Haystack Oncology and Rutgers Cancer Institute Collaborate in a Clinical Study to Examine Haystack MRD as a Guide for Post-Surgical Treatment for Lung Cancer

Rhea-AI Summary

Quest Diagnostics (NYSE:DGX) subsidiary Haystack Oncology announced a research collaboration with Rutgers Cancer Institute to evaluate Haystack MRD®, a ctDNA minimal residual disease test, for optimizing post-surgery treatment in stage II/III non-small cell lung cancer (NSCLC) patients.

The phase II study, dubbed MRD-PORT Trial (NCT06979661), will assess if residual tumor DNA detection post-surgery can guide radiation and systemic therapy decisions. The collaboration follows a 2023 study evaluating the test in early-stage triple-negative breast cancer patients.

Recent research published in NEJM demonstrated Haystack MRD's ability to identify clinical complete response 1.4 months faster than imaging tests. The test received FDA Breakthrough Device Designation in August 2025 for identifying MRD-positive stage II colorectal cancer patients.

Positive

• FDA Breakthrough Device Designation received in August 2025 for stage II colorectal cancer application
• Clinical validation shows 1.4 months faster response detection compared to imaging tests
• 96% of oncologists recognize MRD testing's potential for earlier cancer recurrence detection
• Expansion of test applications into multiple cancer types (NSCLC, breast cancer, colorectal)

Negative

• Study results and clinical utility for NSCLC still pending validation
• Commercialization timeline and regulatory approval for NSCLC indication not yet determined

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SECAUCUS, N.J. and NEW BRUNSWICK, N.J., Sept. 22, 2025 /PRNewswire/ -- Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, today announced a research collaboration with the Rutgers Cancer Institute to evaluate the use of Haystack MRD^®, a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) test, to help optimize postoperative therapy decisions in patients with stage II/III non-small cell lung cancer (NSCLC). Rutgers Cancer Institute together with RWJBarnabas Health is the state's only National Cancer Institute-designated Comprehensive Cancer Center. 

"Trial of ctDNA Guidance to Determine Post Operative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial (NCT06979661)" is a prospective phase II study that will use the Haystack MRD test to assess whether the presence of residual tumor DNA after surgery can help guide the use of radiation and systemic therapies. 

"Circulating tumor DNA is a pivotal marker to figure out how best to individualize patient care for lung cancer," said Salma Jabbour, MD, Vice Chair of Clinical Research and Faculty Development, Department of Radiation Oncology and Associate Director Faculty Affairs and Development, Rutgers Cancer Institute. "Studying new ways to detect this marker are important for helping improve patient outcomes." 

Personalizing postoperative therapy in NSCLC 

The study will evaluate ctDNA in patients with stage II/III NSCLC in the adjuvant setting. Patients who test positive for ctDNA after surgery—indicating potential residual disease—will be considered for adjuvant radiation and systemic therapy, including chemotherapy, immunotherapy, or targeted therapy, based on tumor biology and clinical context. 

"The ability to identify residual disease following curative-intent treatment opens the door to more precise, personalized interventions, moving us closer to truly individualized cancer care," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "While existing data supports the prognostic value of ctDNA in lung cancer, this innovative study will now address the question of how ctDNA-based testing can guide and optimize adjuvant treatment decisions." 

The study is the second by Rutgers Cancer Institute involving Haystack MRD. In 2023, the two parties announced a study to evaluate the test for use in patients being treated for early-stage triple-negative breast cancer. 

Why ctDNA MRD matters 

A growing body of research underscores the potential role of ctDNA MRD tests to identify residual or recurring cancer in patients with solid tumors. In April 2025, a study¹ published in The New England Journal of Medicine (NEJM) found that ctDNA testing, using Haystack MRD, was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months compared to over 6 months using imaging tests. Nearly all oncologists (96%) in a recent survey² by Harris Poll for Quest Diagnostics said MRD testing has the potential to identify cancer recurrence earlier than other current methods. In August 2025, the FDA granted Breakthrough Device Designation to Haystack MRD for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. 

