Daktari collaborates with Merck for rapid HCV screening test

Daktari Diagnostics announced a new collaboration with Merck over the development of its rapid hepatitis C virus infection screening test, according to a press release.

The test, known as the Daktari System, is based on high-sensitivity measurement of the HCV core antigen, which is currently used in Europe and Japan for diagnosing chronic HCV, but has never been available as a point-of-care diagnostic, according to the release. The test uses a point-of-care instrument that can detect low levels of HCV directly in a single drop of blood in approximately 30 minutes. This could enable clinicians to make HCV treatment decisions within the diagnostic appointment.

The new collaboration, which is worth up to $8.5 million over the next 3.5 years, was put in place in hopes of faster development and validation processes, with regulatory approval of the product to follow, according to Daktari founder and CEO, Bill Rodriguez, MD.

“For many patients chronic hepatitis C has become a curable disease,” Rodriguez said in the release. “Merck’s collaboration provides support for an accelerated development and regulatory timeline for our HCV diagnostic.”

Approximately 130 to 150 million people are infected with chronic HCV worldwide, including 2.7 million people in the United States, but fewer than 2% are aware of their infection, according to the release. Simpler and easier screening tests are expected to greatly expand diagnosis of individuals infected with HCV who need treatment.

Disclosures: Rodriguez reports being employed by Daktari.