PGDx Elio Plasma Focus Dx Gains FDA De Novo Marketing Authorization

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• De novo marketing authorization has been granted by the FDA to the PGDx elio^TM plasma focus Dx.
• PGDx elio^TM plasma focus Dx is the industry's first and only kitted, pan-solid tumor liquid biopsy test.
• The testing kit can provide results in 4 to 5 days and has a clinical success rate of over 96%.

The FDA has granted a de novo marketing authorization to the PGDx elio^TM plasma focus Dx, a pan-solid tumor liquid biopsy test for tumor mutation profiling via simple blood draw.¹

“The launch of PGDx elio^TM plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions,” Shakti Ramkissoon, MD, PhD, MBA, vice president, medical lead for oncology at Labcorp, said in a news release.¹ “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.”

As the first and only kitted, pan-solid tumor liquid biopsy test, PGDx elio^TM plasma focus Dx utilizes targeted high throughput hybridization-based capture technology to detect single nucleotide variants (SNVs), insertions, and deletions in 33 genes. The qualitative next-generation sequencing-based in vitro diagnostic also is able to detect copy number amplifications in 5 genes (CCND1, CD274, ERBB2, FGR2, and MET), as well as translocations in ALK, NTRK1, and RET.

PGDx elio^TM plasma focus Dx targets guideline-recommended biomarkers to make more accurate clinical assessments and is paired with automated bioinformatics. This allows for findings to be delivered in a quicker time span.

The testing kit allows clinicians to make timely decisions along with the results from other laboratory and clinical data. PGDx elio^TM plasma focus Dx also promotes sample and data ownership.With a clinical success rate of over 96%, the in vitro diagnostic device can provide results in 4 to 5 days.²

The test demonstrates high sensitivity across all variant types, including analytical sensitivity of more than 0.31% variant allele frequency (VAF) in actionable SNVs and insertions/deletions, over 0.76% VAF in nonactionable SNVs and insertions/deletions, with respective reportable ranges of over 0.1% VAF and at least 0.5% VAF. All amplifications have an analytical sensitivity of at least 1.3-fold, with a minimum 1.2-fold reportable range. Further, all amplifications have an analytical sensitivity of 0.41% fusion read fraction and a reportable range of at least 3 fusion reads.

The panel size used in the test is 0.24 Mb. This is used to examine cell-free DNA samples sized at 25 ng. The read length is 2 x 150 bp. Further, the mean total/de-duplicated error-corrected coverage is 30,000x/2600x.

“When paired with PGDx elio^TM 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,” added Ramkissoon in the press release.

REFERENCES:

1. Labcorp receives FDA de novo marketing authorization for PGDx elio plasma focus Dx. News release. Labcorp. August 2, 2024. Accessed August 5, 2024. https://tinyurl.com/3bn8fw2r

2. PGDx elioTM plasma focus Dx. Labcorp. Accessed August 5, 2024. https://www.personalgenome.com/products/elio-plasma-focus-Dx