18th Jun 2010 07:00
Embargoed: 0700hrs, 18 June 2010
Akers Biosciences, Inc.
("ABI" or the "Company")
ABI ANNOUNCES HIGHLY POSITIVE DATA FROM KETONE TEST CLINICAL DEVELOPMENT
Akers Biosciences, Inc. (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, announces the completion of clinical development of the Breath Ketone "Check" test. The Breath Ketone "Check" was designed by ABI as a potential, significantly improved, replacement for existing blood and urine based testing methods due to its ability to non-invasively identify the presence of ketones at the earliest stages in a test subject's breath condensate. The product's accuracy was demonstrated during clinical trials in which Breath Ketone "Check" results were compared to a standard laboratory method called gas chromatography/liquid chromatography (GC/LC), a technique that analyses a patient's whole blood sample to obtain a quantitative ketone reading. From each of the unique, human breath condensate and whole blood samples obtained during the study protocol, there was 100% agreement between the testing methodologies. Until now, as ketones are present in the blood before they can be detected in urine, medical practitioners have relied upon blood analysis performed in a laboratory for early detection. That ABI's point-of-care test has been shown to correlate 100% with blood testing methods, and to do so in minutes via a disposable breath test is a highly encouraging result.
The Company has now applied for a CE-mark to facilitate the initial launch of Breath Ketone "Check" in the European Union (EU), expected later this year. The test, incorporating ABI's Micro Particle Catalyzed (MPC) Biosensor technology, will be positioned as the only disposable ketone breath test in the world. A USA market introduction will follow once the required market clearance has been obtained.
Ketones are acids that have the potential to build up in the body causing a condition called ketosis. An extreme form of this complication is a life-threatening medical emergency called ketoacidosis. At-risk populations for this severe form of ketosis include those with diabetes and persons who subscribe to restrictive ketogenic diets for epilepsy management or to obtain aggressive weight loss results.
Thomas A. Nicolette, President and Chief Executive of ABI, commented,
"The results of this test are the most encouraging and concrete evidence to date that support our belief that ABI's Breath Ketone "Check" will have a significant improvement in the quality of life for over 220 million diabetic patients around the world at risk of developing ketoacidosis. There is an extensive existing market for testing for this condition using cumbersome and invasive methods for which we have shown to be at least as accurate, and within minutes.
We are identifying the right distribution partners in the EU and are looking forward to introducing the test to that market place later this year."
Enquiries:
Thomas A. Nicolette
President and CEO
Tel. +1 856 848 8698
Ben Simons
M: Communications
Tel. +44 (0)20 7920 2340
Simon Leathers
Daniel Stewart
Tel. +44 (0)20 7776 6550
About Akers Biosciences, Inc.
Akers Biosciences develops, manufactures, and supplies rapid, point of care screening and testing products designed to bring healthcare information both rapidly and directly to the consumer or healthcare provider. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The company's state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. ABI has aligned with major healthcare companies and high volume medical products distributorsto maximize product offerings, and to be a major worldwide competitor in diagnostics. Additional information on the Company and it products can be found at www.akersbiosciences.com.
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