Why it is Imperative that the FDA Oversee Lab Developed Tests

What are Laboratory Developed Tests (LDTs)? These are artificial diagnostic tests that are constructed and used in laboratories to detect diseases and infections. Edward Simpson looks at the matter further...

FDA laboratory developed tests are different from the standard diagnostic tools that medical practitioners are used to. Even though these tests have been there for years now, they have been subject to serious qualms. At present, The Food and Drug administration (FDA) is focused on regulating laboratory tests and coming up with FDA approved lab tests. The reason behind this is that the FDA claims that LDTs may have caused harm to patients as a direct result of misdiagnosis.

The move to regulate the diagnostic tests that have been developed in over a hundred laboratories is picking up quite a debate. The FDA seems to overlook the fact that doctors use diagnostic laboratory developed tests to determine if their patients are at risk for developing serious illnesses. It is for this reason that hospitals strictly use FDA approved kits. However, the a thousand plus single laboratories in the USA are overly motivated and dedicated to designing and using their own tests.

When it all Began

Since 1976, the USFood and Drug Administration have the mandate of regulating LabDeveloped Tests. In the past, the FDA chose not to enforce applicable regulatory requirements because LDTs were just basic lab tests that were used on restricted cases and only for rare conditions.

For over 4 decades now, the FDA has been keeping tabs on several LDTs which are said to pose high risks. The main concern being that people might get carried away and begin to administer treatment that might lead to over and/or under treatment.

The fact that we quickly become accustomed to advancement in technology also means that LDTs are ever evolving. Laboratory developed tests are becoming more complex and since they are widely used across the country, these tests may present higher risks to patients especially those diagnosed with cancer and Alzheimer’s disease.

The FDA made it publicly known that it intended to issue a draft stipulating its oversight framework over LDTs. This was on 31^st July 2014.  Since then, The Food and Drug Administration decided to focus on what LDTs can do for patients rather than shunning them just because they are manufactured and designed in a lab. An excerpt of this draft reads, “The FDA will continue to exercise enforcement discretion for LDTs that are used for rare diseases…”

Should the FDA oversee all Lab Developed Tests?

In its quest to start a premarket view for LabDeveloped Tests, the FDA pays attention to the use of LDTs by observing the following information

• Whether FDA approved diagnostic tests will give patients an effective diagnosis and treatment option.
• Whether these LDTs are used for diagnosis or screening.
• Whether medical practitioners will go beyond LDT results and find more means for diagnosis and treatment.
• Whether the laboratory developed tests used are intended for high risk diseases or not.
•  Whether where LDTs fail, there will be other alternative testing and treatment options used to save lives.
• Whether the adverse effects associated with LDTs is a risk worth taking.

After a recent agency meeting, the FDA informed Congress that is intends to exercise authority over LDTs. The agency went ahead to introduce a proposed regulatory framework and their suggestion to oversee all LDTs elicited a strong response for and against.

The truth of the matter is, times have changed and so have LDTs. Compared to some years back, LDTs have now increased not only in complexity but also in availability hence the urgent need for a FDA test. Having in mind that LDTs are now used to diagnoseboth common and serious medical conditions like heart disease, cancer and Alzheimer’s disease, it is only proper that the FDA oversee these tests to ensure that patients are safe.

With all that said, the answer to the question whether the FDA’s involvement in regulating all LDTs is good or not, the answer is a big Yes!

Fortunately, the FDA is now stepping up efforts to completea proposal for the premarket review of FDA laboratory developed tests. This means that the agency is willing to intensify its oversight role over high risk and low risk Laboratory Developed Tests. As the watch dog agency, the FDA will ensure that LDT tests are supported by evidence in addition to promoting patient confidence in the test results. Plus, it is the responsibility of the FDA to ensure that all LDTs have more accurate product labeling.



 Posted by Edward Simpson