Optimistic Outlook for Ovarian Cancer: Fujirebio Diagnostics Awarded Patent for New HE4 Biomarker
Posted on: Monday, 4 June 2007, 09:00 CDT
Fujirebio Diagnostics, Inc., the premier cancer diagnostics company, announced today it has received notification of allowance for the first of what is expected to be a family of patents for its HE4 biomarker. Covering the measurement of HE4 and antibodies to HE4 in blood, serum and plasma, the patent will allow Fujirebio Diagnostics to develop the biomarker for screening, detecting, monitoring and prognosis of ovarian cancer. The patent includes claims in which HE4 is used in conjunction with other ovarian cancer markers such as Fujirebio Diagnostics' CA 125, the industry's current gold standard for monitoring ovarian cancer. Fujirebio Diagnostics plans to submit to the U.S. Food and Drug Administration (FDA) for regulatory clearance of the HE4 test later this year.
"Since its inception, Fujirebio Diagnostics has committed itself to providing physicians with clinically useful biomarkers to aid in the management of cancer," said Dr. W. Jeffrey Allard, vice president and chief scientific officer, Fujirebio Diagnostics. "We're leading the fight against ovarian cancer. When combined with CA 125, the test covered by this patent represents a major step in the differential diagnosis and detection of ovarian cancer."
Commonly referred to as "the silent killer," ovarian cancer is difficult to diagnose because symptoms can be attributed to a variety of causes. As a result, 70-75 percent of ovarian cancers are diagnosed at a late stage when the five-year overall survival rate is 20-25 percent. However, in women with a diagnosis of Stage I disease, the probability of a cure is 90-95 percent. Early detection of ovarian cancer and surgery performed by a gynecologic oncologist are critical to prolonging life expectancy.
Ovarian cancer is the fifth leading cause of cancer death in women and the second most common female reproductive cancer. This year it is expected that 23,000 women will be diagnosed with ovarian cancer. HE4 is a simple blood test and Fujirebio Diagnostics has completed a multi-center clinical trial to evaluate the clinical utility of the test in the more than 250,000 women that are diagnosed with a suspicious pelvic mass in the United States each year.
About Fujirebio Diagnostics
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.
Source: Business Wire
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