The VALID Act (Verifying Accurate Leading-Edge IVCT Development) is a bill designed to set up a new branch of in-vitro clinical tests, including lab-developed tests (LDTs) and commercial test kits. It has been under discussion by the United States Congress for many years but has finally been approved as part of a larger legislative package. The bill will significantly impact infectious disease surveillance and diagnostic testing if enacted.
Proposed Changes in the VALID Act
Should the VALID Act become law, laboratories working on moderate to high-risk IVCTs will be required to pay a fee before using lab-developed tests they created independently.
This will apply to established commercial test developers, nonprofit labs, medical centers, and individuals with minimal operating budgets. For many of these, such fees will be a cause of disruption to their business by raising their operational costs.
Even in cases where laboratories are exempted from pre-market review requirements, they will still have to register all their Lab-Developed Tests within one year. This regulation will cover new and previously existing tests, presenting a significant financial burden for laboratories.
What the VALID Act Means for Us
The use of LDTs is an essential part of any microbiology laboratory that carries out the surveillance and diagnosis of infectious diseases, meaning that they will be drastically affected by any legislative changes enacted. This type of testing differs from other medical diagnostics in that they do not operate on a standalone basis but are taken as part of a larger diagnostic workup.
By carrying out such diagnostics, laboratories can determine the identity of any given pathogen and determine how resistant they are to conventional drugs, which is the first and most important step we take when combatting infectious diseases.
The recent Covid-19 pandemic is a good example showing the importance of LDTs, and why we need them to operate effectively for our safety and well-being. During the pandemic days, LDTs were vital in diagnosing Covid-19 cases. Even so, more could have been done, especially in the early days.
Laboratories encountered stiff resistance when trying to obtain EUAs (Emergency Use Authorizations) for new tests, and this was further compounded by shortages of reagents due to supply chain troubles.
We can all appreciate the importance of maintaining strict safety standards when discussing medical matters. Still, there have been many recent publications voicing concerns that the proposed VALID Act may harm the ability of laboratories to effectively identify, monitor, and combat infectious diseases.
Laborastories podcast host Dr. Shannon Haymond speaks with Dr. Patricia M. Jones, Chair, AACC Policy and External Affairs Commitee, about the ins and out of the VALID Act bill’s potential impact on both in vitro diagnostic tests ad laboratory developed tests.
Do you think the VALID Act will have drastic modifications to laboratory testing? We would love to hear your thoughts. Shoot us a message at welovecontrol@UTAK.com to further discuss.