Becton, Dickinson and Co (BD), Franklin Lakes, NJ, has announced the availability of the BD Max MDR-TB panel in Europe. Clinicians can use the test to simultaneously detect the bacteria that cause tuberculosis (TB) and to determine whether the bacteria contain mutations associated with resistance to two important first-line drugs—isoniazid (INH) and rifampicin (RIF)—enhancing the information available to direct optimal treatment for patients.
Every year, about 10 million people develop TB, and close to 2 million die from the disease, making it the leading cause of death from a single infectious agent. With proper detection and treatment, TB is curable. Multidrug-resistant TB (MDR-TB), defined as resistance to both INH and RIF, remains a critical hurdle in the fight to eradicate TB, as patients with resistance to therapy will not benefit from those medicines and could spread the resistant forms of the disease to others.1
The BD Max MDR-TB panel is an in vitro diagnostic with CE mark, now available in Europe. The single polymerase chain reaction-based molecular diagnostic is an integrated test intended to help in the detection and diagnosis of TB, including INH- and RIF-resistant strains of the disease.
BD has a long history in TB diagnostics, having launched the first automated liquid culture system, the BD Bactec MGIT system, for comprehensive testing for drug susceptibility and resistance. The new BD Max MDR-TB assay complements this technology, enabling clinicians to rapidly test for TB and multidrug resistance as a first-line test, and then use the BD Bactec MGIT system for broader drug susceptibility testing and patient monitoring.
“We continue to focus on improving the diagnosis of TB so that we can provide clinicians with the best tools for identifying effective treatments for their patients,” says Nikos Pavlidis, vice president and general manager for molecular diagnostics and women’s health at BD Diagnostic Systems. “This new test is a big step forward for clinical practice, as antimicrobial resistance has made this identification more complex. With the BD Max MDR-TB panel and BD Bactec MGIT products, BD is able to offer laboratories a suite of tools for effective and accurate patient diagnosis and management.”
“As antimicrobial resistance becomes a greater problem in TB, understanding the drug-resistance profile has become an increasingly important tool for successful treatment of individual patients,” says Charles Cooper, MD, vice president for medical affairs at BD Diagnostic Systems. “Our global clinical trial of the BD Max MDR-TB assay demonstrated that the assay can reliably detect both INH and RIF resistance. In addition, this assay can rapidly provide clinicians with valuable information necessary to manage patients with TB infections.”
For more information, visit Becton, Dickinson and Co.
- Global Tuberculosis Report 2018. Geneva: World Health Organization, 2018. Available at: www.who.int/tb/publications/global_report/en. Accessed November 20, 2018.