OpGen Rises on Submitting Updated Testing Materials to FDA

OpGen also recently completed the move of its U.S. headquarters to its new facility in Rockville, Maryland.
Publish date:

OpGen  (OPGN) - Get Report rose Monday after the precision medical company said it had submitted updated certification to the Food and Drug Administration.

Shares of the Gaithersburg, Maryland, company were climbing 7.7% to $2.23 on Monday.

Stocks Fall as Wall Street Weighs Inflation and Global Corporate Taxes

The company said it had submitted an updated 510(k) summary document to the FDA for its Acuitas AMR Gene Panel, which is a rapid diagnostic test for the detection of antimicrobial resistance genes. 

An antimicrobial is an agent that kills microorganisms or stops their growth.

A 510(k) summary submission must demonstrate that the device to be marketed is substantially equivalent to a legally marketed device in that it does not raise any new issues of safety and effectiveness.

OpGen said the document incorporates the FDA’s requested updates to various documents such as the package insert, electronic user guide, and operator manual. 

Consistent with the FDA’s previously communicated timeline, the company said, the FDA provided substantive feedback on all of these key documents by the end of May.

The FDA had previously informed OpGen that it intends to complete its review by the end of August, but that it could not commit to a timeline due to such factors the agency's workload and public health priorities.

“We are excited to see the excellent progress that we have been able to make towards completion of our Acuitas AMR Gene Panel for Isolates filings with the FDA and the nice cadence of FDA responses and valuable inputs moving us much closer towards reaching a final FDA clearance decision point in the coming months," CEO Oliver Schacht said in a statement.

In addition, OpGen said it recently completed the move of its U.S. headquarters, laboratories and operations and warehouse to its new Rockville, Maryland facility. 

The new 10,000 square feet facility marks the completion of the business integration and will result in net savings of about $600,000 annually in the coming years, the company said.

The announcement came on the same day the FDA approved aducanumab, Biogen's  (BIIB) - Get Report highly anticipated Alzheimer's disease drug.

Also, Moderna  (MRNA) - Get Report traded at a record high Monday after the drugmaker filed for European approval for its coronavirus vaccine to be used on teenagers.