Indication for Use and Important Risk Information and Limitations

Indication for Use

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System.

ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy.

ColoSense is indicated as a screening test for adults 45 years of age or older who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Important Risk Information and Limitations

The ColoSense test is not indicated for high-risk individuals, including patients with personal history of colorectal cancer, adenomas, or other related cancers. Positive result on another colorectal cancer screening method within the last six months, or: 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT), 36 months for FIT-DNA test. Have personal history of any of the following high-risk conditions for colorectal cancer: Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn’s disease, Familial adenomatous polyposis (FAP), Family history of colorectal cancer, or other hereditary cancer syndromes including but not limited to: Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or “Lynch Syndrome”, Peutz-Jeghers Syndrome, MUTYH Polyposis (MAP), Gardner’s Syndrome, Turcot’s (or Crail’s) Syndrome, Cowden’s Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

The performance of ColoSense has been established in a prospectively designed, blinded, cross sectional, decentralized study. The benefits and risks of programmatic colorectal cancer screening (i.e., repeated testing over an established period of time) with ColoSense has not been studied. Non-inferiority or superiority of ColoSense programmatic sensitivity as compared to other recommended screening methods for colorectal cancer, advanced adenomas, or serrated precancerous lesions has not been established.

Precaution: No colorectal cancer screening test is perfect. ColoSense may produce false negative or false positive results. Based on the clinical validation data for ColoSense, with 25 / 27 colorectal cancers from typical average-risk patients identified (92.6%) and with a 95% two-sided confidence interval lower bound of 75.7%, there is a chance that as many as 24.3% of patients with colorectal cancer may be missed by this test, given the current data available.

  • A positive test result is recommended to be followed up by a colonoscopy. A false positive (incorrect) result occurs when ColoSense produces a positive result even though the individual does not have colorectal cancer or precancerous lesions.
  • A negative test result does not guarantee the absence of colorectal cancer or precancerous lesions. A false negative (incorrect) result may occur when ColoSense does not detect a colorectal cancer or precancerous lesion even though a colonoscopy could find colorectal cancer or precancerous lesions.