Devyser Diagnostics AB has entered an in vitro diagnostic development agreement with Illumina, Inc. The agreement enables Devyser to develop and offer its in vitro diagnostic (IVD) tests on Illumina MiSeqDx next-generation sequencing (NGS) instrument in the United States and Europe. The IVD development agreement allows Devyser to perform regulatory registrations of its tests on Illumina MiSeqDx sequencing instrument. The agreement confirms Illumina's commitment to support Devyser in its registrations and enables Devyser to develop end-to-end IVD approved NGS testing solutions on the FDA regulated and CE-IVD?marked MiSeqDx sequencing platform.

Illumina MiSeqDx System is the first FDA?regulated, CE-IVD?marked, NGS platform for IVD testing. With regulatory approvals in over 50 countries, MiSeqDx has become a trusted platform for hospitals and clinical laboratories running a menu of high-quality diagnostic tests.