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Top-Line Data Show Exact Sciences' Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer All endpoints achieved in 10,000-patient trial of non-invasive ...
The company reported $1.43 billion in revenue last year from its screening business, primarily from sales of its colon cancer test Cologuard, which was approved by the FDA in 2014.
The false positive rate (FPR) is the proportion of all negatives that still yield positive test outcomes, i.e., the conditional probability of a positive test result given an event that was not present. The false positive rate is equal to the significance level. The specificity of the test is equal to 1 minus the false positive rate.
An updated version of Exact Sciences' key product just got regulatory approval. That could help the healthcare stock stage a comeback.
Stool DNA screening test looks for biomarkers associated with colorectal cancer and precancerous lesions, including altered DNA and blood hemoglobin. A positive result should be followed by colonoscopy. FIT-DNA has more false positives than FIT and thus results in more adverse effects. [10]
Fecal occult blood testing (FOBT), as its name implies, aims to detect subtle blood loss in the gastrointestinal tract, anywhere from the mouth to the colon.Positive tests ("positive stool") may result from either upper gastrointestinal bleeding or lower gastrointestinal bleeding and warrant further investigation for peptic ulcers or a malignancy (such as colorectal cancer or gastric cancer).
The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer (CRC). FDA approval was based on findings from the pivotal BLUE-C study, one of ...
Exact Sciences' Cologuard screening laboratory and warehouse in Madison, Wisconsin. A Cologuard test package, ready for return to the lab using the pre-paid UPS shipping label. The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):