TEST:

Labcorp® Plasma Focus™

Liquid biopsy next-generation sequencing assays help guide treatment selection in cancer patients, particularly when tumor tissue is unavailable. Analytical validation an FDA authorized targeted 33-gene kitted assay, PGDx elio™ plasma focus Dx, has shown that detection of cancer-associated variants in ctDNA is highly specific, sensitive, reproducible and accurate.

"Labcorp...announced...it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx – the industry's first and only kitted, pan-solid tumor liquid biopsy test."

Based on this clinical performance and utility real-world dataset, these data suggest that the Labcorp Plasma Focus test is highly effective for the rapid detection and reporting of clinically actionable and relevant biomarkers to help inform precision oncology decision-making.

"Labcorp...has launched Labcorp Plasma Focus, a new liquid biopsy test enabling targeted therapy selection for patients with advanced or metastatic solid tumors. The test allows treating oncologists to evaluate circulating cell-free DNA (cfDNA) released by tumor cells and better manage the care of their patients through a personalized, targeted therapy plan."

Patient accrual for this study initiated in February 2023. Clinical trial information: NCT05585684.

Average positive agreement from precision, reproducibility and repeatability experiments was 97.5% and 88.9% for SNVs/indels and CNAs, respectively, and 100% for translocations and MSI. Taken together, these data demonstrate that the Labcorp Plasma Focus test is a highly accurate, sensitive, and specific approach for cfDNA genomic profiling to supplement tissue testing and inform treatment decisions.

Q4 2022 Laboratory Corporation of America Holdings Earnings Call