Shares of the Nasdaq-listed HTG Molecular Diagnostics Inc. (HTGM) surged 103%, to $4.35 per share, Thursday morning after the company announced that it obtained the CE marking for its genetic lung-cancer diagnostic test, the HTG EdgeSeq ALKPlus Assay EU.
The decision allows the commercial sale of the EdgeSeq in the EU.
Measures Gene Rearrangements for Lung Tumors
The HTG EdgeSeq ALKPlus Assay EU is an in-vitro diagnostic assay, which is used to measure and analyze mRNA ALK gene rearrangements in certain lung tumor samples of patients who were diagnosed with non-small cell lung cancer (NSCLC). In-vitro refers to the technique of performing a given procedure in a controlled environment outside of a living organism. (See also, Heat Biologics Reports Positive NSCLC Drug Results.)
In medical tests, an assay aims to measure the presence of a substance and the amount of that substance. The HTG EdgeSeq ALKPlus Assay EU helps in identification of the patients who may be eligible for treatment with ALK-targeted therapeutics, like crizotinib.
NSCLC accounts for up to 90% of all lung cancers in Europe, which reports around 391,000 lung cancer cases each year. Regular checking for rearrangement in the ALK gene is recommended for all NSCLC patients, and HTG’s assay aims to fill the gap.
The CE marking paves the way for the Tuscon, Arizona-based company’s assay to meet the legal requirements of entering the EU market. CE marking certifies that the medical device or the product meets the essential requirements of all relevant European Medical Device Directives. It is a mandatory and legal requirement before a medical device is placed on the market in the European Union.
"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.” (See also, Merck's Keytruda Approved for Lung Cancer in EU.)