$575M LabCorp acquisition FDA 510(k) · PGDx elio
PGDx elio PlatformFDA Approved
Invented a microhaplotype-based contamination detection method and wrote the software for LabCorp's PGDx elio™ platform — detecting ≥0.2% contamination in unpaired clinical plasma (ctDNA) and tissue (FFPE) tumor samples. Performed the complete failure-mode audit of the elio™ platform prior to FDA submission. Authored technical documents for the successful FDA 510(k) filing. Clinically validated, FDA-approved, covered under Medicare and Medicaid. The platform sequences liquid and solid tumor genomes, diagnoses cancer sub-type, identifies approved targeted therapies, and pre-qualifies patients for experimental drug trials — matching people to studies likely to produce positive outcomes based on their personal genomic data.
