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MED-11 AG ANNOUNCES COMPLETION OF FDA REVIEW OF LUNG CANCER TEST PRE-IDE APPLICATION

lung_cancer.jpgSwiss-based MED-11 AG (Frankfurt Stock Exchange: WKN: A0LGDQ), the holder of two US patented cancer screening test kits for various cancerous and precancerous conditions, has been notified by the USA Food and Drug Administration (FDA) that they have reviewed Med-11′s Lung Cancer Screening Test ‘Investigative Device Exemption’ (IDE) application. The FDA informed Med-11 that there are no other non-invasive screening tests for Lung Cancer.

Med-11 will now conduct a small Clinical Trial as submitted to the FDA to confirm the sensitivity and specificity of the Lung Screening Test when compared with lung biopsies from existing cancer patients. This clinical trial is expected to take six months and will consist of 485 subjects made up of 196 lung cancerous subjects and 289 non-lung cancerous.

 

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