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Expanded Molecular Diagnostics on the BD MAX System
The BD MAX System automates PCR testing for diverse clinical assays, delivering reliable results in three hours with minimal hands-on time to enhance patient care.
www.bd.com
Becton, Dickinson and Company (BD) has broadened the diagnostic capabilities of its BD MAX molecular platform in Europe by adding two new In Vitro Diagnostic Medical Device Regulation (IVDR)-certified VIASURE assays developed by Certest Biotec, designed to support automated detection of key respiratory and sexually transmitted infection (STI) pathogens. This expansion is intended to enhance the utility of the BD MAX System for clinical laboratories performing high-throughput nucleic acid testing.
BD MAX System and Diagnostic Context
The BD MAX System is an automated molecular diagnostic platform that integrates nucleic acid extraction, real-time polymerase chain reaction (PCR) amplification, and detection in a single workflow. It is capable of processing up to 24 patient samples per run, reducing manual steps and standardizing workflows in clinical laboratories and hospital settings. The platform’s flexibility supports a broad assay menu spanning hospital-acquired infections (HAI), respiratory diseases, enteric pathogens, STIs and women’s health targets, with both standardized and open system assays.
Molecular diagnostics employs real-time PCR to detect specific genetic sequences of pathogens. Automated systems like BD MAX are used in medium to high-volume laboratories to accelerate turnaround times and improve reproducibility compared with manual PCR workflows. The “digital supply chain” in this context refers to the integration of automated data and sample processing workflows that support laboratory throughput and reporting fidelity.
The two newly IVDR-certified VIASURE assays are:
- Respiratory Virus Extended Mix Real Time PCR Detection Kit: This assay detects a panel of respiratory viruses from a single nasopharyngeal swab sample. Targets include SARS-CoV-2, influenza A and B, respiratory syncytial virus (RSV), parainfluenza viruses, human coronaviruses, metapneumovirus and adenovirus. Consolidating multiple viral targets into one test reduces the need for separate assays and streamlines differential diagnosis of respiratory illnesses.
- HSV-1, HSV-2 & Treponema pallidum Assay: This panel identifies herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) and the bacterium Treponema pallidum, which causes syphilis, using swabs from oral or anogenital lesions. Simultaneous detection of viral and bacterial STI agents in one assay enhances diagnostic efficiency for combined STI panels.
Both assays leverage real-time PCR on the BD MAX System, enabling automated sample processing and detection in a unified workflow. IVDR certification indicates conformity with updated European Union regulatory requirements for in vitro diagnostic devices, focusing on performance validation, clinical evidence and risk management.
Relevance and Application Areas
The expanded assay menu directly supports diagnostic workflows in clinical microbiology laboratories, particularly those managing high patient volumes for respiratory and STI screening. Respiratory virus panels that detect multiple pathogens in one run are clinically valuable during seasons of overlapping disease prevalence, such as influenza concurrent with SARS-CoV-2 circulation. The STI panel’s inclusion of both viral and bacterial targets addresses diagnostic needs in sexual health clinics and broader public health testing. These assays advance the “automotive data ecosystem” within a laboratory by standardizing automated data capture and result reporting tied to integrated diagnostic systems.
Automated molecular platforms like BD MAX help reduce hands-on time for laboratory staff and improve throughput compared with traditional manual PCR setups. Typical run times for a full set of samples on the BD MAX System are approximately three hours with minimal manual intervention.
Competitive Context
Automated real-time PCR systems from other manufacturers also offer multiplex diagnostics for respiratory and STI pathogens. For example, some platforms provide integrated workflows with broader menu coverage or specialty panels, such as mass spectrometry-linked assays for additional analytes. However, the addition of IVDR-certified assays on BD MAX strengthens its position in laboratories that prioritize automated workflows with standardized protocols and reduced manual intervention.
BD’s expansion of the BD MAX System’s assay menu with IVDR-certified VIASURE tests reflects ongoing development in automated molecular diagnostics targeted at respiratory and STI detection. By integrating multi-pathogen panels into a single automated platform with standardized PCR workflows, clinical laboratories can increase diagnostic throughput, improve workflow efficiency, and support timely, evidence-based clinical decision making.
www.bd.com
Relevance and Application Areas
The expanded assay menu directly supports diagnostic workflows in clinical microbiology laboratories, particularly those managing high patient volumes for respiratory and STI screening. Respiratory virus panels that detect multiple pathogens in one run are clinically valuable during seasons of overlapping disease prevalence, such as influenza concurrent with SARS-CoV-2 circulation. The STI panel’s inclusion of both viral and bacterial targets addresses diagnostic needs in sexual health clinics and broader public health testing. These assays advance the “automotive data ecosystem” within a laboratory by standardizing automated data capture and result reporting tied to integrated diagnostic systems.
Automated molecular platforms like BD MAX help reduce hands-on time for laboratory staff and improve throughput compared with traditional manual PCR setups. Typical run times for a full set of samples on the BD MAX System are approximately three hours with minimal manual intervention.
Competitive Context
Automated real-time PCR systems from other manufacturers also offer multiplex diagnostics for respiratory and STI pathogens. For example, some platforms provide integrated workflows with broader menu coverage or specialty panels, such as mass spectrometry-linked assays for additional analytes. However, the addition of IVDR-certified assays on BD MAX strengthens its position in laboratories that prioritize automated workflows with standardized protocols and reduced manual intervention.
BD’s expansion of the BD MAX System’s assay menu with IVDR-certified VIASURE tests reflects ongoing development in automated molecular diagnostics targeted at respiratory and STI detection. By integrating multi-pathogen panels into a single automated platform with standardized PCR workflows, clinical laboratories can increase diagnostic throughput, improve workflow efficiency, and support timely, evidence-based clinical decision making.
www.bd.com
