Quotient Ltd. Announces FDA Approval of Seven Additional Blood Bank Reagents
JERSEY, Channel Islands, May 21, 2019 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ: QTNT), an established, commercial-stage diagnostics company (the Company), today announced the U.S. Food and Drug Administration (FDA) has approved the commercialization of seven additional blood bank reagents for extended antigen typing, completing the Company’s core product offering to the US market.
The new products are:
Monoclonal Antisera
- ALBAclone® Anti-K
- ALBAclone® Anti-Fya
- ALBAclone® Anti-Jka
- ALBAclone® Anti-Jkb
- ALBAclone® Anti-S
- ALBAclone® Anti-s
- ALBAclone® Anti-P1
In March 2018, seven Quotient reagents were also approved by the FDA, including two market firsts. “Quotient has more than tripled our FDA approved product offering since coming directly to market in the U.S. We continue to be motivated to bring high-quality, customer-friendly products to the U.S. market, and are sincerely grateful to our customers for their ongoing support,” said Bill Brady, VP US Commercial at Quotient.
“The expansion of our Alba by Quotient™ reagent product offering in the U.S. builds on our over 30 years of heritage in transfusion diagnostics. We aim to consistently deliver quality products and services to our customers while continuing the development of our innovative microarray multiplex technology, MosaiQ™ by Quotient,” said Franz Walt, the Company’s Chief Executive Officer.
ALBAclone® monoclonal antisera are used in the laboratory to detect the presence of specific antigens on patient and donor red blood cells.
About Quotient Limited
Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is 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 operational cost savings to laboratories around the world. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania
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, current estimates of first quarter and full year FY19 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; including risks and uncertainties associated with any variation between preliminary and final study results; 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: Chris Lindop, Chief Financial Officer – ; 8
