Molecular Diagnostic Test Could Allow for Rapid Response to Monkeypox

A collaboration between CerTest Biotec and BD seeks to develop a molecular diagnostic test for the Monkeypox virus, according to a BD press release.¹

Monkeypox is a rare disease caused by infection with Monkeypox virus. Additionally, the Monkeypox virus belongs to the Orthopoxvirus genus in the family Poxviridae. The Orthopoxvirus genus also includes the variola virus (which causes smallpox), the vaccinia virus (used in the smallpox vaccine), and the cowpox virus, according to the CDC.²

The disease does not spread easily between people without close contact, and even with the growing number of cases in the United States, the threat of monkeypox to the general population is still relatively low.²

As of June 14, there were more than 70 cases of monkeypox across 18 states in the United States, according to the CDC. In the US outbreak to date, all patients diagnosed with monkeypox have experienced a rash or enanthem.³

The CDC noted that the clinical presentation of monkeypox may be similar to some sexually-transmitted diseases, such as syphilis, herpes, lymphogranuloma venereum, and other etiologies of proctitis.³

The assay will use the BD MAX open system reagent suite to validate the CerTest VIASURE Monkeypox CE/IVD molecular test on the BD MAX System, according to BD. Further, it will be available for BD MAX users and may help advance understanding of the global impact of Monkeypox, according to BD.¹

"Enabling labs to rapidly respond to unexpected challenges is the kind of evolving health care situations for which the BD MAX open system reagent suite is designed," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD, in a press release. "Through our collaboration with CerTest and their ability to rapidly transfer assays on the BD MAX System, we will enable BD MAX System users around the world to access a test for the confirmation of monkeypox."¹

A fully integrated, automated platform, the BD MAX System performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in fewer than 3 hours.

"The strong capabilities of our teams to rapidly develop molecular assays as well our experience working with the BD MAX System enables us to accelerate the development of an assay and further build our collaboration with BD,” said Nelson Fernandes, managing director of CerTest BioTec, in the press release.¹

The Monkeypox PCR Detection Kit for the BD MAX System will be offered in a lyophilized format, and the test will come in a tube that snaps into the test-specific position on the BD MAX ExK TNA extraction strip.¹

REFERENCES

1. CerTest Biotec and BD Announce Collaboration on Molecular Diagnostic Test for Monkeypox. BD. June 8, 2022. Accessed June 14, 2022. https://news.bd.com/2022-06-08-CerTest-Biotec-and-BD-Announce-Collaboration-on-Molecular-Diagnostic-Test-for-Monkeypox
2. About Monkeypox. CDC. June 9, 2022. Accessed June 14, 2022. https://www.cdc.gov/poxvirus/monkeypox/about.html
3. Updated Case-finding Guidance: Monkeypox Outbreak—United States, 2022. CDC. News release. June 14, 2022. https://emergency.cdc.gov/han/2022/han00468.asp