FDA Breakthrough Device Designation for Haystack MRD Test

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FDA Breakthrough Designation: Quest Diagnostics’ Haystack MRD⁣ test received breakthrough ‍device designation⁢ from⁢ the FDA.
What it tests for: The test identifies minimal residual disease (MRD) in patients after surgery for stage⁤ II colorectal cancer. MRD⁢ refers to any remaining cancer cells after⁢ treatment.
How it effectively works: The⁢ test uses a “liquid biopsy” to detect ctDNA (circulating tumor DNA), even in very low levels. This can help determine if a patient would benefit from additional (adjuvant) therapy.
Availability: A clinical laboratory-developed version of the test⁤ was introduced by Quest Diagnostics⁤ in late 2024.
Purpose of ⁣Breakthrough Designation: The FDA ⁢program aims to speed up⁢ access to promising ⁢medical devices for serious conditions.
Future Plans: Haystack Oncology (Quest Diagnostics) plans to validate the use of Haystack MRD for other solid tumors as well.