Coronavirus company news summary - Auburn researchers develop electronic device for instant test results - FDA expands emergency use of Quanterix’s antigen test - Verdict Medical Devices
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Coronavirus company news summary – Auburn researchers develop electronic device for instant test results – FDA expands emergency use of Quanterix’s antigen test

14 Sep 2021

Visby Medical has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its reverse transcription-polymerase chain reaction (RT-PCR) Covid-19 test for pooled patient samples. The instrument-free test previously obtained EUA for single sample testing in point of care settings. With the latest authorisation for testing of up to five samples simultaneously, the company expects an increase in overall lab testing capacity with no other tools or resources needed. The test provides results within 30 minutes.

Researchers and engineers at Auburn University have created an electronic device to instantly identify the Covid-19 virus spike protein. The device is made of two-dimensional materials altered with antibodies. As soon as a sample drop is placed on the device, the virus spike protein interacts with the antibody and the result is shown.  In addition, the faster results delivery could facilitate quicker treatment for Covid-19 positive individuals.

The FDA has expanded the EUA label for Quanterix’s Simoa SARS-CoV-2 N Protein Antigen Test to allow the use of nasal swab and saliva samples, as well as asymptomatic serial testing using nasal swab specimens. The company says it is the first antigen test to secure authorisation for saliva samples. The test can detect all variants of concern that are now designated by the Centers for Disease Control (CDC). Quanterix added that Simoa is the first non-NGS test confirmed to identify the Delta variant (B.1.617.2) in sequence-confirmed clinical samples.