NEW YORK – Personal Genome Diagnostics said on Monday that it has received US Food and Drug Administration clearance for its PGDx Elio Tissue Complete, a next-generation sequencing diagnostic assay that molecular labs can use to perform genomic profiling of cancer.
The Baltimore-based firm said the FDA clearance was supported by data that "demonstrates robustness and consistency" of performance across several lab sites and all variant classes in clinical samples from 35 tumor types.
"Nearly 80 percent of patients aren't getting the clinical insights they need to inform their treatment path, or they aren't being tested in a window of time that makes a difference in determining their care," Megan Bailey, CEO of PGDx, said in a statement. "PGDx Elio Tissue Complete responds to this unmet need by bringing genomic cancer testing of the highest quality directly to healthcare providers."
PGDx's Elio Tissue Complete NGS assay identifies single nucleotide variants and small insertions and deletions in 507 genes, select amplifications and translocations and genomic signatures including microsatellite instability, and tumor mutation burden. The profiling assay includes biomarkers to help inform clinicians so that they can choose appropriate targeted cancer therapies and immunotherapies, as well as to help identify patients for clinical trial participation.