The American Society for Microbiology (ASM) expressed concerns to the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee about the recent Verifying Accurate Leading-Edge IVCT Development (VALID) Act released as part of a legislative package on May 17, 2022.

This legislation, if passed, could have a major impact on clinical microbiology laboratories. ASM has been working independently and in collaboration with peer organizations to express strong opposition to provisions in the bill, which is part of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.

The VALID Act would create a new category of in vitro clinical tests (IVCTs) that includes test kits and laboratory-developed tests (LDTs), and it would give the U.S. Food and Drug Administration the authority to review and approve these tests before they go on the market. ASM released a statement to Congress on May 22, 2022, urging the HELP Committee to address its concerns before advancing the bill as part of the FDASLA.

“We urge you to amend the draft legislation to alleviate the … financial, regulatory and administrative burdens found within the VALID Act that would, among other aspects of the bill, be detrimental to infectious disease diagnostic testing and laboratory capacity throughout the nation,” ASM wrote in its statement.

One concern ASM has with the legislation is the registration of grandfathered and low-risk IVCTs, as it will place a considerable time and personnel burden on laboratories that already face burdens.

“If the registration requirement for all grandfathered and low-risk tests remains as it is currently written in the VALID Act, it will present an unreasonable burden on academic, nonprofit and hospital-based laboratories who do not have dedicated regulatory staff and do not have the funding to hire new staff for these tasks,” ASM wrote.

Even if exempt from premarket assessment, the VALID Act would require laboratories to register all LDTs within a year. According to ASM, this additional requirement would place a severe strain on laboratories that do not have the resources or capacity to respond to such demands, for both grandfathered and new tests. ASM proposed a longer three-year schedule to enable laboratories enough time to complete LDT registration to comply with these new criteria. ASM also recommended using an electronic, internet-based test menu to condense data and make the process even more effective.