Akers Biosciences, Inc. (the "Company" or "ABI"), a leading designer and manufacturer of rapid diagnostic screening and testing products, has commenced clinical trials in the USA for its PIFA PLUSS Chlamydia Assay, the world's first rapid test for Chlamydia diagnosis using a finger stick blood sample.
The study will consist of three populations of patients totaling 200-250 subjects; the population groups will contain normal, newly infected and actively infected subjects, as well as previously infected and treated subjects. It is estimated that the study will last approximately three months, but that time could be extended based on the prevalence of Chlamydia-positive subjects. Regulatory documentation will be submitted in both the US and EU shortly after conclusion of the studies with a view towards seeking regulatory approval to sell the tests.
ABI's PIFA PLUSS Chlamydia Assay, based on the Company's proprietary particle immunofiltration assay technology, provides results in approximately five minutes. ABI's assay was designed to make screening widely available and easy and, unlike current testing procedures, the Company's assay can be run in a wide range of settings including doctors' offices, clinics and school or university health centers. The Company believes that the test, once approved in the US, will be eligible for insurance reimbursement.
Chlamydia trachomatis is one of the most commonly reported notifiable diseases in the US and the UK. It is among the most prevalent of all sexually transmitted diseases ("STDs") and, since 1994, has comprised the largest proportion of all STDs reported to the United States Centers for Disease Control and Prevention ("CDC"). According to the CDC, there are an estimated 2.8 million cases annually in the US.
"Half of all Chlamydia cases in the US go undiagnosed, despite the disease being easily cured with single dose antibiotics," said Raymond F. Akers Jr., Ph.D, Executive Chairman. "Part of the reason for this is that current methodologies remain costly and time consuming and are typically analyzed in a laboratory following an endocervical or urethral swab sample collection. Our technology aims to increase the detection rate of this serious infection by making it easy for individuals to get near-instant results from a simple finger stick blood test, performed confidentially and in a convenient setting," added Dr. Akers.
The clinical trials will be led by Adam Sobel, MD, who will be the principal clinical investigator, and will be performed by the Sobel Medical Group and the Mazzoni Center, both located in Philadelphia, PA.
The study will consist of three populations of patients totaling 200-250 subjects; the population groups will contain normal, newly infected and actively infected subjects, as well as previously infected and treated subjects. It is estimated that the study will last approximately three months, but that time could be extended based on the prevalence of Chlamydia-positive subjects. Regulatory documentation will be submitted in both the US and EU shortly after conclusion of the studies with a view towards seeking regulatory approval to sell the tests.
ABI's PIFA PLUSS Chlamydia Assay, based on the Company's proprietary particle immunofiltration assay technology, provides results in approximately five minutes. ABI's assay was designed to make screening widely available and easy and, unlike current testing procedures, the Company's assay can be run in a wide range of settings including doctors' offices, clinics and school or university health centers. The Company believes that the test, once approved in the US, will be eligible for insurance reimbursement.
Chlamydia trachomatis is one of the most commonly reported notifiable diseases in the US and the UK. It is among the most prevalent of all sexually transmitted diseases ("STDs") and, since 1994, has comprised the largest proportion of all STDs reported to the United States Centers for Disease Control and Prevention ("CDC"). According to the CDC, there are an estimated 2.8 million cases annually in the US.
"Half of all Chlamydia cases in the US go undiagnosed, despite the disease being easily cured with single dose antibiotics," said Raymond F. Akers Jr., Ph.D, Executive Chairman. "Part of the reason for this is that current methodologies remain costly and time consuming and are typically analyzed in a laboratory following an endocervical or urethral swab sample collection. Our technology aims to increase the detection rate of this serious infection by making it easy for individuals to get near-instant results from a simple finger stick blood test, performed confidentially and in a convenient setting," added Dr. Akers.
The clinical trials will be led by Adam Sobel, MD, who will be the principal clinical investigator, and will be performed by the Sobel Medical Group and the Mazzoni Center, both located in Philadelphia, PA.