US-based company that deals with innovative and comprehensive laboratory services Labcorp (NYSE: LH) announced on Friday that the US Food and Drug Administration (FDA) has granted De Novo marketing authorisation for PGDx elio plasma focus Dx, claimed to be the first and only kitted, pan-solid tumour liquid biopsy test.

The company says that the product builds on the success of PGDx elio tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable.

PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridisation-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.

Shakti Ramkissoon, MD, PhD, MBA, vice president, medical lead for oncology at Labcorp, 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.'