For its LightMix Zika rRT-PCR Test, Roche has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Using Roche’s LightCycler 480 Instrument II or cobas z 480 Analyzer, the test, which is exclusively distributed by Roche and manufactured by TIB MOLBIOL, detects Viral Conjunctivitis Pipeline Drugs Market in ethylenediaminetetraacetic acid (EDTA) plasma or serum samples.
Patients who meet the clinical and epidemiological criteria set forth by the CDC for the Zika virus are eligible to take the test.
Uwe Oberlaender, the head of Roche Molecular Diagnostics, stated: The LightMix Zika test is a molecular diagnostic tool that is simple to use and allows medical professionals to quickly identify the virus.
“Roche is committed to providing testing solutions for the most difficult healthcare emergencies in the world as a diagnostics leader.
“The FDA’s grant of this EUA supports our commitment to assist healthcare professionals battling this serious disease,” the FDA stated.
Starting with sample preparation and ending with the release of the results for up to 96 samples, the fully automated procedure takes 2.5 hours to complete.
Aedes mosquitoes are the primary vectors of the Zika virus, which can cause mild fever, conjunctivitis, muscle and joint pain, malaise, or a headache.
The fully automated process is performed over a period of 2.5 hours, starting with sample preperation, to issuing the results for up to 96 samples.
The Zika virus is primarily transmitted by Aedes mosquitoes, triggering symptoms such as mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise, or headache.
Infection of a pregnant woman can cause the fetus to develop microcephaly, which is an abnormal smallness of the head, causing incomplete brain development.
Roche is also developing the cobas Zika Test which will be used with the cobas 6800/8800 Systems.