteomic test gauges a pre-treatment immune profile that has shown in retrospective studies to identify patients who are likely to respond well to anti-PD-1 therapy.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
However, the lack of biomarker-specific treatment data kept researchers from definitively concluding that precision oncology treatments were behind an accelerated rate of NSCLC mortality decline.
GenPro will use its EpiMarker machine-learning platform to identify a network of genomic DNA methylation sites in patients' circulating immune cells that may be predictive of drug response.
The company recently presented results from its Aurora assay for multi-cancer screening and plans to launch a $100 test for the US and Chinese markets.
Researchers reported a correlation between ctDNA clearance and progression-free survival in EGFR-positive, MET-amplified patients treated with Tagrisso and savolitinib.
