Med 11 AG
MED 11 AG Files Application with the FDA for its lung cancer screening test
Med 11 AG / Miscellaneous Release of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement. ---------------------------------------------------------------------- MED 11 AG Files Application with the FDA for its lung cancer screening test ZUG, Switzerland, 02 / 04 / 2008 – Swiss based MED-11 AG, (Frankfurt Stock Exchange: WKN: A0LGDQ), the holder of patented cancer screening tests for detecting cancerous and precancerous conditions, has contracted with the Emergo Group (www.emergogroup.com) to prepare and file an ‘exemption application’ for its lung cancer screening test - Lung Screen Plus - as was recommended by the FDA. It is anticipated that this will be completed by April 15th 2008. The FDA has advised Med-11 that they will require 60 days to review the submission. After approval of the submission, to ascertain the sensitivity and specificity of Lung Screen Plus in detecting early stage lung cancer, Lung Screen Plus will be tested on a total of 485 patients who have previously tested positive or negative in a lung biopsy. This small clinical trial will be managed by Symbio Research (www.symbioresearch.com) - a Clinical Trial Management Services Company. All patients will be tested in Anaheim, California, by the Critical Care Group - an oncology group specializing in disease of the lungs and the respiratory tract. Physician’s Reference Laboratory (www.atprlwecare.com), which was contracted to develop the 'validation plan and assay procedures' required to support the FDA Exemption Application, will conduct all laboratory analysis and data collation. They will submit the Final Validation Report in accordance with the applicable FDA standards. Cancer is a leading cause of death. The FDA informed Med-11 that there are no other non-invasive screening tests for Lung Cancer. Early assessment and prevention can eliminate a large percentage of these deaths; consequently there is an urgent need and vast market potential for cancer screening tests. Market research indicates that the annual sales of the Cancer Screening Tests for lung, colon and breast cancers, in the US alone, once approved by the FDA, should exceed $1.5 Billion a year. About MED-11 (www.med-11diagnostic.com) MED-11 AG is medical service company with a wide range of patented medical products in different market segments. These include Cancer Screening Tests, Cancer Preventive Dietary Supplements; Personal Care Products; and prepackaged Modular Medical Clinics. The Company identified ‘medical diagnostics’ and ‘preventive health care’ as sectors of the medical service industry that were experiencing strong growth. As a result of management’s background and experience in the United States pharmaceutical, nutraceutical and retail industry, Med-11 made several investments and acquired the United States and Japanese patents to, Screening Tests for Colon Cancer, Lung Cancer and Breast Cancer; the worldwide Licenses to manufacture and distribute certain Cancer Preventive Dietary Supplements; the worldwide Licenses to manufacture and distribute Modular Medical Clinics; and distribution agreements for various Personal Care Nutraceutical Products. Through the provision, by Medical Practioners, of evidence-based clinical proof of each products safety and efficacy, the Company aims to acquire a major position in this expanding market. For further information contact: Karsten Behrens, Investor Relations: Phone: +41-41-560-8553 or Email: Behrens@med-11.com or Mail to: MED-11 AG, Alpenstrasse 7, CH-6300, Zug, Switzerland 02.04.2008 Financial News transmitted by DGAP ----------------------------------------------------------------------
Aktuelle News
Aktuelle Berichte
Keine Berichte gefunden
Anstehende Events
Keine Events gefunden
Webcasts
Keine Webcasts gefunden