US-based automated multiplex molecular diagnostic test systems provider Applied BioCode has announced the submission of its BioCode Respiratory Pathogen Panel (RPP) used with the BioCode MDx-3000 Molecular System to the US Food and Drug Administration (FDA) for 510(k) approval.
Applied BioCode said that its BioCode RPP is capable of testing nasopharyngeal swabs for 20 viruses and bacteria that cause upper respiratory infections, and the submission of BioCode RPP for FDA approval is based on the results of a clinical study.
Based on a clinical study, Applied BioCode has submitted BioCode RPP for regulatory approval
Under the clinical study, more than 2,600 prospective samples were collected at five clinical laboratories across different geographical areas in the US.
Applied BioCode president Winston Ho said: “Feedback from our U.S. clinical trial sites has been positive, and reinforces the need for an automated high throughput multiplex MDx system, especially 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.
“In addition to the 17-target BioCode Gastrointestinal Pathogen Panel, which gained FDA clearance in 2018, the BioCode Respiratory Pathogen Panel will be the second of many syndromic multiplex panels to be commercialized on the BioCode MDx-3000.”
The company said that the BioCode RPP is designed to detect and differentiate viruses and bacteria, including Influenza A and its subtypes, Influenza B, Respiratory Syncytial Virus A/B, Parainfluenza virus types, Human Metapneumovirus, Rhinovirus/Enterovirus, Coronavirus, Adenovirus, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis.
The company plans to commercially launch the BioCode RPP in December 2019 after securing the FDA approval.
The BioCode MDx-3000 system is equipped with an automated walk-away system that can perform up to 188 samples in an 8-hour shift in hospitals and reference laboratories for high volume, multiplex molecular testing.
It offers an alternative to high cost, low throughput cartridge-based molecular test systems in high volume laboratories, and provides the capability to run syndromic panels to improve lab workflow and reduce labour and cost.
Furthermore, the system facilitates flexible target masking within panels and addresses variation in test ordering patterns and potential changes in reimbursement.
