Laboratory-Developed Test Oversight FAQs

The Verifying Accurate Leading-edge IVCT Development (VALID) Act is bipartisan, bicameral legislation that creates a new comprehensive regulatory framework for clinical laboratory tests that includes laboratory-developed tests (LDTs).

Here are the main features of the bill:

• Create a risk-based system of oversight utilizing tiers (low-, moderate-, and high-risk) to target FDA oversight.
• Exempt all existing LDTs from FDA premarket review. The FDA may only review an LDT’s validation if there is a safety concern for patients.
• Utilize mitigating measures to shift LDTs to lower tiers of regulation. These measures include such practices as appropriate labeling, performance testing, submission of clinical data, clinical studies, and posting information on a website.
• Offer exemptions from the FDA premarket review process. These exemptions include LDTs in the low-risk category, low volume tests, modified tests, manual interpretation tests, and humanitarian tests.
• Prohibit the FDA from infringing on the practice of medicine.
• Direct the FDA to avoid issuing or enforcing regulation that is duplicative of regulation under CLIA.
• Require the FDA to conduct public hearings on LDT oversight.
• Establish an effective date five years from now in 2027.
• Establish a process by which user fees will be created via negotiations between the agency and the industry, and is subject to congressional approval.

Patient and physician advocacy groups have called on Congress to move the VALID Act forward. For example, 18 advocacy groups urged Congress to prioritize the VALID Act in 2021. Those groups were: the American Cancer Society Cancer Action Network, the American Society of Clinical Oncology, Cancer Support Community, Emerson Collective, FORCE: Facing Our Risk of Cancer Empowered, Friends of Cancer Research, Global Liver Institute, LUNGevity Foundation, Lymphoma Research Foundation, Muscular Dystrophy Association, National Center for Health Research, National Consumers League, National Organization for Rare Disorders, Prevent Cancer Foundation, Theresa's Research Foundation, Triage Cancer, and US Public Interest Research Group.

Laboratory organizations such as the Association for Molecular Pathology, the American Association for Clinical Chemistry, and Association of Pathology Chairs have expressed opposition to the VALID Act. In general, the groups have opposed FDA regulatory oversight of LDTs and cite other reasons for opposing the bill.

The CAP supports many of the provisions in the VALID Act. Our most recent letter details provisions that the CAP supports and suggests other areas for improvement. The CAP expects that the legislation will continue to be modified throughout the legislative process and will be reviewing any additional changes to the bill.

The effective date in the legislation would be October 1, 2027.

The actual effective date in the legislation would be October 1, 2027; however, in the interim, the FDA would be given authority to intervene to review specific LDTs in the market if a patient safety issue is identified with those LDTs. The FDA has this authority today and is exercising that authority, but the legislation specifies this and establishes the limits of FDA authority.

No. The legislation specifically denies the FDA any authority to infringe on the practice of medicine. We understand that some pathologists consider their involvement in the development of laboratory tests to be part of their scope of practice. We have to keep in mind that scope of practice is regulated by the states and not the federal government.

The VALID Act requires documentation of clinical validation activities and outlines how those creating LDTs can demonstrate clinical validity. It doesn’t define which professionals can or cannot perform those activities. To assert that development of laboratory tests is a pathologist scope of practice issue would mean only physicians can perform these clinical validation activities, which we know to be performed by other laboratory professionals. This is acknowledged by the VALID Act.

The VALID Act stipulates those provisions in the bill will not affect a provider’s ability to administer or prescribe an approved in vitro clinical test, or otherwise limit the practice of medicine.

Modifications of tests are also exempt from premarket requirements if those modifications do not affect the analytical or clinical validity the test or change the intended use. For example, modified tests will be exempt when the modification is under an approved change protocol. If a modification adversely impacts compliance with applicable mitigating measures or the test is restricted to any high-risk or moderate-risk test that pose patient safety issues, it will require a regulatory submission.

The VALID Act explicitly states that the Secretary of the Health and Human Services should ensure there is no duplication between CLIA and FDA requirements.

No. The VALID Act does not set specific user fees. Congress would need to grant the authority for the FDA to charge fees. In general, Congress has established several exemptions from user fees (class I and some class II medical devices are exempt from premarket review and payment of an associated fee). Congress has also given small businesses (those with gross receipts below a specified amount) reduced premarket fees or will waive fees altogether.

In the CAP’s letter, we state: While the legislation does not establish the user fees, the CAP believes that if user fees are set too high, it will limit the development of LDTs by clinical laboratories and impede innovation by laboratories which are financially stressed. The CAP encourages minimal user fees, particularly for low and moderate risk LDTs which are already in widespread use.

Laboratory-developed tests have been a concern of patients for many years. One incident that initially led to advocacy by patient advocates surrounded the OvaSure Yale Ovarian Cancer Test in 2008. OvaSure was an LDT intended to be used to identify high-risk women who might have ovarian cancer. It was later determined that 1 in 15 women with a positive test would in fact have ovarian cancer while the other 14 had false-positive tests. There have been several other similar instances involving LDTs through the years. In January 2022, a group of nearly 100 members of Congress expressed serious concern to the FDA over reports of high false-positive rates in noninvasive prenatal test (NIPT) genetic screenings for rare genetic disorders. The FDA responded by writing “[m]any newer LDTs, including the NIPTs described in the New York Times article, are more complex, used broadly, and intended for higher-risk uses.”

During the COVID-19 pandemic, the Department of Health and Human Services (HHS) and FDA also reported that there were more than 500 emergency use authorization (EUA) requests from laboratories. In an analysis of 125 EUA requests for COVID-19 molecular tests, the FDA found two-thirds had either design or validation issues. Most validation issues were related to improperly designed validation studies such that the FDA couldn’t tell if the tests worked or not. Additional follow-ups found performance issues had been masked by improperly performed validation studies.

No. There have been multiple drafts of the VALID Act over a period of several years. Initial discussion about the VALID Act followed a roundtable in 2019, which was when members of Congress discontinued work on another LDT oversight bill referred to as the DAIA Act. The current version of the VALID Act is the third major iteration bill.

For over a decade, federal agencies and Congress have been considering how to design a regulatory framework for LDTs. It is important to understand that both the FDA and CMS currently use third-party accreditors and every proposal on LDT oversight through the years has included a role for third-party accreditors — whether under the CMS or FDA – because neither agency has the workforce and infrastructure to regulate LDTs without outside help. Some proposals by other organizations have also assumed that CAP would be selected to be a third-party accreditor for LDTs, but the CAP has not made that assumption.

If the FDA is granted authority to regulate LDTs, any laboratory organization could apply for third party status, including the CAP. The CAP has not assessed this, and a potential third-party role is not guiding CAP advocacy on this issue.