Exact Sciences recently received FDA approval for an improved version of their stool-based screening test for colon cancer. This new test, called Cologuard Plus, is designed to reduce the number of cancer-free patients who undergo unnecessary follow-up colonoscopies. The FDA approved the test for adults aged 45 and older with an average risk of developing cancer, following a successful large clinical trial known as Blue-C, which involved over 20,000 participants.
Earlier this year, Exact Sciences published a study in the New England Journal of Medicine reporting that the new test was able to detect 94% of cancers and 43% of advanced precancers. These precancers are abnormal cell growths that can precede the development of cancer. Additionally, the company found that Cologuard Plus had a specificity rate of 91%, meaning it correctly identified participants who did not have colon cancer or advanced precancer.
The high accuracy rates of the Cologuard Plus test are promising for improving early detection of colon cancer and reducing the need for unnecessary invasive procedures. By accurately identifying individuals at risk for colon cancer, this test has the potential to save lives through early intervention and treatment.
Colon cancer is a common and potentially deadly form of cancer, but when detected early, it is highly treatable. Screening tests like Cologuard Plus play a crucial role in identifying individuals who may be at risk for developing colon cancer, allowing for timely medical intervention and preventive care.
Exact Sciences continues to innovate in the field of cancer screening, and the FDA approval of Cologuard Plus marks a significant advancement in the fight against colon cancer. With its high detection rates and specificity, this new test has the potential to improve outcomes for patients by enabling early diagnosis and treatment of colon cancer and precancerous conditions.
The approval of Cologuard Plus by the FDA represents a major milestone in the field of cancer screening and underscores the importance of investing in innovative technologies that can save lives. As Exact Sciences moves forward with the commercialization of this improved test, more individuals will have access to a non-invasive and accurate screening option for colon cancer, ultimately leading to better health outcomes and a reduced burden of disease in the population.