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Zika virus

The materials and equipment, which were purchased in August, include supplies to perform the CDC MAC-ELISA test and its Trioplex RT-qPCR assay.

The approval comes about five months after the RT-PCR-based kit, which also detects Dengue and Chikungunya, received CE-IVD marking.

The expanded claim for the Aptima Zika test widens the testing window for the virus to 14 days. 

The US Food and Drug Administration has already granted EUA to the test, which detects viral RNA in serum and urine.

Executives of firms developing and launching various assays believe their diagnostic tests will be among the most important tools in controlling Zika. 

The test runs on Roche's LightCycler 480 instruments or Cobas z 480 analyzers. 

The new guidance could benefit Hologic and Roche, both of which market molecular blood screening tests authorized by the FDA under an investigational new drug study protocol.

The RealStar Zika Virus RT-PCR Kit 1.0 has been listed by the World Health Organization as eligible for procurement agencies and member states.

Facing CMS sanctions, lab industry insiders ponder the firm's options in seeking to launch a Zika virus assay with emergency use authorization on its upcoming miniLab platform.

Mosquito (Aedes aegypti)

The test was designed by diagnostics maker GenArraytion and uses the Luminex xMAP technology.

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