The Labcorp Plasma Complete test is a hybrid capture-based, targeted NGS test, optimized for 25 ng of cfDNA input and is intended for variant detection in all solid cancer indications. The test interrogates all coding exons of 521 genes to comprehensively detect single nucleotide variants (SNVs) and insertion and deletions (indels). The test also reports copy number amplifications (CNAs) gene translocations in 12 genes, and microsatellite instability (MSI).

In total, 631 cancer patient plasma samples were evaluated by the test including lung, breast, colorectal, head and neck, pancreatic, gynecologic, and prostate cancers among other indications. Well-characterized reference samples were utilized to assess analytical specificity. 

Key Highlights:

• Overall, the Labcorp Plasma Complete test addresses a clinical gap in the oncology community by providing highly specific (>99.99%), accurate (97.3% PPA and >99.99% NPA), and sensitive (down to 0.35% or 1.63-fold) variant detection to help direct clinicians towards targeted and personalized therapeutic options for cancer patients.

• There is growing support for comprehensive tumor profiling from plasma in oncology diagnostic practice as a viable and accurate alternative to tumor tissue testing.

• The Labcorp Plasma Complete test is an NGS-based laboratory-developed test for the detection of somatic sequence mutations in 521 clinically actionable or relevant genes, amplification detection in 12 genes, translocation identification in 12 genes, as well as microsatellite instability (MSI) from plasma-derived cfDNA. The test is intended for use by qualified healthcare professionals per professional oncology guidelines for patients already diagnosed with advanced-stage or metastatic solid tumors.

KOL insights

“Labcorp is paving its way for more accurate diagnostics and effective treatments” – Expert Opinion.

Conclusion

To conclude, the analytical validation of the Labcorp Plasma Complete test demonstrates that the liquid biopsy approach is highly sensitive, specific, accurate, reproducible, and robust for comprehensive genomic profiling to complement tissue-based testing and inform clinical decision-making.