TIDMAKR
RNS Number : 2656Q
Akers Biosciences, Inc.
28 November 2016
28 November 2016
This announcement contains inside information
Akers Biosciences, Inc.
Clinical Trial for Diabetic Ketoacidosis Breath Test
Completed
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers
Bio" or the "Company"), a developer of rapid health information
technologies, has completed a clinical trial for BreathScan(R) DKA,
the first single-use, non-invasive breath test to rapidly screen
for diabetic ketoacidosis, a potentially life-threatening
complication of diabetes caused by a lack of insulin in the
body.
The clinical trial was performed at Thomas Jefferson University
Hospital in Philadelphia, PA, on patients admitted to the emergency
department with suspected ketoacidosis. The results were highly
successful, with sensitivity (a true positive result) of 91% and
specificity (a true negative result) of 93%. The overall agreement
between the BreathScan(R) DKA test and the gold standard hospital
blood test was 92%.
The BreathScan(R) DKA test utilizes Akers Bio's proprietary MPC
Biosensor Technology, which permits the rapid identification of
medical or metabolic conditions through biomarkers in exhaled
breath condensate. BreathScan(R) DKA is a first-in-class device
that detects the presence of ketones in a person's breath
condensate. Ketones are present in the blood before they can be
detected in urine; and breath and blood ketone levels are closely
correlated.
Ketones are acids that have the potential to build up in the
body causing a condition referred to as ketosis. An extreme form of
this complication is ketoacidosis. At-risk populations for
ketoacidosis include those with diabetes, and persons who subscribe
to restrictive ketogenic diets for epilepsy management or to obtain
aggressive weight loss results.
Current tests for this condition are primarily performed in a
hospital or reference laboratory, and can take hours to produce a
result. These tests must be run in a laboratory setting, by
licensed technologists, on sophisticated and complex
instrumentation. In contrast, BreathScan(R) DKA is intended for
point-of-care or home use. The simple five-step procedure produces
a color that is visually readable in two minutes. It can reduce the
need for expensive and resource-intensive hospital visits because
patients can be treated at home or in a doctor's office.
Importantly for patients, BreathScan(R) DKA is a significantly
more comfortable testing format as it does not involve a
fingerstick blood sample, but instead uses exhaled breath.
Raymond F. Akers, Jr., Ph.D., Vice Chairman of Akers Bio,
commented:
"We believe the ability to help Type 1 and some Type 2 diabetics
monitor their ketone levels in a non-invasive, more convenient way
than is currently available will represent a significant
advancement in the management of a disease that affects hundreds of
millions of people worldwide. Moreover, BreathScan(R) DKA joins the
growing number of our products that have the capacity to save
people and healthcare providers substantial sums of money.
"This highly successful trial is a further validation of our MPC
Biosensor technology for testing breath condensate. The ability to
correlate a biomarker in breath with a similar - but different -
biomarker in blood - which is a different sample matrix - is
scientifically quite remarkable. We believe that our MPC Biosensor
technology has only scratched the surface of its power to diagnose
many disease states."
Akers Bio is pursuing FDA 510(k) market clearance in the US and
the current study fulfills a requirement of this clearance. In
addition, the Company 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.
For more information:
Akers Biosciences, Inc.
John J. Gormally, Chief Executive Officer
Raymond F. Akers, Jr. PhD, Vice Chairman
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 (Global Public Relations)
Ben Simons / Fiona Henson
Tel. +44 (0)20 7830 9700
Email: akers@vigocomms.com
About Akers Biosciences, Inc.
Akers Bio 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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