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

www.kephera.com

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.

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

Framingham, MA – March 28, 2023.  The National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health (NIH), has awarded a Phase I, $600,000 Small Business Innovative Research (SBIR) grant to Kephera Diagnostics to develop a test for hookworm infection, the company announced today.  The grant will support the development and preliminary evaluation of a test that can be used to monitor the level of hookworm infection in populations undergoing mass drug treatment.

Hookworm, a blood-feeding, soil-transmitted helminth parasite infects approximately 500 million people worldwide, including 44 million pregnant women. It was estimated that hookworm caused 3.2 million disability-adjusted life years (DALYs), accounting for 12.4% of the total disease burden attributed to neglected tropical diseases (NTDs), ranking hookworm just after malaria. While hookworm primarily affects lower-middle income countries, it has seen a resurgence in parts of the U.S. in recent years.

To reduce hookworm-associated morbidity, the World Health Organization (WHO) recommends targeted or community-based mass drug administration (MDA) with anthelmintic drugs such as albendazole.  But it is difficult to measure the success of MDA programs because estimating the prevalence of hookworm in the community currently requires laboratories with microscopy capabilities.  The WHO has called for the development of new diagnostic tools to address this need.

Supported  by the SBIR grant, Kephera plans to develop a test that will indicate hookworm infection based on detection of antibodies to the parasite in blood samples. The test will be in ELISA format to be easy to integrate into an average, non-specialized laboratory.

“Hookworm continues to be an important and well-recognized public health problem in much of the developing world, but the cumbersome methods currently used to detect infection make it very challenging to determine how effective mass drug administration programs have been, whether there are residual hotspots, and whether drug resistance is emerging.  A simple and readily accessible test is much needed. We look forward to the collaboration with Kephera which is aimed at addressing this problem through development and validation of a new test for hookworm infection” said Dr. Michael Cappello, Professor and Chair of the Department of Epidemiology of Microbial Diseases at the Yale School of Public Health, who will be a collaborator under the grant.

“We are very pleased to receive this NIAID award” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the grant.  “Together with our collaborators at Yale University and in Ghana, we will apply our expertise in diagnostics to provide a solution that will hopefully make a significant contribution to the control of this parasitic disease.”

The grant awarded to Kephera Diagnostics is NIH Award No. 1R43AI174487.

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 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