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Applied BioCode Submits Respiratory Pathogen Panel to FDA

NEW YORK – Molecular diagnostics maker Applied BioCode announced yesterday that it has submitted a syndromic panel assay to detect respiratory pathogens to the US Food and Drug Administration for potential 510(k) clearance.

The Applied BioCode Respiratory Pathogens Panel (RPP) detects 20 common viruses and bacteria that can cause upper respiratory infections from nasopharyngeal swab samples with the firm's MDx-3000 instrument.

Specifically, it detects and differentiates H1, H1N1 2009pdm, and H3 influenza A subtypes, influenza B, respiratory syncytial virus A/B, parainfluenza virus types 1, 2, 3, and 4, human metapneumovirus A/B, rhinovirus/enterovirus, coronavirus strains OC43, HKU1, NL63, and 229E, adenovirus, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis.

The Santa Fe Springs, California-based firm received FDA clearance for its MDx-3000 instrument and a 17-target gastrointestinal pathogens panel last year.

The PCR-based MDx-3000 instrument is designed to enable high volume, multiplex molecular testing at large hospitals and reference laboratories. It is a user-friendly, automated, walk-away system that can process up to 188 samples using the firm's syndromic panels in an eight-hour shift, with so-called "flexible target masking" capabilities within the panels "to address variation in test ordering patterns and potential changes in reimbursement," the firm said in a statement.

Winston Ho, Applied BioCode's CEO, said that feedback from the US clinical trial sites for RPP had been positive and reinforced the need for an automated high-throughput multiplex molecular diagnostic system, particularly during flu season.

"The clinical trial sites were very pleased with the ease-of-use of the BioCode system and their ability to quickly train their staff on the system,” Ho said, adding that the RPP will be "the second of many syndromic multiplex panels to be commercialized on the BioCode MDx-3000."

Last year, Applied BioCode raised $13.2 million through a public offering of its common stock. It's GI panel was also recently cleared to run using samples processed on a Roche automated sample prep instrument, the MagNaPure 96 system, which can extract nucleic acids from 96 samples in one hour.

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