Congress Considering Law to Regulate High-Risk Diagnostic Tests

Legislation currently under consideration in the U.S. Congress would increase regulatory oversight of certain diagnostic tests, and a new study by researchers at Massachusetts General Hospital (MGH) and colleagues from several other institutions demonstrates that its potential impact will depend on key details in the bill’s final language. This study, published in JCO Oncology Practice, offers the first evidence-based analysis of how new rules proposed for the regulation of laboratory-developed tests (LDTs) could affect healthcare costs in the United States.

“The idea of having more oversight of LDTs is justified,” says Jochen Lennerz, MD, PhD, medical director of the MGH Center for Integrated Diagnostics and the study’s senior author. “But our results show that it’s very important to align the language in this new law with the intent of what it’s trying to accomplish.”

From a regulatory standpoint, there are two categories of in vitro clinical tests (IVCTs), which include diagnostic tests performed in a test tube, culture dish, or elsewhere outside a living organism. Manufactured tests for many different conditions are commercially available. The U.S. Food and Drug Administration (FDA) closely regulates these tests, requiring manufacturers to submit data for premarket approval before they can be sold. However, clinical laboratories at hospitals and in other healthcare settings can create their own IVCTs for use in-house, which are known as LDTs. Currently, the FDA does not require premarket approval of LDTs and exercises little oversight of their use.

LDTs serve a variety of purposes, but one critically important role is identifying patients for novel drug therapies that target specific DNA variations, particularly if a commercial test is not yet available. This form of therapy, known as personalized medicine, is becoming increasingly important in cancer treatment.

Unfortunately, faulty IVCTs can produce inaccurate results, causing some patients to forgo potentially beneficial treatments and others to receive unnecessary and potentially harmful therapies. The proposed legislation, currently known as the Verifying Accurate and Leading-edge IVCT Development (VALID) Act, clarifies the authority of the FDA over all diagnostics tests.

If passed, VALID would focus on so-called high-complexity IVCTs, which have the greatest potential for patient harm if the results are incorrect. To comply with VALID, clinical laboratories would have to demonstrate accuracy of their LDTs, which includes a process called technology certification.

Lennerz joined lead author Richard Huang, MD, and several colleagues in an effort to model the overall expense of maintaining the technology certification framework under VALID for cancer diagnostics.

The study found that maintenance costs for a lab performing LDTs would differ only slightly under low stringency and moderate stringency enforcement conditions, but would soar under highly stringent enforcement. Extrapolating the data to reflect the added expense for the nation’s 886 cancer treatment centers, complying with VALID could increase U.S. healthcare costs by more than a billion dollars over a three-year period, depending on stringency of enforcement.

Edited by Gary Cramer