Applied BioCode Announces New Nucleic Acid Extraction Claim for KingFisher™ Flex Nucleic Acid Purification System with BioCode® Gastrointestinal Pathogen Panel (GPP)

Published 12 hours ago via Business Wire

Applied BioCode, a leader in molecular diagnostics panel testing, is excited to announce a significant enhancement to its BioCode® Gastrointestinal Pathogen Panel (GPP) with the addition of nucleic acid extraction claim for the widely adopted ThermoFisher Scientific KingFisher™ Flex platform. This expansion enables greater workflow flexibility and optimized sample processing capabilities for clinical laboratories running the BioCode® GPP.

This enhancement to the BioCode® GPP allows for seamless integration with KingFisher™ Flex extraction platform, broadening the panel’s utility and increasing throughput for gastrointestinal testing. Clinical laboratories using these extraction systems can now streamline their operations by pairing them with the BioCode® GPP, providing a comprehensive solution to detect 17 of the most prevalent gastrointestinal pathogens. By improving workflow efficiency, the new claim is expected to significantly impact patient care by accelerating the turnaround of accurate and timely diagnostic information.

“Expanding our nucleic acid extraction options to include KingFisher™ Flex reflects Applied BioCode’s commitment to delivering flexible, high-quality solutions for the molecular diagnostics market,” said Dr. Winston Ho, CEO and founder of Applied BioCode. “We recognize the importance of adaptable testing workflows that meet the evolving needs of our clinical lab partners and ultimately improve patient outcomes.”

The BioCode® GPP now supports multiple extraction platforms, making it one of the most versatile panels in its class for detecting gastrointestinal pathogens in stool samples. This addition aligns with Applied BioCode’s mission to innovate and adapt to the growing demands of healthcare providers, enabling laboratories to maximize the value of their existing instruments while advancing diagnostic capabilities.

With its unique Barcoded Magnetic Bead (BMB) technology, the BioCode® GPP simplifies and accelerates high-throughput molecular diagnostics, offering an economical, accurate, and comprehensive solution for clinical labs across the U.S. and beyond. This nucleic acid extraction expansion will help laboratories improve their workflows, increase operational flexibility, and expand their diagnostic capabilities.

About Applied BioCode

Applied BioCode is an IVD diagnostics company 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 Bead (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 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.

For more information about the new nucleic acid extraction claim for BioCode® GPP or to learn more about Applied BioCode’s innovative diagnostic solutions, please visit https://www.apbiocode.com/products/.

Contacts