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In Brief This Week: Co-Diagnostics, Seegene, CCM Biosciences

NEW YORK – Co-Diagnostics said this week that it has submitted its Co-Dx PCR COVID-19 test, the Co-Dx PCR Pro instrument, and a mobile app for Emergency Use Authorization review by the US Food and Drug Administration. The test is designed for use in point-of-care and at-home settings. According to Salt Lake City-based Co-Diagnostics, the Co-Dx COVID-19 test kit for the PCR Pro instrument has demonstrated in clinical evaluations the ability to detect the SARS-CoV-2 virus in anterior nasal swab specimens. Results can be attained on a user's smartphone or mobile device in 30 minutes, the firm said.

South Korean PCR molecular diagnostics company Seegene has obtained the International Organization for Standardization (ISO) 45001 certification for nine of its facilities this week. The eligibility for ISO 45001 certification was examined by the British Standards Institution.

CCM Biosciences said this week that it has launched a new business unit, CCM 5Prime Sciences, that will be focused on developing and applying proprietary technology in DNA biotechnology, including in vitro diagnostics and synthetic biology. 5Prime's technology platform includes patented methods for molecular cloning, next-generation DNA sequencing, and molecular diagnostics. It derives from work that Raj Chakrabarti, the company's cofounder and CEO, conducted as a graduate student at Princeton University.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.