GREENWOOD VILLAGE, Colo., Sept. 27, 2022 /PRNewswire/ — RAIsonance, Inc., today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its AudibleHealth Dx Software as a Medical Device (SaMD). The device is designed to analyze a user’s Forced Cough Vocalization-Signal Data Signature (FCV-SDS) in the diagnosis of COVID-19 illness. Results in the clinical validation study demonstrated a Positive Percent Agreement (PPA) of 84.39% and a Negative Percent Agreement (NPA) of 85.09% when compared to a reverse transcription-polymerase chain reaction (RT-PCR) test.
“I am beyond thrilled to have submitted our EUA Application for AudibleHealth Dx,” said RAIsonance Founder and CEO, Kitty Kolding. “If authorized, we will immediately bring to market a convenient, accessible, inexpensive, and innovative COVID-19 test that will truly allow everyone to test as often as they wish.”
The submission comes after completion of the Clinical Trial conducted in Florida and enrolled 515 participants, which included 65 COVID-19 positive cases and 450 COVID-19 negative cases for a prevalence of 12.6%. 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 test 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 RT-PCR test, the AudibleHealth Dx has results demonstrating a Positive Percent Agreement (PPA) of 86.67% and a Negative Percent Agreement (NPA) of 85.20%.
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 usability enrollment was 443 participants. Participants 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%.
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.”
The use of signal data signatures is common practice for biometric authentication and other means. 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 6 to 10 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 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.
About the AudibleHealth Dx submission and the TestHub platform, Mark Fogarty, Chief Technical Officer (CTO) and Chief Biotechnical Engineer (CBTE) said, “This submission is the next step towards potentially transforming how organizations scale their COVID testing programs. Our enterprise-class TestHub platform has a comprehensive set of features, from bulk purchasing to one-click distribution and easy monitoring of test results, and it stands ready if FDA authorizes the device.”
Lead Series A investor and Chairman of the Board, Rudy Karsan, details AudibleHealth Dx’s next steps. “RAIsonance’s journey has been remarkable and submitting the application for the EUA is an important next step. If authorized, the test will revolutionize COVID testing for businesses, organizations, and individuals.”
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. Originally 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.
Jamie Mariani, CFO
Ms. Aijalon Ray
SOURCE RAIsonance, Inc.