The Verifying Accurate Leading-edge IVCT Development (VALID) Act could become law later this year, formally giving the U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests, or LDTs. While the VALID Act aims to clarify the FDA’s authority to regulate LDTs, it could also hinder labs’ test development activity.
In a recent 360Dx article, President of Mayo Clinic Laboratories William Morice II, M.D., Ph.D., shares that more than half of Mayo Clinic’s tests are LDTs and were developed at the request of its clinicians. If VALID were to pass, Dr. Morice does not think it would prevent Mayo Clinic from continuing to develop these new tests, but it would likely increase their costs to be compliant with the new law.
He explains how smaller labs and labs with fewer resources could be particularly affected by these changes, although it could also drive new collaborations.
"You may have smaller labs that have ideas around developing tests … and they will need to work with places like a Mayo Clinic or another integrated hospital system," he said. "I think it will probably drive some new partnership and collaboration opportunities."