FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics
Quest Diagnostics (NYSE:DGX) has received FDA Breakthrough Device Designation for its Haystack MRD® test, designed to identify minimal residual disease (MRD) in stage II colorectal cancer patients after surgery. The test helps determine which patients might benefit from adjuvant therapy.
The designation follows Quest's launch of a clinical laboratory-developed version of Haystack MRD in late 2024. The test utilizes circulating tumor DNA (ctDNA) technology to detect residual or recurrent cancer from solid tumors. The Breakthrough Device Program aims to accelerate development and review of medical devices for life-threatening conditions while maintaining FDA safety standards.
Quest Diagnostics (NYSE:DGX) ha ottenuto la Designazione di Dispositivo Sperimentale dalla FDA per il suo test Haystack MRD®, progettato per individuare la malattia minima residua (MRD) nei pazienti con carcinoma colorettale in stadio II dopo l'intervento chirurgico. Il test aiuta a stabilire quali pazienti potrebbero trarre beneficio dalla terapia adiuvante.
La designazione arriva dopo il lancio, a fine 2024, di una versione di laboratorio clinico del test Haystack MRD. Il test sfrutta la tecnologia del DNA tumorale circolante (ctDNA) per rilevare residui o recidive di tumori solidi. Il programma Breakthrough Device della FDA mira ad accelerare lo sviluppo e la revisione di dispositivi medici per condizioni potenzialmente letali, mantenendo gli standard di sicurezza dell'agenzia.
Quest Diagnostics (NYSE:DGX) ha obtenido la Designación de Dispositivo Innovador de la FDA para su prueba Haystack MRD®, diseñada para identificar la enfermedad mínima residual (MRD) en pacientes con cáncer colorrectal en estadio II tras la cirugía. La prueba ayuda a determinar qué pacientes podrían beneficiarse de la terapia adyuvante.
Dicha designación sigue al lanzamiento, a finales de 2024, de una versión desarrollada en laboratorio clínico de Haystack MRD. La prueba utiliza la tecnología de ADN tumoral circulante (ctDNA) para detectar cáncer residual o recurrente de tumores sólidos. El programa Breakthrough Device de la FDA busca acelerar el desarrollo y la revisión de dispositivos médicos para afecciones potencialmente mortales, manteniendo los estándares de seguridad de la agencia.
Quest Diagnostics (NYSE:DGX)가 자사의 Haystack MRD® 검사에 대해 FDA의 혁신적 의료기기(Breakthrough Device) 지정을 받았습니다. 이 검사는 수술 후 II기 대장암 환자의 최소 잔여질환(MRD)을 확인하도록 설계되었으며, 어떤 환자가 보조요법의 혜택을 받을지 판단하는 데 도움을 줍니다.
이번 지정은 2024년 말에 임상 실험실에서 개발한 Haystack MRD 버전을 출시한 데 따른 것입니다. 이 검사는 순환 종양 DNA(ctDNA) 기술을 활용해 고형암의 잔여 또는 재발 암을 감지합니다. FDA의 Breakthrough Device 프로그램은 생명을 위협하는 상태의 의료기기 개발 및 심사를 신속히 진행하되, 기관의 안전 기준을 유지하는 것을 목표로 합니다.
Quest Diagnostics (NYSE:DGX) a obtenu la désignation Breakthrough Device de la FDA pour son test Haystack MRD®, conçu pour identifier la maladie résiduelle minimale (MRD) chez les patients atteints d'un cancer colorectal de stade II après chirurgie. Le test aide à déterminer quels patients pourraient bénéficier d'une thérapie adjuvante.
Cette désignation fait suite au lancement, fin 2024, d'une version développée en laboratoire clinique du test Haystack MRD. Le test utilise la technologie de l'ADN tumoral circulant (ctDNA) pour détecter des résidus ou des récidives de cancers solides. Le programme Breakthrough Device de la FDA vise à accélérer le développement et l'examen des dispositifs médicaux pour des affections potentiellement mortelles, tout en maintenant les normes de sécurité de l'agence.
Quest Diagnostics (NYSE:DGX) hat für seinen Haystack MRD®-Test die Breakthrough Device-Zulassung der FDA erhalten. Der Test ist darauf ausgelegt, minimale Resterkrankung (MRD) bei Patienten mit kolorektalem Krebs im Stadium II nach einer Operation zu erkennen. Er hilft dabei, festzustellen, welche Patienten von einer adjuvanten Therapie profitieren könnten.
