FDA Grants De Novo Marketing Authorization to Labcorp’s Genomic Testing Kit

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FDA granted De Novo marketing authorization to Labcorp for its kitted, pan-solid tumor liquid biopsy test.¹ The PGDx elio plasma focus Dx provides laboratories with the ability to perform genomic profiling in situations when obtaining sample tissue is difficult or impossible.

According to Labcorp, the test is capable of detecting various biomarkers across 33 genes, CNAs in five genes, and translocations in three genes.

In a press release, Labcorp vice president and medical lead for oncology Shakti Ramkissoon, MD, PhD, MBA, said, “The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp's suite of precision oncology solutions. This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients."

This is the latest news to come from Labcorp involing the company expanding its genomic testing capabilities in oncology. In July, the company announced that it had expanded its collaboration with Ultima Genomics and would using that company’s UG 100 sequencing solution to develop novel genome sequencing clinical applications.²

In a press release issued at the time, Ramkissoon said, “By combining Labcorp's leadership, testing capabilities and expansive network with the accuracy, scalability and cost-effectiveness of Ultima's technology, we can help transform oncology testing for pathologists, oncologists and our biopharmaceutical partners. Through this collaboration, Labcorp aims to drive increased efficiency, scalability and cost-effectiveness while improving access to affordable genetic testing in emerging areas with significant unmet need."

Ultima Genomics CEO Gilad Almogy also said, “We look forward to expanding our collaboration with Labcorp to explore the use of our technology in the fast-growing clinical areas of MRD and clinical WGS. At Ultima, we developed our unique sequencing architecture to specifically meet the needs of large-scale applications. The ability to be accurate at extremely low limits of detection with our ppmSeq technology and extreme sequencing depth will be transformational for oncology testing and applications such as cell-free DNA."

Labcorp is also involved in projects designed to improve the clinical trial process. In June of this year, the company announced that it was launching Labcorp Global Trial Connect, a program designed to increase efficiency and speed up processes at investigator sites during clinical trials.³

In a press release issued at the time, Labcorp EVP and president of central laboratories and international Jon DiVincenzo said, “The patient-investigator-biopharma sponsor relationship is at the foundation of a successful clinical trial. Global Trial Connect simplifies the investigator workflow, improves the patient experience and ultimately enables biopharma sponsors to bring therapies to market faster. As the world's leading central laboratory, Labcorp is dedicated to improving the pace of clinical trials focusing on the investigator site experience from study initiation to patient recruitment and data collection."

Sources

1. Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio™ plasma focus Dx. Labcorp. August 2, 2024. https://www.prnewswire.com/news-releases/labcorp-receives-fda-de-novo-marketing-authorization-for-pgdx-elio-plasma-focus-dx-302213353.html
2. Labcorp Expands Collaboration with Ultima Genomics to Advance Whole Genome Sequencing Applications and Oncology Testing Capabilities. Labcorp. July 30, 2024. Accessed August 2, 2024. https://www.prnewswire.com/news-releases/labcorp-expands-collaboration-with-ultima-genomics-to-advance-whole-genome-sequencing-applications-and-oncology-testing-capabilities-302209091.html
3. Labcorp Launches Global Trial Connect to Accelerate Clinical Trials. Labcorp. June 17, 2024. Accessed August 2, 2024. https://www.prnewswire.com/news-releases/labcorp-launches-global-trial-connect-to-accelerate-clinical-trials-302174129.html