Press Release
Abbott Submits New Automated Ovarian Cancer Test for U.S. Approval
- Abbott's ARCHITECT human epididymis protein 4 (HE4) assay submitted for
510(k) clearance
February 8, 2010
Abbott Park, Illinois, (NYSE: ABT)
— A new diagnostic tool physicians can use to monitor patients for the most
common form of ovarian cancer may soon be available in the United States.
Abbott’s ARCHITECT HE4 assay uses a simple blood test to help in
monitoring for the recurrence or progression of epithelial ovarian cancer. If
approved, this important immunoassay would be the first automated HE4 test
available in the United States.
The 2003 Hellstrom et al. study of
known ovarian cancer biomarkers found that HE4, which has been detected in high
levels in the blood of some ovarian cancer patients, shows the highest
sensitivity and specificity of any other marker and is considered the best
single marker for stage 1 of the disease.
According to the American Cancer Society, the five-year survival rate of
ovarian cancer patients is 46 percent. However, when the disease is diagnosed
and treated earlier, the survival rate increases to 93 percent. Less than 20
percent of all ovarian cancer is found in the early stage.
"The ability to monitor the recurrence or progression of ovarian cancer
is a critical part of patient care. The ARCHITECT HE4 assay has the
potential to be a powerful tool for both physicians and patients in the
management of the disease," said Michael Warmuth, senior vice president,
diagnostics, Abbott.
Abbott partnered with Fujirebio Diagnostics, Inc. in the development of the
assay. The ARCHITECT HE4 assay is approved for use in Europe, as well as
in other countries in Asia Pacific and Latin America. It is currently an
investigational device in the United States.
About ARCHITECT HE4 Assay
The ARCHITECT HE4 assay is designed to be used as an aid in
monitoring recurrence or progressive disease in patients with epithelial
ovarian cancer, and must be used in conjunction with other clinical data. The
ARCHITECT HE4 assay should not be used as a cancer screening test. In
addition, certain types of cancer (e.g., mucinous or germ cell tumors) rarely
express HE4, and the use of the ARCHITECT HE4 assay is not recommended
for monitoring patients with those types of cancer.
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 71 women
will develop ovarian cancer in their lifetimes. 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's Diagnostics Businesses
Abbott is a global leader in in vitro diagnostics and offers a broad
range of innovative instrument systems and tests for hospitals, reference labs,
molecular labs, blood banks, physician offices and clinics. With more than
69,000 customers in more than 100 countries, Abbott's diagnostic products offer
customers automation, convenience, bedside testing, cost effectiveness and
flexibility. Abbott has helped transform the practice of medical diagnosis from
an art to a science through the company's commitment to improving patient care
and lowering costs.
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.
Media:
Darcy Ross |
(847) 937-3655 |
Financial:
Tina Ventura |
(847) 935-9390 |
