To diagnose conditions and inform treatment decisions, health care providers use a range of techniques. In vitro diagnostics, which are clinical tests that examine samples taken from the human body, are among the most popular and commonly utilized.
FREMONT, CA: In-Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood or tissue. In-vitro diagnostics can assist cure, treat, or prevent diseases by detecting diseases or other disorders and monitoring a person's overall health.
To diagnose conditions and inform treatment decisions, health care providers use a range of techniques. IVDs which are clinical tests that examine samples taken from the human body, are among the most popular and commonly utilized. Patients may get or refuse medical treatment depending on diagnostic test results; therefore, test reliability is vital. The Food and Drug Administration (FDA) regulates these tests as medical devices, which means that before bringing them to market, manufacturers must submit studies proving the test's accuracy and utility in detecting a certain condition.
However, any IVDs developed and used within the same laboratory, often known as Laboratory-Developed Tests (LDTs), have previously been exempted from this requirement by FDA. Even though some test-makers argue that LDTs are more accurately viewed as procedures that represent the practice of medicine, FDA maintains that these tests are devices that fall under its jurisdiction under the Medical Device Amendments of 1976. LDTs were employed mainly for rare diseases when the bill was passed, and they relied on manual (rather than automated or software-based) analysis and interpretation.
LDTs were exempted from the stricter regulatory criteria for other IVDs since they offered a reduced risk. However, LDTs have become more complex in recent years due to technological advancements that have allowed complex analyses like DNA sequencing both faster and more inexpensive. LDTs, like FDA-approved IVDs, is critical for the diagnosis and treatment of a wide range of illnesses and are a vital component of precision medicine, a still-emerging but very promising approach to clinical care that mainly relies on patient genetic or molecular profiling. Although LDTs have changed, the FDA continues to have little control over them.
Both providers and patients use clinical tests to make treatment decisions. However, while technology has progressed and the way doctors employ diagnostic testing has altered, the regulatory structure has largely stayed the same. Although IVDs and LDTs often perform the same function in clinical practice, they are subject to vastly differing degrees of regulation. This causes market distortions, inhibits regulators from completely understanding the tests used in clinical practice, and puts patients at risk of making important and perhaps irreversible medical decisions based on erroneous test findings.