Framingham, MA – April 30, 2024. Kephera Diagnostics has been awarded a two-year, $606,498 grant from the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health (NIH), the company announced today. The grant, a Phase I Small Business Innovative Research (SBIR) grant, will support development of the first commercial test for congenitally transmitted Chagas disease.

Chagas disease is principally a vector-borne disease caused by the parasite Trypanosoma cruzi, which is found throughout most of Latin America as well as parts of 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. 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, and it is believed that most new infections in the U.S. are acquired in this way. Infants that were infected congenitally are often asymptomatic, but may exhibit a variety of symptoms including hepatosplenomegaly, anemia, jaundice, edema, thrombocytopenia and others which may resemble congenital toxoplasmosis, cytomegalovirus, herpes simplex or other infections. If untreated, infection can lead to chronic, lifelong disease, with a higher risk of death due to cardiac or digestive system impairment. Fortunately, treatment of congenital Chagas disease with the two drugs approved by the FDA for pediatric use, benznidazole and nifurtimox, has a success rate approaching 90%.

Diagnosis of congenital Chagas disease currently relies on either microscopic identification of trypanosomes in the bloodstream, PCR, or detection of IgG antibodies to T. cruzi at 9 months or later in order to exclude maternal IgG which is present in the neonate. There has been no readily available, validated commercial test that can be applied to newborn infants at risk. The Phase I grant will allow Kephera to carry out the development of a blood test that will measure IgM antibody responses to specific parasite antigens. IgM antibodies are typically the first antibodies to appear in the blood in response to an infection, and their presence is a hallmark of acute or recent infection. The Chagas test will be developed in collaboration with academic researchers who developed the original methodology on which the neonate test is based.

“The award of this grant to Kephera will enable us to fill one of the important gaps in the control of Chagas disease, which is the ability to diagnose infection acquired congenitally at the point of delivery” said Andrew Levin, Kephera’s CEO and Principal Investigator under the grant. “Chagas disease in infants can be treated with near 100% success, so an accurate diagnostic test that can be performed while a newborn is still in the hospital will facilitate earlier treatment, breaking the generational cycle of infection toward long-term impact on communities at risk for this disease”.

The grant awarded to Kephera Diagnostics is NIH Award No. R43AI181234.

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 www.kephera.com