Navigation Links
Abbott Submits New Automated Ovarian Cancer Test for U.S. Approval

ABBOTT PARK, Ill., Feb. 8 /PRNewswire-FirstCall/ -- 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.


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

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




Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Abbott and Pierre Fabre SA Announce Collaboration to Research and Develop Novel Treatments for Cancer
2. Abbotts Ibis Technology Named One of the Top Innovations for 2009 by The Scientist
3. The Deal Names Abbott Top Dealmaker for Second Consecutive Year
4. Abbott Completes Visiogen Acquisition
5. Abbott Cuts Use of Oil and Coal by 35 Percent
6. Results from Abbotts PROSPECT Study Provide New Insight into Role of Vulnerable Plaque in Coronary Artery Disease
7. Abbotts XIENCE V(R) Demonstrates Significantly Lower Rates of MACE and Stent Thrombosis Compared to TAXUS(R) Liberte in Investigator-Initiated COMPARE Trial
8. Abbotts XIENCE V(R) Superior to TAXUS(R) in Key Safety and Efficacy Measures in SPIRIT IV Trial
9. Abbotts XIENCE V(R) Continues to Outperform TAXUS With Sustained Clinical Advantages and Impressive Long-Term Safety Results in SPIRIT III Trial
10. HIV/AIDS Research Network Recommends Use of Abbott RealTime Viral Load Test for NIH-Sponsored Clinical Trials
11. New Data for Abbotts TRILIPIX(R) (fenofibric acid) in Combination with Rosuvastatin Calcium Shows Improvement on Key Lipids for Cholesterol Management
Post Your Comments:
(Date:11/27/2015)... 2015  Lannett Company, Inc. (NYSE: LCI ... acquisition of Kremers Urban Pharmaceuticals Inc. (KU), the ... company UCB S.A. (Euronext: UCB). ... KU from UCB for total consideration of approximately ... customary working capital adjustment, a deduction of certain ...
(Date:11/27/2015)... 26, 2015 ... the "2016 Global Tumor Marker Testing ... and Sales Segment Forecasts, Innovative Technologies, Instrumentation ... to their offering. --> ... "2016 Global Tumor Marker Testing Market: ...
(Date:11/26/2015)... Un nuevo enfoque combina la ... cáncer avanzado.   --> Un nuevo ... Bremachlorin para el cáncer avanzado.   --> ... la terapia fotodinámica de Bremachlorin para el cáncer avanzado. ... --> Clinical Cancer Research . --> ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... An inventor, from Hopkinsville, Ky., thought there ... home, so he invented the patent-pending ELECTRONIC M.D. , The ELECTRONIC M.D. provides ... so, it could help to prevent potential overdose situations. As a result, it ...
(Date:11/27/2015)... Aliso Viejo, CA (PRWEB) , ... November 27, 2015 , ... ... exclusively for use in Final Cut Pro X. With ProSidebar: Fasion, video editors ... banners, or use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television ... an interesting show that delves into an array of issues that are presently affecting ... benefit from open dialogue, this show is changing the subjects consumers focus on, one ...
(Date:11/27/2015)... ... November 27, 2015 , ... The men and ... nonprofit healthcare organizations in the country. They have overseen financial turnarounds, shown commitment ... advance the healthcare industry as a whole through their advocacy and professional efforts. ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point ... come together on Thanksgiving Day to share the things that they are most ... Serenity Point YouTube channel, patients displayed what they wrote on index cards, describing ...
Breaking Medicine News(10 mins):