Akers Biosciences, Inc. (NASDAQ:AKER) Completes Clinical Trial; Awaits Market Reaction

Developer of rapid health information technologies, Akers Biosciences, Inc. (NASDAQ:AKER), announces it has completed a clinical trial of BreathScan DKA.

THOROFARE, NJ–(Marketwired – Nov 28, 2016) – 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® 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® DKA test and the gold standard hospital blood test was 92%.

The BreathScan® 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® 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® 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® 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® 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.

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.

Original Source


Akers Biosciences, Inc. (NASDAQ:AKER) shares have moved -5.13% on the news thus far today and have traded in the range of $1.75 – 2.25 during the current session. In order to take a look at where the stock might be headed longer term, investors often look to research firms that cover the stock. Sell-side research firms currently have a consensus one-year price target of $11.00 on the stock.  This is according to brokerage analysts polled by Thomson Reuters First Call.  The sell-side analysts are projecting earnings per share of $0.00 for the next fiscal quarter.  For the current year, analysts are predicting earnings of $-1.24 per share according to First Call.

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In looking at where the stock is trading on a technical level, the stock is trading -38.86% away from its 50-day moving average of $3.03.  Based on the most recent available data, the equity is -50.00% off of its 52-week high of $3.70 and +71.30% away from its 52-week low which is $1.08.

Today, the stock opened at $1.95 and the last bid at the time of writing stood at $1.85.  During the session thus far, the equity dipped down to $1.75 and touched $2.25 as the high point.  Akers Biosciences, Inc. (NASDAQ:AKER) has a market cap of $10.09M and has seen an average daily volume of 36,769 over the past three months.

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