Applied BioCode Submits New Sample Prep Claim to FDA to Expand Use of Respiratory Panel

Orginal from: genomeweb

Applied BioCode said on Monday that is has submitted a new nucleic acid extraction claim for its BioCode Respiratory Pathogen Panel (RPP) to the US Food and Drug Administration, with the goal of expanding use of the panel by clinical laboratories. 

The new claim covers the Thermo Fisher Scientific automated KingFisher Flex nucleic acid preparation system, which can shorten turnaround times and simplify the workflow. 

"This enhancement reinforces our commitment to enabling accurate and timely respiratory pathogen detection for high-volume testing environments," Applied BioCode CSO Elisabeth Laderman said in a statement.

This submission builds on Applied BioCode's Respiratory Pathogens Panel, which detects 20 common viruses and bacteria that can cause upper respiratory infections. The test runs on the firm's PCR-based MDx-3000 instrument. Both the test and instrument have received FDA clearance. 

Santa Fe Springs, California-based Applied BioCode said the FDA has also cleared its Gastrointestinal Pathogen Panel in conjunction with the KingFisher Flex system for sample prep.

Source: Applied BioCode Submits New Sample Prep Claim to FDA to Expand Use of Respiratory Panel