LabCorp + Illumina biopsy kits
LabCorp and Illumina announced combined tissue-and-liquid biopsy kits that deliver comprehensive genomic profiling and whole‑genome sequencing into clinic and hospital settings, supported by real‑world NSCLC data from 7,600 tumors. That deal is designed to democratize biomarker testing at the point of care — meaning more cytology and FNA specimens will be reflexed to molecular pipelines and require tighter cross‑section workflows. (stocktitan.net)
Illumina and Labcorp published an expanded collaboration on March 18, 2026 that specifically calls out development of distributed in‑vitro diagnostic (IVD) test offerings for hospitals and community health systems. (investor.illumina.com) The announcement says the partners will explore co‑commercializing Labcorp’s PGDx elio® plasma focus™ Dx liquid biopsy and Illumina’s TruSight™ Oncology Comprehensive solid‑tumor IVD. (investor.illumina.com) TruSight Oncology Comprehensive was granted FDA approval (PMA P230011) on August 21, 2024 as a distributable CGP kit that interrogates hundreds of tumor genes for companion‑diagnostic claims. (fda.gov) Labcorp’s PGDx elio™ plasma focus Dx received FDA De Novo marketing authorization on August 2, 2024 as a kitted, pan‑solid tumor liquid biopsy that detects SNVs/indels in 33 genes plus select CNAs and fusions. (prnewswire.com) A joint real‑world analysis published by Illumina and Labcorp investigators profiled 7,606 advanced/metastatic NSCLC tumor specimens using the TruSight Oncology 500 assay and reported variants linked to an approved targeted therapy or clinical trial in more than 72% of tumors, with noted associations between specific driver alterations, PD‑L1 and TMB. (frontiersin.org) Labcorp, which completed its acquisition of Personal Genome Diagnostics (PGDx) in February 2022 for about $450 million, markets both the elio tissue and plasma kitted assays that run on the same platform to enable in‑house CGP with a simple verification step and tighter chain‑of‑custody and turnaround control. (businesswire.com) (oncology.labcorp.com) Peer‑reviewed cytology work from MSK showed 4,871 prospectively sequenced clinical cytology samples (smears, liquid‑based preparations, cell blocks and supernatant) achieved success rates up to 93% after process optimization, with residual supernatant cfDNA rescuing results in 71% of cases where cell‑block tissue was depleted—data that underpins the operational changes labs will need to validate cytology/FNA inputs for these distributed CGP and liquid assays. (nature.com)
