Abbott Labs (ABT) recently announced that it has gained approval in Europe for a new diagnostic tool which will help determine the possibility of a pelvic mass being benign or malignant. The blood test named ARCHITECT human epididymis protein 4 (HE4) test, has been designed to facilitate the assessment of epithelial ovarian cancer.
It has been observed that the HE4 test, in combination with other tests such as the CA125 assay, could help measure the risk of epithelial ovarian cancer in pre- and post-menopausal women who have a pelvic mass. The test, which has been developed with Fujirebio Diagnostics, Inc., will run on Abbott’s ARCHITECHT systems.
According to Abbott, ovarian cancer is the leading cause of death from gynecological cancers and the fifth-leading cause of death from cancer, in women. About 1 in 72 women is likely to develop ovarian cancer in her lifetime. Postmenopausal women are at the greatest risk to develop ovarian cancer.
The International Agency for Research on Cancer estimates that the five-year survival rate of ovarian cancer patients is 46%. However, early diagnosis helps increase the survival rate to 94%.
This diagnostic test should see rapid adoption as it will help physicians determine appropriate treatment options for patients. The diagnostic test is currently available in several European countries, and some countries in Asia Pacific and Latin America. Approval is yet to come in the US where Abbott recently submitted an application with the Food and Drug Administration (FDA).
Abbott’s Diagnostic Products segment manufactures and markets diagnostic systems and tests which are sold worldwide to blood banks, hospitals, commercial laboratories, physicians’ offices, alternate-care testing sites, and plasma protein therapeutic companies. Revenues from this segment came in at $3.6 billion, comprising 12.1% of total revenues in 2008. We currently have a Neutral recommendation on Abbott.
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