Press Release by ProofPilot
New York City Health Innovators Launch Remote COVID-19 At-Home Antibody Testing Trial
The participant-self service study sponsored by Radish Health, ProofPilot and Sanesco will be used to assess the effectiveness, usability and impact of COVID-19 antibody testing
NEW YORK – ProofPilot, a digital clinical trial startup, announced today its collaboration with Radish Health, a physician concierge service and Sanesco, a CLIA high complexity certified lab in Asheville, NC, to launch a remote at-home COVID-19 antibody test trial. The At-Home COVID-19 Antibody Test Usability Assessment Study is a fully remote, participant self-service study that aims to confirm antibody test accuracy, as well as assess whether individuals can safely administer and accurately read results from a COVID-19 antibody test at home. The study also aims to examine how test results change social-distancing behaviors and general anxiety over an 8-week period post-test.
With stay-at-home orders in place in nearly all fifty states, the number of unemployed in the United States could reach numbers last seen during the Great Depression. According to the New York Times, the lack of testing available for COVID-19 has led many to suspect that they may have contracted the virus, but without testing they have no way to find out for sure. Without this knowledge both from a personal and societal perspective, it’s difficult to make decisions about bringing individuals back to work and into society.
“Medical professionals are currently overwhelmed with patients with active COVID-19 infections. It is essential that we validate remote COVID-19 antibody testing for at-home use,” said Dr. Viral Patel, Principle Investigator and CEO of Radish Health. “By running this study in a remote at-home manner on ProofPilot, we’re creating incredibly important data for medical and policy decision-makers without impacting scarce medical resources.”
The study will evaluate whether self-administered COVID-19 antibody tests can be safely and accurately used at home. The secondary focus of this study is to examine how the test results impact participant’s social-distancing behavior and anxiety levels using modified versions of assessments like the PROMIS Bank 2.0 Satisfaction with Social Roles and Activities, among others. The basic study designs are influenced by at-home validations of HIV tests completed a decade ago. It includes basic measures of usability and ability to accurately read results, however, much like the HIV test trials that inspired it, this study also looks at how the results impact behavior – in this case social-distance behavior.
“ProofPilot’s goal has always been to make it possible to democratize clinical trials,” says Matthew Amsden, CEO of ProofPilot. “By bringing the barriers down, Radish Health, ProofPilot and Sanesco have been able to launch a study with fewer resources and with greater speed than would have been possible in the past. A similar study I was involved with ten years ago on at-home HIV tests took several years to plan and cost well over $1 million. This study was conceived and launched in 3 weeks with almost no financial resources. We should have some initial results in about two weeks – regardless if the results are good or bad.”
The first volley of the study will focus on the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette with 500 participants in New York City. To reduce the need for external funding that could delay the start of trial, participants will be asked to pay $35 to cover shipping and handling of the tests. If future funding is made available, all proceeds will be donated to charity, and participants will not be charged for the tests themselves. Other trials among different populations and using different test kits are already in planning phases.
“Sanesco strives to stay at the cutting edge of laboratory medicine providing practitioners with innovative clinical tools that bring real value to medical providers and their patients. This project fits perfectly with our goals and vision and provides data that will help clarify whether at-home sampling can become a viable model for COVID-19 testing. In addition, it is certainly reassuring that this testing platform has been used recently for monitoring in both NYC and Santa Clara, CA.”
The study went through an external research ethics review process by Integreview IRB of Austin on April 15th, 2020. The study is queued for public listing on clinicaltrials.gov.
ProofPilot is a platform to design, launch and participate in clinical trials to determine what works (and what doesn’t) to improve human health. ProofPilot’s primary goal is to reduce the costs and timelines associated with clinical trials. Serving the pharma, medical device, social service and health and wellness field, ProofPilot is the only clinical trial platform that provides tools for holistic health. ProofPilot is based in New York City. Key investors include CEO and Co-Founder Matthew Amsden, Cue Ball Capital, Brooklyn Bridge Ventures, and Esther Dyson.
About Radish Health
Radish Health provides a fresh, technology driven perspective to patient care by bringing insurance-covered medical visits into the workplace. Radish Health is a primary care solution enabling employees to see a doctor in-person with digital follow-up care appointments, including an option of additional home visits by a medical assistant. With an emphasis on building patient care through relationships first, then using technology to improve access and convenience, Radish Health improves work productivity for employees and is cost efficient for employers.
Sanesco strives to stay at the cutting edge of laboratory medicine providing practitioners with innovative clinical tools that bring real value to medical providers and their patients. This project fits perfectly with our goals and vision and provides data that will help clarify whether at-home sampling can become a viable model for COVID-19 testing. In addition, it is certainly reassuring that this testing platform has been used recently for monitoring in both NYC and Santa Clara, CA.