30 Apr 2014 07:01
Embargoed: 07:00hrs BST 30 April 2014
Akers Biosciences, Inc.
Akers Biosciences Starts Clinical Trials for PIFA PLUSS Chlamydia Assay
THOROFARE, N.J., April 30, 2014 (GLOBE NEWSWIRE) -- Akers Biosciences, Inc. (Nasdaq:AKER) (LSE:AKR) (the "Company" or "ABI"), a leading designer and manufacturer of rapid diagnostic screening and testing products, 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 US 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 US, will be eligible for insurance reimbursement.
Chlamydia trachomatis is one of the most commonly reported notifiable diseases in the US and the UK. It is among the most prevalent of all sexually transmitted diseases ("STDs") and, since 1994, has comprised the largest proportion of all STDs reported to the United States Centers for Disease Control and Prevention ("CDC"). According to the CDC, there are an estimated 2.8 million cases annually in the US.
"Half of all Chlamydia cases in the US go undiagnosed, despite the disease being easily cured with single dose antibiotics," said Raymond F. Akers Jr., Ph.D, Executive Chairman. "Part of the reason for this is that current methodologies remain costly and time consuming and are typically analyzed in a laboratory following an endocervical or urethral swab sample collection. Our technology aims to increase the detection rate of this serious infection by making it easy for individuals to get near-instant results from a simple finger stick blood test, performed confidentially and in a convenient setting," added Dr. Akers.
The clinical trials will be led by Adam Sobel, MD, who will be the principal clinical investigator, and will be performed by the Sobel Medical Group and the Mazzoni Center, both located in Philadelphia, PA.
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. The Company has aligned with major healthcare companies and high volume medical products distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics. Additional information on the Company and its products can be found at www.akersbiosciences.com.
Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company's expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Akers Biosciences, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company's actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.
For more information:
Raymond F. Akers, Jr. PhD
Executive Chairman of the Board
Akers Biosciences, Inc.
Tel. +1 856 848 8698
Jon Cunningham
RedChip Companies, Inc.
Tel. +1 407 644 4256 x107
Antony Legge / James Thomas
Daniel Stewart (Nomad and Broker)
Tel. +44 (0)20 7776 6550
Ben Simons / Alexandra Roper
Vigo Communications
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