GOLDEN, Colo., Sept. 27 /PRNewswire/ -- CeMines, Inc. today announced that the Company's wholly owned subsidiary -- CeMines International Inc., CeMines Estonia OU -- has filed for CE Mark registration through Trial Form Support AB, its primary Contract Research Organization (CRO) partner for Europe-based regulatory initiatives.
"CeMines is seeking EU clearance for clinical use of the Company's minimally invasive lung cancer-detection test, CellCorrect LAb. CE Mark registration is mandatory in order for CeMines to commercialize our current and future products in 25 European Union and three European Free Trade Association (EFTA) member states," said Roger Attick, President and CEO of CeMines, Inc.
CellCorrect LAb test kits are an accurate and inexpensive way to detect altered autoimmunity and associated patterns (i.e., 'Molecular FingerPrinting(TM)') of disease-related autoantibodies in the bloodstream. CeMines has conducted international clinical studies which demonstrated that unambiguous and consistent patterns of specific antibodies have regularly proven their utility as composite biomarkers to differentiate and characterize cancer -- and can therefore be used as diagnostic tests to support the diagnosis of cancer. The Company uses a proprietary bioinformatics-based statistical analysis and pattern recognition application. This bioinformatics application, known as CeMines Molecular FingerPrinting(TM), evaluates cancer- related antibody patterns and their relevant statistical profiles. These data are presented in an easy-to-read 'score format,' not requiring subjective interpretation by physicians.
"We are very optimistic that ongoing clinical results will show compelling data which uphold findings from previous studies, confirming that the CellCorrect LAb Kit is simple to use, cost effective, and a powerful tool for use in supporting diagnosis of lung cancer," said Roger Attick, Chief Executive Officer and President of CeMines, Inc. "Our integration of CellCorrect LAb and CeMines Molecular FingerPrinting technologies may soon establish CellCorrect as 'the most innovative,' minimally invasive in vitro diagnostic modality available.
"Regarding our partnership with Trial Form Support, CeMines selected TFS as a regulatory partner in Europe for several reasons, not the least of which is their 'track record' and extensive experience in managing a wide range of clinical initiatives," added Roger Attick.
"TFS and our team of medical device, therapeutics and diagnostic experts have had the privilege of being awarded the assignment to apply to the EU for CE Mark approval of CeMines' novel product family, CellCorrect(TM)," said Daniel Spasic, Chief Executive Officer of Trial Form Support International. "This is a momentous assignment for TFS and the team working with CeMines because we believe the CeMines technology is extremely innovative, simple to use, and very efficient in supporting possible earlier diagnosis of cancer."
Spasic added: "In other words, CeMines is developing an impressive pipeline of important oncology products which we believe will fulfill a huge medical need here in the EU, creating significant benefits for patients. It is for these reasons the team at TFS is extremely enthusiastic about contributing to place these novel clinical products on the EU market."
About TFS Group
Trial Form Support, AB (TFS), based in Helsingborg, Sweden, is a full- service Contract Research Organization, providing the pharmaceutical, biotechnology and medical device industries with all clinical trial services covering full clinical trial programs including in vitro diagnostics, devices and therapeutics, from phase I through phase IV. (http://www.trialformsupport.com)
About CeMines, Inc. CeMines, Inc. is a Life Sciences, Systems Biology company specializing in cell biology and regulatory network research and development, that is principal to commercialization of novel clinical products for worldwide use in diagnosis and treatment of cancer. The Company was founded in 2000 by Toomas Neuman, Ph.D., Kaia Palm, Ph.D., and Mr. Richard Cavalli. Company headquarters are located in Golden, Colorado. CeMines' Diagnostics and Theranostics R&D is located in La Jolla, California, and the Company's European Union-based subsidiary of CeMines International, CeMines Estonia OU, is located in Tallinn, Estonia.
Any statements in this press release about future expectations, plans or prospects for the company, including the company's expectations and plans to complete FDA reviews and clearance process, and CE Marking in the EU for CellCorrect LAb, constitute 'Forward-Looking' statements. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in these and previous statements. Forward-looking statements should be evaluated along with other information released by the company.
Ronald Trahan, APR
Ronald Trahan Associates, Inc.