Personal Genome Oncology Diagnostic Kit Cleared

FDA has cleared a Personal Genome Diagnostics 510(k) for PGDx eliotissue complete, a diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer. The device detects single nucleotide variants and small insertions and deletions (indels) in more than 500 genes, select amplifications and translocations, and genomic signatures including microsatellite instability and tumor mutation burden, the company says. “Collectively, the information from this diagnostic kit is intended for use by healthcare professionals to help tailor clinical management for patients based on their tumor’s unique genomic profile in accordance with professional guidelines,” it says. The genomic profiling assay also includes biomarkers to help select targeted cancer therapies and immunotherapies and identify patients for clinical trial participation.