Future Changes for Laboratory Developed Tests (LDTs) Expected

On July 31st, 2014 the Food and Drug Administration (FDA) gave Congress a sixty day notice that they will be delivering two draft guidance documents related to oversight of LDTs.

This is one of the important steps that the Food and Drug Administration (FDA) is taking to clarify policies and better regulate Laboratory Development Tests (LDTs). Their intent is to ensure that LDTs are better regulated through the proper premarketing quality testing and post-market reporting. Historically, the FDA has left LDT regulation in the hands of the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). Contemporary trends in healthcare look to diagnostics testing as a means for carrying out personalized treatment plans. With this shift, the industry has seen high volumes of complex diagnostic tests used nationwide. These tests are used to screen patients for high-risk diseases like Alzheimer’s and breast cancer.

What is a Laboratory Development Test (LDT)?

A Laboratory Development Test (LDT) is a type of in vitro-diagnostic test that is designed, manufactured and used within a single laboratory.  Some LDTs are relatively simple tests that measure single analytes while other LDTs are complex and measure or detect numerous analytes. For example, DNA variations can be detected from a blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health.

While the uses of an Laboratory Development Test (LDT) are often the same as FDA-cleared or approved in vitro-diagnostic tests, some labs may choose to offer their own test. The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or partly outside of the laboratory that offers and uses them.

Why are LTDs important for healthcare today?

Laboratory Development Tests LDTs are important to the continued development of personalized medicine. These types of tests help determine a general course of action for treating a specific disease and can be personalized to see how an individual patient will react to that treatment. It is important that in vitro-diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay needed treatments or become exposed to inappropriate therapies.

What prompted the need for stricter regulations by the Food and Drug Administration?

The Food and Drug Administration (FDA) has generally not enforced premarket review and other applicable FDA requirements because LDTs were relatively simple lab tests and generally available on a limited basis. But, due to advances in technology and business models, LDTs have evolved and proliferated significantly since the FDA first obtained comprehensive authority to regulate all in vitro-diagnostics as devices in 1976. Some LDTs are now more complex, have a nation-wide reach and present higher risks, such as detection of risk for breast cancer and Alzheimer’s disease, which are similar to those of other IVDs that have undergone premarket review.

Be on the lookout for more information pertaining to regulation changes on the Coloaborate blog or contact us today to learn how we can help your lab prepare!

By Kevin Hunter