GREENWOOD VILLAGE, Colo., Aug. 26, 2022 /PRNewswire/ — RAIsonance, Inc., a group of AI-powered technology solutions companies, today reported the preliminary results of its AudibleHealth Dx clinical validation study. The purpose of the trial was to evaluate the AudibleHealth Dx Software as a Medical Device (SaMD) using Forced Cough Vocalization-Signal Data Signature (FCV-SDS) in the diagnosis of COVID-19 illness.
In Q2 of 2022, RAIsonance commenced its Clinical Trial in Florida to validate the AudibleHealth Dx device’s efficacy. Enrollment was 514 participants, with a prevalence of 12.8%. The results of this study will be used to support an Emergency Use Authorization (EUA) submission to the U.S. Food and Drug Administration in the coming weeks.
The study was a prospective, multi-site, non-inferiority trial that compared the AudibleHealth Dx COVID-19 test to a highly sensitive de novo-authorized RT-PCR COVID-19 test when using the AudibleHealth Dx SaMD to detect COVID-19 infections.
For the clinical validation study, the AudibleHealth Dx SaMD’s ability to correctly diagnosis COVID-19 was compared to the BioFire RP2.1 Panel (the first FDA de novo-authorized test for COVID-19). The BioFire RP2.1 Panel runs on the BioFire® FilmArray® Torch and the BioFire® FilmArray® 2.0 Systems in laboratories certified to perform CLIA high complexity or moderate complexity tests.
When compared to this highly sensitive reverse transcription-polymerase chain reaction (RT-PCR) test, the AudibleHealth Dx has results demonstrating at least a Positive Percent Agreement (PPA) of 81% and a Negative Percent Agreement (NPA) of 80%.
Study participants included males and females aged 18 and older who presented for elective, outpatient COVID-19 RT-PCR testing and met the indications for use for the RT-PCR nasal swab test for COVID-19 using the comparator test and AudibleHealth Dx. All participants stated their willingness to comply with all trial procedures, and informed consent was obtained prior to testing.
The validation study included symptomatic and asymptomatic COVID-19 patients as well as healthy subjects who each utilized the AudibleHealth Dx SaMD device on a mobile phone and then immediately were swabbed with an RT-PCR test.
In addition to evaluating the NPA and PPA of the device, the company also conducted a separate, comprehensive Usability Analysis. Total net usability enrollment was 443 participants. Demographics included those between the ages of 18 and 88 as well as notable diversity in both ethnicity/race and educational level. Key Usability Analysis outcomes:
- 97% of participants completed the screens of the application completely independently.
- Over 90% felt confident they would know how to receive their results at home.
- 91% felt they would know how to handle a positive or a negative result correctly.
- 97.7% responded that they had a very easy or easy overall experience using the app.
- 98.4% responded that the app screens were very easy or easy to understand.
- 97.5% stated they would be very likely or likely to choose to take an AudibleHealth Dx test at home over other testing options.
- Average time to complete the test, from beginning the registration steps to the delivery of results, was 5.39 minutes.
- Overall successful test completion rate was 99.39%.
The use of signal data signatures is common practice for biometric authentication and other means but has not yet been used within the medical community. A forced cough vocalization (FCV), the sound produced when a person intentionally coughs, is unique to each individual and also takes on unique qualities if the individual has certain illnesses, such as COVID-19. RAIsonance has taken this knowledge and the field of artificial intelligence and machine learning (AI/ML) to design and develop a SaMD that uses these unique signatures to diagnose COVID-19 illness.
The device, called the AudibleHealth Dx, is designed to diagnose COVID-19 by analyzing the sound of a person’s forced cough vocalization using artificial intelligence. The user interface takes the form of a mobile app. Once the user downloads and registers on the app, they cough 4 to 6 times into their mobile phone, and in about 2 minutes after submitting a cough, they receive their test result in the app. The SaMD approach allows for fast and easy COVID-19 testing with no swabs, no lines, no waste, no expiration dates, and no waiting.
The device is designed so that results are also pushed to a comprehensive Patient Portal where users can learn more about the test, the science, and current public health recommendations regarding COVID-19. Thanks to a technical integration with the Association of Public Health Laboratories (www.APHL.org), the platform is also designed to automatically send any positive results to local public health authorities in all 50 states and 4 U.S. territories.
In addition to the mobile application, the company has also designed a web-based, enterprise class, fully integrated testing solution platform called TestHub, designed for high-volume purchasers. Businesses, employers, universities, sports teams, organizations, and government agencies will be able to use TestHub to acquire any quantity of tests, if authorized by the Food and Drug Administration (FDA), and distribute those tests in any quantities to their users, either once or on a recurring basis, with just a few clicks.
The TestHub dashboard is also designed to enable these high-volume customers to monitor test usage and results to manage risks and support whatever testing protocols they may have in place. In response to the evolving nature of the COVID-19 pandemic, this seamless platform is nimble and versatile enough to flex with policy changes and infection rates.
Of the results, RAIsonance Founder and CEO, Kitty Kolding, said, "We are incredibly proud of the results of these studies. We spent two years refining this technology and building the device itself and were met with dozens of significant challenges along the way. And to ensure that this test can meet the complex testing needs of organizations, we also built a fully integrated, easy to use ecosystem to ensure that users– individuals, businesses, medical professionals, universities, and government agencies – can experience the full benefits of a totally digital COVID-19 testing solution. The combination of our convenient, mobile-app testing interface and our TestHub portal for high-volume purchasers, we believe, is nothing short of revolutionary."
"We are delighted at the results of this study, which was the culmination of two years of intense work and intentional design. As a physician, the utility of a testing solution like this is a dramatic step forward in terms of scale, innovation, ease of use, convenience, and efficiency. We believe it will be an impressive and impactful tool for mitigating the spread of COVID-19, if authorized by FDA," added Karl Kelley, MD, FAADM, RAIsonance’s Chief Medical Officer.
Mona Kelley, Chief of Clinical and Regulatory Affairs for RAIsonance is also pleased with the results. "Given the novelty of the test, understanding the usability of the test was essential. We are very excited about our Usability Analysis results and how well the device performed in that regard."
"I am so proud of the SaMD that we’ve built. Not only is it a complete solution, but it’s also almost infinitely scalable, cost-effective, and user-friendly. Seeing these study results is incredibly gratifying as the validation for all of our work over the past two years," said Mark Fogarty, Chief Technical Officer (CTO) and Chief Biotechnical Engineer (CBTE).
Lead Series A investor and Chairman of the Board, Rudy Karsan, details AudibleHealth Dx’s next steps. "Our SaMD has the potential to add a powerful new tool to conduct COVID-19 testing. With this novel technology, we can facilitate mass testing without supply-chain headaches, inventory issues and excessive costs. We expect this integrated platform, if authorized by FDA, to become indispensable for businesses, healthcare providers, universities, government bodies and any other type of organization that would benefit from routine COVID-19 testing. The scalability is virtually limitless."
RAIsonance, Inc., a family of AI-powered technology solution companies headquartered in the Denver Tech Center, is focused on meeting today’s critical health and safety challenges. Founded in March of 2020, AudibleHealth AI, Inc. is the SaMD division of RAIsonance, specializing in AI/ML diagnostic solutions and platforms. Initially funded by an SBIR grant by the National Science Foundation, the team of medical, artificial intelligence, technology, and medical device specialists focuses on developing leading-edge AI/ML-based, scalable, cost-effective diagnostic products across a range of acute and chronic health conditions. For more information visit us at www.Raisonance.ai and www.AudibleHealth.ai.
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SOURCE RAIsonance, Inc.
