Bucshon, Burr introduce bill creating framework for approval of diagnostic testing

U.S. Rep. Larry Bucshon (R-IN) and U.S. Sen. Richard Burr (R-NC) on June 24 introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, which would modernize the review process for diagnostic testing and better protect patients.

While the use of diagnostic testing has grown, the regulatory framework for these tests is outdated, having been established under the Clinical Laboratory Improvement Amendments of 1988.

The VALID Act would create a unified framework for the review and approval of diagnostic testing, accelerating medical innovation, and accurately reflecting the availability of modern diagnostic tests, according to a statement from Rep. Bucshon’s office. The legislation would also clarify the regulatory authority between the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services, limiting duplication between the two agencies.

“In the operating room time is a precious commodity – even the smallest delay can be the difference between life or death for a patient,” Rep. Bucshon said. “Recent advancements in diagnostic testing technology have transformed the speed and accuracy in which doctors receive this life-changing information, giving patients and doctors what they need most: more time.”

Rep. Bucshon was joined in introducing the bipartisan legislation in the U.S. House by U.S. Rep. Diana DeGette (D-CO), while Sen. Burr introduced a similar Senate bill with U.S. Sen. Michael Bennet (D-CO).

“The coronavirus pandemic demonstrated the importance of diagnostic testing, particularly in the nation’s ability to respond quickly and effectively,” Sen. Burr said.  “This legislation will help modernize the FDA review process for diagnostic tests for the first time. By creating a unified framework, we not only give test developers the certainty they need to invest in cutting-edge technologies and products, but also give Americans confidence in their tests results when making critical health care decisions.”