How the VALID Act Could Impact Clinical Microbiology Labs
What Is the VALID Act?
The Verifying Accurate Leading-edge IVCT Development (VALID Act) is a complex bill that has been under discussion for many years in Congress. Recently it was included in a larger legislative package focused on Food and Drug Administration (FDA) user fees. User fees are akin to application fees levied on for-profit commercial entities for medical devices and drugs that are reviewed by the FDA. User fee agreements help to fund FDA operations and are reauthorized every 5 years, making it “must pass legislation.”
The VALID Act would establish a new category to include in vitro clinical tests (IVCTs) comprised of both commercial test kits and laboratory developed tests (LDTs). Using a risk-based framework, tests would also require pre-market review. If enacted, this legislation could have a significant impact on clinical microbiology laboratories that use LDTs routinely for infectious disease diagnostic testing and surveillance.
What Are the Proposed Changes?
The VALID Act would establish the first user fee program to fund the review for IVCTs. Laboratories seeking approval of moderate and high risk IVCTs would be subject to this fee in order to utilize their own lab-developed tests. These fees would apply not only to large commercial test developers, but also to individual, nonprofit laboratories at academic and other medical centers with extremely small operating budgets. This would be financially disruptive for many in the public health community and delay the development of innovative diagnostic responses to public health crises.
The VALID Act would require laboratories to register all LDTs within 1 year, even if they are exempt from premarket review. This additional requirement for both grandfathered and new tests alike would pose significant burdens on laboratories that do not have the resources or capacity to respond to such requests. In order to adhere to these new standards, ASM has proposed a longer 3-year timeline to give laboratories adequate time to complete LDT registration. To further streamline the process, ASM suggests the implementation of an electronic, internet-based test menu to efficiently consolidate data.
Why Does it Matter?
LDTs are widely used by clinical microbiology laboratories for the diagnosis and monitoring of myriad infectious diseases, and changes in their regulation will have far-reaching implications for these diagnostic labs. Microbiologic testing for infectious diseases (ID) is different than other diagnostic disciplines. ID tests are not used as a “stand alone” diagnostic, but rather, are only a part of the diagnostic work up of a patient. ID diagnostics are used to not only identify a pathogen, but also to determine the pathogen’s drug resistance, which in turn helps guide and select appropriation antimicrobial therapy and monitor treatment response. LDTs in infectious disease also play an important role when testing for uncommon infections, when new pathogens emerge, and when testing special patient populations such as pediatrics and immunocompromised individuals.
For example, LDTs have played a pivotal role in SARS-CoV-2 diagnosis, but the challenges of receiving emergency approval authorization for newly created tests significantly delayed the ability to implement them, compounded by a shortage of traditional reagents. While the intent of Emergency Use Authorizations (EUAs) and their approvals is to safeguard the public and ensure tests are safe and effective early in outbreaks, the authorization process can be a hindrance when these precautions have already been implemented at the laboratory level. Testing is overseen by board-certified doctoral-level directors of clinical laboratories inspected and certified under the Clinical Laboratory Improvement Amendments (CLIA). ASM also developed step-by-step verification procedures to help labs develop efficient and effective verification protocols for SARS-CoV-2 molecular assays. FDA’s decision to expedite LDTs developed in CLIA-certified labs early in the pandemic provided millions of Americans with greater access to COVID-19 testing.
What is ASM Doing?
ASM represents members from academia, community hospitals and non-for-profit labs across the country. ASM is voicing its concerns about the impact these proposed changes would have not only in the productivity of these labs, but in delaying innovative response to public health issues. ASM has been working independently and in partnership with peer organizations to share the infectious disease diagnostics perspective and express strong concerns about provisions in the bill.