Framingham, MA – July 23, 2020. Kephera Diagnostics announced today that it has been awarded a two-year, $1,989,300 Phase II Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health (NIH), to complete the development and launch of a new test for Zika virus infection.
Kephera’s test is aimed at detecting Zika antibodies in a highly specific way that avoids cross-reactivity with the Dengue virus, a serious pathogen related to Zika. The arrival and rapid spread of Zika virus in the Western Hemisphere led to an epidemic in 2015-2016 that infected up to 1 million people, with serious consequences, including microcephaly in newborn infants and Guillain-Barré and other neurological disorders. Zika is a mosquito-borne virus, carried by mosquitoes which are common in much of Latin America and the southern United States. The same mosquitoes carry Dengue virus. Diagnostic tests have struggled to distinguish Zika from Dengue infection due to cross-reactivity between viruses. Moreover, Dengue has been endemic in the same regions as Zika, and many people carry antibodies to Dengue virus which can be confused with antibodies to Zika.
“We are very pleased to receive this Phase II award from the National Institute of Allergy and Infectious Diseases” said Dr. Andrew Levin, Kephera’s Chief Executive Officer. “It confirms the merits of our technology and assay development work over the past several years, aided by our collaborations with leading virology laboratories in Europe and the U.S., which have led to a highly promising new antibody test for Zika virus infection. While Zika retreated from view after 2016, the right conditions could bring it back, as we are experiencing in a parallel scenario with the SARS coronavirus which disappeared after the 2003 outbreak, only to reappear now in a more virulent form. Having tests available for such eventualities is an important resource in the public health arsenal to respond to infectious disease outbreaks, as we are now witnessing on a large scale.”
The grant from NIAID will enable Kephera to complete development of its Zika virus test and carry out the clinical validations needed for approval from FDA and other regulatory agencies. The test will become part of Kephera’s portfolio of infectious disease tests that includes COVID-19 antibody and antigen tests and others for a range of bacterial and parasitic diseases.
Kephera Diagnostics News Release – July 23, 2020