- Purpose: Exact Sciences Corp. has introduced the Riskguard™ hereditary cancer test in the United States to detect genetic changes associated with 10 common cancers.
- Test Coverage: The Riskguard test provides individualized patient reports based on gene-specific and familial risks, using either a blood or saliva sample.
- Covered by Insurance: The test is covered by Medicare and many commercial insurance plans for eligible patients, making it accessible to a wide range of individuals.
- Clinical Utility: For patients already diagnosed with cancer, the test aids in creating personalized treatment plans. It also helps identify changes in cancer-associated genes for patients with a family history of cancer, assisting in risk stratification and management options.
- Integration with Existing Offerings: The Riskguard test complements Exact Sciences’ existing portfolio, including the Oncotype DX® and OncoExTra® tests, which contribute to improved outcomes across the cancer-care continuum.
- Physician Accessibility: Physicians can order all three tests through a single Exact Sciences portal, streamlining management and treatment for patients.
- Validation and Processing: The Riskguard test and its performance characteristics are validated by Exact Sciences Laboratories, adhering to College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations.
- Availability: Health care providers can order the Riskguard hereditary cancer test starting March 12, 2024, through the Precision Oncology portal.
- Forward-Looking Statements: Exact Sciences provides forward-looking statements regarding the commercialization and market acceptance of the Riskguard test, emphasizing the company’s commitment to cancer screening and diagnostic innovation.
- Trademark Notice: Exact Sciences trademarks, including Cologuard®, Riskguard™, Oncotype®, and OncoExTra®, are acknowledged in the release.
Please note that the Riskguard test has not been cleared or approved by the US Food and Drug Administration or other regulatory authorities.