Putting patients first: Why Congress must pass diagnostic test reform

In the rapidly evolving healthcare 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 healthcare 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 US healthcare 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. 

Promoting consistent, reliable performance

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 healthcare 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 healthcare 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, healthcare 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.