Justin Petrone

The year saw the resolution of pressing issues around how IVDs will be regulated in Europe, including the UK, in the future.

Elypta is also developing a third test for the early detection of multiple cancers, which the company believes could eventually be used for routine cancer screening.

FIND plans to expand its activities around its diagnostic network optimization process, including the use of its OptiDx platform, to 15 more countries.

The company recently expanded its collaboration with Sanquin, the Netherlands' central blood bank, to support its diagnostic development activities.

The firm recently debuted its offering, which consists of assay kits, an integrated diagnostic platform, and a results management system.

The Greek molecular diagnostics company, which received CE marking for a SARS-CoV-2 test, plans to obtain a CE-IVD mark for an influenza A assay by December.

Industry observers have welcomed the proposal but cautioned that many challenges remain, regardless of its application date.

The company has tests focused on C-reactive protein and phenylalanine in its pipeline, with regulatory approval possibly next year.

European laboratories that modify existing assays or make their own tests to better care for patients are staring at a substantial increase in oversight.

The companies were recently awarded a €2.4 million Eurostars grant to support the development and validation of the assay.