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Cepheid, BioGX to Jointly Develop Monkeypox PCR Test for GeneXpert System

This article has been updated to correct the headquarters of BioGX and ownership of BioGX B.V.

NEW YORK – Cepheid and BioGX announced on Monday a collaboration to develop a monkeypox assay on the GeneXpert system. Financial and other terms of the deal were not disclosed.

The assay will be delivered as part of Cepheid's FleXible Cartridge program for the GeneXpert, a system that has an installed base of more than 40,000 instruments in 180 countries, the firms noted in a statement.

"Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises," said David Persing, Cepheid's executive VP and CSO, in a statement.

A supplier of lyophilized real-time PCR reagents for molecular diagnostics, BioGX is headquartered in Birmingham, Alabama, and Dallas, Texas. It has a wholly owned subsidiary, BioGX B.V., that is based in the Netherlands.

Michael Vickery, BioGX's executive VP and CSO, noted that the firms previously collaborated on a project with the US Centers for Disease Control and Prevention to develop and manufacture a multiplex monkeypox and orthopoxvirus test for a GeneXpert-based study, which was published in 2017.

In that study, the test demonstrated a sensitivity and specificity of approximately 99 percent and 100 percent, respectively, compared to the CDC's monkeypox PCR assay, when tested on 164 patient samples from the Democratic Republic of Congo.

"Now with Cepheid, we are moving to the validation stage utilizing the FleXible Cartridge," Vickery said, adding that "regional response teams need a PCR test that is fast and easy to implement when they suspect an outbreak due to a novel pathogen."

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