FDA Grants Emergency Use Authorization to PCR Assay Test for Monkeypox Virus

The FDA has granted emergency use authorization (EUA) to a molecular polymerase chain reaction (PCR) assay test manufactured by Becton, Dickinson and Company (BD) and CerTest Biotec for detection of monkeypox (Mpox) virus. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System may help to inhibit the global spread of the infectious virus.

"The Mpox outbreak continues to be designated as a global health emergency—the World Health Organization's highest level of alert," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD, in a press release. "The large installed base of the BD MAX System in hospital labs provides broad access to testing for a wide range of infectious diseases, now including the mpox virus. EUA for the assay enables it to be used for timely diagnosis and may help avert further global spread of the disease."

Mpox is a double-stranded DNA viral infection that was initially discovered when 2 outbreaks occurred in 1958 in a research laboratory with monkeys in Africa. Signs and symptoms of the virus typically present within 3 weeks of exposure with a painful, blister-like rash frequently occurring around the genitals; however, the rash may also develop around the face, chest, hands, or feet.

Other symptoms of Mpox include swollen lymph nodes, fever, fatigue, muscle ache, or respiratory symptoms that present as a cough or sore throat. The virus is self-limiting with a recovery period typically lasting 2 to 4 weeks; however, until the rash resolves and new skin forms, the virus can still spread. Individuals with an active infection should isolate, avoid intimate activity, avoid sharing personal household items, and sanitize hands and any objects or surfaces they come in contact with.

According to the CDC, there have been more than 80,000 Mpox cases reported worldwide. There have been more than 29,000 cases and 14 deaths reported in the United States. The number of Mpox cases is expected to rise, which requires ongoing testing, vaccinations, and medication services by health care providers, including pharmacists.

The fully integrated, automated BD MAX System allows nucleic acid extraction and real-time PCR to produce results for up to 24 samples across multiple syndromes in under 3 hours, according to BD. The system provides an extensive variety of tests for health care-associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women's health, according to BD.

The VIASURE Monkeypox Virus PCR Detection assay for the BD MAX System is available in a lyophilized format. The assay is available in a tube that snaps into a test-specific position on the BD MAX ExK TNA extraction strip supplied by BD.

"We were able to quickly develop the VIASURE mpox molecular test by leveraging the BD MAX System's open system reagent suite," said Nelson Fernandes, managing director of CerTest Biotec, in a press release. "The EUA for the assay enables use for clinical diagnosis of the disease, in addition to surveillance and the research and development of vaccines and treatments."

Reference

BD, CerTest Biotec Announce Emergency Use Authorization for Mpox Diagnostic Test. BD. News release. https://news.bd.com/2023-01-09-BD,-CerTest-Biotec-Announce-Emergency-Use-Authorization-for-Mpox-Diagnostic-Test. January 9, 2023.