NEW YORK – Molecular diagnostic company Canary Global announced on Tuesday that it received CE marking last week for its DigiGene COVID-19 Rapid Molecular Test Kit.
The self-collected saliva test uses biosensors to return positive results in approximately five minutes and negative results in less than 20 minutes, the company said in a statement. The kit can process four test samples simultaneously and is intended for use in point-of-care settings.
The testing kit has a handheld reusable digital reader and disposable test cartridges that use loop-mediated isothermal amplification and smart sensors to detect SARS-CoV-2 RNA in saliva, oral, and nasal passages, along with cloud-based analytics to report results to a smartphone. The test has delivered 95 percent sensitivity and 98 percent specificity in both symptomatic and asymptomatic people with SARS-CoV-2, including cases with variants, the company said.
Canary's test is also being submitted to the US Food and Drug Administration for Emergency Use Authorization for at-home use and point-of-care use, the company added. It noted that it plans to gear up production to supply "millions of units" over the coming months.
"The ability to detect SARS-CoV-2 early, before the onset of symptoms, or those who never develop symptoms, will help drastically reduce household and community transmission," Canary Global CEO Raj Reddy said in a statement. "And in the face of therapies that are currently being developed, a faster diagnosis will make all the difference in controlling and stopping the spread of COVID."