NEW YORK — Applied BioCode said on Monday that it has signed a US distribution agreement for its BioCode MDx-3000 automated molecular diagnostics system and other products with Medline Industries.
Under the terms of the deal, Northfield, Illinois-based Medline will distribute the BioCode MDx-3000 system, along with its menu of tests for upper respiratory and gastrointestinal infections, to clinical laboratory customers in the US. Medline will also distribute Applied BioCode's portfolio of analyte-specific reagents (ASRs), which are used to develop laboratory-developed tests.
Financial and other terms were not disclosed.
Applied BioCode has 510(k) clearances from the US Food and Drug Administration for its 17-plex Respiratory Pathogen Panel (RPP) and 17-plex Gastrointestinal Pathogen Panel (GPP), which are also CE marked. The Santa Fe Springs, California-based company also has received Emergency Use Authorization from the FDA for the BioCode CoV-2 Flu Plus Assay and BioCode SARS-CoV-2 Assay.
All of the tests run on the BioCode MDx-3000 system.
About a year ago, Applied BioCode inked an exclusive agreement for the US distribution of the diagnostic system, test menu, and ASRs with Hardy Diagnostics.