Chembio Diagnostics, a point-of-care diagnostics company focused on infectious diseases, is evaluating the potential to develop a monkeypox rapid point-of-care (POC) test. Chembio is exploring the technical requirements for test development leveraging its multiple technology platforms, DPP, SURE CHECK, and STAT PAK, along with funding partners and the broader market opportunity.
“We are in dialogue with leading health organizations at the federal and state level to evaluate the need for a rapid test to detect and diagnose monkeypox. We are assessing the market needs, timing, regulatory pathway and investment required to develop a test,” says Richard Eberly, Chembio’s president and CEO. “Current tests available for monkeypox are PCR based, and given our history of developing rapid POC tests for infectious disease outbreaks, we believe we may be positioned to leverage our technology to provide a differentiated rapid solution. Based on our findings we will determine if this is a viable future opportunity for Chembio.”
Monkeypox is a rare disease caused by infection with the monkeypox virus. Monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox with symptoms similar to smallpox symptoms, but milder, and rarely fatal.
Monkeypox can spread from person to person through direct contact with the infectious rash, scabs, or body fluids. It also can be spread by respiratory secretions during prolonged, face-to-face contact, or during intimate physical contact. There are now over 11,000 total confirmed monkeypox cases in the United States.
Chembio has a track record of delivering testing solutions for three recent infectious disease outbreaks with the expedited development rapid point-of-care tests, the company says. This includes the rapid development of a Zika product for the U.S. market, when the Zika outbreak was impacting the United States in 2017. The company also developed a DPP Ebola test to help with the outbreak with Ebola in 2018. This was followed by the development of COVID tests when the pandemic hit the U.S. in 2020. Additionally, Chembio has developed rapid point-of-care DPP diagnostic tests for HIV 1/2 and Syphilis with the introduction of STAT PAK and SURE CHECK.
Currently, the FDA has cleared one test to detect monkeypox, offered through the U.S. Centers for Disease Control and Prevention (CDC) as a lab developed test (LDT). The test utilizes a swab sample from a monkeypox lesion, creating the need for earlier detection to limit the spread of the disease and expedite treatment.