HTG Molecular gets CE mark for lung tumor assay
Shares of HTG Molecular Diagnostics Inc. HTGM, +69.21% rocketed 63% in premarket trade Thursday, after the company said it obtained CE marking in the European Union for its in vitro diagnostic assay used to measure and analyze gene rearrangements in lung tumor specimens. CE marking means a product conforms to requirements for sale in the European economic area. “We are pleased to add the HTG EdgeSeq ALKPlus Assay EU to our diagnostic assay menu in Europe,” said HTG Chief executive TJ Johnson in a statement released late Wednesday. “We plan to offer this assay to selected European early adopters as we seek additional regulatory approvals elsewhere.” The stock’s surge comes less than a month after it nearly tripled, running up 159% on Feb. 27 after the company unveiled a new direct-target sequencing chemistry to be launched in the first quarter. Through Wednesday, the stock had dropped 4.5% year to date, while the S&P 500SPX, -0.11% had gained 4.9%.