Vocalis Health’s COVID-19 Screening Tool Receives CE Mark

Israeli startup Vocalis Health, the company pioneering AI-based voice biomarkers in healthcare, announced on Wednesday that its COVID-19 screening tool, VocalisCheck, has received a CE mark, becoming the first device to receive CE mark approval for the medically intended use of screening for COVID-19.

The company also announced the results of a clinical study conducted in collaboration with the Municipal Corporation of Greater Mumbai (MCGM) at their NESCO COVID-19 Center.

The study included over 2,000 participants who spoke numerous languages including English, Hindi, Marathi, and Gujarati.  Results from an unblinded validation set of 288 participants demonstrated an AUC of 0.88, which translated to an accuracy of 81.2 percent, sensitivity of 80.3 percent, and specificity of 81.4 percent.

VocalisCheck is a software-only product that can be accessed via smartphones or other devices. It is not intended to serve as a diagnostic tool, but as a screening tool that can deliver a reliable risk score to guide those who may need additional diagnostic testing, thereby enabling health systems to allocate diagnostic resources more efficiently.

VocalisCheck has proven its reliability to effectively identify COVID-19 risk in multiple studies, including this study in India, the company’s announcement said, delivering reliable risk assessment for COVID-19 infection even in people who are not symptomatic. 

In the study in India, a symptom checker alone correctly identified approximately 66 percent of the people with COVID-19 infection, while Vocalis Health’s COVID-19 vocal biomarker achieved more than 80 percent accuracy in assessing a person’s risk of COVID-19 infection.

“We are encouraged by the study’s findings, which further validate VocalisCheck’s ability to screen for COVID-19,” said Tal Wenderow, CEO of Vocalis Health.  “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.”

“PCR testing is being used to screen for COVID-19, which is an extremely expensive, resource-intensive and time-consuming approach,” said Dr. Shady Hassan, co-founder and chief operating and medical officer of Vocalis Health. “Instead of misusing PCR testing for screening, utilizing a highly scalable screening tool like VocalisCheck can fill a significant gap in the current approach to COVID screening, with the ability to effectively funnel those with high risk of infection to the appropriate diagnostic test.”

Vocalis launched a large-scale study to triage, screen and monitor for COVID-19 symptoms in March 2020, looking for a unique vocal ‘fingerprint’ that could detect a deterioration in the health of coronavirus patients as well as flag potential indications. The company developed a working vocal biomarker for COVID-19 currently in use in a number of clinical validation studies.

Vocalis was established in 2019 as a merger between startups Healthymize (founded in 2016) and Beyond Verbal (founded in 2012, and raised $9 million in a funding round led by VC fund aMoon, co-founded by Dr. Marius Nacht.

Last Novembet, the company announced a partnership with the Mayo Clinic, a leading American academic medical organization to research and develop new voice-based tools to screen and detect patient health.

The clinical validation will use Vocalis Health’s proprietary software, operated from any connected voice platform – mobile, computer, tablet – to analyze patients’ health based on voice recordings.

Vocalis Health and the Mayo Clinic previously worked together on research to establish the vocal characteristics of PH. In this new collaboration, the Mayo research team will conduct a prospective clinical validation study to further develop the vocal biomarkers.

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