The US Food and Drug Administration (FDA) has issued De Novo marketing authorisation for healthcare company Labcorp’s liquid biopsy test, PGDx elio plasma focus Dx.
The kitted, pan-solid tumour liquid biopsy test facilitates genomic profiling when tissue samples are scarce or unavailable.
It is a qualitative in vitro diagnostic device that leverages next-generation sequencing.
The technology behind PGDx elio plasma focus Dx employs targeted high throughput hybridisation-based capture. This approach is instrumental in the detection of single nucleotide variants (SNVs), copy number amplifications (CNAs) in five genes, insertions and deletions (indels) in 33 genes and translocations in three genes.
The assay's automated bioinformatics component ensures rapid delivery of results.
PGDx elio is designed to assist oncologists in making informed treatment decisions in conjunction with other laboratory and clinical findings.
Labcorp oncology medical lead, vice-president Shakti Ramkissoon 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 tumour-profiling solution that spans a wide range of solid-tumour types – particularly when tumour 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 personalised treatments and care plans for patients.”
