Breakthrough Status for Quest’s Haystack MRD Test

FDA has granted Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minimal residual disease (MRD) in patients with Stage II colorectal cancer after curative surgery. Quest says it introduced a laboratory-developed version of Haystack MRD in late 2024 and has been expanding its use among oncologists and pharmaceutical partners. It says it is working with FDA and research collaborators to validate the test in additional solid tumor types.

Haystack MRD uses circulating tumor DNA to detect signs of residual or recurrent cancer, often months before disease becomes visible on imaging, Quest says. Advocates of MRD testing say such early detection can help clinicians tailor surveillance and treatment strategies, it says, adding that a Harris Poll survey last year found that 96% of oncologists believe MRD testing can identify cancer recurrence earlier than current methods.