Investors in HTG Molecular Diagnostics Inc (NASDAQ:HTGM) should be smiling from ear to ear today following the news that the molecular profiling equipment maker has obtained CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU.
The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay 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 (NSCLC). The assay 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.
Lung cancer is a leading cause of cancer death in men and women worldwide. In Europe, approximately 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. Due to the important therapeutic implications, routine testing for rearrangement in the ALK gene is now recommended for all NSCLC patients diagnosed with adenocarcinoma.
“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.”
Shares of HTG Molecular Diagnostics jumped over 100% to $4.38 in Tuesday’s trading session. HTGM has a 1-year high of $4.79 and a 1-year low of $1.20. The stock’s 50-day moving average is $2.13 and its 200-day moving average is $2.19.
On the ratings front, Canaccord analyst Mark Massaro reiterated a Buy rating on HTGM, with a price target of $5.50, in a report issued on January 23. The current price target implies an upside of 17% from current levels. According to TipRanks.com, Massaro has a yearly average return of 5.7%, a 57% success rate, and is ranked #570 out of 4549 analysts.
HTG Molecular Diagnostics, Inc. provides molecular technology solutions. It offers products for miRNA, and mRNA measurement for translational research/medicine and molecular diagnostics. Its qNPA molecular technology platform detects changes in gene expression levels; especially from formalin-fixed, paraffin-embedded tissue and other biological sample types. It also offers pharma and diagnostics services.