In response to the COVID-19 pandemic, the Rapid Acceleration of Diagnostics (RADxsm) initiative was formed to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19.
Background on ACME POCT and the RADx Program
As part of a larger team involving RADx contractors, NIH representatives and FDA colleagues, our center is playing a pivotal role in the Variant Task Force to determine the impact of variants on test performance. In addition, our biochemistry lab has developed a deep mutational screen to map the binding epitopes for assays to provide bioinformatical information demonstrating whether an assay could be at risk with new variants of concern.
The NIH Independent Test Assessment Program (iTAP) tasked ACME with serving as their laboratory, usability, and clinical eyes and ears to de-risk potential new assays that had previously been approved outside the US for SARS-CoV-2 detection. To date, 7 different assays have been assessed as part of the ITAP program, with information provided by ACME helping companies to improve packaging and IFUs, as well as identifying issues with proposed sample types.