On June 27, 2022 Cepheid and BioGX reported a collaboration between the two companies to deliver a PCR test for Monkeypox that will run on the GeneXpert system (Press release, Cepheid, JUN 27, 2022, View Source [SID1234616287]). With a global installed base of over 40,000 GeneXpert systems in 180 countries, this test could be deployed quickly in multiple settings where actionable information is needed .
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According to the Centers for Disease Control and Prevention (CDC), monkeypox is rare and does not spread easily between people without close contact. While the threat of monkeypox to the general U.S. population remains low1, it is important for healthcare providers worldwide to have a preparedness plan. One of the key signs of infection with the virus is fever with development of a maculopapular rash, often appearing as small, raised spots. However, there are many other illnesses, such as chickenpox, measles, bacterial skin infections, syphilis, herpes, and medication-associated allergies that can present with similar symptoms. This underscores the need for a molecular test that can identify monkeypox. The World Health Organization recommends PCR as the preferred laboratory test for monkeypox, using an appropriate skin lesion sample2.
"Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises," said David H. Persing, M.D., Ph.D., Cepheid’s EVP and Chief Scientific Officer. Beginning with Bacillus anthracis (Anthrax) and continuing with Mycobacterium tuberculosis, Influenza H1N1, Ebola virus and SARS-CoV-2 among others, Cepheid has a long history of quickly developing and delivering tests that address urgent public health issues as they emerge."
BioGX also has a successful track record of working with government agencies and diagnostic partners to quickly develop and manufacture at-scale molecular tests for detection of emerging pathogens.
"We previously collaborated on a project with the CDC to develop and manufacture a multiplex Monkeypox/Orthopoxvirus test for a GeneXpert-based study3, and now with Cepheid we are moving to the validation stage utilizing the FleXible cartridge," said Michael Vickery, Ph.D., BioGX’s EVP and Chief Scientific Officer. "Regional response teams need a PCR test that is fast and easy to implement when they suspect an outbreak due to a novel pathogen."
Product in development. Not for use in diagnostic procedures. Not reviewed by any regulatory body. Product in development is subject to change and specifications have not yet been established.