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HTG Molecular Gets CE Mark for Lung Cancer CDx

NEW YORK (GenomeWeb) – HTG Molecular Diagnostics announced yesterday that it has secured CE marking for its HTG EdgeSeq ALKPlus assay EU, clearing the test for sale in the European Union.

The in vitro diagnostic runs on HTG's EdgeSeq next-generation sequencing system and is designed to measure and analyze mRNA ALK gene rearrangements in lung tumor specimens from patients previously diagnosed with non-small cell lung cancer. It can be used to identify patients suitable for treatment with ALK-targeted therapeutics such as Pfizer's Xalkori (crizotinib).

"We are pleased to add the HTG EdgeSeq ALKPlus assay EU to our diagnostic assay menu in Europe," HTG President and CEO T.J. Johnson said in a statement. "We plan to offer this assay to selected European early adopters as we seek additional regulatory approvals elsewhere."

In January, HTG announced that it had submitted the third of four expected modules for the assay's premarket approval application to the US Food and Drug Administration. The fourth module is expected to be completed this year.