FDA Grants Emergency Use Authorization for Thermo Fisher Scientific’s Monkeypox Test
Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours.
- Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours.
- Ensuring that all U.S. laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency, said Manoj Gandhi, senior medical director for Genetic Testing Solutions, Thermo Fisher Scientific.
- In early 2020, Thermo Fisher was among the first companies to distribute an emergency use authorized assay to identify active SARS-CoV-2 infections with the TaqPath COVID-19 Combo Kit .
- For Emergency Use Authorization Only; Rx Only
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion.