The US Food and Drug Administration (FDA) has granted breakthrough device designation for Quest Diagnostics’ Haystack minimal residual disease (MRD) test for colorectal cancer.
Haystack is designed to detect MRD-positive individuals with stage II colorectal cancer post-surgery, potentially guiding adjuvant therapy decisions.
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The FDA’s recognition underscores the clinical and pharmaceutical significance of the Haystack MRD test, which utilises circulating tumour DNA (ctDNA) to detect cancer recurrence.
In late 2024, Quest Diagnostics released a clinical laboratory-developed version of the test and is expanding its availability to pharmaceutical companies and oncologists.
The Haystack MRD test offers a sensitive method for detecting minute quantities of ctDNA in the blood, indicating residual or returning cancer.
This liquid biopsy test has been developed by experts in cancer genomics.
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By GlobalDataHaving been used in numerous clinical trials and studies across North America and Australia, Haystack MRD is part of Quest Diagnostics’ oncology testing portfolio.
More than 75 cancer and academic centres have adopted the test for clinical use. Additionally, Haystack Oncology offers the test for clinical trials as an investigational device in laboratories situated in Baltimore, Hamburg, and Helsinki.
Haystack Oncology vice-president and general manager Dan Edelstein said: “We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumours, building on this first designation for an early-stage colorectal cancer.
“Our goal is to deliver highly accurate, personalised 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.”
In April 2025, Quest Diagnostics introduced a new blood test aimed at assisting physicians in confirming amyloid brain pathology related to Alzheimer’s disease in individuals with mild cognitive impairment or dementia.
