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.
AstraZeneca invests USD2bn in Summit Therapeutics to advance ADC and cancer-drug combinations
BRC Therapeutics participates in regulators' workshop advancing botanical drug development
Lupin announces receipt of US FDA tentative approval for Apixaban Oral Suspension
QIAGEN completes US QIAstat-Dx bloodstream infection portfolio with FDA clearance
Innovent expands global Phase 3 study of IBI363/TAK-928 to include non-squamous NSCLC
FDA approves WELIREG and LENVIMA combination for previously treated advanced renal cell carcinoma
AstraZeneca's IMFINZI combination receives US Priority Review for muscle-invasive bladder cancer
XtalPi submits US FDA IND application for KQTD-126 in chronic intestinal pain
Revvity launches IVDR-certified solution for early detection of type 1 diabetes
FDA Advisory Committee votes in favour of GRAIL's Galleri multi-cancer early detection test