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:
- Patients who have indications for structural exam (symptoms, plus screening test, etc).
- Hereditary colorectal cancer syndromes (eg, HNPCC, FAP).
- Family/personal history of colorectal neoplasia.
- Long-standing inflammatory bowel disease (Crohn's disease, ulcerative colitis).”
Call LabSafe toll free at 1-888-333-LABS to speak with a Medical Counselor for further information on PreGen Plus™.
PreGen Plus™ 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.
