A 5-year-old boy from the Bronx is being tested for Ebola in Manhattan today. The boy developed a fever after travelling to West Africa. It’s likely that he’s undergoing a PCR screening – one of several ways to test for Ebola. These tests are usually only effective once the patient expresses symptoms and can be expensive – between $60 and $200 per test – making mass screenings for travellers and others difficult.
Right now, airports are screening passengers returning from West Africa for fevers and other Ebola symptoms, but are not testing for the disease (which would require blood samples).
But one company is trying to make it cheaper and easier to test for the deadly virus. They’re called Genalyte and they make a pinprick blood testing kit.
“For the last 7 years we’ve been developing a diagnostic platform that can take a finger prick of blood and generate a panel of results in less than 10 minutes. So we’ve been able to demonstrate that on a wide number of [diseases] to date,” said CEO Cary Gunn.
Right now, the company’s test is in use by pharmaceutical companies, just not for Ebola. But Genalyte is working with the FDA to fast track approval to test for Ebola.
“We have a silicon chip that we manufacture and you flow a patient's sample directly over that silicon chip and we’re able to detect proteins in the blood at a very low concentration very quickly,” Gunn said.“The pivot for us to Ebola was a relatively small one and a very easy one that has gone quite well."
“We’re trying to run this on as many real samples as possible,” Gunn said. “As you can imagine, live virus samples in the United States are contained in very special facilities and are very difficult to work with so we’re trying to work with as many of those as possible and use that data to get emergency authorization.”
In order to get approved, Genalyte will likely have to test hundreds of active virus samples and thousands of innocuous samples to ensure the test is accurate and doesn’t create false positives.
Part of fast tracking with the FDA means that instead of multiple filings and analysis, the FDA is directly involved with Genalyte on scientific testing and processes. “[It’s] a direct scientific conversation with the FDA… by the time the FDA gives you the blessing you’ve got the product that’s for sure.”
In some ways, Gunn says the outbreak of Ebola in the U.S. may have advanced his company’s research and work by drawing attention to the process.
“Doing infections disease testing of this type is something that doesn’t get a lot of funding or attention in normal let’s call it ‘peace’ time,’” he said.
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