Molecular diagnostics firm Co-Diagnostics has announced that it has completed the assay development strategy for the Bundibugyo virus (BDBV) currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda.
"We are pleased to report that we have completed the assay development strategy for BDBV, and should a situation arise requiring the assay, we expect we would be well positioned to execute the strategy and rapidly make the test available," said Dwight Egan, Co-Diagnostics Chief Executive Officer. "In addition to the role that rapid, gold-standard PCR diagnostics can play in identifying infected patients and helping limit the spread of deadly diseases like Ebola, we believe recent events also underscore the growing importance of decentralised diagnostics and real-time situational awareness in helping public health authorities track and contain outbreaks."
On 17 May, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda.
The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention (CDC) regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats.
Mr Egan added: "The COVID-19 pandemic reinforced the importance of preparedness and rapid response capabilities for emerging infectious disease threats, and we believe it is important to be positioned to respond quickly as we have in the past when situations like these have emerged. We designed the Co-Dx PCR platform with these types of needs in mind, including the ability to support decentralized testing and cloud-connected architecture. Real-time visibility into outbreak activity can play an important role in helping public health authorities identify, monitor, and respond to emerging infectious disease threats. We look forward to collaboration with governmental and non-governmental agencies and organisations on the future development of this test, as needed."
The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.