Biofire diagnostics3/14/2023 ![]() BioFire respiratory panel 2.1 (RP2.1) instructions for use. BioFire COVID-19 test instructions for use. Published by Elsevier Inc.īioFire Defense, LLC. Conclusively, the BioFire COVID-19 Test and RP2.1 are highly sensitive assays that can be effectively used in the clinical laboratory for rapid SARS-CoV-2 testing.īioFire COVID-19 FilmArray Laboratory Developed Test RP2.1 SARS-CoV-2.Ĭopyright © 2020. Results showed 100% concordance between the BioFire assays and the laboratory-developed test for all clinical samples tested, and acceptable performance of both BioFire assays at their stated limits of detection. A total of 78 tests were performed using the BioFire COVID-19 Test, including 30 clinical specimens and 48 tests in a limit of detection study 57 tests were performed using the RP2.1 for evaluation of SARS-CoV-2 detection, including 30 clinical specimens and 27 tests for limit of detection. We evaluated the performance characteristics of these tests in comparison to a laboratory-developed real-time PCR assay targeting the viral RNA-dependent RNA polymerase and E genes. Food & Drug Administration and Interim Order authorization from Health Canada for use in clinical laboratories. Both tests have received emergency use authorization from the U.S. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. We welcome our new employees and look forward to providing our worldwide customer base with our complete range of diagnostic solutions dedicated to infectious diseases," Belingard added.The BioFire® COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs. ![]() "FilmArray®meets perfectly the growing hospital laboratory demand for high medical value solutions in infectious disease diagnostics, thus ideally complementing our current product offering, especially for emergency situations and critical care. ![]() In addition, bioMerieux will contribute its capabilities to the automation of reagent production, thereby optimizing manufacturing costs.īioMerieux chairman and CEO Jean-Luc Belingard noted the acquisition of BioFire creates strong growth opportunities. FilmArray will benefit from the global and dynamic bioMerieux commercial network. The FilmArray has obtained CE Mark approval and approvals from the US Food and Drug Administration (FDA) Respiratory Panel and FDA Blood Culture Identification Panel.įilmArray is a key differentiating asset in the development of bioMerieux’s franchise in infectious disease diagnostics, its primary area of expertise. The device creates a new standard in this market with its essential combination of speed, accuracy, ease-of-use and comprehensiveness in one single assay. Recently, BioFire has developed FilmArray, a multiplex PCR system that integrates all molecular diagnostics steps – sample preparation, amplification, detection and analysis – into one system.įilmArray has introduced the syndromic approach to infectious disease molecular diagnostics. This acquisition will be essentially funded through bioMerieux’s inaugural €300m issue of seven-year bonds. ![]() Acquisition costs will amount to €6m to be recorded under non-recurring items (about €2m in 2013 and €4m in 2014). The transaction includes a $450m acquisition price and bioMerieuxh’s net financial debt (around $35m), representing a total of €355m. All the BioFire personnel, activities and equipment associated with the defense business are physically transferred to a protected and separate site in Salt Lake City. On September 4, 2013, bioMerieuxh has announced an agreement to purchase BioFire Diagnostics.īioMerieux claims that this acquisition enables the company to consolidate its position as a major player in infectious disease diagnostics and strengthens its presence in the US.īioMerieux and BioFire will now begin integration process, focusing on leveraging the positive synergies between the two companies, and to drive FilmArray sales and menu expansion.Ī wholly-owned subsidiary dedicated to the biodefense activities will be set up in order to meet the expectations of BioFire’s biodefense customers in the US. France-based biotechnology company bioMerieuxh has finalized the acquisition of 100%-ownership in the US-based molecular biology company BioFire Diagnostics.
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