Daktari Diagnostics today announced a collaboration with Merck, known as MSD outside the United States and Canada, to develop Daktari’s rapid hepatitis C virus (HCV) screening test. The deal, worth up to $8.5 million over the next 3.5 years, will support an accelerated development timeline for the clinical validation and regulatory approval of Daktari’s HCV test.
The Daktari technology forms the basis for a point-of-care instrument that can detect low levels of virus directly in a single drop of blood in approximately 30 minutes, making on-the-spot HCV treatment decisions possible. The Daktari test is based on high-sensitivity measurement of the HCV core antigen, which is used in Europe and Japan for the diagnosis of chronic hepatitis C infection, but has never been available as a point-of-care diagnostic.
The Daktari™ System includes an embedded connectivity platform, Daktari InSight, which provides real-time data management through mobile network connectivity and a web-based dashboard, allowing rapid monitoring of test results. The Daktari™ System has the potential to transform public health screening programs and be made available at retail clinics, pharmacies, and doctor’s offices.
“For many patients chronic hepatitis C has become a curable disease,” said Bill Rodriguez, M.D., Founder and CEO of Daktari. “Merck’s collaboration provides support for an accelerated development and regulatory timeline for our HCV diagnostic.”
Globally, HCV is “severely underdiagnosed”.1 Some 130 to 150 million people are infected with chronic HCV worldwide, including 2.7 million people in the United States, but fewer than 2 percent are aware of their infection. Simpler screening tests are expected to greatly expand diagnosis of individuals infected with HCV who need treatment. The World Health Organization recommends that HCV testing be offered in settings of high HCV prevalence or to people at risk for HCV.2 In the United States, the Centers for Disease Control and the U.S. Preventive Services Task Force (USPTF) both recommended HCV testing for all adults born between 1945 and 1965, regardless of risk, and persons of all ages who are at risk for HCV infection.