INDICATIONS FOR USE

The ColoHealth™ test is a qualitative in vitro diagnostic test for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens. Methylation of the target DNA sequence in the promoter region of the SEPT9 v2 transcript has been associated with the occurrence of colorectal cancer (CRC). The test uses a real-time polymerase chain reaction (PCR) with a fluorescent hydrolysis probe for the methylation-specific detection of the Septin 9 DNA target.

The ColoHealth™ test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2021 CRC screening guidelines should be offered and declined prior to offering the ColoHealth™ test. Patients with a positive ColoHealth™ test result should be referred for diagnostic colonoscopy. The ColoHealth™ test results should be used in combination with the physician’s assessment and individual risk factors in guiding patient management. 

WARNINGS, LIMITATIONS, & PRECAUTIONS

The ColoHealth™ test is not intended to replace colorectal cancer screening tests that are recommended by appropriate guidelines (e.g., 2021 USPSTF guidelines) such as colonoscopy, sigmoidoscopy, and high sensitivity fecal occult blood testing. The ColoHealth test is not intended for patients who are willing and able to undergo routine colorectal cancer screening tests that are recommended by appropriate guidelines. 

The ColoHealth™ test is not intended for patients defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease, familial adenomatous polyposis (FAP). People at higher risk also include those with a family history of CRC, particularly with two or more first-degree relatives with CRC, or one or more first-degree relative(s) less than 50 years of age with CRC. 

The ColoHealth™ test has not been evaluated in patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.

REFERENCES

1. United States Preventive Services Task Force (USPSTF).  Final Recommendation Statement: Colorectal Cancer Screening. Oct. 2021
2. D’Andrea, E., Ahnen, D. J., Sussman, D. A., & Najafzadeh, M. (2020). Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality. Cancer medicine, 9(2), 824–836. https://doi.org/10.1002/cam4.2735