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
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.
Quest Diagnostics (NYSE:DGX) la controllata Haystack Oncology ha annunciato una collaborazione di ricerca con il Rutgers Cancer Institute per valutare Haystack MRD®, un test ctDNA per la malattia residua minima, al fine di ottimizzare il trattamento post-operatorio nei pazienti con carcinoma polmonare non a piccole cellule in stadio II/III (NSCLC).
Lo studio di fase II, denominato MRD-PORT Trial (NCT06979661), valuterà se la rilevazione di DNA tumorale residuo post-operatorio possa guidare le decisioni su radioterapia e terapia sistemica. La collaborazione segue uno studio del 2023 che ha valutato il test in pazienti con cancro al seno triplo negativo in stadio precoce.
Ricerche recenti pubblicate su NEJM hanno dimostrato la capacità di Haystack MRD di identificare una risposta clinica completa 1,4 mesi prima delle sole immagini. Il test ha ricevuto la Designazione di Dispositivo Innovativo (FDA Breakthrough Device Designation) dell’FDA nell’agosto 2025 per l’identificazione di pazienti MRD-positivi con tumore colorectal in stadio II.
Quest Diagnostics (NYSE:DGX) la subsidiaria Haystack Oncology anunció una colaboración de investigación con Rutgers Cancer Institute para evaluar Haystack MRD®, una prueba de ctDNA de enfermedad residual mínima, con el fin de optimizar el tratamiento postoperatorio en pacientes con cáncer de pulmón de células no pequeñas en estadio II/III (NSCLC).
El estudio de fase II, denominado MRD-PORT Trial (NCT06979661), evaluará si la detección de ADN tumoral residual tras la cirugía puede guiar las decisiones sobre radiación y terapia sistémica. La colaboración sigue a un estudio de 2023 que evaluó la prueba en pacientes con cáncer de mama triple negativo en estadio temprano.
Investigaciones recientes publicadas en NEJM demostraron la capacidad de Haystack MRD para identificar una respuesta clínica completa 1,4 meses más rápido que las pruebas de imagen. La prueba recibió la Designación de Dispositivo Innovador de la FDA (FDA Breakthrough Device Designation) en agosto de 2025 para identificar pacientes con MRD-positivos en cáncer colorrectal en estadio II.
Quest Diagnostics (NYSE:DGX) 계열사인 Haystack Oncology가 Rutgers Cancer Institute와 연구 협력을 발표했습니다. Haystack MRD®는 ctDNA 미세잔류질환 검사로, 2/3기 비소세포폐암(NSCLC) 환자의 수술 후 치료를 최적화하기 위해 평가됩니다.
2상 연구인 MRD-PORT Trial (NCT06979661)은 수술 후 잔류 종양 DNA의 검출이 방사선 치료 및 전신 치료 결정에 도움을 줄 수 있는지 평가합니다. 이 협력은 초기 단계의 삼중 음성 유방암 환자에서 테스트를 평가한 2023년 연구에 이어집니다.
최근 NEJM에 발표된 연구는 Haystack MRD가 임상적 완전 반응을 영상 검사보다 1.4개월 빠르게 확인할 수 있음을 보여주었습니다. 이 검사는 FDA Breakthrough Device Designation를 2025년 8월에 받아, 2기 대장암 환자의 MRD 양성 여부를 식별합니다.
Quest Diagnostics (NYSE:DGX) est une filiale Haystack Oncology qui a annoncé une collaboration de recherche avec le Rutgers Cancer Institute pour évaluer Haystack MRD®, un test ctDNA de maladie résiduelle minimale, afin d’optimiser le traitement post-opératoire chez des patients détectés en cancer du poumon non à petites cellules au stade II/III (NSCLC).
L’étude de phase II, nommée MRD-PORT Trial (NCT06979661), évaluera si la détection d’ADN tumoral résiduel après la chirurgie peut guider les décisions de radiothérapie et de thérapies systémiques. Cette collaboration fait suite à une étude de 2023 évaluant le test chez des patientes atteintes d’un cancer du sein triple négatif en stade précoce.
Des recherches récentes publiées dans NEJM ont démontré que Haystack MRD peut identifier une réponse clinique complète 1,4 mois plus tôt que les tests d’imagerie. Le test a reçu la FDA Breakthrough Device Designation en août 2025 pour l’identification des patients MRD-positifs avec un cancer colorectal au stade II.
Quest Diagnostics (NYSE:DGX) Tochtergesellschaft Haystack Oncology kündigte eine Forschungskooperation mit dem Rutgers Cancer Institute an, um Haystack MRD®, einen ctDNA-Test auf minimale Resterkrankung, zu bewerten, um die postoperative Behandlung bei Stadium II/III nicht-kleinzelligem Lungenkrebs (NSCLC) zu optimieren.
Die Phase-II-Studie, genannt MRD-PORT Trial (NCT06979661), wird untersuchen, ob der Nachweis von verbleibendem Tumor-DNA nach der Operation Radiations- und Systemtherapieentscheidungen leiten kann. Die Zusammenarbeit folgt einer 2023er Studie, die den Test bei Patienten mit frühestadiumigem dreifach-negativem Brustkrebs untersuchte.
