FDA regulation of laboratory-developed tests would prevent many hospitals from conducting the tests needed for essential care.

1. What are laboratory-developed tests?

A laboratory-developed test (LDT) is a new or significantly modified test that is developed, validated, and used within a single CMS CLIA-licensed laboratory in response to a specific patient care need. These tests are typically not advertised and packaged or sold as a kit to other testing facilities. Only labs approved by CLIA as “high-complexity” labs are allowed to perform LDTs.

2. Why are LDTs so important for patients?

Most LDTs are developed because there is not already an FDA-approved test available, and they are often used to diagnose rare conditions, such as inherited genetic abnormalities in children. Physicians work with laboratory scientists to develop these LDTs to obtain vital information for diagnosing a patient.

View examples of LDTs that are essential to patient care.

3. How are LDTs regulated now? Is this an efficient system?

Laboratories have been regulated by CMS under CLIA for 30 years. The high-complexity labs creating LDTs are routinely inspected to ensure that they provide highly accurate testing. To date, no one has demonstrated a problem with the use of LDTs.

4. What is the VALID Act?

The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 is a complex bill proposing dramatic modifications to current oversight mechanisms of both in vitro diagnostic tests and LDTs. VALID has the potential to significantly impact many clinical testing laboratories, public health laboratories, healthcare providers, and patients throughout the United States.

5. What is the problem with including VALID in MDUFA?

A bill as complex as the VALID Act requires careful consideration to avoid unintended consequences. If added to legislation to reauthorize MDUFA, VALID would not go through the typical deliberative process in Congress as MDUFA has already been through significant negotiations before even being submitted to Congress. With the intense pre-submission negotiation step, Congress expects that the agency and the regulated industry have come to agreement on terms. MDUFA is considered a “must-pass” agreement, and it is negotiated between the FDA and the medical device industry it regulates. Clinical labs were not part of the negotiations that led to the agreed-upon language in MDUFA, and if VALID is added after the fact then the necessity to pass MDUFA will keep all the potential consequences of the VALID Act from being carefully deliberated upon.

6. What is the potential issue with putting LDT regulation under FDA?

Simply, this would create a dual, expensive, and potentially contradictory regulatory environment for labs, eliminating most labs’ ability to perform LDTs and drastically limiting patients’ access to critical laboratory test results.

7. How could duplicate regulation impact the care that patients receive? Who are the patients most likely to be impacted by this duplication?

VALID would involve significant regulatory costs for hospitals and other clinical labs. If labs are forced to stop providing this service, physicians may not able to get the vital information they need to diagnose and/or manage the treatment of their patients. For example, physicians often use LDTs to determine whether to perform surgery to remove certain cancerous masses as well as to monitor a patient’s response to therapy. In addition, physicians often use LDTs to monitor whether a patient is at risk for rejecting an organ transplant. These LDTs are the gold standard of testing in these situations and many others.

8. What would this mean for patient care?

Patients would lose access entirely to certain tests. Other tests would be provided by labs far away from where patients are being treated, which would delay diagnosis and treatment – in some cases with significant and dire consequences.

9. If LDTs were regulated under FDA in 2020, would that have been better or worse for our response to COVID?

Labs routinely develop LDTs. The biggest barrier labs encountered in offering COVID tests was the FDA. Once agency barriers were removed, labs were able to quickly introduce LDTs to meet the public need for COVID-19 testing at the beginning of the COVID-19 pandemic. If VALID is enacted – under MDUFA or otherwise -- hospitals will stop performing LDTs. Thus, they would not be in a position to offer these tests in a future pandemic.