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Diagnostics Companies Partner on Monkeypox Test

Patient with monkey pox

Person in Democratic Republic of the Congo with monkeypox (CDC.gov)

27 June 2022. Two developers of tests for infectious diseases are collaborating on a molecular test to detect monkeypox, an emerging international public health concern. Financial terms of the agreement between Cepheid in Sunnyvale, California and BioGX Inc. in Birmingham, Alabama were not disclosed.

Monkeypox is a viral zoonotic disease, one that spreads from animals to humans, occurring initially in central and west Africa. The virus is part of the orthopoxvirus sub-family that includes smallpox, with symptoms similar to smallpox. Those symptoms typically last two to four weeks, including a rash with raised blisters, fever, headache, muscle aches, chills, fatigue, and swollen lymph nodes. Monkeypox is spread from lesions on the skin through close physical contact, such as sexual or close respiratory contact, or with infected materials like bedding. The disease is considered less contagious and deadly than smallpox, with a fatality rate of three to six percent.

Up to recently, monkeypox has been a health concern in central and west African countries. According to World Health Organization, the disease began spreading outside of Africa in 2003 through contacts with wild animal pets, then from contacts with Nigerian travelers to Israel and the U.K. starting in 2018. From 2019 to 2022, cases were reported in the U.S. and Singapore. Centers for Disease Control and Prevention says as 24 June 2022, 201 confirmed cases of monkeypox or other orthopoxvirus are reported in the U.S.

PCR needed for definitive diagnosis

Cepheid designs and develops diagnostic molecular diagnostic tests to detect genetic indicators of infectious diseases and cancer built on an automated platform. That platform, called GeneXpert, uses polymerase chain reaction or PCR, a genetic lab technique that quickly reproduces short DNA segments from small samples to amplify the DNA for genetic analysis. In the  GeneXpert system, samples for testing are captured in interchangeable cartridges. In the case of monkeypox, samples for testing are taken from skin lesions. Because many monkeypox symptoms are similar to other diseases, says Cepheid, PCR testing is needed to give a more definitive diagnosis.

BioGX also makes diagnostic tests, including PCR tests, as well as materials including chemical reagents for PCR tests. Many of the company’s testing materials are lyophilized, or freeze-dried, which removes the need for refrigeration for storage or shipping. The two companies have worked together before. In a test of the GeneXpert cartridge system to detect monkeypox in Democratic Republic the Congo, published in a research journal in 2017, Cepheid used reagents made by BioGX.

“Our flexible cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises,” says Cepheid chief scientist David Persing in a company statement. BioGX’s founder and chief scientist Michael Vickery adds, “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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