MEDTOX Receives ISO Certification and Is Granted New Patent for 'On-Site Drug Testing Method'
04 Décembre 2003 - 6:30PM
PR Newswire (US)
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/
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