AKR.L Regulatory News (AKR)

28 Apr 2005 06:00

Embargoed: 0700hrs, 28 April 2005 Akers Biosciences Inc. Akers Biosciences Receives CLIA Waived Status from FDA for its Lithium Rapid Test Product Thorofare, NJ , USA- 28 April , 2005--Akers Biosciences Inc. (LSE:AKR)announced today that it has received a notification of waived status under theClinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for oneof its rapid test systems for the detection of blood lithium levels. The CLIAwaiver announced today will now allow the Company to market its InstaRead‚®Lithium Test System through its partner directly to psychiatrists and the pointof care market, which will significantly facilitate the management of patientswith bipolar disorder and other psychiatric conditions. Each of the Company'srapid lithium test formats has now received the approvals necessary formarketing in the US and Europe. The InstaRead‚® Lithium Test System is scheduledfor release in the US in June of this year.The InstaRead‚® Lithium System is the first rapid in-office point of care systemthat allows psychiatrists to monitor the blood levels of patients that havebeen prescribed lithium. It replaces an invasive venipuncture method with afinger-stick blood collection method that can be read in minutes in a doctor'soffice for seamless testing and treatment of the patient at the time of visit.Until now, lithium levels were determined only in a laboratory usingsophisticated instruments and taking several days to get results.Dr. Ray Akers, CEO of Akers Biosciences said, "This CLIA waiver is key to thepenetration of psychiatrists' office and other point of care markets in the US.Psychiatrists can now make clinical decisions at the time of treatment based onrapid test data, and patients can gain confidence that their treatment levelsare therapeutic and safe. Just as instant glucose meters advanced the wayphysicians treat diabetes, the CLIA waived status of the InstaRead‚® LithiumSystem marks the beginning of an age when psychiatrists too can use rapiddiagnostic tools in their own practice of medicine."Enquiries: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 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 advanc ed 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 INC