If our test fails the validation, then it's not fit to go to market, i'm happy to go through whatever validation they want us to go through.

Brigette Bard

How they fail tests when there is no specification, I literally have no idea. We have been begging to be told what to do. We have a test ready to submit, we need to get our test approved, and they're not giving us an option of how to get it approved.

There will be specifications released for tests this week by MHRA (the Medicines and Healthcare products Regulatory Agency) which will help companies understand the technical performance expected for their kits.