Akers Biosciences Starts Clinical Trials for PIFA PLUSS Chlamydia Assay
April 30 2014 - 2:00AM
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.
CONTACT: 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
Tel. +44 (0)20 7016 9574
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