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OpGen Nabs CE-IVD Mark for SARS-CoV-2 Kit

NEW YORK – OpGen announced Thursday that its subsidiary Curetis has received CE marking for its SARS-CoV-2 Kit with PULB.

The company is launching the kit in Europe. 

The RT-PCR kit qualitatively detects the virus from oropharyngeal and nasopharyngeal swabs and works with isolated RNA or swabs treated with PCR-Compatible Universal Lysis Buffer, or PULB, which is provided in the kit. Offering PULB allows labs to bypass the need for extraction equipment and reagents, OpGen said.

Results are provided in about an hour and the kit runs on a variety of PCR instruments, such as the Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 Real-Time PCR System and Bio-Rad Laboratories' CFX96 Real-Time PCR Detection System.

Previously, OpGen had been distributing BGI's SARS-CoV-2 test kit but will stop distributing it effective immediately, CEO Oliver Schacht said in a statement.

In early morning trading on the Nasdaq Thursday, OpGen's stock was up 76 percent to $3.60.