MEDTOX Scientific Submits New PROFILEŽ-II Test To The Food And Drug Administration

ST. PAUL, Minn., June 25 /
PRNewswire/

MEDTOX Scientific, Inc. (Amex: TOX - news) 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.

Note: Forward-looking statements contained in this press release are made under the Private Securities Reform Act of 1995. Actual results may differ. Certain factors that may cause such results to differ are identified on page three of the Company’s 1997 annual report on Form 1O-K and incorporated herein by reference.

SOURCE: MEDTOX Scientific, Inc.