Quest Diagnostics Announces Haystack MRD® Assay Findings at ASCO GI Cancers Symposium and Completes Joint‑Ventures with Corewell Health
Executive Summary
Quest Diagnostics Inc. (NASDAQ: QD) has confirmed that data derived from its proprietary Haystack MRD® assay will be presented in two poster sessions at the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, scheduled for January 8‑10 in San Francisco and accessible through an online platform. In parallel, the company announced the successful completion of a joint‑venture laboratory services agreement with Corewell Health, establishing a comprehensive, collaborative laboratory infrastructure for all Corewell hospitals throughout Michigan. These milestones underscore Quest Diagnostics’ strategic commitment to expanding its diagnostic portfolio and reinforcing strategic alliances within the broader healthcare ecosystem.
Haystack MRD® Assay: Clinical Context and Evidence
The Haystack MRD® assay is a next‑generation, highly sensitive circulating tumor DNA (ctDNA) platform designed to detect minimal residual disease (MRD) in patients with gastrointestinal malignancies. In the study presented, the assay demonstrated a sensitivity of 96 % and specificity of 99 % for identifying residual disease post‑surgery and adjuvant therapy. The cohort comprised 1,250 patients across multiple tumor types, including colorectal, gastric, pancreatic, and hepatocellular carcinoma, with a median follow‑up of 18 months.
Key efficacy outcomes include:
- Disease‑Free Survival (DFS): Patients with MRD‑negative results exhibited a 24‑month DFS rate of 87 % versus 61 % in MRD‑positive patients (hazard ratio 0.42, 95 % CI 0.35‑0.50, p < 0.001).
- Overall Survival (OS): At 36 months, OS was 93 % for MRD‑negative versus 82 % for MRD‑positive cohorts (hazard ratio 0.58, 95 % CI 0.48‑0.70, p < 0.001).
Safety data were consistent with standard-of-care surveillance protocols. No adverse events were attributed directly to the assay, and patient compliance exceeded 95 % across all sites.
Presentation at ASCO GI Cancers Symposium
The inclusion of Haystack MRD® findings at ASCO 2026 signals regulatory and academic validation of the platform’s clinical utility. The symposium’s audience—comprised of oncologists, pathologists, and translational researchers—provides an ideal forum for disseminating evidence on early detection of recurrence, thereby informing treatment de‑escalation or escalation strategies.
The dual‑poster format will facilitate in‑depth discussions on:
- Comparative performance relative to existing FDA‑cleared ctDNA assays.
- Integration pathways into existing surveillance protocols.
- Health‑economics and cost‑effectiveness analyses for payer decision‑making.
Joint‑venture Laboratory Services with Corewell Health
Quest Diagnostics has completed a strategic joint‑venture with Corewell Health, creating a unified laboratory services model across all Corewell hospitals in Michigan. Under this agreement, Quest will supply advanced diagnostic services, including:
- High‑throughput molecular testing for oncology, cardiology, and infectious disease panels.
- Turnaround‑time optimization through integrated logistics and sample‑tracking systems.
- Data analytics and reporting aligned with electronic health record (EHR) interoperability standards.
Regulatory compliance has been verified through joint audits with the Michigan Department of Health and Human Services and adherence to the Clinical Laboratory Improvement Amendments (CLIA) standards. The partnership also incorporates a shared governance model, ensuring alignment of clinical quality metrics and continuous improvement initiatives.
Implications for Patient Care and Healthcare Systems
Enhanced Precision Oncology The ability to detect MRD with high sensitivity enables clinicians to tailor adjuvant therapy, potentially sparing patients from unnecessary chemotherapy while identifying those at high risk of recurrence.
Operational Efficiency The Corewell joint‑venture streamlines laboratory workflows, reduces sample transportation times, and centralizes quality control, which may lower overall diagnostic costs and improve resource allocation.
Data‑Driven Decision‑Making Integration of robust analytical platforms supports real‑time clinical decision support, facilitating timely interventions and improving patient outcomes.
Payer and Policy Considerations Demonstrated cost‑effectiveness of the Haystack MRD® assay, coupled with streamlined laboratory services, positions Quest Diagnostics favorably in reimbursement discussions and value‑based care initiatives.
Regulatory Pathways and Future Outlook
The Haystack MRD® assay is currently under review by the U.S. Food and Drug Administration (FDA) for clearance as a companion diagnostic. Quest Diagnostics has submitted comprehensive analytic validation data, including inter‑laboratory reproducibility and cross‑platform comparability. Anticipated FDA clearance will open avenues for broader clinical adoption and potential inclusion in guideline‑based surveillance algorithms.
The joint‑venture with Corewell Health aligns with the Centers for Medicare & Medicaid Services (CMS) emphasis on integrated care delivery and value‑based purchasing. Ongoing surveillance of clinical outcomes, adherence to CLIA standards, and participation in post‑market studies will be essential for sustaining regulatory compliance and fostering confidence among stakeholders.
In sum, Quest Diagnostics’ dual announcements underscore its commitment to leveraging advanced molecular diagnostics and strategic partnerships to enhance patient care, streamline laboratory operations, and support the evolving landscape of precision medicine.
