Framingham, MA – April 3, 2023. The National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health (NIH), has awarded a Phase II, $3,050,000 Small Business Innovative Research (SBIR) grant to Kephera Diagnostics to complete the development of a new rapid, point-of-care test for Chagas disease, the company announced today. The 3-year grant will enable Kephera to carry out a multicenter clinical evaluation in the U.S. and Latin America and to advance the test to commercialization.
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 now expanding into the U.S. It is the most prevalent parasitic disease in the western hemisphere, infecting 6-7 million people with over 70 million at risk. Moreover, CDC 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.
Because of the diversity of strains of the parasite that causes Chagas disease in different parts of Latin America, as well as other factors, current diagnostic tests are often challenged to detect the disease with adequate sensitivity, especially in individuals from Central America and Mexico. Kephera’s new test aims to solve this problem through a novel approach whose feasibility the company had successfully demonstrated in Phase I of the grant.
“Chagas disease is an under-recognized problem among Latin American migrants in the U.S., and is an important neglected tropical disease in Mexico, Central and South America. Better diagnostic tools, especially at the point of care, are greatly needed to improve patient care. We look forward to working with Kephera to evaluate their new test on patients seen at our clinic” said Dr. Davidson Hamer of Boston University School of Public Health and Boston Medical Center, who will be a collaborator under the grant. The company will also collaborate with Chagas disease researchers at Johns Hopkins University.
“The award of this Phase II grant from NIAID is a major achievement for Kephera, and will enable us to complete the development and clinical validation of our novel Chagas disease test” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract. “We are very fortunate to be working with experts in the field at Boston University/Boston Medical Center and Johns Hopkins University on the pivotal clinical studies which will be a key step on the path to the commercial launch of this test”.
The grant awarded to Kephera Diagnostics is NIH Award No. R44AI136172.
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