FDA grants breakthrough device designation to Haystack MRD test

The FDA granted breakthrough device designation to Quest Diagnostics’ Haystack MRD test for identifying patients with minimal residual disease after curative-intent surgical treatment for stage II colorectal cancer .

The liquid biopsy test — which is used to detect low levels of ctDNA — can be used to help determine which patients could benefit from adjuvant therapy.

The FDA granted breakthrough device designation to Quest Diagnostics’ Haystack MRD test for identifying patients with minimal residual disease after curative-intent surgical treatment for stage II colorectal cancer.

“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,”