American Heart Association Volunteer Testifies on the Need for Increased Oversight of Laboratory-Developed Tests

September 09, 2014 Categories: Advocacy News

Washington, D.C., Sept. 9, 2014 – American Heart Association volunteer Christopher Newton-Cheh, M.D., M.P.H., testified today before the House Energy and Commerce Subcommittee on Health on the need for increased oversight of laboratory-developed tests (LDTs). A cardiologist at Massachusetts General Hospital and Assistant Professor of Medicine at Harvard Medical School, Dr. Newton-Cheh’s remarks focused primarily on concerns surrounding the lack of regulations for LDTs.

Patients and health care providers are increasingly using LDTs to help predict, prevent and treat cardiovascular diseases despite the fact that these tests have come to market without being clinically validated by the Food and Drug Administration (FDA) or any other government agency. Basing treatment decisions on information from LDTs that have not been demonstrated as safe, effective and valid can create additional health issues and concerns.

“A lack of oversight for laboratory tests means that there is no guarantee of test quality and performance, and that doctors – attempting to make an accurate diagnosis or prediction of risk – and patients – interested in reducing their risk for disease – may receive and take action based on inaccurate or misleading results,” said Dr. Newton-Cheh.

“Ultimately, we may be able to achieve significant medical advances with the development of new genetic tools that assist with preventing and treating heart disease and stroke,” Dr. Newton-Cheh said. “But, for this to come to fruition, health care providers need accurate and reliable tests they can interpret to guide shared decision-making with patients.”

In 2006 and again in 2010, the U.S. Government Accountability Office led an investigation of genetic testing companies and found some companies “mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers.” In addition, Dr. Newton-Cheh highlighted in his testimony the danger of undermining public and health care provider confidence in using these genetic tools if LDTs do not have rigorous oversight.

Recently, the FDA announced its decision to reconsider its enforcement discretion with the regulation of LDTs. The association commended the agency for taking this important step for patients, and strongly supports the release of this proposed guidance so that stakeholders can begin a public dialogue about how best to proceed.




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