Neuere in NEJM veröffentlichte Forschungen zeigten, dass Haystack MRD in der Lage ist, eine klinische Complete-Response 1,4 Monate schneller als Bildgebungsverfahren zu identifizieren. Der Test erhielt FDA Breakthrough Device Designation im August 2025 zur Identifizierung von MRD-positiven Patienten mit Stadium II kolorektalem Krebs.
Quest Diagnostics (NYSE:DGX) أعلنت شركة Haystack Oncology التابعة عن تعاون بحثي مع Rutgers Cancer Institute لتقييم Haystack MRD®، وهو اختبار ctDNA للمرض المتبقي الحدّي، بهدف تحسين العلاج بعد الجراحة لدى مرضى سرطان الرئة غير صغير الخلايا في مرحلتي II/III (NSCLC).
ستقيّم الدراسة من المرحلة II، المسماة MRD-PORT Trial (NCT06979661)، ما إذا كان الكشف عن DNA الورمي المتبقي بعد الجراحة يمكن أن يوجه قرارات الإشعاع والعلاج الجهازي. يتبع هذا التعاون دراسة من عام 2023 قيمت الاختبار لدى مرضى سرطان الثدي الثلاثي السلبي في المرحلة المبكرة.
أظهرت أبحاث حديثة منشورة في NEJM قدرة Haystack MRD على تحديد استجابة سريرية كاملة أسرع بواقع 1.4 شهر مقارنة بالتصوير. كما منحته إدارة الغذاء والدواء الأمريكية Designación de Dispositivo Breakthrough في أغسطس 2025 لتحديد مرضى MRD-الإيجابي في سرطان القولون والمستقيم في المرحلة II.
Quest Diagnostics (NYSE:DGX) 的子公司 Haystack Oncology 宣布与 Rutgers Cancer Institute 建立研究合作，评估 Haystack MRD®，这是一种 ctDNA 微量残留病变检测，用于在 II/III 期非小细胞肺癌（NSCLC）患者中优化术后治疗。
这项二期研究，命名为 MRD-PORT Trial (NCT06979661)，将评估术后残留肿瘤DNA 的检测是否可指导放疗和全身治疗的决策。此合作是在 2023 年一项评估早期阶段三重阴性乳腺癌患者的测试的研究之后。
最近发表于 NEJM 的研究表明，Haystack MRD 能在影像学检测之前 1.4 个月更早地识别临床完全缓解。该检测在 2025 年 8 月获得 FDA 的 突破性设备认定（FDA Breakthrough Device Designation），用于识别 II 期结直肠癌患者的 MRD 阳性。
- 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)
- Study results and clinical utility for NSCLC still pending validation
- Commercialization timeline and regulatory approval for NSCLC indication not yet determined
Insights
Quest's Haystack MRD test being evaluated to personalize lung cancer treatment based on ctDNA detection could transform post-surgical care.
This collaboration between Quest Diagnostics' Haystack Oncology and Rutgers Cancer Institute represents a significant advancement in precision oncology for non-small cell lung cancer (NSCLC). The phase II MRD-PORT trial will evaluate how circulating tumor DNA (ctDNA) detection can guide personalized post-operative treatment decisions for stage II/III NSCLC patients.
The clinical value proposition is compelling: by identifying patients with residual disease at the molecular level after surgery, oncologists could make more informed decisions about adjuvant radiation and systemic therapy. This addresses a critical clinical challenge in NSCLC management – determining which patients truly need additional treatments following surgery.
What's particularly notable is the timing advantage demonstrated in their earlier NEJM study, where Haystack MRD identified complete responses 1.4 months versus 6+ months with conventional imaging. This dramatic improvement in detection time could substantially impact treatment outcomes by allowing earlier intervention.
The FDA Breakthrough Device Designation for colorectal cancer applications signals regulatory recognition of the technology's potential clinical utility. Expanding research into NSCLC represents a logical progression for this technology given the high mortality and recurrence rates associated with lung cancer.
For Quest Diagnostics, this research expands their oncology diagnostics portfolio and positions them in the rapidly growing field of liquid biopsy and MRD testing – a market with substantial growth potential as cancer care increasingly focuses on molecular monitoring and personalized treatment approaches.
"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 (
About Lung Cancer
Lung cancer is the leading cause of cancer-related deaths in the
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
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
About Rutgers Cancer Institute
As
References
- 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.
- 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.
- 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/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-302561905.html
SOURCE Quest Diagnostics
FAQ
What is the purpose of Quest Diagnostics' Haystack MRD trial with Rutgers Cancer Institute?
What breakthrough designation did DGX's Haystack MRD receive from the FDA in 2025?
How much faster can Haystack MRD detect clinical complete response compared to imaging?
What types of cancer is Quest Diagnostics' Haystack MRD being evaluated for?
How many oncologists support the potential of MRD testing for cancer recurrence detection?
