HAYWARD, Calif., April 26 (Bernama-BUSINESS WIRE) — Mawi DNA Technologies (Mawi), a biotechnology company focusing on the development of innovative technologies for biosampling, announces that Prime Discoveries has successfully developed CovidDetect™, a rapid isothermal amplification diagnostic assay for detecting SARS-CoV-2. Without the need for RNA extraction and purification, the sample result occurs in less than 30 minutes. The assay uses Mawi’s new iSWAB Microbiome-EL (Extraction-Less) sample collection technology. This allows RNA release from the sample and maintains stability, protecting it from degradation and allowing room temperature storage and transport.
Prime Discoveries recently received CE IVD marking for CovidDetect™ and plans to pursue FDA 510K approval soon. Clinical results from Prime CovidDetect™ has been peer reviewed and recently published in PLOS ONE under “A Rapid, Specific, Extraction-Less, and Cost-Effective RT-LAMP Test for the Detection of SARS-CoV-2 in Clinical Specimens.” The CE marking allows deployment of a solution to countries in Africa and Asia where rapid, inexpensive diagnostics for various infections with minimal technical expertise and equipment infrastructure is highly required.