Tuesday, July 28, 2009

HE4 Diagnostic Biomarker Test Shows Promise in Monitoring Ovarian Cancer

Ovarian malignancies are a leading cause of cancer death in women because they are usually detected in the late stages when the disease is incurable.

Encouraging new research presented by Abbott and Fujirebio Diagnostics last week at the AACC (American Association for Clinical Chemistry) annual meeting shows that a novel diagnostic marker HE4, combined with other tests, can be used to more effectively monitor for early-stage ovarian cancer.

This can improve treatment options for many of the 22,000 women in the US who develop this deadly disease each year.

New research on HE4 presented by Richard Moore, MD at a scientific workshop provides important validation for the use of the HE4 test in combination with CA125 (the current standard for monitoring ovarian cancer) in estimating EOC risk in women presenting with pelvic masses.

The HE4 test was developed through research efforts aimed at identifying combinations of biomarkers to add sensitivity to the CA125 test, which is limited in its sensitivity and specificity, as well as its ability to monitor early stage epithelial ovarian cancer.

“Our results show that the dual marker combination of HE4 and CA125 can aid in the differentiation of benign pelvic masses from ovarian malignancies in women diagnosed with a pelvic mass,” said Moore. “This is exciting as it will help us improve the care we give to the many women who are afflicted by this deadly disease.” Dr. Moore is associate professor in the Program for Women's Oncology at Women and Infants’ Hospital and Brown University.

“More than 250,000 women present to their physician each year with a suspicious pelvic mass, yet there is still no reliable tool to differentiate malignant disease from other benign gynecologic conditions, making early detection a significant challenge,” said Robert Doss, Ph.D., divisional vice president, research and development, Abbott Diagnostics. “HE4 represents an important advancement in monitoring these pelvic masses.”

Fujirebio Diagnostics, Inc. and Abbott have signed a license agreement to develop this new ovarian cancer marker for use on Abbott’s automated ARCHITECT® diagnostic analyzers. A manual form of the HE4 test has been approved by the Food and Drug Administration (FDA) as an aid in monitoring recurrence or progressive disease in patients with EOC and is CE marked for use within the European Union as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women.

The team from Stinson Brand Innovation attended the AACC conference in support of Fujirebio Diagnostics. We created a brand experience in the booth, including a touchscreen kiosk program to inform lab directors of the clinical application of the HE4 biomarker. Here are a few photos from the exhibit.

About Ovarian Cancer

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. An estimated one in 72 women will develop ovarian cancer in their lifetimes. It accounts for 31% of cancers of the female genital organs. Women who are postmenopausal are at the greatest risk for ovarian cancer.

About Abbott Diagnostics

Abbott Diagnostics is a global leader in in-vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnostics from an art to a science through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. 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. Fujirebio Diagnostics is a wholly owned subsidiary of Fujirebio Inc. Fujirebio Inc.is a leading healthcare company in Japan with a focus on diagnostics, and is a group company of MiraHoldings. Fujirebio Diagnostics has a worldwide distribution network which enables physicians and patients to access its diagnostic products. For more information about Fujirebio Diagnostics, please call 610/248-3800 or visit www.fdi.com.

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