Abbott Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test
By Abbott, PRNEWednesday, January 13, 2010
Abbott announces CE Mark (Conformite Europeene) certification for the ARCHITECT human epididymis protein 4 (HE4) test
ABBOTT PARK, Illinois, January 14 - A new diagnostic tool, which studies show can aid in determining the risk
of whether a pelvic mass is benign or malignant, is now available in Europe.
This simple blood test is expected to help in the assessment of epithelial
ovarian cancer, the most lethal form of gynecological cancer. This important
immunoassay, which will run on Abbott's ARCHITECT systems, is the first
automated HE4 test available anywhere in the world.
Research has shown that this novel diagnostic marker, combined with other
tests such as the CA125 assay, can aid in measuring the risk of epithelial
ovarian cancer in pre- and post-menopausal women who have a pelvic mass.
According to the International Agency for Research on Cancer, the
five-year survival rate of ovarian cancer patients is 46 percent. However,
when the disease is diagnosed earlier, the survival rate increases to 94
percent.
"The ability of this test to help physicians predict whether a pelvic
mass is benign or malignant is an important development for both patients and
physicians," said Michael Warmuth, senior vice president, diagnostics,
Abbott. "Abbott's ARCHITECT HE4 test will aid physicians in determining the
most appropriate treatment for their patients."
Abbott partnered with Fujirebio Diagnostics, Inc. in the development of
the assay. The test is now available in several European countries, as well
as in some countries in Asia Pacific and Latin America. The ARCHITECT HE4
Assay was recently submitted to the FDA for 510(k) clearance.
About Ovarian Cancer
Ovarian cancer is the leading cause of death from gynecological cancers
and the fifth-leading cause of cancer death in women. An estimated one in 72
women will develop ovarian cancer in her lifetime. It accounts for 31 percent
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. 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 Abbott
Abbott (NYSE: ABT) 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 72,000 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.
Media, Darcy Ross, +1-847-937-3655, or Financial, Tina Ventura, +1-847-935-9390, both of Abbott
Tags: Abbott, Abbott park, Illinois, Western Europe