Justin Petrone

GLX Analytix has reached a milestone in its quest to use an overlooked class of biomarkers to deliver new molecular tests to market.

Montpellier-based Alcediag also recently obtained a CE-IVD mark for the test, called Edit-B.

Europe's new In Vitro Diagnostic Regulation is reshaping the way that laboratories in the region use in-house assays for diagnostics.

The company recently presented data on the use of its spectroscopic liquid biopsy test for the early-stage detection of multiple cancers at ASCO.

Previous guidelines for clinical NGS, published by the society in collaboration with EuroGenTest in 2016, focused mainly on whole-exome sequencing.

InfanDx plans to introduce an initial version of the assay as a laboratory-developed, mass spectrometry-based test later this year.

The test can be prepared in a lateral flow format, requires no additional instruments, and can be run in at-home settings.

Europe is still struggling to meet the requirements of the regulation, which calls for the clearance of most tests by notified bodies before they can be sold for clinical use.

To accelerate diagnostic development, the Newcastle-based firm recently snagged a £272,000 Innovate UK grant.

The Italian Ministry of Economic Development has committed €8 million to the project to develop a new whole-genome sequencing assay called the Dante Citizen Test.