A groundbreaking advancement in non-invasive cancer detection is here!

  • FDA approves Exact Sciences’ Cologuard Plus test for colorectal cancer screening.
  • Cologuard Plus shows 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions.
  • The test significantly outperforms traditional fecal immunochemical tests (FIT).
  • Cologuard Plus aims to improve early detection of colorectal cancer, which is highly preventable.
  • The test will be commercially available in 2025 and is expected to be covered by Medicare.

Exact Sciences Corp. has announced that the U.S. Food and Drug Administration (FDA) has approved its Cologuard Plusâ„¢ test, a next-generation multitarget stool DNA test designed for colorectal cancer screening. This test is now available for adults aged 45 and older who are at average risk for colorectal cancer (CRC). The approval follows the pivotal BLUE-C study, one of the largest head-to-head studies in CRC screening, which involved nearly 19,000 participants. The results showed that Cologuard Plus achieved an impressive 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions, with a specificity of 94% and no findings on colonoscopy. nnDr. Thomas F. Imperiale, a principal investigator for the BLUE-C study, emphasized the importance of early detection in improving outcomes for colorectal cancer. He noted that the high sensitivity and specificity of Cologuard Plus provide confidence in its ability to detect cancer early while minimizing false positives. Kevin Conroy, Chairman and CEO of Exact Sciences, stated that Cologuard Plus sets a new performance standard, detecting cancers and precancerous polyps with greater sensitivity than its predecessor, Cologuard, while reducing false positives by over 30%. nnColorectal cancer is the second deadliest cancer in the U.S., yet it is highly preventable. The Cologuard Plus test builds on the success of the original Cologuard test, which has been used over 17 million times and has significantly improved national screening rates. The new test is expected to launch in 2025 and will be supported by Exact Sciences’ commercial organization and the ExactNexusâ„¢ technology platform, ensuring seamless ordering and results for over 350 health systems. It is anticipated to be covered by Medicare and included in U.S. Preventive Services Taskforce guidelines, making it a vital tool in the fight against colorectal cancer.·

Factuality Level: 8
Factuality Justification: The article provides factual information about the FDA approval of the Cologuard Plus test, including study results and expert opinions. However, it contains some promotional language and may present the test’s benefits in a slightly biased manner, which affects its overall objectivity.·
Noise Level: 8
Noise Justification: The article provides a detailed overview of the Cologuard Plus test, including its FDA approval, performance metrics, and implications for colorectal cancer screening. It supports its claims with data from the BLUE-C study and includes expert opinions, which adds to its scientific rigor. However, it primarily serves as a promotional piece for Exact Sciences and lacks critical analysis of broader implications or accountability, which prevents it from achieving a perfect score.·
Public Companies: Exact Sciences Corp. (EXAS)
Key People: Thomas F. Imperiale (MD, professor of medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study), Kevin Conroy (Chairman and CEO of Exact Sciences)

Track all markets on TradingView

Financial Relevance: Yes
Financial Markets Impacted: Yes
Financial Rating Justification: The article discusses the FDA approval of Exact Sciences Corp.’s Cologuard Plus test, which is a significant development in the cancer screening market. This approval can impact Exact Sciences’ stock performance and market position, as it is expected to enhance their product offerings and potentially increase revenue. The financial topics include the commercialization of a new medical test and its anticipated coverage by Medicare, which are critical for the company’s financial outlook.·
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Extreme Rating Justification: The article discusses the approval of a new cancer screening test but does not report on an extreme event that occurred in the last 48 hours.·
Move Size: No market move size mentioned.
Sector: Healthcare
Direction: Up
Magnitude: Large
Affected Instruments: Stocks

Reported publicly: www.businesswire.com