Framingham, MA – April 14, 2023. Kephera Diagnostics announced today, on World Chagas Day, that it will be launching testing for Chagas disease through its CLIA-certified laboratory in May 2023. Kephera will offer two tests – an FDA-approved ELISA and a new, multiplex test for Chagas disease – both of which detect antibodies to the parasitic agent that causes the disease. Kephera will follow a testing algorithm similar to the one in use at CDC, in which blood samples are tested in parallel on two different serological tests. According to the algorithm, determination of the final result requires concordance between the two tests.
Further information on the tests, including ordering information and pricing, is available from the company through its email address, info@kephera.com, and will be available on the company’s website, www.kephera.com. Kephera Diagnostics specializes in parasitic and other esoteric infectious diseases, with unique tests for neurocysticercosis, human liver fluke, and Lyme disease also available through its CLIA laboratory.
Chagas disease, caused by the parasite Trypanosoma cruzi, is primarily transmitted by an insect called the triatomine or kissing bug which is found throughout most of Latin America, and is also present in some regions of the U.S. Chagas has become recognized as an emerging problem in the U.S., both due to environmental factors which favor spread of the pathogen and due to increasing surveillance and testing. It is the most prevalent parasitic disease in the western hemisphere, infecting 6-7 million people with over 70 million at risk. CDC currently estimates approximately 300,000 cases in the U.S., principally among individuals who acquired it in endemic countries, although some infections caused by local transmission have also been reported. Chagas can also be transmitted congenitally, via consumption of food contaminated by kissing bugs, and by blood transfusion or organ transplantation. Infection can lead to chronic disease lasting decades, with a higher risk of death due to cardiac or digestive system impairment; up to one third of infections result in debilitating symptoms, while the remainder are asymptomatic. Treatment for Chagas disease currently relies on two drugs, benznidazole and nifurtimox, which have recently been approved by the U.S. Food and Drug Administration for pediatric use.
“We look forward to the launch of our two Chagas tests as a significant step that is in line with our focus on emerging and neglected disease diagnostics” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and CLIA Laboratory Director. “By offering the two tests in parallel, we are aiming to provide a streamlined and efficient solution that will contribute to improving the diagnosis of Chagas disease in the U.S.”
About Kephera Diagnostics
Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology. Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications. Kephera has recently been funded for development of new tests for several infectious diseases of global significance.
Contact:
Andrew Levin, PhD
Chief Executive Officer and Chief Scientific Officer
617-834-0950 cell
alevin@kephera.com
Kephera Diagnostics, LLC
One Grant St., Suite 300
Framingham, MA 01702 USA
