SAN FRANCISCO and SEATTLE, July 14, 2021 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, today announced that InBios successfully utilized Curebase's virtual site solution to power clinical studies for its SCoV-2 Ag Detect™ Rapid Test, which was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) on May 6, 2021.
For this study, Curebase converted drive-through COVID-19 testing centers in southern California into clinical research sites with its unique decentralized clinical trial software platform and virtual site support model. Study participants were able to be screened and offer consent in real time from the safety of their vehicles while they were waiting for a COVID-19 test. By accessing a specific study website on their own phones, candidates could answer screening questions and consent to participate in the InBios study all in the time it took to wait in line at the drive-up clinic. This process required no physical interaction with patients and enabled hundreds of people to be screened in a few weeks.
"The Curebase approach turns virtually any non-traditional point of care, such as a COVID drive-through testing center, into a research site," said Tom Lemberg, CEO and founder of Curebase. "The InBios study proves our system can successfully be used to activate testing sites essential to generating data in support of FDA submissions and, ultimately, product use authorizations."
The SCoV-2 Ag Detect™ Rapid Test is a patent-pending lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleoprotein antigen in direct nasal swab specimens. The point-of-care test requires no instrumentation or transport media step and can be performed on-site with results delivered in about 20 minutes. The point-of-care test accurately determined 86.67% of study participants who were positive (PPA) and 100% of those who were negative (NPA) for SARS-CoV-2. It is the fourth EUA granted to InBios for COVID-19 diagnostics.
An EUA permits use of certain medical products that may be effective during a public health emergency, which was declared for COVID-19 on February 4, 2020. The SCoV-2 Ag Detect™ Rapid Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The study was the latest in which Curebase demonstrated how its platform and support model allows nontraditional sites to be used for clinical trials. This flexibility, as the pandemic has shown, is critical for clinical trials being conducted in response to and during a public health crisis. With Curebase's platform, trial sponsors can have virtual studies up and running in less than two weeks.
Curebase's decentralized model ensures more diverse studies because unique populations – typically underrepresented in clinical trials – can be included. Virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase system is being used by physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
"Keeping the SARS-CoV-2 virus under control requires continuous monitoring and testing," said Dr. Syamal Raychaudhuri, InBios chief scientific officer. "Our research collaboration with Curebase proves that rapid, highly accurate testing can be performed wherever it's needed."
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.
InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Located in Seattle, InBios offers superior quality products which are accurate, easy to use and cost effective. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified. For more information, visit http://www.inbios.com.
SOURCE Bio Space