BD (Becton, Dickinson and Company) Expands BD MAX™ System with New IVDR-Certified VIASURE Assays
BD (NYSE: BDX), a leader in medical technology, announced the enhancement of its respiratory and sexually transmitted infection (STI) diagnostics in Europe. This follows the recent In Vitro Diagnostic Medical Device Regulation (IVDR) certification of two new VIASURE assays from Certest Biotec, designed to run on the BD MAX™ System. This partnership allows clinical laboratories to swiftly and accurately identify a wide variety of pathogens through a fully automated molecular platform.
New IVDR-Certified Assays Overview
The BD MAX™ System now includes the following certified assays:
- VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit: Capable of detecting multiple respiratory viruses including SARS-CoV-2, flu (A and B), RSV, parainfluenza, human coronavirus, metapneumovirus, and adenovirus, all from a single nasopharyngeal swab.
- VIASURE HSV-1, HSV-2 & Treponema pallidum Assay: This assay identifies the presence of herpes simplex viruses (HSV-1 and HSV-2) as well as the bacteria responsible for syphilis (Treponema pallidum) using swabs from anogenital and oral skin lesions.
Implications for Clinical Laboratories
Philippe Villiard, Vice President of BD Diagnostic Solutions in Europe, stated, “With these two assays, we are adding clinically relevant, targeted molecular panels to our already robust respiratory and STI menu. Our partnership with Certest Biotec has been instrumental in enhancing the BD MAX™ System offerings, demonstrating our commitment to innovative diagnostic solutions for infectious diseases.”
The BD MAX™ System is designed to streamline processes in clinical laboratories and hospitals, processing up to 24 samples per run. It features a comprehensive assay menu covering healthcare-associated infections (HAI), respiratory, enteric, STI, and women's health panels. Utilizing real-time PCR technology, the BD MAX™ System integrates nucleic acid extraction, amplification, and detection into a single workflow that delivers results in about three hours with minimal hands-on time.
Future Collaboration with Certest Biotec
Nelson Fernandes, CEO of Certest Biotec, expressed enthusiasm for the ongoing collaboration, stating, “Our partnership with BD, which began in 2017, continues to grow. We are excited to strengthen our collaboration further and are confident that our joint efforts will produce exceptional projects in the future.”
About BD
BD is recognized as one of the largest global medical technology companies, dedicated to advancing healthcare through innovations in medical discovery, diagnostics, and the delivery of care. With a workforce of over 70,000 employees, BD plays a pivotal role in enhancing clinical therapy and laboratory processes for healthcare providers worldwide.
For more information on BD, visit bd.com or connect with the company on LinkedIn and X (formerly Twitter) at @BDandCo, and on Instagram at @becton_dickinson.
About Certest Biotec
Founded in 2002, Certest Biotec specializes in developing, manufacturing, and commercializing in vitro diagnostic medical devices. It operates within four business sectors: Raw Materials (Alaset), Immunodiagnostics (Rapid Tests, Turbidimetry, and CLIA), Molecular Biology (PCR and NGS), and Pharma. Certest is committed to providing high-quality, reliable diagnostic solutions for medical professionals globally.
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