Exact Sciences Reports the US FDA’s Approval of Cologuard Plus Test for Non-Invasive Colorectal Cancer Screening
Shots:
- The US FDA has approved Cologuard Plus test (next-gen. stool DNA test), developed with Mayo Clinic, for screening CRC adults (≥45yrs.) at average risk, with its commercialization planned in 2025
- Approval was based on pivotal BLUE-C trial of Cologuard Plus test & the company’s blood-based CRC screening test involving >20,000 adults (≥40yrs.), using colonoscopy as a reference & comparing it with an independent fecal immunochemical test (FIT)
- Study depicted 95% & 43% sensitivities for overall cancer & advanced precancerous lesions, respectively, plus 94% specificity without findings on colonoscopy. It surpassed independent FIT on CRC (overall & stages I-III), high-grade dysplasia & advanced precancerous lesion sensitivity
Ref: Exact Sciences | Image: Exact Sciences
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
