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DynaGen has already received FDA marketing clearance for the NicCheck I test, which detects nicotine and its metabolites in urine, thereby identifying smokers and classifying them as "low" or "high" nicotine consumers.
The NicCheck I test has potential applications in smoking cessation programs as well as in doctor's offices for determining nicotine consumption levels.
Under the terms of the distribution agreement, Henry Schein will initially target the NicCheck I product to physician customers within specific specialties.
NicCheck I could provide the physician with a simple means of identifying smokers, confirming their level of nicotine consumption, and using the results to motivate them to quit smoking.
DynaGen has been marketing the NicCheck I product directly to smoking cessation groups and other professional organizations that want to test for nicotine.
NicCheck I is the first commercially available test cleared by the FDA that detects nicotine and its metabolites.
We believe that the availability of NicCheck I will broaden the potential utility of smoking status verification beyond insurance companies and into newer markets that would find information on nicotine consumption levels valuable," said Dr.
NicCheck I consists of a narrow strip coated with chemicals that produce a pink color in the presence of nicotine and its metabolites.
Food and Drug Administration (FDA) seeking clearance to market its NicCheck I test.
Analysis of the clinical trial data also shows that NicCheck I is more reliable than simply using the number of cigarettes smoked each day as an indication of nicotine consumption.
We have worked with FDA for over three years to correctly determine the best way for NicCheck to be clinically evaluated and the most appropriate filing procedure for seeking clearance to market the product," said Dr.
DynaGen is developing NicErase sublingual lobeline sulfate for smoking cessation, NicCheck for immediate assessment of smoking status, and OrthoDyn polymers for bone repair.