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| Image created by Dr. Michael J. Miller |
Cepheid and BioGX announced a collaboration between the two companies to deliver a PCR test for Monkeypox that will run on the GeneXpert system. 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.
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 low (1), 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 sample (2).
"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 study (3), 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.
References:
1. https://www.cdc.gov/poxvirus/monkeypox/index.html
2. https://www.who.int/news-room/fact-sheets/detail/monkeypox
3. Li D., Wilkins K., McCollum A.M., Osadebe L., Kabamba J., Nquete B., Likafi T., Balilo M.P., Lushima R.S., Malekani J., et al. Evaluation of the GeneXpert for human monkeypox diagnosis. Am. J. Trop. Med. Hyg. 2017;96:405–410. doi: 10.4269/ajtmh.16-0567. - DOI https://www.ajtmh.org/view/journals/tpmd/96/2/article-p405.xml
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.
About BioGX
BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively "BioGX"), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX's 60+ multiplex real-time PCR products are marketed and sold worldwide through its Global Distribution Network.
Image credit: US Centers for Disease Control.