The legislation currently under consideration at the U.S. Congress would increase oversight of certain diagnostic tests, and a new study by researchers at Massachusetts General Hospital (MGH) and colleagues from several other institutions shows that their potential effects depend on the key details in the final Bill will depend on language. This study, published in JCO Oncological Practice, provides the first evidence-based analysis of how new rules for regulating laboratory-developed tests (LDTs) could affect healthcare costs in the United States.
“The idea of having more control over LDTs is justified,” says Dr. Jochen Lennerz, Medical Director of the MGH Center for Integrated Diagnostics and lead author of the study. “However, our results show that it is very important to align the language in this new law with the intent of what it is to achieve.”
From a regulatory perspective, there are two categories of in vitro clinical tests (IVCTs), which include diagnostic tests performed in a test tube, culture dish, or other location outside of a living organism. Prepared tests for a wide variety of conditions are available commercially. The U.S. Food and Drug Administration (FDA) strictly regulates these tests and requires manufacturers to submit marketing approval data before they can be sold. However, clinical laboratories in hospitals and other health care facilities can create their own IVCTs for in-house use called LDTs. Currently, the FDA does not require LDTs to be marketed and has little control over their use.
LDTs serve a variety of purposes, but a critical role is to identify patients for novel drug therapies that target specific DNA variations, especially when a commercial test is not yet available. This form of therapy, known as personalized medicine, is becoming increasingly important in cancer treatment.
Unfortunately, flawed IVCTs can lead to inaccurate results, leading some patients to forego potentially beneficial treatments and receive others from unnecessary and potentially harmful therapies. The proposed legislation, currently known as the Verifying Accurate and Leading-Edge IVCT Development (VALID) Act, illustrates the authority of the FDA over all diagnostic testing.
If passed, VALID would focus on what are known as highly complex IVCTs, which have the greatest potential for patient harm if the results are incorrect. To comply with VALIDITY, clinical laboratories would need to demonstrate the accuracy of their LDTs, including a process known as technology certification.
Lennerz worked with lead author Richard Huang, MD, and several colleagues to model the total cost of maintaining the technology certification framework under VALID for cancer diagnostics.
The study found that maintenance costs for a laboratory performing LDTs differed little under low stringency and moderate stringency conditions, but would increase sharply under high stringency conditions. By extrapolating the data to reflect the additional cost to the country’s 886 cancer treatment centers, VALID compliance could add more than $ 1 billion to U.S. healthcare costs over three years, depending on strict enforcement.
Edited by Gary Cramer