Colorectal Cancer Test - PreGen-Plus™ is a completely non-invasive Colorectal Cancer Screening Test that analyses a stool sample for changes to DNA that may indicate the presence of colorectal cancer. It is not intended to replace a colonoscopy in those patients who are willing to undergo the procedure. Additionally, while it may be used adjunctively or in noncompliant patients, it is not intended as a primary screening tool for individuals at increased risk for developing disease. These situations include: 1. Patients who have indications for structural exam (symptoms, plus screening test, etc) 2. Hereditary colorectal cancer syndromes (eg, HNPCC, FAP) 3. Family/personal history of colorectal neoplasia 4. Long-standing inflammatory bowel disease (Crohn's disease, ulcerative colitis)”
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This test has not been cleared by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not currently required.
