Pillar Biosciences PMA Approved for Diagnostic

FDA has approved a Pillar Biosciences PMA for its oncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing (NGS) tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer tumors.

Pillar says the approval was based on clinically validated data, and allows for the test to be used as a companion diagnostic for all FDA approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapies for NSCLC targeting certain EGFR mutations and KRAS wild-type tumor tissue (for metastatic colorectal cancer patients. The assay is intended to help clinicians determine when targeted treatment with Eli Lilly’s Erbitux (cetuximab) or Amgen’s Vectibix (panitumumab) is warranted. This panel is intended to be used on the Illumina MiSeq Dx instrument, Illumina’s NGS platform for in vitro diagnostic testing.