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FDA Reviewed (IDE) Application/ Lung Cancer Screening Test


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http://www.ad-hoc-news.de/drucken.html?art_id=18098182

EXCERPT FROM CORPORATE NEWS RELEASE:

. . . . . . . . .

ZUG, Switzerland -- Swiss-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.

Following the Clinical Trial, Med-11 will submit a Pre-Market Approval (PMA) to the FDA as a Class III medical diagnostic device. This application will request an accelerated review by the FDA as lung cancer is a leading cause of death in the USA. Early assessment and prevention can eliminate a large percentage of these deaths; consequently there is an urgent need and vast market potential for this product. Market research indicates that the annual sales of the Cancer Screening Tests for Lung Cancer in the US alone, once approved by the FDA, should exceed $1 Billion a year.

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(ad hoc news release, Transmitted by DGAP, July 4, 2008)

Disclaimer:

The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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