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Crystal Diagnostics Steps into Ebola Rapid Test Market

Just four companies worldwide are cleared to trial their quick tests for the deadly Ebola virus.

And Crystal Diagnostics hopes to soon join its Broomfield neighbor Corgenix Medical Corp. on that short list.

When Corgenix's ReEBOV product became the first rapid Ebola test to receive the World Health Organization's blessing this year, it was among fewer than 20 Ebola-related products submitted for the agency's assessment.

Now Crystal Diagnostics, which developed a liquid crystal-based commercial product to test for pathogens in food, is adapting its device to test for diseases such as the Ebola virus.

After a couple months of testing surrogate products that mimicked the Ebola infection, Crystal Diagnostics' test was successful in detecting a live-virus sample in less than 20 minutes — putting it on par with the Corgenix test, officials said.

"It's very fast, very accurate, and our system is very automated," said Crystal Diagnostics CEO Jim Bruce, whose company is less than a mile from Corgenix.

And where Corgenix fills a need in providing an inexpensive test that can be used in remote locations, Bruce believes Crystal Diagnostics can create an automated product better suited for hospitals, airports and clinics. Crystal Diagnostics' test would cost $30, or about double the price of ReEBOV, Bruce estimated.

But to get to that point, Crystal Diagnostics will need to conduct additional research, including field testing in Africa, where the virus remains active in Guinea, Libera and Sierra Leone. The company has submitted a grant application to the Paul G. Allen Family Foundation, which helped fund development of Cogenix's quick test. It also plans to apply to the Biomedical Advanced Research and Development Authority.

If all goes well on the research front, Crystal Diagnostics could receive approvals from WHO and the Food and Drug Administration in less than a year, Bruce said.

Through this process, Bruce and Crystal Diagnostics' officials have knocked on their neighbor's door, querying Corgenix about its path to approval. Corgenix's test can detect the virus in less than 15 minutes, instead of hours or days.

Bruce also has consulted with the Viral Hemorrhagic Fever Consortium, of which Corgenix is a member.

Former Corgenix CEO Doug Simpson, who now oversees the company's infectious-diseases group, is taking a many-hands-make-light-work approach when it comes to Ebola-related technologies.

"It's not just a Corgenix technology," Simpson said, noting ReEBOV was developed in concert with academic entities, including the Viral Hemorrhagic Fever Consortium. "If there are other ways that (VHFC reagent) could be of use, maybe in different segments of the market, that's fine."

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