Die Zulassung folgt auf die Einführung einer in einem klinischen Labor entwickelten Version von Haystack MRD Ende 2024. Der Test nutzt zirkulierende Tumor-DNA (ctDNA)-Technologie, um verbleibende oder wiederkehrende Tumorerkrankungen bei soliden Tumoren nachzuweisen. Das Breakthrough Device-Programm der FDA zielt darauf ab, die Entwicklung und Prüfung medizinischer Geräte für lebensbedrohliche Erkrankungen zu beschleunigen und dabei die Sicherheitsstandards der Behörde aufrechtzuerhalten.
- FDA Breakthrough Device Designation received for Haystack MRD test
- Test already commercially available as laboratory-developed version since 2024
- Potential to expand test applications to various solid tumors beyond colorectal cancer
- Accelerated regulatory pathway through FDA's Breakthrough Devices Program
- None.
Insights
FDA Breakthrough Device Designation for Quest's Haystack MRD test accelerates its path to market, potentially enhancing colorectal cancer treatment decisions.
The FDA's Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test represents a significant regulatory milestone that could accelerate its path to market. This designation is strategically valuable as it's designed to expedite development, assessment, and review processes for medical devices addressing life-threatening conditions.
The test specifically targets stage II colorectal cancer patients following surgery, aiming to identify those with minimal residual disease (MRD) who might benefit from adjuvant therapy. The core technology—circulating tumor DNA (ctDNA) testing—allows for non-invasive cancer detection at molecular levels.
Quest has positioned this test in both clinical and pharmaceutical landscapes, having already launched it as a laboratory-developed test in
This regulatory advancement follows Quest's strategic acquisition of Haystack Oncology, showing the company's commitment to expanding its precision oncology portfolio. The Breakthrough Designation specifically validates the test's potential clinical utility in treatment decision-making for colorectal cancer patients.
For context, MRD testing addresses a critical clinical need: identifying which early-stage cancer patients truly need additional treatment after surgery. Without such precision tools, many patients receive unnecessary chemotherapy while others who might benefit are missed. By detecting microscopic disease presence, this technology could significantly refine treatment decision-making in oncology.
The new designation adds to growing evidence of the value of the Haystack MRD test for both clinical and pharmaceutical applications. It also aligns with a robust body of research supporting the potential of ctDNA-based MRD tests to detect residual or recurrent cancer from solid tumors. Quest introduced a clinical laboratory-developed test version of Haystack MRD in late 2024 and is broadening access for oncologists and pharmaceutical partners.
"We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumors, building on this first designation for an early-stage colorectal cancer," said Dan Edelstein, Vice President and General Manager, Haystack Oncology. "Our goal is to deliver highly accurate, personalized monitoring of treatment response and recurrence to more patients, both in clinical care and in pharmaceutical trials, and this Breakthrough Designation brings us closer to our goal."
The Breakthrough Devices Program applies to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization, after undergoing the FDA's rigorous standards for device safety and effectiveness.
About ctDNA MRD
A growing body of research underscores the value of ctDNA MRD tests for identifying residual or recurring cancer in solid tumors. By detecting trace amounts of tumor-derived DNA in the bloodstream, ctDNA MRD testing can reveal molecular evidence of disease recurrence months before it becomes apparent through imaging or other conventional monitoring methods. This early insight can help clinicians tailor surveillance strategies, adjust treatment plans, and potentially intervene before disease progression becomes clinically evident. Nearly all oncologists (
About Haystack MRD™
Haystack MRD is a highly sensitive and specific liquid biopsy test designed by cancer genomic pioneers and liquid biopsy experts to uncover low levels of circulating-tumor DNA (ctDNA)—tiny fragments of DNA in the bloodstream that originate from tumor cancer cells that can signify residual, recurrent, or resistant disease in patients diagnosed with cancer. Used in multiple clinical trials and research studies with top institutions in the U.S., Canada, and Australia, and by clinicians at over 75 top cancer and academic centers and health systems, Haystack MRD is now available for clinical use as part of the leading oncology testing portfolio of 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 de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our more than 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.
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SOURCE Quest Diagnostics
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