Vocalis Identifies Vocal COVID-19 Biomarker; Announces Clinical Results And CE Mark
Source : Medtech Insight
Vocalis, a Massachusetts-based artificial intelligence diagnostics company, has completed a successful clinical trial of its COVID-19 screening tool, announced on 17 February.
The study, co-sponsored with the Municipal Corporation of Greater Mumbai, included 2,000 participants with native languages including English, Hindi, Marathi and Gujarat and had them count from 50 to 70 into their smartphones. Results of the study are included in a Vocalis' white paper.
The recordings in the study were processed by Vocalis’ VocalisCheck AI, a cloud-based software, and broken into a spectrogram containing 512 unique features, known as vocal biomarkers. These features are used to provide a result indicating the likelihood of COVID-19 infection, with the process taking roughly two minutes.
Results from an unblinded validation set of 288 people showed a diagnostic accuracy of 81.2% – well above the approximately 60% accuracy for symptom tracking apps previously tested by the same cohort.
In addition to the clinical trial results, Vocalis also announced that it had received a CE mark for the VocalisCheck system, making VocalisCheck the first device intended for medical COVID-19 screening cleared for marketing in Europe.
Vocalis CEO Tal Wenderow said, “These new results, combined with our recent CE-mark approval, demonstrate our commercial readiness to deploy the VocalisCheck screening tool to help businesses, governments, universities and others safely return to work, school, healthcare and leisure while lightening the burden on health systems."
A key advantage of VocalisCheck compared to other diagnostics techniques is the scalability. Since the test is simple to administer with a smartphone and takes just a few minutes, it could have massive potential as a pre-screening tool, directing only patients with a high risk of having COVID-19 towards slower in vitro diagnostics like polymerase chain reaction tests.
Vocalis chief medical officer and cofounder Shady Hassan described VocalisCheck as “highly scalable screening tool” that “can fill a significant gap in the current approach to COVID screening.”
A spokesperson for Vocalis told Medtech Insight, “There has been interest from both state and federal governments. It is being used commercially today, primarily by businesses trying to get their employees safely back to work."
The successful CE mark and trial of VocalisCheck rides off the success of Vocalis’ other CE marked product, VocalisTrack. VocalisTrack is an app which is used daily by patients to record the quality of their respiratory function by checking for shortness of breath. This daily measurement builds up a “diary” that can be used by a physician to identify issues with treatment and track the progression of a patient.
The company is also working with the Mayo Clinic to further validate vocal biomarkers to detect pulmonary hypertension.
By Barnaby Pickering