Abbott Labs (ABT) recently announced that it is seeking US Food and Drug Administration (FDA) approval for a new diagnostic tool which can be used to monitor patients for the detection of the most common form of ovarian cancer. The ARCHITECT human epididymis protein 4 (HE4) assay has been designed to help monitor the recurrence or progression of epithelial ovarian cancer.
The test, which has been developed under a partnership with Fujirebio Diagnostics, Inc., recently received approval in Europe. Abbott stated that FDA approval would make this the first automated HE4 test to be available in the US.
According to Abbott, ovarian cancer is the leading cause of death from gynecological cancers and the fifth-leading cause of cancer death 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 American Cancer Society estimates that the five-year survival rate of ovarian cancer patients is 46%. However, early diagnosis helps increase the survival rate to 93%.
This diagnostic test, once launched in the US, should see rapid adoption as it will help physicians determine the appropriate treatment option for their patients. In addition to Europe, the diagnostic test is approved in some countries of Asia Pacific and Latin America.
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 11.6% of total revenues in 2009. We currently have a Neutral recommendation on Abbott.
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