Maryland-based OpGen Inc (Nasdaq:OPGN) has seen its stock price skyrocket after the company announced that its subsidiary, Curetis GmbH has gained the CE mark certification needed in the European Union for its COVID-19 test.
Its share price is up at $3.51 after a 71.22% higher premarket. Yesterday saw its shares close at $2.05 after a near 1% fall.
The test takes mouth and nose swabs to test people suspected of having the COVID-19 virus.
The company says that the test circumvents the need for extraction equipment and kits, which thereby provides operational efficiencies and saves time and money.
“Our customers will benefit from an optimized workflow and a test that delivers great performance and significantly shorter time-to-result at favorable economics compared to many of the commercially available open PCR platform COVID-19 tests including the BGI SARS-CoV-2 kit,” said Oliver Schacht, PhD, CEO of OpGen.
OpGen said that the test, which is manufactured by Curetis’ team in Germany, can provide test results in one hour.
“The CE-IVD Marking is an important step in advancing our efforts to support critical COVID-19 testing; the Curetis SARS-CoV-2 Kit with PULB provides additional testing capacity in countries that recognize the CE Mark to test patients,” said Johannes Bacher, COO of OpGen.