PGDx receives FDA clearance for comprehensive genomic profiling diagnostic kit for oncology

May 11, 2020

Personal Genome Diagnostics announced that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner.

By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

“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,” said Megan Bailey, Chief Executive Officer, PGDx.

PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI) and tumor mutation burden (TMB). 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.

The broad genomic profiling assay includes biomarkers to help inform the use of targeted cancer therapies and immunotherapies and can help oncologists identify patients for clinical trial participation. This FDA clearance was supported by a magnitude of data that demonstrates consistency of performance across multiple lab sites, and accuracy data across all variant classes in clinical samples from 35 tumor types.

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