The US Food and Drug Administration (FDA) defines a Laboratory Developed Test (LDT), also called a “home brew” test, as an in vitro diagnostic (IVD) test that is manufactured by and used within a single laboratory with CLIA certification. Because they are classified as devices, LDTs are subject to regulatory oversight by the FDA.
Critical components of LDTs are referred to as ASRs. They are defined as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences [oligonucleotides], and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens."
Eurogentec is registered (#3008004341) with the FDA as a Class I manufacturer of custom ASR oligonucleotides which are intended for use in in vitro diagnostic (IVD) applications. Our ASR oligonucleotides are manufactured under a Quality System based upon FDA 21CFR 820 regulations. Class I ASRs must be labeled as “Analyte Specific Reagent. Analytical and performance characteristics are not established.”
We offer a price attractive, customizable manufacturing process to cater to the specifications and use of your Class I ASRs. Please contact us to learn more about our manufacturing programs, to ask for a consultation or to request a project quote.