Labcorp has announced the clinical availability of Labcorp Plasma Complete, a new circulating tumour DNA (ctDNA)-based genomic profiling solution for advanced solid tumours.
This liquid biopsy test is intended to help oncologists make personalised treatment decisions from a simple blood draw.
It is said to offer comprehensive genomic profiling for patients with advanced cancer.
Labcorp Plasma Complete is designed to detect genomic alterations in ctDNA across 521 genes.
It identifies single nucleotide variants (SNVs), insertions/deletions (InDels), amplifications in 12 genes, translocations related to 12 genes, and microsatellite instability (MSI) high status.
This assay includes both established and emerging biomarkers linked to US Food and Drug Administration (FDA)-approved therapies, guideline-driven treatments, and clinical trial eligibility.
According to Labcorp, the new genomic profiling solution delivers clear, comprehensive clinical reports, supported by bioinformatics, thereby simplifying the interpretation of complex genomic data for oncologists.
This integration with the company’s cancer diagnostic portfolio brings down complexity and guides treatment decisions throughout all stages of cancer care.
Additionally, Labcorp Plasma Complete remains available for biopharmaceutical research alongside its new application for clinical patient care.
It is a laboratory-developed test (LDT), validated in Labcorp’s College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Labcorp vice president and oncology medical lead Shakti Ramkissoon said: “Labcorp Plasma Complete delivers powerful and comprehensive genomic insights and helps guide targeted treatment decisions even when tissue-based testing is not feasible.
“Now available for clinical use, Labcorp’s solution further expands Labcorp’s extensive oncology portfolio and reflects our commitment to supporting oncologists in delivering more personalised patient care.”
Labcorp said that the genomic profiling solution’s clinical accuracy and reliability has been confirmed in several validation studies. The test offered a reportable range with a variant allele frequency as low as 0.1% and a specificity greater than 99.99%.
This enables precise detection of tumour-specific biomarkers linked to disease progression and therapy resistance, the laboratory services provider said. The ability to identify actionable mutations at low levels gives oncologists confidence in making informed treatment decisions.
In December 2024, Labcorp introduced its new H5 bird flu molecular test in the US to support the diagnosis of human infection with H5 bird flu.
