Benzinga | Nov 30, 2021 04:45PM EST

GBS Inc. Announces Plans For Clinical SARS-CoV-2 Antibody Trials Following Validation Study

GBS Inc. (NASDAQ:GBS), a life sciences company developing non-invasive, real-time diagnostic testing for patients and their primary health practitioners at point-of-care, today announced it will commence preparation for clinical trials of its rapid SARS-CoV-2 Antibody test following the recent successful completion of a clinical validation study.



As previously referenced, a clinical validation study was conducted at the Wyss Institute for Biologically Inspired Engineering at Harvard University. The objective of this study was to develop a diagnostic test to detect SARS-CoV-2 IgG in human plasma. The statistical design of the study was powered in accordance with this study objective. Preliminary findings were:

* The SARS-CoV-2 Antibody biosensor assay was 100% sensitive and 100% specific using positive and negative SARS CoV-2 human plasma samples.

* The time in obtaining results was less than 10 minutes.

Following the above findings, the company is planning to commence clinical saliva SARS-CoV-2 Antibody trials, with the objective of submitting an Emergency Use Authorization (EUA) request to the United States Food and Drug Administration (FDA).

"We believe evidence from the validation study at the Wyss Institute supports the efficacy of our SARS-CoV-2 Antibody test, and we are now in a confident position to commence preparations for the next stage of trials," Interim GBS CEO and Chairman of the Board, Dr. Steven Boyages said.

"Our objective is to deliver an antibody test to supplement the ongoing rollout of COVID-19 vaccines, and the subsequent testing of the global population. As we have witnessed with the Delta variant, and now the emerging Omicron variant, COVID-19 is going to be a part of our lives for the foreseeable future. It is therefore paramount we succeed in delivering our technology to the people that need it the most as soon as possible for both population and post-vaccination screenings."