In vitro diagnostics solutions provider bioMérieux has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its FilmArray Respiratory Panel EZ (RP EZ).
The company has also received Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA for the assay.
CLIA waiver allows to use the test in sites such as physician offices and urgent care centers, in addition to traditional clinical laboratories.
FilmArray is a multiplex PCR system, which incorporates sample preparation, amplification, and detection into one closed system.
FilmArray RP EZ can detect 11 viral and 3 bacterial pathogens associated with respiratory infections from a single patient sample. It is a simplified version of the CE–IVD and FDA-cleared FilmArray respiratory panel (RP)
The assay has been designed to run on a single computer/instrument configuration of the FilmArray 2.0 system.
Through its Defense Threat Reduction Agency (DTRA), the US Department of Defense Chemical and Biological Defense program had supported the new assay’s clinical trials that were conducted in primary care, pediatric, community, and family practice clinics.
bioMérieux molecular biology vice president Randy Rasmussen said: “The CLIA waiver will make the high medical value associated with FilmArray even more accessible.
“Syndromic testing is becoming a standard of care for respiratory infections in hospital laboratories. Further decentralization of the FilmArray across provider networks moves the benefits of syndromic testing nearer to the patient.”
With operations in around 150 countries, bioMérieux provides diagnostic solutions such as reagents, instruments and software.