Birmingham-based BioGX is collaborating with a California-based molecular diagnostics company to develop a PCR test for monkeypox.
It will team up with Cepheid to deliver a test that will run on the GeneXpert system. With a global installed base of over 40,000 GeneXpert systems in 180 countries, the test could be deployed quickly in multiple settings where actionable information is needed.
According to the Centers for Disease Control and Prevention, monkeypox can be spread through direct contact with body fluids or respiratory secretions during prolonged, face-to-face contact. While the CDC currently classifies the threat of monkeypox to the general U.S. population as low, it stated it is important for health care providers worldwide to be alert for patients presenting with a rash illness.
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 is why it is important to have a molecular test that can identify monkeypox, leaders say. The World Health Organization recommends PCR as the preferred laboratory test for monkeypox, using an appropriate skin lesion sample.
BioGX 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, and now with Cepheid we are moving to the validation stage utilizing the FleXible cartridge," said Michael Vickery, BioGX's executive vice president and chief scientific officer in a release. "Regional response teams need a PCR test that is fast and easy to implement when they suspect an outbreak due to a novel pathogen."
Cepheid also has a history of developing and delivering tests to address public health issues.
"Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises," said Dr. David Persing, Cepheid's executive vice president and chief scientific officer.
