Test may help physicians identify effective treatment earlier
MALVERN, Pa. and Abbott Park, Ill., Jan. 27 /PRNewswire/ -- Fujirebio Diagnostics, Inc. and Abbott have signed a license agreement to develop a new ovarian cancer test for use on Abbott's automated ARCHITECT(R) diagnostic analyzers. Under the agreement, Fujirebio Diagnostics will develop and manufacture for Abbott the HE4 biomarker, a simple blood test that may help in the risk stratification of women at high risk for ovarian cancer, a difficult disease to detect in its early stage.
"While the medical industry has familiarized the public with warning signs and symptoms of ovarian cancer, the key to combating this lethal disease is better detection tools and technologies," said Olle Nilsson, Ph.D., vice president and chief scientific officer, Fujirebio Diagnostics. "The HE4 test, which is expected to be available in 2009, will allow Abbott, on the ARCHITECT system, to provide clinicians worldwide with a tool to help define a pelvic mass so that appropriate treatment can be best identified earlier and more effectively."
HE4 in a manual format is currently FDA-cleared for monitoring recurrent or progressive disease in patients with epithelial ovarian cancer (EOC), and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with a pelvic mass. The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA(TM)) are pending clearance by the United States Food and Drug Administration (FDA) for use in women who present with a pelvic mass.
"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," said Robert Doss, Ph.D., divisional vice president, research and development, Abbott Diagnostics. "HE4 represents an important marker for the assessment of these pelvic masses, and we're pleased to partner with Fujirebio Diagnostics on the development of a test for the ARCHITECT System."
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. It accounts for 31% of cancers of the female genital organs. There are an estimated 22,000 new cases annually in the U.S. Women who are postmenopausal are at the greatest risk for ovarian cancer. An estimated 1 in 72 women will develop ovarian cancer in their lifetimes.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
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 Miraca Holdings. 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 610-240-3800 or visit www.fdi.com.
CONTACT: Maureen Miller of JFK Communications, +1-609-514-5117, Mobile:
+1-609-268-5113, firstname.lastname@example.org; or Don Braakman of Abbott,
Web site: http://www.fdi.com/