Since the World Health Organization started raising alarms about the mosquito-borne Zika virus spreading throughout the Americas, deep-pocketed pharmaceutical companies have been racing to find a vaccine.
“The stars aligned; it doesn’t always work that quickly,” said Paul Schaudies, chief executive of GenArraytion. “We haven’t done anything this fast before, but there was never a pressing need like this before.”
The test has not been approved or evaluated by any government body, and the company says it should only be used as a research tool to monitor mosquito populations. The company is in talks with the U.S. Food and Drug Administration to understand the study requirements for what’s known as pre-emergency use authorization, a special designation that can allow the use of unapproved medical products during public health emergencies.
On Monday, the WHO declared the virus a public health emergency. Zika is a mosquito-borne virus that can cause a form of paralysis in adults and may be linked to birth defects when pregnant mothers get infected.
GenArraytion executives argue their test can be useful in tracking the spread of the virus in mosquitoes — a form of environmental surveillance — to help authorities determine where to target their efforts. The test employs a proprietary analytical software to conduct rapid genome analysis of bugs collected from a particular area, drawing on gene-sequencing data maintained by the National Institutes of Health.
“You’re stopping the problem at the source rather than chasing the fire engine down the road,” Schaudies said.
GenArraytion is a privately held biotech company that works on molecular-level tests for infectious diseases. The company was founded in 2007 and has held bio-defense contracts with the Department of Defense,and the Environmental Protection Agency. Apart from some work with Inova-Fairfax hospital, the bulk of the company’s revenue comes directly or indirectly from government agencies.
The company has received outside funding in the past, including a $50,000 grant from Montgomery County’s Economic Development Department, but it didn’t rely on any outside funding for the Zika test.
That means GenArraytion has full ownership over the intellectual property. Schaudies says he wants to either license or outright sell the intellectual property to another company, which would handle the nuts and bolts of supply and distribution.
Through an arrangement with Luminex, a Texas-based biotechnology company, GenArraytion is talking to surveillance labs in Brazil about using the Zika test.
