The new FEMTELLE uPA/PAI-1 Test from American Diagnostica allows for improved risk assessment of the course of the disease in node-negative breast-cancer patients. After many years (> 10 years) of clinical studies the value of the test has been confirmed in a population of more than 8000 patients.
FEMTELLE is intended for the quantitative determination of human urokinase-type plasminogen activator (uPA) and its inhibitor PAI-1 in tumour tissue extracts. The test results are useful to identify patients who are either at high risk (uPA and/or PAI-1 high) or low risk (uPA and PAI-1 low) for disease recurrence after surgery.
uPA and PAI-1 are the first novel tumour biological prognostic factors for which the prognostic impact has been validated at the highest level of evidence and hence all evaluation criteria for transfer into clinical praxis have been fulfilled. The assay is robust and its high reproducibility has been demonstrated in the prospective evaluation of an international quality assurance program. FEMTELLE is registered as a CE marked IVD (in vitro diagnostic medical device).
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