Epitope Announces Approval for European CE Mark and Federal
BEAVERTON, Ore., April 15 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO)
today announced that it had received approvals permitting sale of the
OraSure(R) oral specimen collection device in Europe and facilitating the
purchase of the device by U.S. government agencies.
Epitope has received approval to use the CE Mark, which is required to
sell the OraSure device in all fifteen countries of the European Economic
Community. The approval followed a recent inspection of Epitope's facilities
and processes by representatives of the European Notified Body. OraSure has
been registered under European regulations as a Class III medical device, the
classification requiring the highest degree of scrutiny for CE Mark approval.
Epitope distributors are actively marketing the device in England, Ireland and
Greece. The company has begun shipments to Europe under the new CE Mark
Epitope has also received approval to be listed in the General Services
Administration (GSA) Federal Supply Schedule. Government agencies are
encouraged to purchase from the Federal Supply Schedule, which offers the best
pricing for approved products. This schedule applies to various federal
agencies, including the Veteran's Administration, the military, the Federal
Bureau of Prisons, JobCorp, the Federal Aviation Administration, the National
Institutes of Health, and many others. Epitope will launch a direct marketing
program in the near future to capitalize on this new approval. Market studies
indicate that the number of HIV tests associated with GSA contracts is
currently about 2 million per year.
John W. Morgan, Epitope's president and CEO, commented, "These two
approvals, covering the European Economic Community and U.S. federal
government agencies, will open markets that have significant potential for
Epitope's products. We intend to aggressively market to customers in both
areas, and to add future products to these approvals as they become ready for
Epitope, Inc. is an Oregon-based corporation that develops and markets
medical devices and diagnostic products. Its focus is on products that use
oral fluid in the detection to HIV infection, with emphasis in the life
insurance and public health markets, and on the use of oral fluid testing for
detection of drugs of abuse and other analytes.
Statements in this press release about future sales levels or other future
events or performance are forward-looking statements. The company's actual
results could be significantly different. Factors that could affect results
include the extent of future use of oral fluid testing and OraSure in the
insurance industry or other key markets; loss or impairment of sources of
capital; ability of the company to develop product distribution channels;
ability of the company to develop new products; development of competing
products; changes in international, federal or state law or regulations;
uncertainties related to customers' and suppliers' ability to achieve year
2000 compliance; and loss of key personnel. Although forward-looking
statements help to provide complete information about the company, readers
should keep in mind that forward-looking statements are much less reliable
than historical information.
SOURCE Epitope, Inc.