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From M2 Europharma (January 14, 2010)
14 January 2010 - US-based health care company Abbott Laboratories Inc (NYSE: ABT) said today it received CE Mark (Conformite Europeene) certification for its ARCHITECT human epididymis protein 4 (HE4) test expected to help in the assessment of epithelial ovarian cancer.
The diagnostic tool can aid in determining the risk of whether a pelvic mass is benign or malignant andaÃ?â?? is the first automated HE4 test available anywhere in the world.
The test is now available in several European countries, as well as in some countries in Asia Pacific and Latin America. Recently, Abbott filed for marketing approval of the ARCHITECT HE4 Assay with the US Food and Drug Administration (FDA).
For the development of the assay, Abbott partnered with Japanese Fujirebio Diagnostics Inc, a subsidiary of local pharmaceutical company Miraca Holdings Inc (TYO:4544).
According to the International Agency for Research on Cancer, the five-year survival rate of ovarian cancer patients is 46%. However, when the disease is diagnosed earlier, the survival rate increases to 94%.
((Comments on this story may be sent to tww.feedback@m2.com))
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