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News (Media Awareness Project) - US MN: Wire: Medtox Scientific Submits New Profiler-II Test to the FDA
Title:US MN: Wire: Medtox Scientific Submits New Profiler-II Test to the FDA
Published On:1998-06-25
Source:PRNewswire
Fetched On:2008-09-07 07:16:59
MEDTOX SCIENTIFIC SUBMITS NEW PROFILER-II TEST TO THE FDA

ST. PAUL, Minn.-- MEDTOX Scientific, Inc. (Amex: TOX) announced today that
its subsidiary, MEDTOX Diagnostics, Inc., has submitted its newly developed
PROFILE-II product to the United States Food and Drug Administration for
510(k) pre-market clearance.

The PROFILE-II device is the first of a new generation of on-site test kits
being developed by MEDTOX Diagnostics. It is intended for use in the
detection of multiple drugs of abuse.

PROFILE-II will allow the end user to perform an on-site screen for the
presence of five of the most commonly abused drugs -- cocaine, amphetamines,
cannabinoids (marijuana), opiates, and phencyclidine (PCP). The screen is a
one-step process that produces results in five minutes.

PROFILE-II will be sold as both a stand-alone product and more significantly
as part of a comprehensive testing system utilizing the stringent standards
followed by MEDTOX's federally certified drug testing laboratory. The
comprehensive system for employment drug testing will utilize the PROFILE-II
device, trained and certified collectors/testers, a chain of custody form
for each donor, split specimen collections kits, automatic laboratory
(GC/MS) confirmation on non-negative on-site screening results, and
centralized data management for clients' tests results.

This system will provide clients with the most comprehensive, legally and
forensically defensible on-site screening system available in the market place.

Response from clients and focus groups bas been extremely positive.

It is estimated that there are currently over 30 million laboratory
employment drug tests performed annually in the United States. The Company
concurs with other industry experts who believe that twenty to thirty
percent of these tests could eventually be conducted on site within the next
three years.

The Company also believes that the ease and immediate turnaround time of
on-site testing should expand the drug testing market.

Additionally, a number of states have introduced regulations that provide
for a discount in workers compensation premiums for employers that adopt
drug testing programs.

This will encourage many smaller employers who do not currently test to
adopt programs.

The quick turnaround time of a high quality comprehensive on-site system
should appeal to this new segment of the drug testing market.

Currently no other company can complement a federally certified laboratory
and all of its resources with its own patented on-site device packaged in a
high quality comprehensive system.

PROFILE-II and its comprehensive system will provide added value to the
market place for a price comparable to current laboratory testing.

While pricing will be competitive for the customer the Company expects to
achieve gross margins more in line with medical device manufacturers, as
opposed to gross margins realized from laboratory services.

The Company believes it can be a market leader in making the transition from
laboratory employment drug testing to on-site screening for drugs of abuse.

The PROFILE-II product is the twelfth product to be submitted by the Company
to the United States Food and Drug Administration. The prior eleven product
submissions received 510(k) pre-market clearance in an average time of 72
days, with a maximum of 141 days and a minimum of 20 days. Although no
maximum statutory response time has been set for review of a 51O(k)
submission, as a matter of policy the United States Food and Drug
Administration attempts to complete review of 510(k) submissions within 90 days.

MEDTOX Scientific, Inc. is headquartered in St. Paul, MN. Through its MEDTOX
Laboratories subsidiary, it is a leader in providing esoteric toxicology
services to hospitals and laboratories nationwide. The subsidiary also
provides employment drug testing and occupational health testing, including
biological monitoring for exposure to industrial chemicals, heavy metals and
solvents.

Its MEDTOX Diagnostics subsidiary develops and manufactures diagnostic
devices for quick and economical on-site analysis for drugs of abuse,
agricultural toxins, and antibiotic residues. Additionally, the diagnostics
subsidiary provides contract manufacturing utilizing its patented technology
and proprietary manufacturing processes.

Checked-by: Melodi Cornett
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