Laboratory Developed Tests (LDT) & Analyte Specific Reagents (ASR)

Laboratory development tests (LDTs) are in vitro diagnostic (IVD) tests designed, manufactured, and utilized within a single laboratory. They provide high quality results for patients suffering from conditions for which no commercial test yet exists, or for which existing tests fail to meet the evolving clinical needs of. Therefore, the majority of LDTs have been developed in response to an unmet need, and are not commercially available. LDTs can detect a wide variety of substances in a human sample, such as proteins, chemical compounds, and nucleic acids. Their complexity varies from single analyte identification, to measuring and detecting multiple analytes in a single sample. For example, certain tests will simply measure sodium levels, while others are usefool tools for diagnosing genetic diseases, as they are able to detect multiple DNA variants from a single blood sample.

The FDA only considers diagnostic devices LDTs if they are fully and completely manufactured in the laboratory that offers and utilizes them. Results from LDTs and IVD tests inform patient treatment, which is why it is of the utmost importance that they are accurate and timely. Patients deserve the best care available to them, without becoming exposed to inappropriate therapies, treatments, or delays. Integrating TriLink as part of your test design is a preliminary step to ensure the success of your LDT.

Analyte Specific Reagents (ASRs) are molecules used to identify and measure how much of a given substance is present in a biological specimen. They are intended for diagnostic applications, as they can identify and quantify an individual chemical substance in a specimen through specific binding or chemical reactions with multiple substances in the specimen. Simply put, an ASR is the active ingredient of an in-house test. TriLink Molecules that fall under this category include, but are not limited to, nucleic acid sequences and more.

ASRs are considered medical devices, and as such, they are regulated by the U.S Food and Drug Administration (FDA). The FDA created this regulatory status to ensure that reagents with specific quality requirements would be made readily available for clinical laboratories developing Laboratory Developed Tests (LDTs).