Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.

The U.S. FDA has granted emergency use authorization (EUA) to Quanterix Corp.’s SARS-CoV-2 IgG antibody test, which tests blood samples for evidence of recent or prior COVID-19 infection. The test could also be used to measure antibody response to a COVID-19 vaccine. The Simoa Semi-Quantitative SARS-CoV-2 IgG antibody test is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma from a venous blood draw.

Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision. For the biopharma sector, the impact of COVID-19 was wide-ranging, in many cases showing the industry at its best, with the speedy mobilization of scientific efforts that spawned vaccine approvals at record rates and a host of therapeutics making their way through development. But biopharma suffered COVID-19-related setbacks as well, from a negative impact on clinical trials to the increasing politicization of science that could make the industry’s job harder as the world moves hopefully to end the pandemic in 2021. In looking back over the past year, BioWorld has compiled the biggest trends and lessons from the year of COVID-19.

PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.

Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.

Two-Photon Research Inc. (TPR) has launched a diagnostics platform it said improves coronavirus detection via aptamers, small molecules that change shape when binding to a protein at the surface of the SARS-CoV-2 molecule that causes COVID-19. Light shone onto a vial containing a patient’s saliva and the Aptamer Molecular Photonic Beacon (AMPB) generates negative or positive results that are instantly displayed on a smartphone and stored for planning purposes by public health officials.