Applied BioCode Announces FDA Clearance for KingFisher™ Nucleic Acid Extraction with BioCode® Respiratory Pathogen Panel for IVD Use

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode, a leader in multiplex molecular diagnostic solutions, today announced a significant enhancement to its BioCode^® Respiratory Pathogen Panel (RPP) workflow with the addition of nucleic acid extraction claims for the widely used Thermo Fisher Scientific KingFisher™ Flex platform. This expansion provides clinical laboratories running BioCode^® RPP with greater workflow flexibility and optimized sample processing capabilities.

This enhancement to the BioCode^® RPP enables seamless integration of the KingFisher™ Flex extraction platform and the BioCode^® MDx-3000 automated detection system, expanding the panel’s utility and increasing throughput for respiratory testing. Clinical laboratories using these extraction systems can now streamline their workflows by pairing them with the BioCode^® RPP, providing an affordable and comprehensive solution for detecting 17 prevalent respiratory pathogens. By improving workflow efficiency, this new claim is expected to enhance patient care by accelerating the delivery of accurate and timely diagnostic results.

“Adding the Thermo Fisher KingFisher™ Flex extraction system demonstrates Applied BioCode’s commitment to delivering flexible, high-quality solutions for the molecular diagnostics market,” said Dr. Winston Ho, CEO and founder of the Applied BioCode. “This enhancement reinforces our commitment to enabling accurate and timely respiratory pathogen detection in high-volume testing environments.”

This submission builds on Applied BioCode’s previous FDA clearance of the BioCode^® Gastrointestinal Pathogen Panel (GPP) with the KingFisher™ Flex system, highlighting the company’s ongoing success in validating flexible, high-throughput extraction solutions across its multiplexed panel portfolio.

Applied BioCode continues to advance molecular diagnostic solutions that meet the evolving needs of clinical laboratories, supporting patient care with accurate, reliable, and actionable results.

About Applied BioCode

Applied BioCode is a leading provider of molecular diagnostic solutions, dedicated to delivering innovative technologies that empower laboratories, improve workflow efficiency, and enhance patient care.

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