How a Key European Decision Is Making All the Difference at HTG

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HTG Molecular Diagnostics Inc. (NASDAQ: HTGM) saw its shares make a massive move to the upside after the company announced that it has obtained CE Marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU.

The CE Marking literally means “European conformity,” or that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. The CE Marking on a product ensures the free movement of the product within the European Free Trade Association (EFTA) and EU.

The purpose of the HTG EdgeSeq ALKPlus Assay EU is 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 (NSCLC). It may be used to aid in the identification of patients eligible for treatment with ALK-targeted therapeutics, such as crizotinib, and is automated on the HTG EdgeSeq system using a next-generation sequencer for detection.

Due to the important therapeutic implications, routine testing for rearrangement in the ALK gene is now recommended for all NSCLC patients diagnosed with adenocarcinoma.

T.J. Johnson, HTG’s president and CEO, commented:

We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our diagnostic assay menu in Europe. 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.

On a worldwide basis, lung cancer is a leading cause of cancer death in men and women. In Europe, roughly 391,000 people were diagnosed with lung cancer in a single year, according to the European Society for Medical Oncology, and NSCLC accounts for 85% to 90% of all lung cancer cases.

Shares of HTG traded up more than 45% at $3.11 early Thursday, with a consensus analyst price target of $5.00 and a 52-week trading range of $1.20 to $4.45.