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Quest Diagnostics Says Haystack MRD Test Granted US FDA Breakthrough Device Designation
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Quest Diagnostics Says Haystack MRD Test Granted US FDA Breakthrough Device Designation
Aug 25, 2025 6:36 AM

09:12 AM EDT, 08/25/2025 (MT Newswires) -- Quest Diagnostics ( DGX ) said Monday that the US Food and Drug Administration granted breakthrough device designation for its Haystack MRD test to identify MRD-positive patients with stage II colorectal cancer following treatment.

The breakthrough device designation enables sped up development, assessment, and review for premarket approval, the company said.

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