Applied BioCode Announces the Launch of the Fungal Panel Assay for Research Use

Applied BioCode today announced the addition of the RUO Fungal Panel Assay to the MDx-3000 System

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)-- Applied BioCode now offers Fungal Panel on the BioCode® MDx-3000 system for research use only (RUO).

The Fungal Panel Assay was developed to detect the most common agents of invasive fungal infections (IFIs) particularly in lower respiratory samples. This Panel detects fungal agents including Aspergillus species, Rhizopus, Mucor, Rhizomucor, Cunninghamella, Lomentospora, Fusarium, Cryptococcus, Pneumocystis jirovecii and dimorphic pathogens (Coccidioides immitis/posadasii, Histoplasma capsulatum and Blastomyces dermatiditis). The panel will provide 20 distinct results along with an internal control and will be primarily for use on the company’s BioCode MDx-3000 instrument. Detection of IFI is difficult, and recovery by culture could take several days to weeks with poor sensitivity. Faster and more sensitive detection of IFI can be helpful in clinical management, especially for immunocompromised patients.

Applied BioCode’s Fungal Panel is intended for research use only and may be used in infectious disease research or pharmaceutical development. The test has an easy-to-use protocol and reporting software designed to handle the workflow in a clinical microbiology lab environment with up to 96 samples per test run. “Applied BioCode is thrilled to announce our first release of an RUO panel under our new product strategy. This RUO release and future releases will allow us to give laboratories early access to cutting edge, one-of-a-kind panels, collect real world clinical data, while continuing to expand the footprint of the MDx-3000 platform in the US. The MDx-3000 is the only non-restrictive label, high throughput multiplex PCR platform currently on the market and is FDA-cleared for use with the Respiratory Pathogen Panel (RPP) and Gastrointestinal Pathogen Panel (GPP). The instrument will now run RUO assays in its User Defined Mode (UDM),” said Chris Bernard, CEO of Applied BioCode. “The recent and upcoming product launches are expected to drive long-term growth in Applied BioCode’s molecular microbiology business, with a particular eye toward Infectious diseases and antimicrobial resistance.”

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.

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