Labcorp, a US-based laboratory services provider, has secured the CE mark for its PGDx elio tissue complete solution under the European Union’s (EU) new In Vitro Diagnostic Regulation (IVDR).
The development enhances access to personalised cancer care for patients across the EU.
PGDx elio tissue complete is a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device.
It analyses DNA from formalin-fixed paraffin-embedded (FFPE) tumour tissue to detect clinically relevant gene alterations across 505 genes for pan-solid tumours.
The in-house comprehensive tumour profiling assay provides genomic insights with a clinical success rate of 93.2%.
Approved by the US Food and Drug Administration (FDA), the assay supports physicians in delivering guideline-based care for patients with solid tumours.
Its capability to analyse multiple biomarkers simultaneously, even with limited tissue samples, offers insights that can aid patient care and clinical management.
The test reduces the burden of implementation and accelerates the time to go-live.
The IVDR certification ensures alignment with the highest safety and performance standards in the EU, eliminating the need for full validation and requiring only on-site verification steps.
Custom implementation support and dedicated project management further expedite the path to go-live.
The PGDx elio tissue complete provides robust, reliable, and clinically comprehensive profiling.
It targets guideline-driven biomarkers for pan-solid tumours, including 505 clinically relevant genes and key genomic signatures such as microsatellite instability (MSI) and tumour mutational burden (TMB), achieving a high clinical success rate of 93.2%.
The assay opens avenues for both research and clinical studies by maintaining sample chain of custody for accurate reporting and clinical compliance, while retaining access to archival samples to drive novel insights.
With the CE-marking, the test can now be offered by more laboratories across the EU, expanding patient access to personalised cancer care.
PGDx elio tissue complete facilitates in-house testing for laboratories, reducing costs, accelerating implementation, and enabling patients to get tested sooner.
Labcorp plans to commercialise the assay for biopharma partners and for investigational use in global clinical trials through its central laboratory in Geneva, Switzerland.
Labcorp vice president, oncology medical lead Shakti Ramkissoon said: “This accomplishment reflects Labcorp’s commitment to advancing precision medicine and improving patient care.
“With both FDA clearance and IVDR CE-mark, this test sets a new standard for quality and performance in cancer diagnostics.
“Importantly, it also provides our biopharma partners with a reliable, regulatory-ready solution to de-risk multiyear clinical trial strategies, ensuring continuity in NGS testing for trials that will extend beyond the IVDR transition timelines.”
