Shares of Akers Biosciences Inc. (NASDAQ:AKER) surged 15.8% to close at $3.22 following the completion of a clinical trial on the company’s Chlamydia rapid test, based on its proprietary Particle ImmunoFiltration Assay (PIFA) technology.
Per Akers, “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. Per Centers for Disease Control and Prevention, more than 1.4 million cases of Chlamydia in the U.S. were reported in 2015.
Nucleic acid amplification tests (NAATs) are the most sensitive tests for detecting chlamydia NAATs can be performed on endocervical, urethral, vaginal, pharyngeal, rectal, or urine samples. However, PIFA/Chlamydia is a non-invasive test as compared to NAATs and can identify the infection within five minutes from a finger stick blood sample.
The Chlamydia rapid test is one of the several products Akers is planning to launch in the U.S. and international markets. The company is in talks with the FDA for a 510(k) approval for the test and is also evaluating regulatory requirements of the international markets.
The Chlamydia rapid test is part of Akers’ innovative product pipeline that includes rapid test solutions for lung cancer, asthma, chronic obstructive pulmonary disease, diabetes and cardiac arrest.
Most recently, Akers signed a distribution agreement with Aero-Med, a division of Cardinal Health (NYSE:CAH) , to distribute its disposable breathalyzer -- BreathScan OxiChek. We believe that the distribution deal is a major step forward for Akers to fast penetrate the U.S. market. Growing adoption of rapid test devices also opens up a new source of revenue for the company.
Moreover, Akers’ flagship PIFA Heparin/PF4 Rapid Assay product continues to gain solid traction in the domestic market as well as China. Additionally, Akers expects revenue contribution from the alcohol, ketones (METRON) and oxidative stress tests in full-year 2016.
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