BD Launches Molecular Test to Detect Tuberculosis and Multi-Drug Resistant TB

BD (Becton, Dickinson and Company), a global medical technology company, today announced the availability of the BD MAX MDR-TB panel in Europe. Clinicians can use the test to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first line drugs, isoniazid (INH) and rifampicin (RIF), enhancing the information available to direct the optimal treatment for their patients.
 
Every year, about 10 million people develop TB disease 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 PCR-based molecular diagnostic test is an integrated diagnostic test intended to help in the detection and diagnosis of TB, and INH- and RIF- resistance.
 
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,” said Nikos Pavlidis, vice president and general manager of Molecular Diagnostics & Women’s Health for 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.”
 
Preliminary results from an international clinical study of the BD MAX MDR-TB assay will be presented followed by an expert panel discussion on the value of a multi-pronged approach to fighting TB at the 49th Union World Conference on Lung Health (TB Union) at The Hague in The Netherlands on Thursday, October 25 at 6:00 p.m.
 
“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,” said Charles Cooper, M.D., vice president of medical affairs for 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.”
 
Reference
¹ World Health Organization. Global Tuberculosis Report 2018. Geneva: WHO, 2018.