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OraSure gets FDA nod for emergency use of rapid Ebola test

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OraSure CEO Douglas Michels

OraSure Technologies ($OSUR) snagged the FDA's Emergency Use Authorization (EUA) for its rapid Ebola test, a couple of months after the company got $10.4 million from the U.S. Department of Health and Human Services (HHS) to develop its product.

The Bethlehem, PA-based company's OraQuick Ebola Rapid Antigen Test screens for the Ebola Zaire virus from fingerstick and whole blood samples, offering results in as few as four minutes, OraSure said in a statement. The test has only two operational steps and includes a straightforward visual read. And the product does not require additional instruments and is shelf-stable in a wide range of conditions--a potential boon for areas without lab infrastructure.

"The OraQuick Rapid Ebola Antigen Test is an easy to use, rapid test, that we believe will be a critical tool in containing and controlling current outbreaks of the Ebola virus," OraSure CEO Douglas Michels said in a statement. "We are grateful to the FDA for working closely with us throughout the EUA process to expedite deployment of our test."

Ebolavirus under an electron microscope--Courtesy of CDC

The FDA blessing comes on the heels of more good news for OraSure. Last month, the company struck a three-year deal with the HHS' Biomedical Advanced Research and Development Authority to beef up R&D for its rapid Ebola test. As part of the agreement, OraSure will get $1.8 million in funding upfront and another $8.6 million further down the line for clinical and regulatory milestones. OraQuick, which includes the same technology as the company's FDA-approved HIV and hep C tests, is already under investigational use by the CDC in Africa.

But OraSure is not the only company zeroing in on rapid tests for Ebola. Diagnostics heavyweight Roche ($RHHBY) and other diagnostics outfits such as bioMérieux and Corgenix are forging ahead with their own products, grabbing regulatory signoffs and sinking funds into R&D. Last year, bioMérieux snagged an FDA OK for emergency use of two of its rapid Ebola tests. In December, Roche got an FDA green light for emergency use of its quick diagnostic for the virus.

In March, Corgenix picked up the agency's EUA for its 20-minute Ebola diagnostic. The World Health Organization (WHO) said at the time that the company's protein-based test can pinpoint 92% of Ebola victims and is 85% accurate in Ebola-negative patients, allowing healthcare workers to isolate and treat patients sooner.

- read OraSure's statement

Related Articles:
OraSure to receive up to $10M from feds to develop rapid Ebola test
FDA grants emergency use authorization to Corgenix's fast-acting Ebola diagnostic
Biocartis develops rapid Ebola triage test with Janssen Diagnostics
Roche wins FDA approval for emergency use of rapid Ebola test
FDA grants bioMérieux emergency authorization for one-hour Ebola Dx

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