OpGen’s Subsidiary Curetis Receives Batch of Ten New C-Series Unyvero A30 Instruments

Rhea-AI Summary

OpGen's German subsidiary, Curetis GmbH, has received a batch of ten Unyvero A30 C-Series instruments that have passed testing and are optimized for production and clinical trials. The instruments will enable rapid sample-to-answer molecular testing with various chemistries and assay formats. The C-Series instruments have been improved for manufacturability, serviceability, and robustness, with extended lifetime of key moving parts and reduced manufacturing costs. The company plans to use these instruments for further product development, clinical trials, and regulatory submissions.

Positive

• OpGen's German subsidiary, Curetis GmbH, has received a batch of ten Unyvero A30 C-Series instruments that are optimized for production and clinical trials. These instruments will enable rapid sample-to-answer molecular testing with various chemistries and assay formats. The improvements made to the C-Series instruments include enhanced manufacturability, serviceability, and robustness, as well as extended lifetime of key moving parts. The company intends to use these instruments for further product development, clinical trials, and regulatory submissions.

Negative

• None.

• Following final assembly and successful testing, a batch of ten Unyvero A30 instrument systems has been received
• Latest C-Series Unyvero A30 instruments optimized for series production and clinical trials

ROCKVILLE, Md., June 22, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported that its German subsidiary, Curetis GmbH, has received the full set of ten Unyvero A30 C-Series instruments, which have been assembled by its development partner, DMTPe, in Germany. The instruments have successfully passed electrical and functional testing and will allow rapid sample-to-answer molecular testing with numerous chemistries and assay formats.

These C-Series instruments incorporate all learnings from extensive testing of the 10 B-Series instruments over the past 12 months. The C-Series instruments have been optimized and improved for manufacturability, serviceability and robustness. They have also been optimized for extended lifetime of all key moving parts inside the instruments, as well as cost of goods in the manufacturing process of these A30 instruments.

Andreas Boos, CTO of Curetis and program lead of the Unyvero A30 platform project commented: “We are excited to have taken possession of this newest batch of instruments. With all of the improvements made to date, this is now very close to the final release version of the product. We intend to use the A30 C-Series instruments in all further product development and clinical trials as well as regulatory submissions for our application cartridges on the A30 system.” Mr. Boos added that, “all of our ten B-Series instruments have also been upgraded to this latest standard to plan for sufficient A30 instruments to be available for the continued development of our own assays and cartridges in house, and for collaborative projects such as the FIND R&D collaboration which aims to bring an A30 platform and antimicrobial resistance (AMR) test from blood cultures to low and middle income countries, as well as for other R&D collaboration projects funded by third party partners.”

About OpGen, Inc.

OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, ARESasp, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.

For more information, please visit www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding OpGen’s C-Series Unyvero A30 instruments.   These statements and other statements regarding OpGen’s future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the success of our commercialization efforts, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use proceeds from recent financings, our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com

OpGen Investor & Press Contact:
Alyssa Factor
Edison Group
afactor@edisongroup.com

FAQ

What is OpGen's German subsidiary?

OpGen's German subsidiary is Curetis GmbH.

What are the features of the Unyvero A30 C-Series instruments?

The Unyvero A30 C-Series instruments enable rapid sample-to-answer molecular testing with various chemistries and assay formats.

What improvements have been made to the C-Series instruments?

The C-Series instruments have been improved for manufacturability, serviceability, and robustness, with extended lifetime of key moving parts.

What are the plans for using the C-Series instruments?

The company plans to use the C-Series instruments for further product development, clinical trials, and regulatory submissions.