Framingham, MA – June 5, 2023. Kephera Diagnostics announced today the launch of CLIA laboratory tests for Chagas disease, neurocysticercosis, and liver fluke infection, which add to its existing CLIA tests for Lyme disease. For Chagas disease, 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, a diagnostic 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, firstname.lastname@example.org, and will be available on the company’s website, www.kephera.com. Kephera Diagnostics specializes in parasitic and other esoteric infectious diseases, as a developer of rapid point-of-care tests as well as in-house CLIA tests.
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 the 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.
Neurocysticercosis (NCC) is an infection of the central nervous system with the cystic form of the pork tapeworm, Taenia solium, which can lead to epileptic-like seizures and can be incapacitating or fatal if untreated. NCC accounts for approximately one-third of all cases of seizures worldwide and is the most important neurologic disease of parasitic origin according to the World Health Organization. The disease affects over 25 million individuals in endemic, and increasingly non-endemic, regions. In the U.S., it has been found in 2% of seizure patients presenting to hospital emergency departments.
Liver fluke infection is an infection of the bile ducts caused by the parasite Clonorchis sinensis or other species that are endemic in Southeast Asia, and is acquired by eating raw or undercooked fish. It has been identified as a biological carcinogen linked to cholangiocarcinoma, or cancer of the bile duct, a highly lethal form of cancer that is frequently not diagnosed until it has reached advanced stages. Kephera’s test is for antibodies to Clonorchis sinensis.
“We look forward to the launch of these CLIA tests as a significant contribution to the diagnosis of parasitic diseases in the U.S., many of which are underrecognized due to the lack of available, validated tests” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and CLIA Laboratory Director. “While we are developing these tests for eventual point-of-care use, we have the opportunity to make them available through our CLIA lab as a first step towards broader access”.
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.
Andrew Levin, PhD
Chief Executive Officer and Chief Scientific Officer
Kephera Diagnostics, LLC
One Grant St., Suite 300
Framingham, MA 01702 USA