Co-Diagnostics, Inc Receives CE Marking for Direct Saliva SARS-CoV-2 Test

June 25, 2021

Co-Diagnostics has obtained regulatory authorization to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of COVID-19 in markets that accept CE markings.

The Co-Diagnostics Logix Smart DS test kit detects the presence of certain genes of the COVID-19 virus directly from human saliva samples while eliminating RNA extraction of the samples. Eliminating the extraction process can increase throughput and lower costs of not only COVID-19 testing, but also other Co-Diagnostic saliva tests aimed at other pathogens.

Dwight Egan, Chief Executive Officer of Co-Diagnostics, commented, “We are pleased to announce that this new, simplified PCR testing method is now available as an IVD in any country that accepts a CE marking as valid regulatory approval to aid in the ongoing battle against the COVID-19 pandemic, which we anticipate will drive demand for diagnostics as normalization testing protocols are established. We believe that the need for testing will especially persist in countries where vaccination rates lag substantially behind those of the United States.”

Co-Diagnostics’ testing has a national and global reach, including in over 50 countries internationally. Since the earliest days of the pandemic, the company has dedicated itself to the fight against COVID-19.

“Co-Diagnostics was one of the first diagnostics companies to develop a high-quality COVID-19 test, and with this new regulatory approval for their saliva test, the company continues to demonstrate it’s ability to innovate and respond to the needs of market, particularly as we continue to navigate the global head winds of the pandemic,” said Kelvyn Cullimore, president and CEO of BioUtah.