FDA Grants Emergency Use Authorization for Thermo Fisher Scientific’s Monkeypox Test

December 14, 2022 |

2 min read

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.

CARLSBAD, Calif.--(BUSINESS WIRE)-- 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.

The test is intended for the qualitative detection of DNA from monkeypox virus (clade I/II) and screening for non-variola Orthopoxviruses in human lesion swab specimens from individuals suspected of monkeypox (mpox) infection by their healthcare provider.

The TaqPath Monkeypox/Orthopox Virus DNA Kit is also designed for identification of other non-variola Orthopoxvirus DNA. While positive results are indicative of the presence of DNA from monkeypox virus or other non-variola Orthopoxvirus, clinicians must correlate PCR results with patient history and other diagnostic information to determine infection status.

“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. “This helps expedite availability of results so that patients can receive the appropriate treatment quickly. Authorized testing also enables public health agencies to stay one step ahead of the virus by monitoring viral spread and addressing affected populations accordingly.”

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. The TaqPath Monkeypox/Orthopox Virus DNA Kit builds off that technology and reflects Thermo Fisher’s continued commitment to develop diagnostic tools designed to address pressing public health emergencies as soon as possible.

For more information on Thermo Fisher’s infectious disease testing platform, please visit the website.

For In Vitro Diagnostic Use. For Emergency Use Authorization Only; Rx Only

About Thermo Fisher

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.