PGDx Elio Plasma Focus Dx Receives FDA De Novo Marketing Authorization for Pan–Solid Tumor Liquid Biopsy

FDA

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

PGDx elio plasma focus DX is the first and only kitted, pan–solid tumor liquid biopsy test. The qualitative next-generation sequencing–based in vitro diagnostic uses a targeted high throughput hybridization-based approach to capture single-nucleotide variants (SNVs), insertions, and deletions in 33 genes. Additionally, the test can detect copy number amplifications and translocations in 5 and 3 genes, respectively. The test is designed to detect amplifications in CCND1, CD274, ERBB2, FGR2, and MET, as well as translocations in ALK, NTRK1, and RET.^1,2

The testing kit provides results in 4 to 5 days with a clinical success rate of over 96%. It provides analytical sensitivity of more than 0.31% variant allele frequency (VAF) in actionable SNVs and indels, over 0.76% VAF in nonactionable SNVs and indels, with respective reportable ranges of over 0.1% VAF and at least 0.5% VAF. Additionally, all amplifications have an analytical sensitivity of at least 1.3-fold, with a minimum 1.2-fold reportable range, and all amplifications have an analytical sensitivity of 0.41% fusion read fraction, with a reportable range of at least 3 fusion reads.²

“The launch of PGDx elio 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, stated 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. 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.”

PGDx elio plasma focus DX is directed toward guideline-recommended biomarkers and is paired with automated bioinformatics to allow for more accurate clinical assessments and to produce findings in an accelerated time span. The test enables clinicians to make timely decisions with the input of other laboratory and clinical data; it also promotes sample and data ownership.¹

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

PGDx elio plasma builds upon the PGDx elio tissue complete test to allow laboratories to execute genomic testing when tissue samples are limited or unavailable. PGDx elio tissue complete is an FDA-cleared tumor profiling kit that delivers automated findings with a clinical success rate of more than 92%. The test examines 505 tumor-related genes and provides easy-to-interpret reports outlining genetic alterations with the potential to affect cancer care decisions. The test provides a variant report within 5 days using isolated nucleic acid in 35 solid tumor types.^1,3

References

1. Labcorp receives FDA de novo marketing authorization for PGDx elio plasma focus Dx. News release. Labcorp. August 2, 2024. Accessed August 2, 2024. https://www.labcorp.com/labcorp-receives-fda-de-novo-marketing-authorization-pgdx-eliotm-plasma-focus-dx
2. PGDx elio plasma focus Dx. Labcorp. Accessed August 2, 2024. https://www.personalgenome.com/products/elio-plasma-focus-Dx
3. PGDx elio tissue complete. Labcorp. Accessed August 2, 2024. https://www.personalgenome.com/products/elio-tissue-complete