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Applied BioCode, Hardy Diagnostics Ink US Distribution Agreement for MDx System, Test Menu

NEW YORK ─ Applied BioCode on Monday announced it has entered an exclusive agreement with Hardy Diagnostics for the distribution of Applied BioCode's MDx-3000 System and testing menu for the diagnosis of upper respiratory and gastrointestinal infections, and a suite of analyte specific reagents (ASRs) that high-complexity laboratories can use to develop laboratory-developed tests.

Under the terms of the agreement, Hardy Diagnostics will begin offering the MDx-3000 System and tests as well as ASRs to US hospitals and reference laboratories.

Financial and other terms of the agreement were not disclosed.

Applied BioCode noted it has combined digital barcodes with immuno- and molecular chemistry to develop barcoded magnetic bead (BMB) technology. Micro BMBs are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned, the firm said.

The Santa Fe Springs, California-based company has obtained US Food and Drug Administration 510(k) clearances for its 17-plex Respiratory Pathogen Panel (RPP) and 17-plex Gastrointestinal Pathogen Panel (GPP) based on its BioCode MDx-3000 automated system. Both panels are also CE-marked.

Additionally, Applied BioCode has also been granted FDA Emergency Use Authorization for its BioCode SARS-CoV-2 Flu Plus Assay and BioCode SARS-CoV-2 Assay, and has obtained an FDA EUA for pooled COVID-19 testing.