Rapid prototyping and regulated manufacture of 2 million CE-mark Covid-19 tests

We were approached by a major UK headquartered diagnostic developer in April 2020 looking for assistance with the development of a custom lyophilised RT-PCR SARS-CoV-2 assay.

Listing Our extensive lyophilisation expertise, we were able to provide a comprehensive  proof-of-concept study  to assess the performance of the mastermix and associated reagents.

A triple batch validation followed and we were able to support QuantuMDx in achieving their CE-mark status.

Following the successful awarding of the CE-mark, we were then appointed as their contract manufacture partner and went on deliver in excess of 2 million tests.

Read the client’s press release for more details