SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode today announced an agreement with Hardy Diagnostics, a leader in manufactured and distributed microbiology products in the United States, for the distribution of the MDx-3000 System and its comprehensive menu for the diagnosis of upper respiratory infections, gastrointestinal infections as well as a suite of Analyte Specific Reagents (ASRs) which can be used by high-complexity laboratories to develop their own laboratory developed tests (LDTs). Under the terms of the exclusive agreement, Hardy Diagnostics will begin offering the MDx-3000 System to clinical laboratory customers in the United States.
“Applied BioCode is thrilled to partner with Hardy Diagnostics, and we look forward to working closely with the Hardy team to expand our reach to hospitals and reference laboratories in the US,” said Winston Ho, President of Applied BioCode.
Jay Hardy, Chief Executive Officer of Hardy Diagnostics, said, "We are very excited to add the Applied BioCode MDx-3000 molecular platform to our lineup of instruments to streamline the processes for microbiologists." Hardy adds, "Our Company prides itself on offering our laboratory partners innovative solutions to detect and diagnose disease. With the pandemic workload inundating our laboratory partners, we are pleased to be able to offer an easy-to-use automated system that offers reduced hands-on time, accelerated turnaround times, complete assay panels with minimal potential for sample contamination."
For more information on the Applied BioCode’s platform and products, visit: https://apbiocode.com/products.htm
About Applied BioCode
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 (BMB) 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 510(k) clearances for their 17-plex Respiratory Pathogen Panel (RPP) and 17-plex Gastrointestinal Pathogen Panel (GPP) based on their BioCode® MDx-3000 automated system. The GPP and RPP are CE-Marked for use in European countries conforming to CE-Mark regulations. Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*. 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.
ⱡ This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, Influenza A (with H1 pdm09, H1 seasonal, H3 subtypes), Influenza B, and/or Respiratory Syncytial Virus (RSV), not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.
