Quotient Limited Announces Receipt of CE Mark for the Extended Immunohematology Microarray

Rhea-AI Summary

Quotient Limited (NASDAQ:QTNT) has received the CE Mark for its MosaiQ Extended Immunohematology Microarray, allowing commercialization across the EU. This platform simplifies blood testing with improved workflow, reduced operating costs, and a broader range of tests, including Antibody Screening and Antigen Typing. CE marking confirms compliance with European Medical Devices Directive. The CEO highlighted the potential for better matched blood transfusions, reducing life-threatening risks. Quotient aims to enhance diagnostics based on over 30 years of experience in transfusion diagnostics.

Positive

• Received CE Mark for MosaiQ Extended Immunohematology Microarray, enabling commercialization in the EU.
• Improved laboratory workflow and reduced operating costs.
• Comprehensive range of tests enhances blood donor sample characterization.
• Potential for better matched blood transfusions reduces risk of adverse events.

Negative

• None.

The Extended Immunohematology microarray provides labs with comprehensive characterization, simplified workflow, and high throughput—all on a single multimodal multiplexing platform

JERSEY, Channel Islands, March 08, 2022 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today announced it has received Conformité Européenne (CE) Mark for its MosaiQ Extended Immunohematology (IH) Microarray. The CE marking confirms the Extended IH Microarray meets the requirements of the European Medical Devices Directive. This allows the Company to commercialize the microarray for use with the Company's MosaiQ instrument across the European Union and other CE Mark recognizing geographies. The Company's MosaiQ platform offers an all-in-one, fully automated, high-performance solution in blood-testing laboratory and other settings. The IH microarray for which the CE mark was just obtained substantially increases the range of tests that can be run on the platform.

Improved Economic & Clinical Value with MosaiQ Extended Immunohematology on a Single Platform

The MosaiQ Extended IH solution empowers laboratories and clinicians by delivering improved workflow, leading to lower operating costs. The newly-CE marked IH microarray offers Antibody Screening, Antigen Typing, including ABO forward and reverse grouping. This expanded array of features allows for comprehensive characterization of blood donor samples (blood typing and disease screening) through a single test procedure.

“By enhancing the laboratory’s ability to provide rapid, more comprehensive red blood cell phenotyping, health care providers can deliver better matched blood and reduce the risk of transfusion adverse events that may be life-threatening,” said Dr. Christine C. Ginocchio, Chief Scientific and Medical Officer.

“We are proud to receive the CE mark for our MosaiQ Extended IH microarray and have leveraged our over 30 years of experience within transfusion diagnostics to provide a high-quality solution for laboratories and donors. We are excited to enter the MosaiQ commercialization phase and look forward to providing our stakeholders with a suite of multimodal multiplexing capabilities to help continue to drive the value and clinical utility of the MosaiQ solution on a global scale,” said Manuel O. Méndez, Chief Executive Officer of Quotient.

About Quotient Limited

Building on over 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that it believes reshape the way diagnostics are practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and create operational cost savings to laboratories around the world. Quotient's operations are based in Switzerland, Scotland and the United States of America.

Forward-Looking Statements

This news release contains 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 the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements regarding our expectations of continued growth, the development, regulatory approval, commercialization and impact of MosaiQ and other new products (including the potential for using the Company’s MosaiQ technology to infectious disease diagnostics), current estimates of fourth quarter and full year fiscal 2022 operating results and expectations regarding our future funding sources. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceedings; continued or worsening adverse conditions in the general domestic and global economic markets, including as a result of the global COVID-19 pandemic; as well as the other risks set forth in the Company's filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.

The Quotient logo, Quotient MosaiQ and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

CONTACT
Investor Relations
+41 22 545 52 26
IR@quotientbd.com

FAQ

What does the CE Mark for Quotient Limited's MosaiQ Extended Immunohematology Microarray signify?

The CE Mark indicates that the product meets European safety and performance requirements, allowing commercialization in EU member states.

How does the MosaiQ platform improve blood testing efficiency?

It simplifies workflow, lowers operating costs, and allows for a broader range of tests on a single platform.

What are the key features of the MosaiQ Extended Immunohematology Microarray?

Key features include Antibody Screening and Antigen Typing, which enhance the characterization of blood donor samples.

When was the CE Mark for the MosaiQ Extended Microarray announced?

The CE Mark was announced on March 8, 2022.