Medtox Scientfic (AMEX:TOX)
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MEDTOX Receives ISO Certification and Is Granted New Patent for 'On-Site Drug
Testing Method'
ST. PAUL, Dec. 4 /PRNewswire-FirstCall/ -- MEDTOX Scientific, Inc. , announced
today that its subsidiary MEDTOX Diagnostics, Inc., has developed and
implemented a Quality System to satisfy the needs of its customers and to
improve quality management of the Company.
In October, MEDTOX Diagnostics, Inc., contracted TUV Rheinland to perform a
certification audit to EN ISO 13485:2000 and a registration audit to CMDCAS ISO
13485 (Canadian Medical Devices Conformity Assessment System). The scope of the
audit included the activities of Design, Development, Manufacture and
Distribution of Point-Of-Collection diagnostic screening devices for drugs of
abuse and other testing. Processes in various departments were audited to
verify conformity to the quality standards and requirements.
The audit findings concluded that MEDTOX Diagnostics furnished proof that it
maintains a quality management system fulfilling the requirements of EN ISO
13485 and CMDCAS ISO 13485, Quality Systems - Medical Devices and ISO 9001:2000
- Quality Management Systems - Requirements. The audit report states,
"Management documented its commitment to implement and maintain the quality
system by approval of the Quality Manual. The quality policy and the defined
quality objectives were disseminated through all levels of the organization.
The company implemented and maintained procedures and processes to achieve
defined quality objectives. Personnel on all levels of the organization had the
necessary awareness of the quality management system." "During the audit, no
deviation was found."
MEDTOX Diagnostics has been issued the TUV Rheinland Product Safety GmbH quality
system certificate to EN ISO 13485:2000 and the TUV Rheinland of North America
Inc., quality system certificate to ISO 13485 under CMDCAS.
On November 25, 2003, the United States Patent and Trademark Office granted
MEDTOX a business method patent for its "On-Site Drug Testing Method," U.S.
Patent No. 6,653,139. This is a continuation of application Ser. No.
09/358.340, filed on Jul. 21, 1999, and now U.S. Pat. No. 6,376,251, issued on
Apr. 23, 2003, which is based on provisional application No. 60/118,452 filed
Feb. 3, 1999, and claims priority therefrom. MEDTOX believes this patent to be
a significant addition to its growing intellectual property portfolio. There are
approximately 25 million laboratory drug screens for drugs of abuse performed
annually in the U.S. workplace market. In 2003, MEDTOX will perform between 1.5
and 2 million of those lab based DAU screens. In the last three years, there
has been an increasing transition from laboratory screening for DAU to on-site
or point-of-care (POC) screening with disposable devices. MEDTOX will provide
its workplace customers over 750,000 POC devices in 2003, of which an increasing
number are purchasing the patented PROFILE-II Test System(R), that includes the
patented PROFILE(R)-II A device with its on board adulterant test strip. The
growing transition to POC screening will increase the value of these patents to
MEDTOX and its strategic partners. Additionally, MEDTOX is unique in that it
operates both a federally certified laboratory and a POC device manufacturing
plant. This allows the Company to provide a seamless transition for clients
moving from one model of screening to the other.
Delivery of the PROFILE-II Test System(R) is further enhanced by WebTox(TM),
MEDTOX's proprietary web platform and interactive program management system. By
placing the power of information directly in the hands of our customers, through
the Internet, WebTox integrates point-of-collection screening and rapid
laboratory confirmations with a feature-rich data reporting and tracking system.
When fully implemented, WebTox will provide customers with testing results and
tracking, chain-of-custody verification, supplies ordering capability,
statistical reporting, and sample collection and site location information.
The "On-Site Drug Testing Method" patent contains 29 claims applicable to a
system for screening (testing) of other sample types in addition to urine, such
as oral fluids, blood and serum. MEDTOX believes this patent may have
applications beyond workplace drugs of abuse testing. MEDTOX is currently
working with its intellectual property counsel to implement its strategic
approach to maximizing opportunities for itself and its strategic partners
surrounding this patent. In addition to patent protection for the on-site
testing method, the United States Copyright Office has issued a registration for
MEDTOX's copyright(s) in material relating to the method of its application and
training. MEDTOX has sought the broadest protection possible for its
proprietary on-site testing method.
MEDTOX Diagnostic, Inc. is also pleased to announce that Dr. Robert C. Bohannon
has recently joined the Company as Vice President of Technology, Research and
Development. Dr. Bohannon holds a Doctorate in Molecular Virology from The
Baylor College of Medicine as well as a B.A. in Molecular, Cellular, and
Developmental Biology coupled with undergraduate work in organic chemistry. He
is an extremely creative scientist with extensive experience in research and
product development in all aspects of immunology, molecular biology,
epidemiology and virology. He has been issued a number of patents in these
related fields. Dr. Bohannon will significantly enhance our ability to not only
improve our existing products but also bring new products and technologies to
the POC market. As part of his employment agreement and as an inducement to
accept this position and relocate to North Carolina, he will be granted 20,000
non-qualified stock options and 5,500 restricted shares.
MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high
quality specialized laboratory and on-site/point-of-collection (POC) devices.
The company also supports customers with complete logistics, data and program
management services. MEDTOX develops and manufactures diagnostic devices for
quick and economical on-site/point-of-collection analysis for drugs of abuse,
therapeutic drugs and biological and agricultural toxins and provides employment
drug screening and occupational health testing. MEDTOX is a leader in providing
esoteric laboratory testing services to hospitals and laboratories nationwide.
This includes both central laboratory and bio- analytical testing for
pharmaceutical clinical trials. To be automatically alerted by e-mail about
company information, please go to
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=tox&script=1900 and
follow the directions on the page. For more information see
http://www.medtox.com/ .
Note: Forward-looking statements contained in this press release are made under
the Private Securities Reform Act of 1995. Actual results may differ due to a
number of factors including a change in the employment pattern of client
companies, the ability of MEDTOX to acquire new business, and changes in the
competitive environment. Further discussions of factors that may cause such
results to differ are identified on page three of the Company's 2002 annual
report on Form 10-K and incorporated herein by reference.
DATASOURCE: MEDTOX Scientific, Inc.
CONTACT: Stephen Anderson of MEDTOX Scientific, Inc., +1-877-715-7236
Web site: http://www.medtox.com/