Hardy Diagnostics, a leader in manufactured and distributed microbiology products, is pleased to announce it is now the exclusive distributor for the United States and its territories of the BioCode® MDx-3000, an automated high throughput multiplex molecular diagnostic system. The MDx-3000 is developed by Applied BioCode, an IVD manufacturer that designs, develops, and commercializes multiplex testing products. "Applied BioCode is thrilled to partner with Hardy Diagnostics," said Winston Ho, President of Applied BioCode. "We look forward to working with the Hardy Diagnostics team to expand our reach in hospitals and reference laboratories in the US."

The MDx-3000 Molecular System utilizes a 96-well microplate format to carry out multiplex PCR amplification, hybridization/target capture, and detection steps of molecular testing. Laboratories can process up to 188 patient samples in an 8-hour shift. Additionally, up to three different assay panels, which have the same protocols, can be run on the system at the same time. Along with a number of other advantages designed to optimize laboratory workflow. The system’s data management automation includes Laboratory Information System (LIS) connectivity.

The MDx-3000 Molecular System offers:

• Patented Barcoded Magnetic Bead Technology with up to 4,096 different digital codes
• FDA 510(k) Cleared Gastrointestinal Pathogen Panel  
• FDA 510(k) Cleared Respiratory Pathogen Panel
• EUA authorized SARS-CoV-2 Assay* for automation of up to 564 individual samples in a day and 2,820 samples a day by pooled testing
• EUA authorized SARS-CoV-2 Flu Plus Assay**
• User Defined Mode supports the use of Laboratory Developed Tests

Pathogens Detected with BioCode^® Gastrointestinal Pathogen Panel
Bacteria: Campylobacter (C. jejuni/C. coli); Clostridium difficile toxins A and B; Escherichia coli O157; Enterotoxigenic E. coli LT/ST (ETEC); Enteroaggregative E. coli (EAEC); Salmonella spp.; Shiga-like toxin producing E. coli stx1/stx2 (STEC); Shigella/ Enteroinvasive E. coli (EIEC); Vibrio spp. (V. cholerae/ V. parahaemolyticus/ V. vulnicus); Vibrio parahemolyticus; Yersinia enterocolitica
Viruses: Adenovirus 40/41; Norovirus GI/GII; Rotavirus A
Parasites: Cryptosporidium (C. hominis/ C. parvum); Entamoeba histolytica; Giardia lamblia

Pathogens Detected with BioCode® Respiratory Pathogen Panel
Viruses: Adenovirus; Coronavirus (229E, OC43, HKU1, and NL63); Human Metapneumovirus A/B; Influenza A (subtypes H1 seasonal, H1 pdm09, and H3); Influenza B; Parainfluenza 1; Parainfluenza 2; Parainfluenza 3; Parainfluenza 4; Respiratory Syncytial Virus A/B; Rhinovirus/Enterovirus
Bacteria: Bordetella pertussis; Chlamydia pneumoniae; Mycoplasma pneumoniae

Jay Hardy, Hardy Diagnostics Chief Executive Officer said, "We are very excited to add the 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 can offer reduced hands-on time, accelerated turnaround times, and complete assay panels with minimal potential for sample contamination."

Andre Hsiung, Chief Scientific Officer at Hardy Diagnostics, who catalyzed the partnership said, "We are very proud of our partnership with Applied BioCode and the introduction of this technology to Hardy's instrumentation offering."

Hardy Diagnostics has previously introduced mass spectrometer, automated Gram stain and automated Hematology stain instruments, as well as air sampling, automated serial dilution, and automated plate reading instrumentation.

Find more information at HardyDiagnostics.com or click on the Request Information button below.

* ^{The BioCode® SARS-CoV-2 test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by licensed 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 declaration is terminated or authorization is revoked sooner.}

^{** The BioCode® SARS-CoV-2 Flu Plus test has not been FDA cleared 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.}