Exhalation Technology Announces Updated Clinical Trial Data for its Rapid Covid-19 Diagnostic Test
Cambridge, England, 4 January 2021 – Exhalation Technology (ETL), a Cambridge, UK-based company, announced updated results from its clinical study on humans with its novel, rapid (<5 minutes) CoronaCheck Point-of-Care diagnostic test for Covid-19 in exhaled breath condensate (EBC).
ETL have developed CoronaCheck, a rapid test specific for Covid-19 virus, exploiting their expertise in exhaled breath diagnostics. ETL is pleased to announce that with 62 patients tested so far, CoronaCheck has detected with 100% specificity and 100% sensitivity those patients who are either positive or negative for Covid-19. Some patients in the cohort who tested positive for Covid-19 were asymptomatic.
CoronaCheck outcomes were verified by a verification with an industry standard, albeit non-POC laboratory test using rtPCR, the Hologic Panther system.
CoronaCheck uses electrochemical sensor detection similar to that employed for glucose testing in diabetic patients, and is capable of mass production with an IP-protected approach.
ETL have also announced that CoronaCheck has been tested successfully against an FDA-approved panel of pooled respiratory viruses and bacteria, including a number of recognised Coronavirus variants. CoronaCheck confirmed with 100% accuracy the pools containing all Coronavirus variants, and reported as negative those samples lacking Coronavirus but containing other standard respiratory viruses such as seasonal flu and other non-Corona respiratory viruses.
CoronaCheck is a rapid test (aims for a result in under 5 minutes) of high specificity and sensitivity for Covid-19, meeting the need for efficient and accurate testing in a wide range of environments including hospitals, care homes, airports, retail outlets, schools and similar spaces.
ETL has applied to the US FDA regulatory [H|ET1] authorities for Emergency Use Authorisation. CoronaCheck will be CE marked in Europe.