They used central lab with conventional test equipment to consolidate and process patient samples (not their magic lab on the bench device) and issue the results. The problem was that their central lab(s) was run poorly (multiple violations) so the results were questioned. (Similar to lets say a bread factory making bread, then the inspector comes in and finds out that certain fridges used for yeast storage were out of spec by 5 degrees, no batch log files etc. and shuts down the factory. The bread that was produced at such factory was definitely not "fake").
I believe its a case of completely incompetent leadership that ultimately snowballed into MUCH bigger issues (what else to expect from a 19 year old girl with no experience running a company in one of the hardest/most complicated and most heavily regulated industries?)!
They used central lab with conventional test equipment to consolidate and process patient samples (not their magic lab on the bench device) and issue the results. The problem was that their central lab(s) was run poorly (multiple violations) so the results were questioned. (Similar to lets say a bread factory making bread, then the inspector comes in and finds out that certain fridges used for yeast storage were out of spec by 5 degrees, no batch log files etc. and shuts down the factory. The bread that was produced at such factory was definitely not "fake").
I believe its a case of completely incompetent leadership that ultimately snowballed into MUCH bigger issues (what else to expect from a 19 year old girl with no experience running a company in one of the hardest/most complicated and most heavily regulated industries?)!