Curebase Solutions Supports Another InBios FDA Emergency Use Authorization for COVID-19 IgG Antibody Rapid Test
September 30, 2021
SAN FRANCISCO, Sept. 30, 2021 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, teamed up again this summer with InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, to test InBios' SCoV-2 Detect IgG Rapid Test. This research resulted in FDA Emergency Use Authorization (EUA) for use in the United States.
"Time and again during the pandemic, the Curebase DCT model has proven to be effective at securing EUA for a variety of tests," said Tom Lemberg, founder and CEO of Curebase. "Our team is very proud to have built a high-quality and agile solution to help these innovative companies secure EUA for their products. By locally activating points of care in the community to collect clinical data, such as drive through testing sites, we can more conveniently and quickly obtain data for the FDA's requirements. We know that there's a better way to effectively and efficiently conduct healthcare research, and our team is doing terrific work to advance the global healthcare industry."
Working with the Curebase solution, in a clinical evaluation at point-of-care settings using fingerstick whole blood of individuals who were 15 days or more post symptom onset, InBios' SCoV-2 Detect IgG Rapid Test accurately determined 96.9% (PPA) of those who were positive and 100% of those who were negative (NPA) for SARS-CoV-2 (COVID-19) IgG antibodies. The InBios test includes all reagents and controls required to run 50 test specimens with results in approximately 20 minutes.
This rapid test is intended to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The SCoV-2 Detect IgG Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection. Currently, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
While the SCoV-2 Detect IgG Rapid Test has not been FDA cleared or approved, it has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for detecting the presence of IgG antibodies to 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
"The ultimate goal of these projects is to advance healthcare and save lives," said Lemberg. "Our team is grateful to have the opportunity to help InBios with this lifesaving work and look forward to future opportunities to make healthcare research more accessible for the world."
Curebase's decentralized clinical trial model ensures more diverse studies because unique populations can be rapidly identified and included. The company's virtual research sites also provide physicians with new and unique options to offer, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Located in Seattle, Washington, 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.
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.