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 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 solutions and improve patient outcomes, the systems data management automation includes Laboratory Information System (LIS) connectivity.
The MDx-3000 Molecular System offers:
- Unique barcoded magnetic bead patented technology with up to 4,096 different digital codes
- FDA 510(k) Cleared Gastrointestinal Pathogen Panel (GPP)
- FDA 510(k) Cleared Respiratory Pathogen Panel (RPP)
- EUA authorized SARS-CoV-2 Assay for automation of up to 564 samples in a day, and 2,820 pooled samples a day.
- EUA authorized SARS-CoV-2 Flu Plus Assay.
- Custom User Defined Mode supports the use of Laboratory Developed Tests
Pathogens Detected with BioCode® Gastrointestinal Pathogen Panel (GPP)
Bacterial Gastroenteritis/colitis: Campylobacter (C. jejuni/C. coli); Clostridium dicile 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
Viral Gastroenteritis: 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 (RPP)
Viruses: Adenovirus; Coronavirus (229E, OC43, HKU1, and NL63); Human Metapneumovirus A/B; Inuenza A (subtypes H1 seasonal, H1 pdm09, and H3); Inuenza B; Parainuenza 1; Parainuenza 2; Parainuenza 3; Parainuenza 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.”
“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.”
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.
Hardy Diagnostics is an FDA-licensed manufacturer of medical devices for microbiology testing with an ISO 13485 certified Quality Management System. Hardy Diagnostics manufactures more than 2,700 products for the culture and identification of bacteria and fungi from its California and Ohio manufacturing facilities and maintains nine distribution centers nationwide. Hardy Diagnostics distributes more than 13,000 products, services more than 10,000 laboratories and exports to more than 80 foreign distributors. Hardy Diagnostics’ mission is to produce and distribute the finest products for the detection of microorganisms and partner with its laboratory customers to diagnose and prevent disease.