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

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SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Dec 22, 2025--

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 supports optimized extraction protocols on the KingFisher™ Flex system, providing laboratories with enhanced flexibility and efficiency for high-throughput respiratory pathogen testing. By pairing the proven capabilities of the BioCode® RPP with the KingFisher™ Flex system, labs can expect faster turnaround times, simplified processes, and consistent performance across multiple targets.

“Submitting this claim represents a significant step in our mission to support clinical laboratories with versatile, high-performance molecular testing solutions,” said Elisabeth Laderman, CSO. “This enhancement reinforces our commitment to enabling accurate and timely respiratory pathogen detection for high-volume testing environments.”

This submission builds on Applied BioCode’s prior FDA clearance of the BioCode® Gastrointestinal Pathogen Panel (GPP) with the KingFisher™ Flex system, demonstrating the company’s continued 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/.

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CONTACT: Media Contact:

Applied BioCode

Winston Ho

[email protected]

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY GENERAL HEALTH PHARMACEUTICAL HEALTH SCIENCE OTHER SCIENCE

SOURCE: Applied BioCode

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PUB: 12/22/2025 09:00 AM/DISC: 12/22/2025 09:00 AM

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