FDA Review On Akers Product

1 Mar 2005 07:00

1 March 2005, 0700hrs Akers Biosciences Inc. Akers Biosciences Receives Expedited Review Status from US FDA for its White Blood Cell Count Tests Thorofare, NJ , USA-March 1 , 2005--Akers Biosciences Inc. (LSE:AKR) announcestoday that it has received expedited review status from the United States Foodand Drug Administration while seeking market clearance for its rapid tests fortotal white blood cell ("WBC") counts and absolute neutrophil cell ("ANC")counts. This status reflects the critical need perceived for these tests inclinical laboratory medicine; there are currently no such rapid tests availablefor these analytes to the best of the Company's knowledge. Akers' rapid WBC andANC count assays have been developed to monitor a deleterious side effect ofcertain drug therapies, which is manifested by the decrease of white bloodcells critical in the control of certain infections. Drugs which can producethese side effects include clozapine, an anti-schizophrenic agent, as well ascertain chemotherapeutic agents used in the treatment of cancer.Based on Akers Biosciences' new, proprietary, minDNA¢â€ž¢ technology, these rapidwhite cell counting assays provide quantitative cell counts in less than oneminute for total white blood cells and absolute neutrophils. Each assay isperformed with the minDNAnalyzer, a digital hand-held reflectance photometerpowered by the One-Touch¢â€ž¢ electronics system. Disposable reagents and cassettesare packaged in unitized or bulk formats.The minDNAnalyzer is designed to measure and interpret a color produced on themembranes in the cassettes by the reagents through the reflectance of a certainwavelength of light. The color intensity is proportional to the amount of whiteblood cells or absolute neutrophils in the patient's sample.The color read by the analyzer is produced in the membranes by reagents in thedisposable cassette. The white blood cells are captured on these membranes; DNAis then extracted from these cells and reacted with a highly selectivechromophore to produce a color on the membrane.Using finger stick whole blood specimens, these easy to use assays can beutilized at the point-of-care setting by non-clinical laboratory personnel, aswell as in the hospital and emergency room environments.Other applications of minDNA technology can result in tests necessary for thesafety of the blood supply, specific identification of parasitic infections,and biowarfare agent detection. minDNA-based assays can be produced in bothrapid manual or electronic reader versions.Dr. Ray Akers, CEO of Akers Biosciences said, "We are pleased that FDA willexpedite the review of these tests. We are confident that, once cleared, thesetests can significantly impact the course of drug therapy for many patients,including certain neuropsychiatric and cancer patients, thereby improving thestandard of care for these patients. In addition, these tests can also aid manyareas of clinical medicine, such as pediatrics or emergency medicine, wherestat white blood cell counts are critical to diagnosis."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 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.comEnquiries: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/ 07713090135 END