Illumina, Inc. (NASDAQ: ILMN) and Labcorp (NYSE: LH) announced on March 18, 2026 an expanded collaboration to advance precision oncology through innovative applications of next-generation sequencing (NGS) across the healthcare ecosystem. The partnership will focus on developing distributed IVD test offerings, co-commercializing complementary liquid and tissue biopsy assays, and generating evidence to facilitate payer coverage, bringing advanced biomarker testing closer to patients in community health systems and underserved regions.
Strategic Focus: Distributed NGS-Based IVD Development
The expanded collaboration centers on developing applications of NGS solutions as distributed in vitro diagnostic (IVD) tests for comprehensive genomic profiling (CGP) and whole-genome sequencing (WGS). This distributed model allows hospitals and community health systems to perform testing locally rather than sending samples to centralized reference laboratories, reducing turnaround time and improving access to actionable biomarker information.
Traci Pawlowski, Vice President of Clinical Product Development at Illumina, explained the rationale:
By deepening our collaboration, we’ll continue to leverage the strengths of our respective teams to innovate and improve access to critical biomarker testing for patients with cancer. Our longstanding collaboration is rooted in a shared vision to advance precision oncology through groundbreaking research and leading-edge technologies.
Co-Commercialization of Complementary Liquid and Tissue Biopsy Assays
A cornerstone of the partnership is the co-commercialization of two complementary FDA-authorized/approved IVD platforms:
Liquid Biopsy: PGDx elio® plasma focus™ Dx
- FDA-authorized liquid biopsy assay developed by Labcorp’s Personal Genome Diagnostics (PGDx) subsidiary
- Analyzes circulating tumor DNA (ctDNA) from blood samples
- Enables non-invasive genomic profiling when tissue biopsy is unavailable or insufficient
Tissue Biopsy: TruSight™ Oncology Comprehensive
- FDA-approved solid tumor profiling assay developed by Illumina
- Comprehensive genomic profiling of tumor tissue samples
- Detects mutations, fusions, and other genomic alterations
Together, these distributed IVD test kits aim to expand access to both tissue and liquid biopsy testing for hospitals and community health systems, bringing advanced biomarker testing closer to patients and helping provide more specific diagnoses and identify eligibility for targeted treatments and clinical trials.
Companion Diagnostics and Pharmaceutical Partnerships
The distributed offering provides pharmaceutical companies with differentiated opportunities for companion diagnostic (CDx) development, supporting both tissue and liquid biopsy needs for targeted therapy approvals. This dual-platform approach addresses the increasing regulatory requirement for companion diagnostics that identify patients likely to benefit from specific targeted therapies or immunotherapies.
Clinical Evidence: 72% Actionable Mutation Rate in NSCLC
The partnership is supported by robust clinical evidence demonstrating the utility of CGP in identifying actionable genomic alterations. In a collaborative study published in Frontiers in Oncology, researchers evaluated more than 7,600 non-small cell lung cancer (NSCLC) tumor samples using Illumina CGP technology.
Key Findings:
| Metric | Result |
| Samples analyzed | 7,600+ NSCLC tumors |
| Actionable mutations detected | 72% of patient tumors |
| Clinical utility | Variants with current targeted therapy or clinical trial identified |
The study demonstrated that CGP detected variants with a current targeted therapy or clinical trial in more than 72% of patient tumors, highlighting the clinical value of comprehensive genomic profiling over single-gene or limited panel testing.
Track Record of Scientific Collaboration
The expanded partnership builds on a strong foundation of scientific collaboration:
- 8 joint publications in oncology since 2022
- 18 posters and presentations at industry conferences
- Multiple real-world evidence studies demonstrating clinical utility of CGP
Dr. Shakti Ramkissoon, MD, PhD, MBA, Vice President and Medical Lead for Oncology at Labcorp, emphasized the shared commitment:
This collaboration reflects Labcorp and Illumina’s shared commitment to improving cancer care through innovation and access. Building on our longstanding medical and scientific collaborations and our ongoing efforts to generate clinical evidence and expand access to advanced genomics, we are combining our expertise to deliver transformative testing solutions that support more timely, equitable cancer care.
Addressing Health Equity and Access Gaps
A central goal of the expanded collaboration is promoting equitable access to cancer biomarker testing by bringing it closer to patients through new distributed test offerings. Current barriers to advanced genomic testing include:
- Geographic limitations: Centralized testing requires sample shipping, delaying results
- Access disparities: Community hospitals often lack access to comprehensive genomic profiling
- Reimbursement challenges: Evidence generation efforts aim to facilitate payer coverage
Addressing Areas of Unmet Need
New test development under the collaboration is expected to span advanced oncology research and IVD tests for CGP and WGS, with solutions aimed at addressing areas of unmet need in precision oncology and helping bridge existing testing gaps. Potential focus areas include:
- Rare cancer types with limited genomic profiling data
- Minimal residual disease (MRD) monitoring using liquid biopsy
- Tumor mutational burden (TMB) and microsatellite instability (MSI) assessment
- RNA-based biomarkers for immunotherapy response prediction
Competitive Landscape and Market Implications
The Illumina-Labcorp partnership positions both companies to compete in the rapidly expanding precision oncology diagnostics market against:
- Foundation Medicine (Roche): Leader in centralized CGP testing with FoundationOne CDx
- Guardant Health: Liquid biopsy specialist with Guardant360 CDx
- Tempus: Integrated diagnostics and data platform
- Exact Sciences: Tissue and liquid biopsy offerings
The distributed IVD model represents a differentiated strategy that could accelerate market penetration in community oncology settings while maintaining quality standards through FDA-authorized/approved platforms.
Key Takeaways
- Illumina and Labcorp expand partnership to develop distributed NGS-based IVD tests for precision oncology
- Co-commercialization of FDA-authorized PGDx elio plasma focus Dx (liquid biopsy) and FDA-approved TruSight Oncology Comprehensive (tissue)
- Aims to expand access to community hospitals and underserved regions through local testing capabilities
- Clinical evidence: 72% actionable mutation rate in 7,600+ NSCLC samples using Illumina CGP75
- 8 joint publications and 18 conference presentations since 2022 demonstrate scientific collaboration
- Distributed model provides differentiated companion diagnostic opportunities for pharmaceutical partners
- Focus on generating evidence to facilitate payer coverage and addressing health equity gaps
- Solutions address unmet needs in precision oncology and bridge existing testing gaps
Read more biotech insights on OncoDaily Biotech.
Written by: Semiramida Nina Markosyan, Editor, OncoDaily Canada