Summary: Labcorp has received De Novo marketing authorization from the FDA for its PGDx elio plasma focus Dx, a new liquid biopsy test for genomic profiling of pan-solid tumors when tissue samples are limited or unavailable.

Takeaways:

  1. Advanced Genomic Profiling: The PGDx elio plasma focus Dx uses next-generation sequencing to detect various genetic alterations in 33 genes, offering a high-throughput, hybridization-based capture technology for precise clinical assessments.
  2. Enhanced Clinical Decision-Making: The test targets guideline-recommended biomarkers and integrates automated bioinformatics, allowing oncologists to make timely treatment decisions with more accurate data.
  3. Convenience and Integration: Labcorp’s new liquid biopsy test provides a cost-effective solution for laboratories, seamlessly integrating with existing workflows and complementing the PGDx elio tissue complete assay for comprehensive tissue and liquid profiling.

Labcorp has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its PGDx elio plasma focus Dx, a new kitted, pan-solid tumor liquid biopsy test.

PGDx elio plasma focus Dx builds on the success of PGDx elio tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable.

About PGDx elio plasma focus Dx

PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions, and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. 

The assay targets guideline-recommended biomarkers to enable more accurate clinical assessments and is coupled with automated bioinformatics to deliver accelerated results. This solution enhances oncologists’ ability to make timely treatment decisions in conjunction with other laboratory and clinical findings while also promoting sample and data ownership.

“The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions,” says Shakti Ramkissoon, MD, PhD, MBA, vice president, medical lead for oncology at Labcorp. “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.”

Further reading: Labcorp Launches Global Trial Connect to Accelerate Clinical Trials

Photo: Labcorp