Partnership with Certest Biotec adds respiratory and STI molecular diagnostic panels for European laboratories.
BD (Becton, Dickinson and Company) has expanded its respiratory and sexually transmitted infection (STI) diagnostics offerings in Europe with the addition of two In Vitro Diagnostic Medical Device Regulation (IVDR)-certified Viasure assays developed by Certest Biotec for use on the BD Max System.
The newly certified assays include the Viasure Respiratory 7 Real Time PCR Detection Kit and the Viasure STI 11 Real Time PCR Detection Kit. Both molecular panels are now available to clinical laboratories across Europe following certification under the In Vitro Diagnostic Medical Device Regulation.
The Respiratory 7 panel detects seven key respiratory pathogens, while the STI 11 panel identifies 11 sexually transmitted infection pathogens. The assays enable laboratories to detect multiple pathogens simultaneously using the BD Max System’s automated molecular platform.
“With these two assays, we are adding clinically relevant, targeted molecular panels to our already broad respiratory and STI menu,” says Philippe Villiard, vice president, BD Diagnostic Solutions in Europe, in a release. “Our partnership with Certest Biotec has been instrumental in expanding the BD Max System menu and supports our commitment to delivering innovative diagnostic solutions that enable faster, more extensive detection of infectious diseases on the BD Max System.”
Automated Molecular Testing Platform
The BD Max System processes up to 24 samples per run and offers an assay menu spanning healthcare-associated infections, respiratory, enteric, STI, and women’s health panels. The system also provides open system capabilities for laboratory-developed tests.
Designed for clinical laboratories and hospitals, the platform combines real-time PCR technology with automated nucleic acid extraction, amplification, and detection in a single workflow. The system delivers results in approximately three hours with less than one minute of hands-on time per sample, according to the company.
The partnership between BD and Certest Biotec began in 2017 and continues to expand the available testing options for the BD Max System.
“Our partnership with BD, which began in 2017, continues to grow, and we are excited to strengthen our collaboration once again. We are confident that our joint efforts will result in exceptional projects in the future,” says Nelson Fernandes, Certest’s CEO, in a release.
European Regulatory Compliance
The IVDR certification allows European laboratories to implement these molecular diagnostic panels as part of their infectious disease testing protocols. The regulation, which replaced the previous In Vitro Diagnostic Directive, requires enhanced clinical evidence and performance data for diagnostic devices used in European markets.
Certest Biotec, established in 2002, develops and manufactures in vitro diagnostic medical devices across four business areas: raw materials, immunodiagnostics, molecular biology, and pharma. The company’s Viasure brand focuses on PCR and next-generation sequencing applications for molecular diagnostics.
The expanded BD Max System menu provides clinical laboratories with additional options for molecular testing of respiratory and sexually transmitted infections, supporting faster diagnostic workflows and treatment decisions.
