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News Breaks
April 30, 2014
05:44 EDTAKERAkers Biosciences starts clinical trials for PIFA PLUSS Chlamydia assay
Akers Biosciences has commenced clinical trials in the USA for its PIFA PLUSS Chlamydia Assay, the world's first rapid test for Chlamydia diagnosis using a finger stick blood sample. The study will consist of three populations of patients totaling 200-250 subjects; the population groups will contain normal, newly infected and actively infected subjects, as well as previously infected and treated subjects. It is estimated that the study will last approximately three months, but that time could be extended based on the prevalence of Chlamydia-positive subjects. Regulatory documentation will be submitted in both the U.S. and EU shortly after conclusion of the studies with a view towards seeking regulatory approval to sell the tests. ABI's PIFA PLUSS Chlamydia Assay, based on the company's proprietary particle immunofiltration assay technology, provides results in approximately five minutes. ABI's assay was designed to make screening widely available and easy and, unlike current testing procedures, the Company's assay can be run in a wide range of settings including doctors' offices, clinics and school or university health centers. The company believes that the test, once approved in the U.S., will be eligible for insurance reimbursement.
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July 28, 2014
05:33 EDTAKERAkers Biosciences signs feasibility study deal with Konica Minolta
Akers Biosciences (AKER) has signed a feasibility study deal with Konica Minolta, Inc. (KNCAY) to develop a rapid test for the early detection of cardiac muscle tissue damage a condition commonly observed in patients suffering myocardial infarction. Heart attacks are the leading cause of death in U.S., with approximately 1.1M Americans suffering heart attacks each year. Konica Minolta, has asked Akers to study a diagnostic test based on Akers' proprietary Particle Immuno Filtration Assay, or PIFA, technology which, if successful, will facilitate the rapid detection of biomarkers present in a blood sample which can be used to identify cardiac muscle tissue damage. Such tissue damage can occur even at the early stages of a heart attack so early diagnosis could have a significant beneficial impact on patient treatment. The PIFA technology, when combined with Akers' proprietary Rapid Blood Cell Separation Technology, seraSTAT, permits the testing of whole blood from a finger prick sample allowing a test to be carried out in minutes at the point of care. Currently available tests for cardiac muscle tissue damage require a blood draw and the use of an interpretation device; and typically take 20-30 minutes to complete in a laboratory. Konica Minolta, at its own cost, has asked Akers to study a test which can be performed in under 10 minutes, using only a small blood sample obtained from a finger stick; and which can be read visually at the point of care.

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