3rd May 2006 07:00
Embargoed: 0700hrs, 3 May 2006 Akers Biosciences, Inc. ("Akers" or the "Company") Akers Biosciences Receives FDA Clearance to Market its Rapid Alcohol Breathalyzers Thorofare, NJ, USA-3 May, 2006--Akers Biosciences Inc. (LSE:AKR) is pleased toannounce today that it has received market clearance from the U.S. Food andDrug Administration ("FDA") for its rapid alcohol breathalyzers. Four differentversions of the product were cleared, each detecting a specific amount ofbreath alcohol. The Company markets its breathalyzers under the BreathScan andBreath Alcohol Check brands.The Company's breathalyzers provide reliable indicators of alcohol present in aperson's breath, which is, in turn, related to a person's blood alcohol level.The single-use devices are portable and low-cost, and can be read visually orwith the use of an inexpensive electronic reader developed by the Company. TheCompany's breathalyzers are used in many different situations, including, amongothers, law enforcement, transport industries, education sectors, employeescreening, and personal use. Akers is the only manufacturer of portable alcoholbreathalyzers in the United States and, following the acquisition of WNCK, Incin February, is also the leading United States distributor in this field.The FDA has recently begun to regulate alcohol breathalyzers as medicaldevices, and now requires regulatory clearance that indicates that thebreathalyzer is safe and effective. In addition, all alcohol breathalyzers mustnow be manufactured according to Good Manufacturing Practices (GMP). The Akersproducts are one of the first such devices to be cleared by the FDA. In fact,as of today, there are only two other breathalyzer products that have beencleared by the FDA, and both are electronic devices.The market clearance is key in that many US government agencies, including theUS military, require that alcohol breathalyzers are FDA-cleared prior topurchase. With the benefit of this clearance now obtained, the Company expectsit will be able to penetrate new areas of the market not previously possibleprior to this point.Dr. Ray Akers, CEO of Akers Biosciences said, "We are delighted to be able toannounce this market clearance today. This is a significant milestone in theexpansion of our breathalyzer business. We are ahead of the competition withrespect to regulatory clearances, and this should have a positive impact on ourmarket penetration."For further information, please contact,Dr. Ray Akers Chief Executive Officer, Akers 020 7917 9476 Biosciences, Inc. Paul Freedman 001 856 848 8698 Chief Financial Officer, Akers Biosciences, Inc. Bill Roberts CTC, Inc. 001 937 434 2700 Ben Simons Hansard Communications 020 7245 1100 Akers BiosciencesAkers Biosciences, Inc. develops, manufactures, and supplies rapid, point ofcare screening and testing products designed to bring healthcare informationboth rapidly and directly to the patient or healthcare provider. The Companyhas advanced the science of diagnostics while responding to major shifts inhealthcare through the development of several proprietary platformtechnologies. The company's state-of-the-art rapid diagnostic assays can beperformed virtually anywhere in minutes when time is of the essence. Akers hasaligned with major healthcare companies and high volume medical products distributors to maximize product offerings, and to be a major worldwidecompetitor in diagnostics. Additional information on the Company and itsproducts can be found at www.akersbiosciences.com.ENDAKERS BIOSCIENCES INCRelated Shares:
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