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Applied BioCode Receives FDA Clearance for Syndromic Respiratory Pathogen Panel

NEW YORK – Applied BioCode announced Monday that it has received 510(k) clearance from the US Food and Drug Administration for its BioCode Respiratory Pathogen Panel (RPP) for use on the BioCode MDx-3000 system.

The firm said its panel tests nasopharyngeal swabs for the most common viruses and bacteria including influenza A and subtypes H1, H1N1 2009pdm, and H3; influenza B; respiratory syncytial virus A/B; parainfluenza virus types 1, 2, 3, and 4; human metapneumovirus A/B; adenovirus; rhinovirus/enterovirus; coronavirus (229E, OC43, HKU1, and NL63); Mycoplasma pneumoniae; Chlamydia pneumoniae; and Bordetella pertussis.

The FDA had cleared the BioCode Gastrointestinal Pathogen Panel (GPP) in October 2018.

Its MDx-3000 system allows users to run RPP and GPP combo panels at the same time, providing both time and labor-saving efficiencies, the firm said.

An alternative to high cost, low throughput cartridge-based molecular test systems, the MDx-3000 system enables flexible ordering and reporting to address variation in test ordering patterns and potential changes in reimbursement, BioCode said.

Enabling testing of up to 188 samples in eight hours, the system is designed for use in moderate- to high-volume laboratories where it can improve lab workflow and reduce labor and costs, the firm added.

The system's user-defined mode enables labs to develop their own multiplex assays.

Santa Fe Springs, California-based Applied BioCode had submitted its syndromic panel assay to detect respiratory pathogens for FDA clearance in September 2019.

In June last year, the firm said it had received FDA clearance for the use of the Roche MagNa Pure 96 Extraction System with the BioCode MDx-3000 and BioCode GPP.