Without YOUR HELP, Congress may soon approve it
ASCP is urging members of the pathology and laboratory medicine community to help prevent Congress from imposing restrictive and burdensome legislation on the laboratory community. The Verifying Leading-edge IVCT Development Act, or VALID Act, could undermine the ability of clinical laboratories to develop and use these critical patient diagnostic services.
Laboratory developed tests, or LDTs, are tests developed and/or modified by clinical laboratories. These tests are used every day at clinical laboratories throughout the Unites States, including in situations where no commercial diagnostic is available. For example, children’s hospitals rely on LDTs to identify the unique genetic characteristics of certain pediatric cancers that commercial panels may miss.
The VALID Act would give the U.S. Food and Drug Administration (FDA) authority over LDTs, requiring many of these tests to go through the same costly, time-consuming approval process as commercial diagnostic manufacturers. The VALID Act will result in huge costs and lengthy delays, which could prevent clinical laboratories from providing patients access to these critical diagnostics.
Supporters of the VALID Act are trying to attach this flawed bill to “must-pass” legislation on which Congress is working. ASCP urges you to use this Action Alert to contact your members of Congress and ask them to oppose the VALID Act.
