Policy & Regulation
Applied BioCode Launches 28 New Fungal Analyte Specific Reagents in the US
23 November 2021 - - US-based IVD manufacturer Applied BioCode has released 28 Fungal Analyte Specific Reagents (ASRs) for use in molecular tests. (15 ASRs for mold pathogens, 10 ASRs for yeast pathogens, and 3 ASRs to detect dimorphic fungi), the company said.

These ASR products utilize the company's proprietary Barcoded Magnetic Bead technology for specific detection of targeted organisms.

For use as building blocks to develop and validate tests for the diagnosis of infectious diseases, ASRs may be sold to in vitro diagnostic manufacturers, and clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988, as qualified to perform high complexity testing.

ASRs may also be sold to organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

The primer pairs or probes coupled to BMBs are classified as ASRs, which can be used by high-complexity laboratories to develop their own laboratory developed tests.

The US Food and Drug Administration defines Analyte Specific Reagents as "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, 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." 21 CFR 864.4020

Under 42 CFR part 493, regulated under VHA Directive 1106 (available from Department of Veterans Affairs, Veterans Health Administration, Washington, DC 20420).

Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products.

The company has combined "digital barcodes" with immuno- and molecular chemistry to create a new, bio-inspired Barcoded Magnetic Beads technology.

The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets.

The company has FDA 510K clearances for their Respiratory 17-plex Pathogen Panel and Gastrointestinal 17-plex Pathogen Panel based on their BioCode MDx-3000 automated system.

Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.
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