Draft Legislation Would Delay and Eliminate Laboratory Developed Testing for Infectious Diseases

IDSA Board Member Angela Caliendo, MD, PhD, FIDSA explains the importance of LDTs and what is at risk.

Congress is considering draft legislation that would initiate FDA regulation of laboratory developed tests (LDTs). The Verifying Accurate, Leading-edge IVCT Development (VALID) Act would reduce patient access to testing and put patients’ lives and public health at risk. This bill would also set back transplant medicine by 20 years and severely limit the availability of diagnostics for rare infectious diseases, emerging diseases, and unmet needs.

The bill would require LDTs be subject to the same FDA approval processes as commercial tests, creating an unaffordable burden to academic medical centers and hospitals; as a result, these tests would not be performed or would be outsourced, delaying results and ultimately delaying life-saving care.

Angela Caliendo, MD, PhD, FIDSA, an IDSA Board member and a leader in infectious diseases diagnostics, was on Capitol Hill last week communicating the challenges of this legislation to Congress. Following her Hill visits she participated in a Facebook Live event, discussing the importance of this issue with IDSA’s Senior Vice President for Public Policy and Government Relations, Amanda Jezek. If you missed the event, you can watch it here.

As an expert and a constituent, you can amplify her voice and lend your expertise to the issue by taking two minutes to educate your members of Congress on how LDTs are used in ID patient care and ask them to help protect innovation and access to testing.