[1] Laboratory-developed tests (LDTs) are a class of in vitro diagnostics (IVDs) designed, manufactured, and used within a single laboratory.
They are employed for various medical diagnoses and research applications, offering advantages in flexibility and fostering innovation in the diagnostics field.
[2] In the United States, the Food and Drug Administration (FDA) has determined that while such tests qualify as medical devices, these products could enter the market without prior approval from the agency.
[6][7] Direct-to-consumer tests are regulated as medical devices, although they are not necessarily reviewed by the FDA.
[3] Several prominent companies are at the forefront of developing innovative Laboratory Developed Tests solutions, including Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, and Illumina [2] The global market for laboratory-developed testing (LDT) is experiencing significant growth, with a projected value of US$ 4582.6 million by 2030 from US$ 3518.7 million in 2023 (CAGR of 3.8%) [2] This growth is driven by advancements in genetic testing, the increasing demand for personalized medicine, and the ongoing expansion of the healthcare and diagnostics sectors [2]