The Codex4SMEs project, which has a €3.1 million budget, involves seven countries to increase cooperation in Europe's northwest region to develop companion diagnostics.
Backed by €19 million in EU funding, the initiative, called BigData@Heart, will create a research platform that could change the way cardiovascular diseases are diagnosed and treated.
While stakeholders hope that the country will continue to accept the CE-IVD mark after Brexit, the issue is unresolved, leaving firms in the dark as to what the future may bring.
The firm's CEO said that its assay is applicable in other indications where immunosuppressive therapies are used, such as rheumatoid arthritis.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
The initiative includes academic and private sector partners and aims to train new researchers in the early diagnosis of brain cancer.
The new algorithm, called TOPSPIN, complements the company's MMprofiler test. It is considering making TOPSPIN-generated data available to its MMprofiler patients.
A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.
If approved, the new rules for IVDs would take effect in 2022.
The collaborators are developing tests for rectal cancer based on microRNA and messenger RNA signatures.