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Investors in HTG Molecular Diagnostics Inc (NASDAQ:HTGM) were celebrating today as the shares rocketed over 104% to $4.38.
The firm said it had been granted CE marking in the European Union for its in vitro diagnostic assay used to measure and analyze gene rearrangements in lung tumor specimens.
The HTG EdgeSeq ALKPlus Assay EU is intended for patients previously diagnosed with non-small cell lung cancer (NSCLC).
It potentially fires the starting gun on sales of the product in Europe.
Lung cancer is a leading cause of cancer death in men and women. In Europe, around 391,000 people were diagnosed in a single year, according to the European Society for Medical Oncology, and NSCLC accounts for 85 to 90% of all cases.
“We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our diagnostic assay menu in Europe,” said HTG chief executive and president 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.”
Story by ProactiveInvestors