LabCorp Receives Emergency FDA Approval for Molecular Zika Test

By Ron Shinkman, Editor, Laboratory Industry Report

LabCorp has received emergency approval from the U.S. Food and Drug Administration for a molecular-based rapid detection test for the Zika virus.

The assay, called the RealStar RT-PCR test, was developed in conjunction with the German firm altona Diagnostics. It can be used to detect the virus in either blood serum or urine.

Zika is not typically deadly, but pregnant women who contract the virus are at risk for giving birth to children with serious defects. The spread of the virus—and an absence of a rapid test—has left some public health officials alarmed.

Altogether, there have been 618 documented in the United States and its territories to date. All cases have been associated with travel to South and Central America, but officials believe that it could begin to spread through domestic transmission later this year, necessitating the need for rapid detection tests.

“Public health officials anticipate that the U.S. will become an area of active Zika virus transmission this year,” said Marcia Eisenberg, Ph.D., chief scientific officer for LabCorp Diagnostics. “LabCorp is pleased to support the effort to help identify and minimize human transmission of this disease in the U.S. by offering the RealStar test as a new tool that can help to improve health and improve lives.”

LabCorp did not release a list price for the test, or plans for distribution. The test was approved under an emergency use authorization from the FDA for CLIA high complexity laboratories, which will be rescinded once circumstances surrounding the spread of the Zika virus change.

For more indepth coverage of Zika testing, see the June issue of Diagnostic Testing and Emerging Technologies.