Akers Biosciences Completes Clinical Trial For Rapid Chlamydia Test
THOROFARE, NJ--(Marketwired - June 30, 2016) -
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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.
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