Printer Friendly
The Free Library
19,595,263 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

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


GOLDEN, Colo. -- CeMines(R), Inc.:
"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


CeMines(R), Inc. today announced that the Company's wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 -- 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 lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. .

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 Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent"
above all, most especially
, 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 modality /mo·dal·i·ty/ (mo-dal´i-te)
1. a method of application of, or the employment of, any therapeutic agent, especially a physical agent.

2.
 available today."

In the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , CeMines announced on May 16, 2005, that it had filed a 510(k) application with the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
), 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 immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 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 TFS The Forum Site (online forum)
TFS Team Foundation Server (Microsoft Visual Source Safe)
TFS Toyota Financial Services
TFS Thanks for Sharing
TFS Tactical Fighter Squadron
TFS Three-Five Systems Inc.
 is very enthusiastic about managing the regulatory approval process for other CeMines tests in the development pipeline for Europe."

About CeMines(R), Inc.

CeMines, Inc. is a Life Sciences, Systems Biology Systems biology, a field of study in the biosciences, focuses on the systematic study of complex interactions in biological systems. Particularly from 2000 onwards, the term is used widely in the biosciences, and in a variety of contexts.  company specializing in cell biology Cell biology

The study of the activities, functions, properties, and structures of cells. Cells were discovered in the middle of the seventeenth century after the microscope was invented.
 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 The City of Golden is a home rule municipality that is the county seat of Jefferson County, Colorado, United States. Golden lies along Clear Creek at the eastern edge of the foothills of the Front Range of the Rocky Mountains. . CeMines' Diagnostics and Theranostics R&D is located in La Jolla La Jolla (lə hoi`yə), on the Pacific Ocean, S Calif., an uninc. district within the confines of San Diego; founded 1869. The beautiful ocean beaches, in particular La Jolla shores and Black's Beach, and sea-washed caves attract visitors and , 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 In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. , devices and therapeutics, from phase I through phase IV. The company's Web address is www.trialformsupport.com.

Forward-Looking Statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.


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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jan 11, 2006
Words:830
Previous Article:Sepracor Inc. Sets Conference Call and Webcast for Fourth Quarter and Full-Year 2005 Operating Results.
Next Article:Regis Second Quarter Revenues Grew 13 Percent to $607 Million; Second Quarter Same-Store Sales Increased 1.2 Percent.
Topics:



Related Articles
ORGANON GETS FIRST EUROPEAN MARKETING APPROVAL FOR REMERON.
CeMines to Present at Medtech Insight's ``Investment In Innovation'' Conference.
GPC BIOTECH PRESENTS NEW SATRAPLATIN DATA AT AACR.
CeMines(R) receives multiple USPTO Patent-Issue Notifications, two of which protect its discovery of a significant new class of oncology targets for...
CeMines(R) Announces Intent to Sell Its Research Tools Business, Including Multi-Million-Dollar Inventory of Polyclonal Antibodies, cDNA and mRNA.
Nymox Obtains CE Mark for NicAlert-TM-; Product Now Available in Europe.
Nymox Signs Italian Distribution Deal for NicAlert(TM) with Alifax S.p.A.
New Nymox Product Study Data to be Presented at World Conference on Tobacco.
Nymox NicAlert(TM) Product to be Used in Large Collaboration For Smoking Cessation in U.K.
NicAlert(TM) Study in Children to be Presented at American Thoracic Society Conference in San Francisco.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles