FDA Licenses Eight New Quotient Reagent Products for Sale in the U.S.
March 23 2017 - 4:05PM
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
Fya and Fyb ; S and s; Kell; Jka and Jkb and
P1.
“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
MosaiQTM 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 MosaiQTM. 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
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