Haystack Oncology and Rutgers Cancer Institute Collaborate on Circulating Tumor DNA Study for NSCLC Patients

Haystack Oncology, a Quest Diagnostics company, has announced a research collaboration with the Rutgers Cancer Institute to evaluate the use of Haystack MRD, a highly sensitive ctDNA test, to help optimize postoperative therapy decisions in patients with stage II/III non-small cell lung cancer (NSCLC). The study, titled "Trial of ctDNA Guidance to Determine Post Operative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial (NCT06979661)," will use the Haystack MRD test to assess whether the presence of residual tumor DNA after surgery can guide the use of radiation and systemic therapies.

This collaboration marks the second study between Rutgers Cancer Institute and Haystack Oncology, following a previous study evaluating the test for use in patients with early-stage triple-negative breast cancer. The study aims to personalize postoperative therapy in NSCLC patients by detecting 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, such as 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 the field closer to truly individualized cancer care. A growing body of research underscores the potential role of ctDNA MRD tests in identifying residual or recurring cancer in patients with solid tumors. Studies have shown that patients who test positive for ctDNA after surgery have dramatically worse progression-free survival and overall survival compared to ctDNA-negative patients.

Key Takeaways:

  • The study will evaluate ctDNA in patients with stage II/III NSCLC in the adjuvant setting.
  • Patients who test positive for ctDNA after surgery will be considered for adjuvant radiation and systemic therapy.
  • The study aims to personalize postoperative therapy in NSCLC patients.
  • Haystack MRD has the potential to identify residual disease earlier than current methods.
  • The FDA has Breakthrough Device Designation to Haystack MRD for identifying MRD-positive patients with stage II colorectal cancer.
  • Lung cancer is the leading cause of cancer deaths in the U.S.
  • 45,000 Americans die of lung cancer annually.
  • Studies have shown that patients with positive ctDNA after surgery have dramatically worse progression-free survival and overall survival compared to ctDNA-negative patients.
  • Haystack MRD has exceptional sensitivity in detecting ultralow levels of ctDNA.

Statistics:

  • 45,000 Americans die of lung cancer annually (Source: American Cancer Society, 2025).
  • Lung cancer is the leading cause of cancer deaths in the U.S. (Source: American Cancer Society, 2025).
  • 96% of oncologists believe MRD testing has the potential to identify cancer recurrence earlier than other current methods (Source: Harris Poll, 2025).
  • 1 in 3 adult Americans has had laboratory testing with Quest Diagnostics (Source: Quest Diagnostics).

Sources:

  • 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.
  • American Cancer Society. (2025). Cancer Facts & Figures 2025. Atlanta, GA.
  • National Cancer Institute. SEER Cancer Stat Facts: Lung and Bronchus Cancer. (2025).
  • 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.
  • 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.
  • 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.