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Opgen Inc: 1 director
A director at Opgen Inc bought 25,000 shares at 0.850USD and the significance rating of the trade was 58/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly show...
- Sean Conroy
OpGen - AMR Gene Panel clearance expected shortly
OpGen has announced that it submitted an updated 510(k) summary of its Acuitas AMR Gene Panel test in bacterial isolates to the FDA in June and believes that the review of the 510(k) clearance should be completed by the end of August (a timeline previously communicated to the company by the FDA). That said, given the ongoing pandemic, this timeline is not guaranteed. Also, OpGen continues to plan to initiate a clinical trial program for complicated urinary tract infections (cUTI) with the Unyver...
- Sean Conroy
OpGen - AMR Gene Panel clearance expected shortly
OpGen has announced that it submitted an updated 510(k) summary of its Acuitas AMR Gene Panel test in bacterial isolates to the FDA in June and believes that the review of the 510(k) clearance should be completed by the end of August (a timeline previously communicated to the company by the FDA). That said, given the ongoing pandemic, this timeline is not guaranteed. Also, OpGen continues to plan to initiate a clinical trial program for complicated urinary tract infections (cUTI) with the Unyver...
- Sean Conroy
OpGen - Q121 results
OpGen reported Q121 sales of $0.8m, up 35% compared to Q120, with growth mainly due to the April 2020 business combination with Curetis. The company expects to be able to build on this level with the help of the future 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates as well as potential approvals for the Unyvero platform in China and Colombia. To maintain the momentum, OpGen plans to initiate a clinical trial program for complicated urinary tract infections (cUTI) with ...
- Sean Conroy
OpGen - 2020 results
OpGen reported 2020 sales of $4.2m, up 20% compared to the $3.5m in sales in 2019, with growth mainly due to the merger with Curetis. We expect the company to be able to build on this level with the help of the future 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates as well as potential approvals for the Unyvero platform in China and Colombia. To maintain the momentum, OpGen plans to initiate a clinical trial program for complicated urinary tract infections (cUTI) and in...
- Sean Conroy
OpGen - An increased focus on Unyvero
OpGen Q320 sales were $1.1m, up 63% from Q319, thanks to the merger with Curetis. The company announced that it will be increasing its focus on the Unyvero platform, partly due to its level of automation and ease-of-use and partly due to the desire to improve the company’s operating efficiency. In light of this, OpGen has decided to discontinue the legacy FISH products business as of mid-2021 and also to discontinue the Acuitas AMR Gene Panel clinical trial in urine samples for complicated urina...
- Sean Conroy
OpGen - Q220 results
OpGen recently reported its Q220 results. Sales were $1.2m, up 18% from Q219, thanks to the inclusion of the Curetis business. Importantly, the company announced in June that it has extended its partnership with the New York State Department of Health for a second year, which will have a contract value of up to $450,000. OpGen also recently announced a strategic partnership with Menarini Silicon Biosystems to co-promote COVID-19 related products in North America.
- Sean Conroy
OpGen - Merger with Curetis closes
Following approval from both OpGen and Curetis shareholders, the merger between the two companies has now closed. Curetis is a Germany-based molecular diagnostics company with a focus on infectious disease. It has two main business lines: the Unyvero A50 high-plex polymerase chain reaction (PCR) platform for the diagnosis of infectious disease in hospital patients; and the ARES AMR database (ARESdb), which includes data on 40,000 sequenced strains with a focus on resistant pathogens. Together, O...
- Sean Conroy
OpGen - Shareholder votes on Curetis merger coming
In September, OpGen announced a merger with Curetis, a Germany-based molecular diagnostics company with a similar focus on infectious disease. Curetis has two main business lines, the Unyvero A50 high-plex polymerase chain reaction (PCR) platform for the diagnosis of infectious disease in hospital patients and the ARES AMR database (ARESdb), which includes data on 40,000 sequenced strains with a focus on resistant pathogens. Closure is dependent on certain conditions including approval by both O...
- Maxim Jacobs
OpGen - First 510(k) filed with the FDA
OpGen has announced that it has filed for 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates with the FDA, with clearance expected by the end of the year. The company continues to expect to file a follow-on De Novo 510(k) submission in Q419 for approval of the Acuitas AMR Gene Panel test in urine samples, with another De Novo 510(k) submission for the Acuitas Lighthouse software soon thereafter or at approximately the same time.
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