March 2020

In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT, or VALID Act.  This legislation would alter the current regulatory landscape for many types of diagnostic tests, particularly those that are developed and run in a single laboratory – so called “laboratory developed tests” or LDT’s.  Historically, the FDA has not regulated LDTs and instead left the Centers for Medicare and Medicaid Services (“CMS”) to regulate these tests through the Clinical Laboratory Improvement Amendments (“CLIA”).

At its core, the VALID Act would explicitly grant the FDA authority to regulate LDTs through a risk-based framework that categorizes LDTs as high risk or low risk, with high-risk tests facing approval requirements that are comparable to existing medical device regulations.  Currently, high risk tests are designated as those that pose an unreasonable risk for serious or irreversible harm to patients is tests results were inaccurate.  Diagnostic innovators are concerned that a new regulatory framework could disrupt innovation and limit patient access, as clinical laboratories may face new requirements, including FDA registration, quality requirements, investigational studies, premarket review and approval, adverse event reporting, and product corrections and removals.  However, the legislation only includes a framework for addressing these issues, and final requirements will be developed by the FDA following passage of the legislation.

In addition to the VALID Act, the Verified Innovative Testing in American Laboratories (VITAL) Act was recently introduced in the U.S. Senate.  The VITAL Act is intended to accelerate test approval during public health emergencies by placing LDTs solely under the oversight of CLIA regulations. Furthermore and in contrast to the VALID Act, the VITAL Act would exclude FDA from any oversight role over LDTs, even during a public health emergency.

Boston Healthcare works with companies developing innovative diagnostic tests, both within the LDT and IVD settings. Contact us and learn how our team can assist in developing comprehensive commercialization plans that account for key regulatory and market access considerations.