About Lung Cancer 

Lung cancer is the leading cause of cancer-related deaths in the U.S³. Despite advances in surgery and systemic therapies, recurrence rates remain high, especially for patients with stage II and III NSCLC.⁴ Studies show that patients who test positive for ctDNA after surgery have dramatically worse progression-free survival and overall survival compared to ctDNA-negative patients.^5,6,7 

About Haystack Oncology 

Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD^®, a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA to uncover residual or recurrent disease with exceptional sensitivity. Haystack Oncology works with biopharmaceutical companies to accelerate and inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics. Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for commercial use as a lab-developed test (LDT) by Quest Diagnostics. Haystack MRD is also available for clinical trials as an investigational device by Haystack Oncology in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland. www.haystackmrd.com 

About Quest Diagnostics 

Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of deidentified clinical lab results, diagnostic insights provided by Quest reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and over 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com. 

 About Rutgers Cancer Institute 

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, provides patients access to the most advanced cancer treatment options including clinical trials close to home at our facilities throughout the state. Our groundbreaking cancer research is the engine that drives access to the most advanced cancer treatments, where our discoveries become your care. 

References

1. Cercek A, Foote MB, Rousseau B, et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med. Published online 2025. doi:10.1056/nejmoa2404512. 
2. https://newsroom.questdiagnostics.com/2025-05-13-Oncologists-Report-Seeing-More-Advanced-Cancers-and-Say-Current-Tests-Are-Not-Catching-Cancer-Recurrence-Early-Enough,-New-Quest-Diagnostics-Report-Finds. 
3. American Cancer Society. (2025). Cancer Facts & Figures 2025. Atlanta, GA. 
4. National Cancer Institute. SEER Cancer Stat Facts: Lung and Bronchus Cancer. (2025). 
5. Tie J, Wang Y, Tomasetti C, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016;8(346):346ra92. doi:10.1126/scitranslmed.aaf6219. 
6. Wang Y, Li L, Cohen JD, et al. Prognostic Potential of Circulating Tumor DNA Measurement in Postoperative Surveillance of Nonmetastatic Colorectal Cancer. JAMA Oncol. 2019;5(8):1118–1123. doi:10.1001/jamaoncol.2019.0512. 
7. Tie J, Cohen JD, Wang Y, et al. Serial circulating tumour DNA analysis during multimodality treatment of locally advanced rectal cancer: a prospective biomarker study. Gut. 2019;68(4):663-671. doi:10.1136/gutjnl-2017-315852. 

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SOURCE Quest Diagnostics

FAQ

What is the purpose of Quest Diagnostics' Haystack MRD trial with Rutgers Cancer Institute?

The phase II trial aims to evaluate if Haystack MRD's ctDNA test can help optimize post-surgical therapy decisions for stage II/III non-small cell lung cancer patients by detecting residual tumor DNA.

What breakthrough designation did DGX's Haystack MRD receive from the FDA in 2025?

In August 2025, Haystack MRD received FDA Breakthrough Device Designation for identifying MRD-positive patients with stage II colorectal cancer who may benefit from adjuvant therapy after surgery.

How much faster can Haystack MRD detect clinical complete response compared to imaging?

According to a 2025 NEJM study, Haystack MRD can identify clinical complete response in 1.4 months compared to over 6 months using traditional imaging tests.

What types of cancer is Quest Diagnostics' Haystack MRD being evaluated for?

Haystack MRD is being evaluated for multiple cancer types, including non-small cell lung cancer, triple-negative breast cancer, and colorectal cancer.

How many oncologists support the potential of MRD testing for cancer recurrence detection?

According to a Harris Poll survey, 96% of oncologists believe MRD testing has the potential to identify cancer recurrence earlier than current methods.