Applied BioCode Announces the Launch of the STI + Resistance Panel Assay for Research Use Only

Applied BioCode today announced the addition of the STI + Resistance Panel (RUO) Assay to the MDx-3000 System.

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

Applied BioCode Inc., a pioneer in molecular diagnostics, proudly announces the launch of its latest innovation, the BioCode® STI + Resistance Panel (RUO). This multiplex nucleic acid amplification test is meticulously crafted to qualitatively detect DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), as well as macrolide-resistant and fluoroquinolone-resistant single nucleotide polymorphism (SNP) mutations in a single reaction. The panel is exclusively intended for research purposes and is not intended for diagnostic procedures.

Engineered with precision for seamless integration with the BioCode® MDx-3000 automated system, it delivers timely test results approximately 4 hours post-DNA extraction. The system boasts an intuitive protocol and reporting software, meticulously tailored to enhance workflows in research clinical microbiology lab environments, accommodating up to 96 samples per test run.

“We are thrilled to announce the release of the STI + Resistance Panel for research use under our new product strategy. This RUO release and future releases will provide laboratories early access to cutting-edge panels, facilitating the collection of real-world clinical data while broadening the menu on the MDx-3000 platform in the US,” stated Winston Ho, Founder and Chief Technology Officer at Applied BioCode Inc.

To learn more about the Applied BioCode team and offerings, visit: https://www.apbiocode.com/products/

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 Assayⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*. Furthermore, Applied BioCode, Inc. has received RUO (Research Use Only) designation for the BioCode® Fungal Panel and STI + Resistance Panel (RUO). 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.