An emerging area of FDA regulation
Laboratory developed tests (LDTs) are being increasingly integrated into the standard practice of diagnosing and predicting the risk of developing a disease, as well as informing decisions regarding the management of disease states like cancer, heart disease and diabetes. LDTs are in vitro diagnostic tests that are designed, manufactured and used within a single laboratory. LDT providers typically create the necessary reagents themselves or purchase reagents from outside vendors and then develop their own proprietary tests for in-house pathology and diagnostic purposes, which facilitate the evaluation of alterations in biomarker levels and/or the presence or absence of genetic susceptibility mutations in patients. These diagnostic tests may aid in clinical decision making pertaining to the prevention, treatment and management of an array of common diseases.
Estimates suggest that tens of thousands of diagnostic tests, including the majority of genetic tests, are currently offered as LDTs.1 The growing reliance on diagnostic tests in guiding critical treatment decisions, combined with the dramatic increase in the number and complexity of LDTs, have created legitimate concerns over the safety and effectiveness of new LDTs. Accordingly, regulatory safeguards that ensure the accuracy of LDTs, particularly high-risk LDTs, are warranted so that patients do not seek unnecessary treatments, delay needed treatments or become exposed to inappropriate therapies.
Read more: Laboratory Developed Tests (LDTs)
Source: PersonalizedMedicine
