BD MAX™ Molecular Multi-Drug Resistant Tuberculosis Test To Be Included In WHO Updated Consolidated Guidelines On Tuberculosis
On April 13, 2021, BD (NYSE: BDX) announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay has been recognized by the WHO as part of the moderate complexity automated NAAT class for TB diagnostics. This assay allows simultaneous detection of the TB bacteria and mutations for resistance to isoniazid (INH) and rifampicin (RIF). BD emphasizes its commitment to combating antimicrobial resistance and improving TB treatment, marking a significant milestone for the product. The BD MAX™ system is already CE marked and available in Europe and beyond.
- WHO recognition enhances BD MAX™ MDR-TB Assay's credibility in the market.
- The assay allows for simultaneous detection of TB and drug resistance, improving treatment decision-making.
- BD's long history in TB diagnostics strengthens its market position.
- None.
FRANKLIN LAKES, N.J., April 13, 2021 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay was included in the moderate complexity automated NAAT class of molecular diagnostic technologies that were recognized for high diagnostic accuracy for tuberculosis testing by the World Health Organization (WHO) in advance of an update to its guidelines for TB diagnostic tests.
Laboratorians and clinicians can use the BD MAX™ MDR-TB Assay 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.
"BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX™ MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients," said Dave Hickey, president of Life Sciences for BD. "This recognition by WHO is a significant milestone for this product and furthers BD's commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year."
The BD MAX™ MDR-TB Assay is an in vitro diagnostic device with CE mark available in Europe and other countries around the world. The 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 in a single assay.
Every year, about 10 million people develop TB and 1.4 million die from the disease. Until the global COVID-19 pandemic, TB was 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 isoniazid and rifampicin, remains a critical hurdle in the fight to eradicate tuberculosis as patients with this type of TB will not benefit from those key medicines and could spread the resistant forms of the disease to others.1 Additionally standard testing that only detects RIF resistance can miss cases of TB infection resistant to INH further delaying appropriate treatment and cure for those in need.
BD has a long history in TB diagnostics, having launched the first automated liquid culture system, the BD BACTEC™ MGIT™ Automated Mycobacterial Detection System for comprehensive testing for TB, drug susceptibility and monitoring patients' response to treatment. The 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.
BD offers a free on-demand webinar featuring Dr. Daniela Maria Cirillo, president of the European Society of Mycobacteriology and head of the Emerging Bacterial Pathogen Research unit at San Raffaele Scientific Institute in Milan. The webinar explores the importance of laboratory diagnostics to stop TB, as well as how the STOP TB Partnership and the ongoing work of the European Society of Mycobacteriology are working to help fight TB. View the on-demand webinar at labroots.com (https://www.labroots.com/webinar/importance-laboratory-diagnostics-fight-tuberculosis).
For more information on BD's role in TB diagnostics please visit: https://www.bd.com/en-us/company/global-health/infectious-diseases/tuberculosis. For more information on BD's molecular platform visit: https://advancing-diagnostics.eu/.
About BD MAX™ SYSTEM
The BD MAX™ System is a molecular diagnostic platform already in use at thousands of laboratories worldwide. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously, and up to several hundred samples per 24-hour period. Each unit is capable of performing assays for respiratory infections, enterics, hospital acquired infections, and sexually transmitted infections.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.
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Media: | Investors: |
Mela Sera, APR | Kristen M. Stewart, CFA |
BD Public Relations | SVP, Strategy & Investor Relations |
443.824.8012 | 201.847.5378 |
1 World Health Organization. Global Tuberculosis Report 2020. Geneva: WHO, 2020.
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SOURCE BD (Becton, Dickinson and Company)
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