MIAMI, April 17, 2020 /PRNewswire/ -- Igenomix, a leading reproductive and fertility bio-tech company, launched today their FDA-EUA approved COVID-19 RT-PCR Test in an effort to combat the impact of the current pandemic. This test, already available, combined with a COVID-19 Antibody Test, will make up the Igenomix Biological Passport, a service that will allow for organizations to plan for a safe return to the workplace.
The SARS-CoV-2 RT-PCR (Real-time Reverse Transcription Polymerase Chain Reaction) Test is a diagnostic test designed to confirm if an individual is currently infected. It is able to detect the virus even in the early stages of the infection, when the viral load is lowest and differentiate it from other similar viruses, due to its sensitivity and specificity, respectively. This test has been designed to detect the pathogen itself by detecting its RNA and it is especially valuable in the initial stages of an infection when the aim is to prevent infectivity when antibodies have not yet been built.
Samples are to be collected by health specialists using nasopharyngeal swabs and processed in Igenomix labs under the FDA Emergency Use Authorization (EUA). All Igenomix labs are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to carry out highly complex tests.
Igenomix offers its COVID-19 RT-PCR test with no out-of-pocket cost to insured patients and is ready to process up to 1500 samples per day with results available in 48-72 hours.
Igenomix Biological Passport
The Igenomix Biological Passport is comprised of two tests, a COVID-19 RT-PCR Test and a serological antibody test, which aims to cover both patients who are currently infected and those who have been exposed and developed immunity.
The serological test examines the presence of antibodies, therefore identifying individuals who have previously been exposed to the virus and acquired natural immunity against it. The international network of Igenomix laboratories is currently directing its efforts towards accelerating the development of this test.
With the Igenomix Biological Passport, the population can be screened and identified as infected, at risk, or immune, which provides a biological map for companies to ensure a safe work environment. People with negative COVID-19 RT-PCR Test and positive COVID-19 Antibody Test would be ready for a safe transition back to normal life.
"Amidst the ongoing COVID-19 outbreak, our way of life has changed as we know it. Today, we believe our duty is to break one more barrier, the barrier that prevents us from returning to our normal lives. We hope that by applying our know-how in genetics to COVID-19 testing, we can help enable access to a COVID-19 free society," said Carlos Simon, Head of the Scientific Advisory Board of Igenomix.
In addition to testing, the Igenomix Foundation, a non-profit institution that promotes both basic and applied research in the field of reproductive medicine, is hosting a series of webinars. This series will provide valuable information and insight into the current pandemic crisis related to the reproductive field. The Igenomix Foundation is also preparing a research project to find answers related to the impact of COVID-19 on pregnancy and IVF.
Igenomix works to make a world in which infertility is no longer an impossible barrier. Together with clinics and fertility doctors worldwide, Igenomix investigates human reproduction to change the lives of couples who are trying to conceive.
Learn more at www.igenomix.com.
Paula Miquel, Marketing Manager, USA and Canada
Igenomix, 7955 NW 12th Street, Suite 415, Miami, FL 33126
Phone: +1 (305) 501-4948 // Cell: +1(786)566-7798
SOURCE IGENOMIX USA, LLC