US-based healthcare company Labcorp has received the US Food and Drug Administration (FDA) De Novo marketing authorisation for its PGDx elio plasma focus Dx.
The PGDx elio plasma focus Dx is a qualitative sequencing-based in-vitro diagnostic device that leverages targeted high-throughput hybridisation-based capture technology.
The in vitro diagnostic device is designed to enable in-house liquid biopsy profiling and serves as a reliable alternative to tissue genomic profiling for advanced cancers.
It can detect single nucleotide variants (SNVs), insertions and deletions in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes.
Also, the device offers actionable insights with a more than 96% clinical success rate.
The PGDx elio plasma focus Dx is the world’s first, and only kitted, pan-solid tumour liquid biopsy test, said the diagnostic devices maker.
Labcorp vice president and oncology medical lead 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.
According to Labcorp, PGDx elio plasma focus Dx is designed based on its PGDx elio tissue complete and allows laboratories to perform genomic profiling when tissue is limited.
The assay targets guideline-recommended biomarkers for accurate clinical assessments and delivers advanced results together with automated bioinformatics.
It enhances oncologists’ ability to make timely treatment decisions in conjunction with other laboratory and clinical findings while also promoting sample and data ownership.
Ramkissoon added: “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.”
Recently, Labcorp expanded its partnership with Ultima Genomics to explore new whole genome sequencing (WGS) clinical applications, using its UG 100 sequencing solution.
