Dutch Qiagen ($QGEN) is stepping up to help laboratories respond to the ongoing Ebola outbreak in West Africa. The company said it has partnered with Germany's Altona Diagnostics to distribute an Ebola test both in and outside the U.S.
Developed by Altona, the RealStar diagnostic kit is designed to detect all four known strains of Ebola viruses, including the Zaire strain, which is responsible for the current epidemic. The RealStar test uses a technique called reverse transcription polymerase chain reaction (RT-PCR) to determine the presence of RNA from Ebola.
Qiagen's agreement with Altona expands an existing collaboration between the two companies that was inked in the third quarter of 2014.
|Qiagen CEO Peer Schatz|
"Qiagen is taking an active role in the world's fight against Ebola, building on our capabilities as a leading provider of testing solutions demonstrated in previous outbreaks. We are making Ebola diagnostic workflows accessible to public health authorities, scientists and healthcare providers through our commercial networks around the world, including in Africa," Qiagen CEO Peer Schatz said in a statement.
The FDA on Nov. 10 initially granted Altona emergency use authorization (EUA) for the molecular diagnostic test. Then on Nov. 26, the regulatory agency amended that decision and authorized distribution and use of the test in U.S. and non-U.S. laboratories. Under the special authorization, the test can be used on specified instruments in plasma from individuals with Ebola symptoms. The test has not been cleared or approved by the FDA.
Qiagen also said it will distribute Altona's RealStar Filovirus RT-PCR Kit, which is for both Ebola and Marburg viruses and does not fall under the EUA. That test has a CE mark for use as an in vitro diagnostic.
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