Exact Sciences' Cologuard non-invasive colon cancer test becomes the 1st product to win simultaneous approvals from the FDA and CMS.
Wisconsin-based Exact Sciences (NSDQ:EXAS) won landmark approval for its Cologuard home colorectal cancer test, becoming the 1st company to successfully navigate a pilot program for parallel review by both FDA and Medicare regulators.
Exact Sciences Corp., Center for Devices and Radiological Health (CDRH), Centers for Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA)
News Well, Regulatory/Clearance, Genomics/Molecular Diagnostics, Medicare, Oncology, Pre-Market Approval (PMA), Reimbursement
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