In the rapidly evolving health care landscape, medical advancements are continuously pushing boundaries. In vitro diagnostic tests are no different. New, innovative versions of those tests – using blood or tissue from the human body – emerge all the time.
Millions of Americans rely on them to diagnose everything from strep throat to cancer and to identify cancer risk-increasing genes. The results are critical to life-saving health care decisions, like preventive cancer surgery, and to monitor disease progression and treatment effectiveness. COVID-19 underscored the need for available, reliable tests to the American people.
An estimated 70 percent of all U.S. health care decisions are based on in vitro diagnostic test results. Approximately 3.3 billion tests are performed in the United States each year.
Despite the rapid growth of test types and rapid uptake of use, federal oversight hasn’t kept pace. The FDA is doing its best to operate in a framework that worked in 1976, when Congress approved the relevant regulatory authority, but when tests were much fewer. The Congress of our nation’s Bicentennial couldn’t have anticipated the incredible technology of today.
Fortunately, today’s Congress has shown what a modern, harmonized regulatory process for these essential tools could look like: the bipartisan Verifying Accurate, Leading-edge IVCT Development (VALID) Act. This legislation, or something like it, could serve in vitro test innovators and patients for the next 50 years.
Currently, the FDA oversees in vitro diagnostic tests made in a manufacturing facility, not those developed and run in a single laboratory. The VALID Act proposes a uniform FDA regulatory framework for all diagnostic tests, regardless of where they are made. The legislation aims to establish consistent standards of accuracy and reliability for every in vitro diagnostic test.
Under current practices, the tests that don’t fall under FDA regulation lack the agency’s oversight of product performance and quality assurance, known as post-market surveillance and adverse event reporting. The FDA regime works well. The trust and transparency between the agency and medtech innovators keep the agency agile and health care practitioners and the public reassured. In applying these standards to all diagnostic tests, the VALID Act promotes consistent, reliable performance before products reach consumers and after the products are in use, both critical components for maintaining patient trust and the integrity of health care decisions.
Unlike existing medical device regulations, which do not fully address the unique complexities and nuances of tests, the VALID Act introduces a fit-for-purpose regulatory program. This program is the result of nearly a decade of collaborative efforts among diagnostic developers, health care professionals, patient advocacy groups, and policymakers. It is finely tuned to meet the dynamic needs of existing and emerging technology, ensuring that these critical diagnostic tools can be brought to market efficiently, without compromising quality or patient safety.
Some observers might argue increased regulation could impede innovation. However, the VALID Act fosters innovation. By streamlining the approval process for new diagnostic tests, the legislation supports rapid advancements in the field. This is particularly crucial for emergencies like COVID-19, a then-unknown pathogen requiring swift identification, action, and response.
The VALID Act also supports the development of tests for rare diseases, where swift and flexible regulatory pathways can significantly impact patient outcomes. The legislation thoughtfully incorporates exemptions and flexible approaches, particularly for specialized tests. This balance between regulation and innovation is key to advancing patient care while ensuring safety and reliability.
The new regulatory system could mean an increase in the number and types of tests available to consumers. It could help increase competition among test developers, not only serving patients but also possibly reducing testing costs.
By bringing tests under the FDA umbrella, a VALID Act-like approach would help ease the concerns over test accuracy, safety, and marketing claims that have put certain tests in the spotlight.
The FDA and the Centers for Medicare and Medicaid Services recently urged testing regulatory reform to better serve patients. Congress came close to passing the VALID Act in its last session. It’s time to finish the job.
The VALID Act approach lays the groundwork for a future where patient care is even more enhanced by reliable, accurate, and innovative diagnostic tools than what we enjoy today. It represents a significant advancement in the regulatory landscape for in vitro diagnostic tests, addressing both current needs and future challenges in diagnostic medicine. By passing the VALID Act, or something like it, Congress will not only be updating regulatory standards but also championing patient care and safety in an age of unprecedented medical progress. Patients should have the full benefit of diagnostics that will continue to see explosive growth and use. As science advances, so should the oversight that promotes medtech innovation and patient trust.
Thierry Bernard is CEO of QIAGEN, a global leader in molecular diagnostics and life sciences, and chair of the AdvaMedDx board of directors. AdvaMedDx represents manufacturers of innovative in vitro diagnostic tests and technologies. AdvaMedDx is a division of AdvaMed, the world’s largest association representing medtech innovators. Scott Whitaker is AdvaMed CEO and president.
