PCR testing company Vela Diagnostics reported on Tuesday the receipt of the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the ViroKey SARS-CoV-2 RT-PCR Test v2.0 to detect SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs.
Vela Diagnostics said its automated probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus responsible for COVID-19. Laboratories in the US certified under the Clinical Laboratory Improvement Amendments can use the test for COVID-19 detection.
According to the company, the ViroKey SARS-CoV-2 RT-PCR Test v2.0 is an automated probe-based reverse transcription PCR test optimized for a workflow consisting of its Sentosa SX101 and the Sentosa SA201 instrument (or ABI 7500 Fast Dx). The automated test enables high throughput testing of up to 46 samples in a single run, with reduced hands-on time.
In addition, the company's ViroKey SARS-CoV-2 RT-PCR Test v2.0 has received the CE mark and Provisional Authorisation from the Singapore Health Sciences Authority.
Akeso's ligufalimab (CD47 mAb) granted FDA Orphan Drug Designation for AML
Krystal Biotech receives FDA approval for updated VYJUVEK label
Renalytix signs collaboration agreement with Tempus AI to expand KidneyIntelX.dkd access
Biophytis secures Brazilian funding and partnerships for obesity Phase 2 trial
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch