Company touts 10-minute Ebola test

A startup is pushing the Obama administration to approve a new test for Ebola that it says can diagnose infections within 10 minutes.

San Diego-based Genalyte says it needs approval from the government to start selling the technology, which tests for the virus using a drop of blood. 

"There are rapid tests and there are sensitive tests, but there are no rapid, sensitive tests — and that's where we fit in," founder and CEO Cary Gunn told The Hill.

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Genalyte, which was founded in 2007 and works with nine of the world's top 15 pharmaceutical companies, has asked the Food and Drug Administration to fast-track approval of the product.

The company said it has been in discussions with the Centers for Disease Control and Prevention, military agencies, and lawmakers about how the test could be used in the efforts to contain the virus.

A delayed Ebola diagnosis was a problem in the treatment of Thomas Eric Duncan, who was in the hospital for more than two days before test results confirmed he had Ebola. Diagnosing Ebola early is critical for providing proper care to a patient and preventing the virus from spreading.

So far, the FDA has only approved emergency use of the Defense Department's polymerase chain reaction test utilizing Thermo Fisher Scientific instruments to produce results within two hours, according to the company.

Another company, Colorado-based Corgenix, is using nearly $3 million in federal funds to develop a 15-minute Ebola test with the help of scientists at Tulane University. That company is also awaiting federal approval.

Genalyte has received federal funding in the past and is currently the recipient of a National Cancer Institute grant, though it is primarily backed by private equity and venture capital.

The company is touting its technology as superior to other early-stage diagnostic tools, and says its 15-inch device can process up to 100 tests per hour.

That capacity could be useful, the company says, as the Obama administration implements new Ebola screening procedures at five U.S. airports and put troops on the front lines in West Africa.

Genalyte says it is prepared to ramp up manufacturing of its product and deploy the platform immediately, pending FDA approval.

“We're at the point where this can make a big difference," Gunn said.