William J. Clinton Foundation prior to co-founding the startup in 2008—initially saw the need for his firm’s diagnostics while consulting the Vietnamese government on treating its population of HIV patients in 2000, he said. The firm’s device would test for levels of CD4 proteins on blood cells, an indicator of immune system strength that tells doctors how aggressively they should treat people with HIV. In Vietnam, he noticed that, though there were drugs for HIV, there was no system for using CD4 tests to keep track of the health of patients.
During our meeting last week, Rodriguez showed me a main part of Daktari’s test—a credit card-sized chip made of six pieces of molded plastic. At one end of the chip, the patient presses a drop of his or her blood, which travels down tiny channels into round test wells, where the blood makes contact with pre-loaded antibodies. The antibodies attach to the CD4-presenting cells. The chip is loaded into an analyzer (which the CEO didn’t have on hand to show me) that is the size of a lunchbox and weighs five pounds. The system separates the CD4 cells from other blood cells, and then electrical currents are used to provide readouts of CD4 levels in a patient’s blood within six and a half minutes, Rodriguez says.
The startup also plans to develop the technology for sputum test for tuberculosis and to detect viral levels in HIV patients. It’s no mistake that the firm’s initial focus is on developing countries. According to the World Health Organization, 30 million of the 34 million people worldwide who have HIV live in low- or middle-income countries.
For CD4 testing, Rodriguez estimates that the test chips will cost $5 apiece, and each of the analyzers will cost around $800. It could be a cheaper alternative to the primary lab tools used for the tests today called flow cytometers, which often cost tens of thousands of dollars he said. Also, flow cytometers are typically bulky machines that aren’t easily moved from one place to the next like the portable system Daktari is designing.
A major test of Daktari’s CD4 counter is expected to begin at PATH in August in Seattle. There the device will be used to test CD4 levels from the blood of 50 patients who are HIV positive. Later this year, the firm plans to begin testing its technology in an 800-patient trial in Kenya, also funded by PATH. The Gates Foundation has also provided funds to begin testing the system in studies starting in September in Botswana, South Africa, and Uganda, according to Rodriguez.
Daktari plans to bring its CD4 test to market in developing countries within 18 months, Rodriguez says. The firm also expects to raise a Series B funding round later this year to finance further development of its technology.
