BD and Euroclone Announce Development and Global Distribution Agreement for Tests to Detect Emerging Sexually-Transmitted Pathogens

New Molecular Assays Will be for Use on the BD MAX™ System

Sep 20, 2017

FRANKLIN LAKES, N.J., and SIZIANO, ITALY, September 20, 2017 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Euroclone (Euroclone Diagnostica Srl) today announced a development and global distribution agreement for molecular tests to detect emerging sexually-transmitted pathogens.

According to the World Health Organization, more than 1 million sexually transmitted infections (STIs) are acquired each day, with the increasing prevalence of drug resistance posing a significant threat to reducing the effectiveness of STI treatment.1

The molecular assays in development will offer an increased likelihood of patients receiving proper diagnoses and therapy whether or not they are exhibiting symptoms. The new assays will also support clinical laboratories in antimicrobial stewardship efforts and assist institutions in complying with European STI screening guidelines.2,3

By using the fully-automated BD MAX™ System, the collaborative solutions will detect infectious genital mycoplasmas, including Mycoplasma and Ureaplasma species. These specific pathogens are difficult to identify by conventional methods,2,3 and if not diagnosed and treated appropriately, place infected individuals at risk for immediate and long-term health consequences, such as infertility and increased susceptibility to HIV2,4. The assays will also identify resistance markers of common drug therapies, including macrolides, a class of antibiotics often used as first-line treatment for STIs, which enables physicians to prescribe an appropriate course of antibiotic therapy.

“There is growing concern worldwide for macrolide resistance in Mycoplasma genitalium and more recent reports that have indicated increasingly prevalent quinolone resistance are worrying,” commented Dr. Suneeta Soni, consultant in Sexual Health and HIV, Brighton, United Kingdom.

BD is a global leader in providing solutions for women’s health and STIs. With the addition of these assays to the existing BD MAX portfolio, in conjunction with BD SurePath™, a liquid-based Pap test, and the BD Onclarity™ HPV assay*, a molecular test for the detection of 14 high-risk HPV genotypes, BD continues to enhance its comprehensive solutions that enable clinical laboratories to address evolving diagnostic needs and regional guidelines2,3, and help mitigate the threat of antimicrobial resistance.5

“BD and Euroclone share a passion for reducing the risks associated with undiagnosed STIs, as well as the burden of symptoms that impact the lives of many worldwide,” said Doug White, vice president of Women’s Health & Molecular Diagnostics for BD.

“Our collaboration with BD is a very important and strategic path for the future of Euroclone. It brings us great satisfaction to work together to address the emerging threat of genital mycoplasmas,” said Franco Aiolfi, chief executive officer of Euroclone SpA and Euroclone Diagnostica Srl.

BD and Euroclone plan to develop and commercialize the assays for launch outside of the U.S. beginning in 2018 and in the U.S. at a later date.

About Euroclone Diagnostica Srl
Euroclone Diagnostica Srl (http://www.euroclonediagnostica.it) is a subsidiary of Euroclone S.p.A. headquartered in Siziano, Italy with a focus on the development, production and commercialization of innovative diagnostics, particularly in the area of molecular biology. Euroclone Diagnostica Srl operates regionally and internationally, supporting products in the areas of genetics diagnostics, diagnostics infectivity, oncology, nucleic acid extraction and drugs of abuse.

Euroclone Contact:
Fabio Bolchi
Euroclone Communications & Public Relations
+39.02.38195331
f.bolchi@euroclone.it

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 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to better diagnose 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. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.

For more information on BD, please visit bd.com.

Gwen Gordon

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Monique N. Dolecki

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Note

*This product is not for sale in the U.S.

References
  1. Sexually transmitted infections (STIs). (2016, August). Retrieved June 14, 2017, from http://www.who.int/mediacentre/factsheets/fs110/en/
  2. Jensen, J. S., et al. (2016). 2016 European guideline on Mycoplasma genitalium infections (H. Moi, Ed.). Journal of the European Academy of Dematology and Venereology. doi:10.1111/jdv.13849
  3. Horner, P. J., Blee, K., & Van der Meijden, W. (2016). 2016 European guideline on the management of non-gonococcal urethritis. (H. Moi, Ed.). International Journal of STD & Aids, 27(11), 928-937. doi:10.1177/0956462416648585
  4. Ona, S., Molina, R. L., & Diouf, K. (2016). Mycoplasma genitalium: An Overlooked Sexually Transmitted Pathogen in Women? (L. Hafner, Ed.). Infectious Diseases in Obstetrics and Gynecology, 2016(4513089), 1-9.
    http://dx.doi.org/10.1155/2016/4513089
  5. Soni S, et al. Sex Transm Infect 2017;0:1–2. doi:10.1136/sextrans-2016-053077