NEW YORK – OpGen announced on Wednesday preliminary fourth quarter revenue of $1.3 million, up nearly 63 percent compared to the previous year.
The infectious disease diagnostics firm, however, noted that preliminary fiscal year 2020 revenue was $5.2 million, down 13 percent from $6.0 million in 2019. OpGen's cash position was $13.3 million as of the end of 2020.
OpGen also said it expects a near-term decision from the US Food and Drug Administration for marketing clearance of its Acuitas AMR Gene Panel in the first quarter of 2021. The panel was originally submitted to the FDA in May 2019, and the agency has requested additional information twice.
"We have strong lines of communication open with the FDA regarding the Acuitas AMR Gene Panel for Isolates," OpGen CEO Oliver Schacht said. "Based on the most recent feedback from the FDA, we expect them to resume review activities following a COVID-19 related staffing surge, and we … are fully prepared to follow with a swift commercial launch once FDA cleared."
OpGen subsidiary Ares Genetics' exclusive negotiation with an undisclosed in vitro diagnostic partner to collaborate and license its clinical diagnostics technology expired, but the company said it is still discussing non-exclusive licensing and collaboration deals.