Deepverge has published initial data from its ongoing Phase III clinical studies for the detection of SARS-CoV-2 from samples of breath condensate and identification of confirmed COVID-19 positive patients.
The studies demonstrated detection and identification of the virus S-Protein in quantities as low as 40 femtogram per millilitre (‘Fg/mL’) at close to 100% sensitivity and specificity on DeepVerge’s Microtox® BT nano-optofluidic chip. Capable of being confirmed within 60 seconds and indicating a nine-times increase in the digital spectrum signal when using Microtox® BT, compared to controls of nano-optofluidic chips with binding agents, this represents the passing of a significant technological milestone.
Although additional supervised breath test clinical trials from a larger group of patients now need to be completed, Deepverge’s management consider these will provide sufficient data to meet the ‘desired’ and ‘acceptable’ criteria specified in the UK Target Product Profile (‘TPP’) that should, in turn, enable the product to secure its CE marking followed by a broad roll-out for COVID-19 (and other pathogen) breath tests which might be expected before the end of 2021.
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