Monday, Abbott Laboratories (ABT) said that it submitted a new automated ovarian cancer test for 510(k) approval in the United States. Abbott's new 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 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, the company indicated.
Abbott said that 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%. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93%. Less than 20% of all ovarian cancer is found in the early stage. It is revealed by the authorities that 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.
ABT is traded at $53.64 down $0.33 or 0.61% on a volume of 2.553 shares on the NYSE.
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