On December 02, 2021 FDA issued a report to blood collection centers and hospitals that documented four geographically diverse septic reactions, including two fatalities, caused by the transfusion of bacterially contaminated pathogen-reduced platelets. The Agency emphasized these cases demonstrate the need to recognize the residual risk of bacterial contamination of platelets, including pathogen-reduced platelet components.
The Company's first product is the Platelet PGD Test – a rapid test for the detection of bacterial contamination in platelets.