AbbVie ($ABBV) and Gilead ($GILD) have a stranglehold on the hepatitis C market thanks to their powerful drugs that have allowed them to command high prices, much to the chagrin of other stakeholders. Merck ($MRK) enlisted Daktari Diagnostics to help it break into that market and execute its strategy of appealing to unserved niche patients, such as hep C patients on dialysis, and those with rare genotype 4 of the virus.
It's an approach that necessitates diagnostics and genetic analysis. In July, the FDA agreed to review Merck's hep C med, and a decision is expected by Jan. 28.
"While we have not yet completed all the necessary testing across genotypes, it is our expectation based on our work thus far that the test will work across all (6) genotypes," Daktari technical marketing manager Tiana Veldwisch told FierceDiagnostics in an email.
Under the deal, Daktari will receive up to $8.5 million over the next 3.5 years to develop and bring a point-of-care test to the market. The company says its technology can form the basis of such a test, which would diagnose the disease in about 30 minutes from a single drop of blood.
It would be based on high-sensitivity measurement of the HCV core antigen (as opposed to antibodies or RNA), according to a release; the approach is already used in Europe and Japan via lab equipment like Abbott's Architect immunoassay analyzer, but not as a point-of-care test that provides on-the-spot analysis.
For many patients, chronic hepatitis C has become a curable disease," said Daktari CEO and founder Dr. Bill Rodriguez. "Merck's collaboration provides support for an accelerated development and regulatory timeline for our HCV diagnostic."
In March, the National Institutes of Health funded Daktari's hep C diagnostics initiative for the second time, giving Daktari a $1.2 million Small Business Innovation Research grant.
Merck's Global Health Innovation Fund last year participated in Daktari's $13 million, Series C funding round. And in March the Big Pharma's VC arm co-led a $15.5 million Series D round.
Daktari says hep C is severely under-diagnosed with less than 2% of 130 million to 150 million people infected worldwide aware that they posses the disease.
- read the release