FDA Clears Exact Sciences' Next-Generation Colorectal Cancer Diagnostic Test
Portfolio Pulse from Vandana Singh
The FDA has approved Exact Sciences Corp.'s Cologuard Plus test, a next-generation colorectal cancer diagnostic for adults 45 and older. The test showed high sensitivity and specificity in the pivotal BLUE-C study. It will launch in 2025 and is expected to be covered by Medicare. Exact Sciences' stock rose 1.94% following the news.
October 04, 2024 | 1:41 pm
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POSITIVE IMPACT
Exact Sciences' Cologuard Plus test received FDA approval, demonstrating high sensitivity and specificity in CRC screening. The test will launch in 2025 and is expected to be covered by Medicare, potentially boosting Exact Sciences' market position.
The FDA approval of the Cologuard Plus test is a significant milestone for Exact Sciences, as it enhances their product portfolio and market reach. The high sensitivity and specificity demonstrated in the BLUE-C study, along with Medicare coverage, are likely to drive demand and positively impact the stock price.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100
NEUTRAL IMPACT
Guardant Health's Shield blood test for CRC screening was approved by the FDA in July, marking it as the first blood test for CRC screening. This positions Guardant Health as a competitor in the non-invasive CRC screening market.
While the article primarily focuses on Exact Sciences, it mentions Guardant Health's Shield test as a competitor in the CRC screening market. The prior FDA approval of Shield positions Guardant Health as a key player, but the immediate impact on its stock is neutral given the focus on Exact Sciences.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 50