Bringing the biomarkers together

BD and Fujirebio Diagnostics to jointly develop biomarker assays for early ovarian cancer detection

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FRANKLIN LAKES, N.J—Becton, Dickinson and Co. (BD) and Fujirebio Diagnostics Inc., last month announced the signing of a worldwide development and supply agreement for oncology diagnostic assays. Under the agreement, 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 FDA-cleared for monitoring the progression or recurrence of epithelial ovarian cancer. Fujirebio Diagnostics will also grant BD, through its BD Diagnostics-TriPath platform, access to its other cancer biomarkers for inclusion in future multiplex diagnostic products, which are likely to include breast and prostate cancers.

"Fujirebio and BD have been working on some of the same biomarkers and they have others we don't have. This fits BD's model of providing the best 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," says Wayne Brinster, BD's vice president and general manager of Women's Health and Cancer. He adds that the two sets of scientists have been working on similar things and are excited about working together to isolate biomarkers and eliminate noise.

Brinster estimates that there are four to six million women in the United States, Western Europe and Japan who present to OB/GYNs with symptoms annually, with about 20 percent of them having cancer. There is also the challenge, he notes, of monitoring another two to three million who have had cancer, with perhaps another 20 to 30 million in the high risk group due to BRCA 1 or 2 gene mutations or family history. "Finally, if incorporating Fujirebio Diagnostics' cancer biomarkers within our own cancer diagnostics development program provides markers that are sensitive enough, we could have a PSA-type screening test. We believe that we are poised to provide clinicians with innovative diagnostic tools for improved patient management," he adds. Brinster says it's early, but with 12 years of development behind them at BD, a product may be out in about two years.

"This alliance with BD is an excellent strategic fit for Fujirebio Diagnostics' business," says Paul Touhey, president and CEO of Fujirebio Diagnostics, and he adds that he agrees with Brinster's two-year estimate of time-to-market.

"BD was interested in making a significant contribution to the diagnosis, management and monitoring of ovarian cancer, areas where Fujirebio is recognized as the gold standard," he says. 

The agreement calls for BD to make an undisclosed up-front payment to Fujirebio and additional milestone payments. Fujirebio will be the exclusive manufacturer for BD.

Studies indicate that early cancer detection can significantly reduce mortality. For example, ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer death in women. The disease is difficult to detect early because it typically triggers few if any symptoms. By the time ovarian cancer is detected, it is often too advanced to control. Research has shown that the five-year survival rate for women diagnosed in the later stages of the disease is as low as 20 to 30 percent. However, the survival rate can be greater than 90 percent when ovarian cancer is detected in its early stages.

Fujirebio Diagnostics developed an HE4 test to be used in conjunction with the company's existing CA125 biomarker, the current gold standard for monitoring ovarian cancer. This combination of biomarkers, as published clinical data shows, provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone. Improved sensitivity and specificity should allow clinicians to distinguish between benign and malignant pelvic masses more accurately, helping to ensure that patients receive appropriate therapy earlier.

Fujirebio Diagnostics is one of the group companies of Miraca Holdings Inc., in Japan, set up in July 2005 to combine Fujirebio Inc., a leading in vitro diagnostics company, and SRL Inc., the top provider of clinical laboratory testing services in Japan. Fujirebio Diagnostics has a worldwide distribution network, which enables physicians and patients to access its diagnostic products.

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