Quotient Limited Announces FDA Approval of Seven Blood Bank Reagents, Including Two Market Firsts

News provided by

Quotient

24 Apr, 2018, 07:00 GMT

JERSEY, Channel Islands, April 24, 2018 /PRNewswire/ --

Quotient Limited ("Quotient") (NASDAQ: QTNT), an established, commercial-stage diagnostics company, today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts.

     (Logo: https://mma.prnewswire.com/media/680939/Quotient_Logo.jpg )

The new products are:

Monoclonal Antisera

  • ALBAclone® Anti-Fy[b]
  • ALBAclone® Anti-C[w]
  • ALBAclone® Anti-e
  • ALBAclone® Anti-C

Anti-Human Globulin (AHG):

  • Anti-IgG
  • Anti-IgG,-C3d; Polyspecific
  • Anti-C3d

"We are very proud to be first to market with FDA approved monoclonal Anti-Fy[b] and monoclonal Anti-C[w]. Our new Anti-Fy[b] and Anti-C[w] antisera give robust reactions with significantly shorter incubation times, improving technologist efficiency and confidence while Anti-C and Anti-e complete our line of Rh antisera," said Bill Brady, VP US Commercial at Quotient Biodiagnostics Inc.

"In addition to our four new monoclonal antisera, we are adding three essential AHG products to our extensive line of reagent red cells, ABO/Rh reagents, antisera, QC, and specialty products. The introduction of these new products is a continuation of Quotient's promise to innovate and grow our product offering in the US market," Mr Brady added.

Anti-Human Globulin (AHG) is an essential tool for laboratories responsible for blood transfusion. 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 

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 serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company's operations are based in Edinburgh, Scotland; Eysins, Switzerland 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 include statements regarding our expectations relating to our management team and the development, regulatory approval, commercialization and impact of MosaiQ.  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.