SANTA MARIA, Calif., March 14, 2022 (GLOBE NEWSWIRE) -- 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. For more information on products and services, visit www.hardydiagnostics.com.
Find more information at HardyDiagnostics.com/ABC.
Media inquiries can be directed to Megan Roesner at roesnerm@hardydiagnostics.com
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, 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 The COVID/Flu 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.
* The COVID 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-CoV2, 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.
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