AKR6 Dec 2011 07:08
Launch of revolutionary PIFA PLUSS PF4 Rapid Assay
whole blood technology
Akers Biosciences, Inc. (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to announce that its patented blood cell separator technology (the "Technology") will be integrated into the Company's PIFA Rapid Assay platform and launched into market in January 2012.
The Technology enables the immediate separation of serum (the liquid component of blood) from a patient's finger stick or venous whole blood sample and then introduces the extracted specimen into a rapid assay device to provide a real-time result. In addition, whole blood treated with certain anticoagulants, commonly used in some coagulation laboratories, will now be compatible with the Company's PIFA Rapid Assay platform.
The Technology, which fulfills all of the requirements of the FDA for marketability, is designed to be adaptable and can also be applied to other diagnostic testing methodologies.
This enhancement drastically improves assay turn-around-time which is critical not only to point-of-care ("POC") screening, but to all in vitro diagnostic testing overseen by the laboratory. In the Company's interim statement of 7 September 2011, the product was referred to as "PIFA POC"; it will now be branded under the trade name PIFA PLUSS to represent the addition of our Serum Separation technology into the PIFA platform.
The initial introduction of this product line extension will expand the Company's franchise in the Heparin-Induced Thrombocytopenia ("HIT") rapid testing market. The PIFA PLUSS PF4 Rapid Assay will be uniquely positioned as the only whole blood, disposable screening device for the rapid detection of antibodies which are a major determinant in the pathogenesis of HIT, a life-and limb-threatening complication of treatment with the blood-thinner Heparin.
The Company plans to apply the Technology to many of its other diagnostic products, including its infectious disease suite of rapid assays, which includes diagnosis of Chlamydia and Malaria. In the USA, the PIFA PLUSS PF4 Rapid Assay will be sold to end-users exclusively by ABI's direct sales force; the Company is actively seeking partners for non-USA distribution.