The Food and Drug Administration has granted an emergency use authorization to a Siemens subsidiary for an assay kit built to detect the presence of the mosquito-borne Zika virus in patients. PCR Zika Virus assay VERSANT Zika RNA 1.0 Assay (kPCR) Kit.
The FDA uses the EUA designation to clear unapproved medical products and unapproved uses of them in certain circumstances due to a lack of sufficient, approved and accessible options, Siemens said Monday.
Siemens’ Healthcare Diagnostics subsidiary is authorized to operate the VERSANT Zika RNA 1.0 Assay kPCR Kit at U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, while other qualified labs overseas can operate the technology for highly complex tests.
Fernando Beils, head of molecular diagnostics at Siemens, said the FDA issued the EAU designation in an effort to help physicians manage affected patients and stop the spread of the Zika virus through quick diagnoses.
The assay works to detect the Zika Virus through a molecular test operated from Siemens’ VERSANT kPCR Sample Prep automated platform to verify the plasma, serum and urine from individuals that either meet the Centers for Disease Control and Prevention‘s Zika virus clinical criteria or CDC’s epidemiological criteria.