Fyodor Biotechnology Inc. expects to complete human trials on its product to detect malaria next year, with commercial production to begin in 2014. The Baltimore biotech firm is also in the planning stages for a second product, a variation of the first, that should be ready for production by 2015. The tests are significant for diagnosis and treatment of an illness that is endemic in developing countries around the world.
“The tests will be revolutionary in malaria circles,” said Eddy Agbo, CEO and chairman of the board of Fyodor, which has established a global network of malaria health professionals.
Fyodor Biotechnology is working with partners who will manufacture and distribute the tests, which will be sold to government and non-government organizations like the World Health Organization, travelers and the military. The tests are for citizens and visitors to countries in the “frontier” market, aka developing countries.
The University of Maryland School of Medicine is conducting the human trials on the first product in Nigeria and Mali. The Urine Malaria Test is the first urine-based test geared to the type of malaria seen in Africa, the Caribbean and South America. The second product will detect the malaria strain found in Asia, China and India. It, too, is the first urine-based test for this malarial type and human trials will also be conducted.
The human trials are required to obtain approval from the US. Food and Drug Administration. While FDA approval is not necessary to sell the products in other countries, it validates them, Agbo said.
Agbo said the tests resulted from Johns Hopkins University’s global health initiative. Using technology that came out of the initiative, Fyodor created a one-step test that is accurate, easy to use and quick. Test results are available within 20 minutes.
Founded in 2008, Fyodor was initially housed in the University of Maryland BioInnovation Center. It subsequently moved to the University of Maryland BioPark where, in July, it relocated from a 700-square foot space to a 2,000-square foot space.
The company is doubling its staff, from its current three full-time employees to hiring another three full-time employees by 2013 with expertise in chemistry and recumbent DNA technology. It is also looking for several part-time employees and interns who are familiar with biology, chemistry and laboratory procedures.
So far, Fyodor has attracted a total of $2 million in state and federal grants and from private investors, including Maryland Technology Development Corp. and the National Science Foundation (NSF). In August, NSF awarded the company a grant of $476,000 to continue its research.