HTG Molecular announced that it has obtained CE marking in the European Union for its HTG EdgeSeqALKPlus Assay EU, an in vitro diagnostic assay which is intended to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer.
The company further stated that its diagnostic tool could be used to aid in the identification of patients eligible for treatment with ALK-targeted therapeutics, including crizotinib. Also, the tool is automated on the HTG EdgeSeq system and uses a next-generation sequencer for detection.
Lung Cancer
HTG Molecular highlighted the fact that lung cancer is a leading cause of cancer death across the world. In Europe alone, around 391,000 people cold be diagnosed with lunch cancer in just one year and NSCLC accounts for 85 percent to 90 percent of all lung cancer cases.
"We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our diagnostic assay menu in Europe," stated TJ Johnson, HTG's president and CEO. "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."
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