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.

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.