ASCP urges you to oppose the VALID Act: Take Action Now!
ASCP is urging our members to help ensure that legislation under consideration in Congress doesn’t over regulate laboratory testing and block patient access to critical testing services. ASCP is concerned that the Verifying Leading-edge IVCT Development Act, or VALID Act, could undermine the use and development of laboratory developed tests (LDTS) by clinical laboratories.
LDTs are tests developed and/or modified within clinical laboratories. These tests are used every day at clinical laboratories throughout the Unites States to diagnose illness and provide key information for the timely diagnosis and treatment of numerous patients. LDTs fill a critical need in the practice of medicine. Academic medical centers and other clinical laboratories use these tests to provide specialized diagnostic and clinical care for their patients. For example, children’s hospitals have to rely on LDTs to identify the unique genetic characteristics of certain pediatric cancers because many commercial panels do not identify these pediatric genetic characteristics.
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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. This could mean that clinical laboratories required to submit premarket applications could be forced to pay hundreds of thousands of dollars per test. Given that some labs have developed hundreds of LDTs, the cost and delays of FDA oversight could be enormous and could block clinical laboratories from relying on these critical tools.
Unfortunately, the Senate may soon approve legislation, called the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. ASCP is asking all its members to urge Congress not to approve the VALID Act as part of the FDASLA Act or any other bill.
Take Action Now!
