Advancing Patient Care through Appropriate and Transparent Diagnostic Testing Regulation


The Diagnostic Test Working Group (DTWG) is a coalition of leading In Vitro Clinical Tests (IVCT) manufacturers and clinical laboratories that are committed to advancing patient care through the development, manufacture and performance of high quality, high value diagnostic tests.

DTWG members share with other stakeholders the mission of providing physicians and patients access to analytically and clinically valid IVCTs using risk based, least burdensome principles. DTWG seeks to advance innovation and to eliminate duplicative or non-value-added regulation.

Members of DTWG include ARUP Laboratories, Becton Dickinson, Caris Life Sciences, Exact Sciences, Labcorp, Mayo Clinic, Myriad Genetic Laboratories, Quest Diagnostics and Roche Diagnostics.


IVCTs can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. IVCTs may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies.

Our Mission

The Working Group brings together technical expertise, real world experience, regulatory knowledge, and public policy understanding to assess current regulatory frameworks and issues and, as appropriate, develop consensus proposals to focus and improve oversight of diagnostic tests to benefit patients and providers.