SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu. The MDx-3000 menu consists of products that enable the diagnosis of upper respiratory infections and gastrointestinal infections, as well as a suite of Analyte Specific Reagents (ASRs), which high-complexity laboratories can use to develop their own laboratory developed tests (LDTs).
Medline is focused on improving the overall operating performance of healthcare, partnering with healthcare systems and facilities across the continuum of care to provide clinical and supply chain resources. Under the terms of the distribution agreement, Medline will offer the MDx-3000 System to clinical laboratory customers across the U.S.
“Applied BioCode is thrilled to partner with Medline Industries, and we look forward to continuing our expansion into hospitals and reference laboratories in the U.S.,” said Chris Bernard, CEO of Applied BioCode.
“We are excited to combine the strength of Medline’s expansive lab portfolio with the MDx-3000 System, helping to offer a more comprehensive range of products and services to hospitals and reference laboratories,” said Nicole Krpan, general manager of the Laboratory division for Medline.
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 510K 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.
