Single Check on BD MAX™ System Identifies and Differentiates A number of Respiratory Infectious Illnesses from One Pattern
FRANKLIN LAKES, N.J. , Aug. 1, 2023 /PRNewswire/ — BD ( Becton, Dickinson and Firm ) (NYSE: BDX), a number one world medical know-how firm, right now introduced U.S. Meals and Drug Administration (FDA) 510(okay) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic mixture take a look at that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in roughly two hours.
The take a look at, which has been accessible in the USA since February by an Emergency Use Authorization (EUA) from FDA, makes use of a single nasal swab or a single nasopharyngeal swab pattern to find out if a affected person has COVID-19 or the flu or RSV. The BD RVP take a look at helps eradicate the necessity for a number of particular person assessments or physician visits and may also help clinicians implement the correct remedy plan rapidly. The co-testing method additionally helps enhance testing capability throughout the busy flu season and velocity up the time for analysis.
“Final 12 months, we skilled a risk of a ‘tripledemic’ with COVID, flu and RSV circulating concurrently, and that risk stays for the approaching respiratory season,” mentioned Nikos Pavlidis , vice chairman and common supervisor for Diagnostics at BD. “As affected person signs and scientific presentation might be practically equivalent, a mixed testing panel is essential to enabling clinicians to rapidly and effectively diagnose, differentiate and deal with sufferers, and assist handle the unfold of the infections. The superior robotic structure of the BD MAX™ System automates handbook, time-intensive processes, which has by no means been extra necessary than in right now’s atmosphere of staffing shortages and laboratory scientist burnout.”
The BD MAX™ System, a molecular diagnostic platform, is already in use at 1000’s of hospitals and medium-throughput laboratories worldwide, and every unit is able to analyzing a whole lot of samples over a 24-hour interval. The BD MAX™ RVP take a look at is an RT-PCR assay that detects and differentiates the RNA of SARS-CoV-2, flu A, flu B and RSV in roughly two hours, with the straightforward and automatic “walkaway workflow” of the BD MAX™ System that requires minimal human interplay.
The BD Respiratory Viral Panel for BD MAX™ System was CE marked beneath the IVD directive 98/79/EC in Could of 2022, and now with the 510(okay) clearance, BD will discontinue the BD RVP EUA model and change it with the 510(okay) model, with no gaps in availability of the take a look at.
The respiratory viral panel is a vital addition to the in depth variety of assays accessible on the BD MAX™ System throughout respiratory infections, sexually transmitted infections, gastrointestinal infections, ladies’s well being and well being care related infections. The BD MAX™ open system additionally permits prospects to leverage analysis use solely (RUO) assays and user-defined protocols (UDP) to deal with rising wants rapidly.
Growth of this mixture take a look at has been funded in entire or partly with federal funds from the U.S. Division of Well being and Human Providers ; Administration for Strategic Preparedness and Response; Biomedical Superior Analysis and Growth Authority , beneath contract quantity 75A50121C00025.
About BD
BD is without doubt one of the largest world medical know-how corporations on the planet and is advancing the world of well being by enhancing medical discovery, diagnostics and the supply of care. The corporate helps the heroes on the frontlines of well being care by growing revolutionary know-how, providers and options that assist advance each scientific remedy for sufferers and scientific course of for well being care suppliers. BD and its 77,000 workers have a ardour and dedication to assist improve the protection and effectivity of clinicians’ care supply course of, allow laboratory scientists to precisely detect illness and advance researchers’ capabilities to develop the subsequent era of diagnostics and therapeutics. BD has a presence in nearly each nation and companions with organizations around the globe to deal with a few of the most difficult world well being points. By working in shut collaboration with prospects, BD may also help improve outcomes, decrease prices, enhance efficiencies, enhance security and increase entry to well being care. For extra info on BD, please go to bd.com or join with us on LinkedIn at www.linkedin.com/firm/bd1/ and Twitter @BDandCo.
Contacts:
Media : Traders : Troy Kirkpatrick Francesca DeMartino VP, Public Relations SVP, Head of Investor Relations 858.617.2361 201.847.5743 troy.kirkpatrick@bd.com francesca.demartino@bd.com
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