Healthcare Industry News:  CeMines 

Diagnostics Regulatory Oncology

 News Release - January 11, 2006

CeMines(R) Granted European Union Regulatory Clearance and CE Mark Registration of Its CellCorrect LAb(R) Clinical Dx Test for Lung Cancer

"European Union (EU) regulatory clearance is a strategic milestone for CeMines. While this event clearly represents an essential 'validation' of our molecular diagnostic technology, it also serves as a vital catalyst, enabling CeMines to proceed with final preparations necessary to commercialize this 'first to market' product from our CellCorrect family of molecular diagnostic kits. Simply stated, CeMines will soon offer physicians across Europe a broader range of less invasive Dx tools to assist them in detection and diagnosis of cancer." Roger Attick, President and CEO, CeMines, Inc.

"CeMines' CellCorrect family of molecular diagnostic test kits are the first of their kind, representing a powerful diagnostic modality that is both minimally invasive and extremely cost-effective. More importantly, the CellCorrect KvA-40 LAb Kit (as it will be marketed in Europe) offers physicians a clear and desirable alternative to the 'legacy procedures' currently used to diagnose lung cancer." Daniel Spasic, CEO, Trial Form Support, AB


GOLDEN, Colo.--(HSMN NewsFeed)--Jan. 11, 2006--CeMines, Inc. today announced that the Company's wholly owned subsidiary -- CeMines International Inc., CeMines Estonia OU -- received notice from the State Agency of Medicines-Department of Medical Devices on December 30, 2005, that the company was granted CE Mark registration and clearance for clinical use of its CellCorrect LAb Detection Kit, a minimally invasive molecular blood test to aid physicians in detection and diagnosis of lung cancer.

The test will be marketed and distributed in the EU under the brand name, CellCorrect KvA-40 LAb Kit.

"Our regulatory clearance in the EU, CE Mark registration, represents the culmination of an outstanding effort by the CeMines team. This company milestone is without a doubt our most significant accomplishment to date. Further, CE Mark registration validates physicians' demands for more accurate, less invasive (lower risk) and cost-effective options that aid in the diagnosis of lung cancer. Most importantly, the CE Mark registration validates that our CellCorrect LAb Kit (CellCorrect KvA-40-LAb Kit) is a simple-to-use, cost-effective, and powerful test," said Roger Attick, President and CEO of CeMines. "We believe that our integration of the CellCorrect diagnostic array protocol and CeMines' Molecular FingerPrinting(TM) bioinformatics applications will eventually establish the CellCorrect product family as the most cost-effective and operationally efficient DX modality available today."

In the United States, CeMines announced on May 16, 2005, that it had filed a 510(k) application with the Food and Drug Administration (FDA), seeking regulatory clearance for clinical use of CellCorrect LAb. CeMines reports that it has held "productive discussions with the FDA" and, as a result, "CeMines is proceeding in a direction that the Company hopes will result in substantial forward progress later in 2006," added Mr. Attick.

CellCorrect LAb test kits (CellCorrect KvA-40-LAb Kits) are an inexpensive way to detect altered autoimmunity and associated patterns ('Molecular FingerPrinting') of disease-related autoantibodies in the bloodstream that are produced by the immune system upon detection of cancer. CeMines has conducted international patient studies which demonstrated that consistent patterns of specific biomarkers have proven their utility as viable composite biomarkers necessary to differentiate and characterize cancer. The Company uses a patent-pending, proprietary bioinformatics application for biomarker analysis, followed by specific pattern-recognition algorithms. The data are presented in an easy-to-read 'score format', not requiring subjective interpretation by physicians.

"Our team of medical device, therapeutics and diagnostic experts is honored to have had the privilege of managing the CE Mark application process for CeMines' novel product family, CellCorrect(TM)," said Daniel Spasic, Chief Executive Officer of Trial Form Support. "Given that CeMines is developing an impressive pipeline of important oncology products to satisfy a huge medical need throughout the EU, TFS is very enthusiastic about managing the regulatory approval process for other CeMines tests in the development pipeline for Europe."

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 possible treatment of cancer. The Company was founded in 2000. 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, CeMines Estonia OU, is located in Tallinn, Estonia.

About TFS Group(TM)

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. The company's Web address is www.trialformsupport.com.

Forward-Looking Statements

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.


Source: CeMines

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.