US-based molecular diagnostics company Co-Diagnostics has announced that its partner, Clinical Reference Laboratory (CRL), has secured FDA Emergency Use Authorization for CRL Rapid Response. The saliva-based Covid-19 test can be self-administered at home, or any other setting, and then tested using Co-Diagnostics’ CoPrimer technology.
South Korea-based biotech firm Macrogen has secured the CE marking for In-Vitro Diagnostic (CE-IVD) devices for its Covid-19 test kit, Axen COVID-19 RT. The CE-IVD is an important certification in Europe for the distribution of in-vitro diagnostic reagents. The test kit uses RT-PCR, and can confirm whether the person is infected with Covid-19 in just two hours, allowing large numbers of tests to be conducted quickly and efficiently. Given that the kit identifies ORF1ab and E genes, the two genes related to Covid-19, it is claimed to have a high level of accuracy and target detection.
Decision Diagnostics, through its subsidiary Pharma Tech Solutions, has announced its support for the FDA Covid-19 At-Home Use Template recently issued. The firm stated that it “contains much of what was in our May 1st At-Home Application to the FDA.” The firm added that is now preparing to amend its first EUA submission PEUA200947 for its GenViro! Blood Swift Kit for at-home use. Soon after that, the company expects to file a separate EUA application with the FDA for its GenViro! Saliva Swift Kit for home use.