-

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.

“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.

Share

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/.

Contacts

Media Contact:
Applied BioCode
Winston Ho
Communications@apbiocode.com

Industry:

Applied BioCode

TWSE:6598
Release Versions
English

Contacts

Media Contact:
Applied BioCode
Winston Ho
Communications@apbiocode.com

More News From Applied BioCode

Applied BioCode Announces Distribution Agreement with Henry Schein

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode today announced a distribution agreement with Henry Schein, a leading provider of healthcare products and services, to expand the availability of its BioCode® MDx-3000 System and comprehensive molecular diagnostics menu. The BioCode® MDx-3000 is an automated, high-throughput multiplex molecular diagnostic platform designed to support high-complexity clinical laboratories. Its testing menu includes upper respiratory and gastrointestinal...

Applied BioCode Reports Record Financial Results for the First Half of 2026; Revenue Increases 81% Year Over Year, Driven by Strong U.S. Molecular Diagnostics Growth

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode, Inc., a leader in high-throughput multiplex molecular diagnostics, today announced financial results for the six months ended June 30, 2026. For the six months ended June 30, 2026, the Company reported consolidated revenue of $13.59 million, an 81% increase from the same period in 2025. This performance was driven by expansion of the Company's installed base in U.S. clinical and veterinary laboratories and increased utilization of its...

Applied BioCode Submits BioCode® Respiratory Pathogen Panel (RPP) with KingFisher™ Nucleic Acid Extraction Claim to the FDA

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode, a leader in innovative molecular diagnostic solutions, announced today the submission of a new nucleic acid extraction claim for the KingFisher™ Flex Nucleic Acid Purification System in combination with the BioCode® Respiratory Pathogen Panel (RPP). This submission is aimed at expanding the use of the BioCode® RPP, enabling laboratories to further streamline workflows while maintaining high-quality, reliable results. The new submission...
Back to Newsroom