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HTG Molecular Diagnostics booms as its EdgeSeq ALKPlus assay gets EU regulatory approval

Thursday, March 23, 2017 7:17
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Shares in HTG Molecular Diagnostics Inc (NASDAQ:HTGM) soared almost 50% higher on Thursday morning after it received regulatory approval for one of its products in Europe.

HTG obtained CE marking in the European Union for its HTG EdgeSeq ALKPlus assay, an in-vitro diagnostic assay used to measure and analyse gene arrangements in lung tumour specimens.

Doctors might use the assay to work out which patients are eligible for treatment with ALK-targeted therapeutics, such as crizotinib, HTG said.

The CE mark means that a product means the product satisfies various requirements which allows it to be sold within the European economic area.

“We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our diagnostic assay menu in Europe,” said HTG President and chief executive TJ Johnson.

“Lung cancer is a significant global health problem and an important focus area for HTG. We plan to offer this assay to selected European early adopters as we seek additional regulatory approvals elsewhere.”

Today’s rise comes only weeks after HTG’s stock price more than doubled after the Tucson-based company unveiled a new direct target sequencing chemistry to be launched in the first quarter.

The stock was up US$0.96, or 45%, to US$3.10 on Thursday morning.

Story by ProactiveInvestors



Source: http://www.proactiveinvestors.com/companies/news/175303/htg-molecular-diagnostics-booms-as-its-edgeseq-alkplus-assay-gets-eu-regulatory-approval-175303.html

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