Merck & Co. will partner with Daktari Diagnostics to develop Daktari’s rapid hepatitis C virus (HCV) screening test, under a collaboration that will generate up to $8.5 million over three years for the diagnostics developer.
The collaboration is designed to support an accelerated development timeline for the clinical validation and regulatory approval of the HCV test, according to Daktari, which announced the deal today.
Daktari’s technology will form the basis of a point-of-care instrument intended to 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, designed to provide real-time data management through mobile network connectivity and a web-based dashboard, allowing rapid monitoring of test results.
According to Daktari, the system could be made available at retail clinics, pharmacies, and doctor's offices.
“Merck's collaboration provides support for an accelerated development and regulatory timeline for our HCV diagnostic,” Bill Rodriguez, M.D., Daktari’s founder and CEO, said in a statement.
The collaboration extends Merck’s involvement in Daktari. Merck’s Global Health Innovation (Merck GHI) fund led Daktari’s $10 million staged financing round completed in 2011; co-led a $13 million series C round that closed in 2014; and co-led the diagnostics developer’s $15.5 million series D financing round, closed in March.
In addition to hepatitis C, HIV, and other infectious diseases, Daktari said, it is also developing cardiology and hematology tests for use in doctor's offices and emergency rooms.