FDA Report Cites Benefits of LDT Oversight

Washington, DC -- November 16, 2015 -- The Food & Drug Administration (FDA) released a report this afternoon looking at the evidence supporting oversight of lab-developed tests. See the link below to the report and an FDA blog post. Beneath those is a statement from the American Cancer Society Cancer Action Network (ACS CAN): http://blogs.fda.gov/fdavoice/index.php/2015/11/why-fda-should-oversee-laboratory-developed-tests/ Statement from ACS CAN: The FDA report provides examples of how a lack of oversight of laboratory developed tests can result in misdiagnoses that can have life-threatening consequences. False results, or missed or incorrect diagnoses, could mean that patients either will not receive the therapy they need, or will be subject to adverse effects and costs of therapy that will not work for them. It is paramount that patients and their physicians know that regardless of how or where a test is manufactured or performed, they can trust the information produced by that test. The FDA is the most appropriate agency to evaluate the analytical and clinical validity of diagnostic tests, along with their safety, to help ensure that patients and their doctors are able to make appropriate treatment decisions based on accurate information. ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.fightcancer.org FOR MORE INFORMATION CONTACT: Alissa Crispino or Steven Weiss American Cancer Society Cancer Action Network (ACS CAN) 202-661-5772 or 202-661-5711 [email protected] or [email protected]