Framingham, MA- April 12, 2024. As World Chagas Day approaches on April 14th, Kephera Diagnostics is excited to announce the addition of a third serological test for Chagas disease, the TESA immunoblot, to its CLIA-certified, CAP-accredited clinical laboratory test menu. Kephera first launched Chagas disease testing in 2023, offering the FDA-approved Wiener Chagatest ELISA recombinante v.3.0 and the InfYnity Biomarkers Multi-Cruzi multiplex ELISA. The current algorithm for Chagas serodiagnosis requires two concordant results on tests using different antigens or approaches. In the event of disagreement between the two tests, a third tiebreaker test is required. With the addition of the TESA immunoblot to its CLIA test offerings, Kephera is now able to provide definitive Chagas serodiagnosis for all clinical samples, offering two of the same Chagas tests as the CDC Parasitic Diagnostic Reference Laboratory.

Chagas disease, caused by the parasite Trypanosoma cruzi, is primarily transmitted by triatomine insects, which are found throughout most of the Americas. It is the most prevalent parasitic disease in the western hemisphere, with approximately 300,000 cases estimated in the U.S., principally among individuals who acquired it in Latin America, although locally acquired infections 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.  Treatment for Chagas disease currently relies on two drugs, benznidazole and nifurtimox, both of which are much more effective when given during early stages of infection.

The TESA immunoblot is based on electrophoretically separated Trypomastigote Excreted-Secreted Antigens and has been shown to have high sensitivity and specificity (between 97-100%) in research-use settings. Serum or plasma samples are considered positive when antibodies in the sample bind to a parasite antigen, producing a visible band. Kephera Diagnostics is the only company currently offering a complete, three test Chagas serodiagnostic algorithm, including the TESA immunoblot, commercially through its CLIA laboratory.

“We are proud to launch the TESA immunoblot to complete our Chagas testing panel and enable a complete and timely diagnostic solution for clinicians and their patients” said Andrew Levin, Kephera’s Chief Executive and Chief Scientific Officer.  “Kephera is the only CLIA laboratory in the U.S. that specializes in emerging and parasitic diseases, with a particular interest and deep research expertise in Chagas disease”.

Further information on the tests, including ordering information, turnaround time, and pricing, is available from the company through its website, https://kephera.com or by email to info@kephera.com. Information on Kephera’s other CLIA tests for neurocysticercosis, liver fluke and Lyme disease can similarly be obtained by website or email.

About Kephera Diagnostics 

Kephera Diagnostics is an emerging company that aims to address the public health challenges of global infectious diseases with a combination of CLIA laboratory offerings and new point of care assay technology.  Our mission is to promote more effective and more affordable medical treatment through faster, more accurate 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 by the National Institutes of Health (NIH) 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  https://kephera.com