BD Forms Alliance to Develop And Supply Oncology Diagnostics

Becton, Dickinson and Company (BD; Franklin Lakes, NJ, USA) and Fujirebio Diagnostics, Inc. (Malvern, PA, USA) signed a worldwide development and supply agreement for oncology diagnostic assays.

The two companies will develop diagnostic products that incorporate Fujirebio Diagnostics' cancer biomarkers for use on BD's multiplex testing platform. The initial products will be directed to the ovarian cancer biomarker, HE4, which is U.S. Food and Drug Administration (FDA; Rockville; MD, USA)-cleared for monitoring the progression or recurrence of epithelial ovarian cancer. Fujirebio Diagnostics also grants BD, through its TriPath platform, access to its other cancer biomarkers for inclusion in future multiplex diagnostic products.

Fujirebio Diagnostics developed the HE4 test to be used in conjunction with the company's existing CA (cancer antigen) 125 biomarker, the current gold standard for monitoring ovarian cancer. This combination of biomarkers provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone.

"BD is investing in the development of tools and technologies essential for biomarker-guided cancer care. We believe that biomarker testing in a multiplex format can provide clinicians with a powerful toolset for detecting cancer at an earlier stage, which could allow them to begin treatment sooner and improve outcomes," said Wayne Brinster, vice president and general manager for Women's Health and Cancer, BD.

Fujirebio Diagnostics specializes in the clinical development, manufacturing, and commercialization of in vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

BD is a global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery, and production of new drugs and vaccines.

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Becton, Dickinson and Company
Fujirebio Diagnostics, Inc.
U.S. Food and Drug Administration