TIDMAKR
RNS Number : 7101C
Akers Biosciences, Inc.
30 June 2016
Akers Biosciences, Inc.
Clinical Trial for Rapid Chlamydia Test Completed
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), (the
"Company" or "Akers Bio"), a developer of rapid health information
technologies, has completed a clinical trial of its PIFA/Chlamydia
Rapid Assay, the first rapid test for Chlamydia diagnosis using a
finger stick blood sample.
The clinical trial was carried out across two sites in PA, USA.
The results were highly successful with sensitivity (a true
positive result) of 91%; and specificity (a true negative result)
of 98%. The overall agreement between the PIFA/Chlamydia Rapid
Assay and the reference laboratory method was 96% in patient
populations of acute infection and historical exposure.
Chlamydia trachomatis is the most common cause of sexually
transmitted venereal infection in the world. The Centers for
Disease Control and Prevention reported over 1.4 million cases of
Chlamydia in the US in 2015, making it the most common venereal
disease in the country. The actual number of cases is likely to be
greater due to underreporting. Complications of Chlamydial
infection in women include cervicitis, urethritis, endometriosis,
pelvic inflammatory disease and increased evidence of ectopic
pregnancy and infertility.
Current laboratory testing methods are primarily based on DNA
technologies that detect the Chlamydia organism in urine or vaginal
swab specimens. These assays are typically performed in reference
laboratories or large hospital laboratories with a turnaround of up
to 10 days.
Akers Bio's PIFA/Chlamydia Rapid Assay is an antibody test that
has been developed to identify infection of Chlamydia in five
minutes or less from only a finger stick blood sample. The assay is
based on the Company's proprietary platform technology, Particle
ImmunoFiltration Assay (PIFA), the same technology within the
Company's flagship PIFA/Heparin Platelet Factor 4 Rapid Assay and
other tests under development.
As most Chlamydial infections are asymptomatic, the Company
believes the availability of a rapid test in doctors' offices or
health clinics that does not require an invasive genital swab
procedure - and can lead to the provision of immediate therapy -
could have a significant impact in reducing the spread of the
disease by those unaware of their infection.
Raymond F. Akers, Jr. PhD, Co-founder and Chief Scientific
Director at Akers Bio, said: "We are delighted with the outcome of
these clinical trial results. The test performed extremely well,
with a 96% correlation to the gold standard reference laboratory
method. It is a very exciting outcome to have a five-minute rapid
test demonstrate that level of accuracy. This bodes well not only
for the PIFA/Chlamydia Rapid Assay but for our other proprietary
PIFA technology based tests in development."
Adam C. Sobel M.D., Director, Medical at Akers Bio who oversaw
the clinical trial, added: "I was pleased to be involved in the
trial of a test which I believe can help a large number of people -
particularly women - who are infected with Chlamydia but who are
unaware of the disease due to its typically asymptomatic
nature."
"While women who are under routine gynecological care may not
require this test, there are a great many more women who need a
test like this at public health clinics, not-for-profit clinics,
and minute clinics. This test will permit the immediate dispensing
of antibiotics that will cure this disease, and prevent further
spread by the infected person," added Dr. Sobel.
Akers Bio is pursuing FDA 510(k) market clearance for the US and
is evaluating the regulatory requirements in the territories
covered by its international distribution network. The Company will
announce any developments with regards to the future
commercialization of the test as and when appropriate.
About Akers Biosciences, Inc.
Akers Biosciences develops, manufactures, and supplies rapid
screening and testing products designed to deliver quicker and more
cost-effective healthcare information to healthcare providers and
consumers. 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 product 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.akersbio.com. Follow us on Twitter @AkersBio.
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:
Akers Biosciences, Inc.
Raymond F. Akers, Jr. PhD
Co-founder and Chief Scientific Director
Tel. +1 856 848 8698
Taglich Brothers, Inc. (Investor Relations)
Chris Schreiber
Tel. +1 917 445 6207
Email: cs@taglichbrothers.com
finnCap (UK Nominated Adviser and Broker)
Adrian Hargrave / Scott Mathieson (Corporate Finance)
Steve Norcross (Broking)
Tel. +44 (0)20 7220 0500
Vigo Communications (Public Relations)
Ben Simons / Fiona Henson
Tel. +44 (0)20 7830 9700
Email: akers@vigocomms.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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