Quest gets FDA Emergency Use Authorization for first commercial Zika test

Rick Pesano, Quest's VP of R&D

Quest Diagnostics ($DGX) got the FDA's Emergency Use Authorization for its rapid Zika test, the first diagnostic from a commercial lab to receive the distinction.

Quest's Focus Diagnostics unit developed the test, which screens for RNA from the Zika virus in blood samples. Quest plans to make the tool available to doctors for patient testing in locations in the U.S. and Puerto Rico early next week, the company said in a statement.

"Quest's expertise in molecular, infectious disease, and women's health diagnostics, and relationships with half of the country's physicians and hospitals, allow us to quickly make useful tests widely available for clinical use," Rick Pesano, Quest's VP of R&D, said in a statement. "This capability uniquely positions Quest to complement the response of public health laboratories for Zika outbreaks where access to FDA authorized diagnostic tests can potentially influence the quality of patient management."

The company's test comes at a critical moment. The Zika epidemic continues to rage on in countries such as Brazil, and health officials are warning that outbreaks could occur in the U.S.

Up until now, the FDA had only authorized Zika tests from the Centers for Disease Control and Prevention (CDC). A new commercial test could screen more patients and identify individuals with the disease earlier.

Quest is not the only one getting in on the effort. Chembio Diagnostics said in March that it's working with Brazilian biotech organization Bio-Manguinhos/Fiocruz to develop POC Zika tests. The tools could help scientists better understand the link between Zika and microcephaly, a birth defect associated with the virus.

"Preliminary testing results are highly encouraging and our ongoing collaborations with Bio-Manguinhos/Fiocruz and the global scientific community are extremely helpful as we move toward a rapid and affordable solution," Chembio CSO Javan Esfandiari said at the time.

- read the release

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