- Products are rare antisera blood typing reagents developed and manufactured by Quotient
- U.S. commercialization of these products will extend the range and method of reagents available in the market for antigen phenotyping
- Equivalent products are already approved and commercialized outside of the U.S.
- Five additional rare antisera products are anticipated to be licensed for sale in the U.S. by the FDA later in 2017
JERSEY, Channel Islands, March 23, 2017 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ: QTNT ), a commercial-stage diagnostics company, today announced that eight new rare antisera blood typing reagent products have been licensed for commercialization in the U.S. by the U.S. Food and Drug Administration (“FDA”).
The licensed rare antisera products are for use in transfusion diagnostics, and are formulated specifically for antigen phenotyping. These products are the most frequently used for special antigen testing by customers, yielding significant potential for customer uptake and benefit. The products cover Fy a and Fy b ; S and s; Kell; Jk a and Jk b and P 1 .
“These licenses represent another significant milestone in the expansion of our transfusion diagnostics product offering, leveraging our acknowledged expertise in the development and regulatory approval of transfusion medicine diagnostic products,” said Jeremy Stackawitz, President of Quotient.
Five additional rare antisera products are awaiting FDA license, with regulatory approval and commercialization anticipated later in 2017.
About Quotient Limited
Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing its proprietary MosaiQ TM technology platform to disrupt and transform the $3.4 billion global transfusion diagnostics market. Quotient has over 30 years of experience developing, manufacturing and commercializing transfusion diagnostic products. The company’s operations are based in Switzerland, Scotland and the US.”
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 and the development, regulatory approval, commercialization and impact of MosaiQ TM . 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 proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; 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 and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
CONTACT: Paul Cowan, Chairman & Chief Executive Officer – CEO@quotientbd.com; +1 267 756 0842
