Molecular diagnostics company Co-Diagnostics has submitted its first US Food and Drug Administration (FDA) application for its Co-Dx PCR Pro instrument’s 510(k) clearance.
US-based Co-Diagnostics has also filed an application for FDA clearance of its Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.
The company submitted the application through the FDA’s electronic Submissions Template And Resource (eSTAR) system. It also received the confirmation of receipt from the FDA.
eSTAR helps medical device manufacturers in consolidating essential information required for 510(k) submissions.
The Co-Dx PCR platform aims to reduce the access gap in infectious disease diagnostics by enabling widespread decentralisation of polymerase chain reaction (PCR) testing.
According to Co-Diagnostics, the platform features a compact, robust real-time PCR instrument designed for use in point-of-care or at-home settings.
It operates through an intuitive smartphone interface and utilises test cups powered by patented Co-Dx Co-Primers technology.
Additionally, Co-Diagnostics plans to apply soon for the Co-Dx PCR COVID-19 test on this new instrument, intended for point-of-care testing (POCT).
Furthermore, the company is advancing other diagnostics for the platform, currently in various stages of development or preparing for clinical evaluation.
These include tests for tuberculosis, human papillomavirus (HPV), streptococcus A, and a respiratory multiplex assay capable of detecting influenza A, influenza B, Covid-19, and respiratory syncytial virus (RSV) in a single test.
Co-Diagnostics CEO Dwight Egan said: “While we have identified markets for this initial diagnostic offering and we are eager to begin commercialisation once cleared to do so, we expect that the other tests to follow will be even more transformative, and we are quickly moving to complete the requirements to initiate clinical evaluations and submit regulatory filings for these tests in their respective target markets.”
The Co-Dx PCR platform, encompassing the PCR Home, PCR Pro, mobile app, and all related tests, is presently undergoing FDA review and is not yet available for sale.
