Akers Biosciences 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 BreathScan DKA clinical trial was performed at Thomas Jefferson University Hospital in Philadelphia, PA, on patients admitted to the emergency department with suspected ketoacidosis. The results showed that BreathScan DKA test to rapidly screen for diabetic ketoacidosis is 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%, said Akers in its press release issued on Monday.
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, explained Akers.
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, Akers concluded.