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Quotient Limited Announces MosaiQ™ Expanded IH EU Field Trial Performance Data

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Quotient Limited (NASDAQ:QTNT) announced preliminary EU field trial data for its MosaiQ Expanded Immunohematology Microarray, showing high accuracy in blood donor testing. Over 4000 samples yielded a concordance rate of 100% for several antigen types, and 99% for others. The company aims for CE mark submission by year-end and plans a US field trial with initial results expected mid-2021. Quotient's technology promises to enhance lab efficiency and lower operational costs.

Positive
  • Preliminary EU field trial showed 100% concordance for multiple antigen types.
  • Plans for CE mark submission by year-end to enhance market access.
  • Anticipates US field trial with results by mid-2021, expanding growth opportunities.
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  • None.

JERSEY, Channel Islands, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today reported preliminary EU field trial performance data for its MosaiQ Expanded Immunohematology (IH) Microarray. The data suggest that tests performed with Quotient's Microarray are highly accurate.

Expanded IH Microarray Preliminary Performance

To date in the EU field trial, over 4000 randomly selected human blood donor samples have been tested. The concordance data obtained through the study are as follows:

Antigen TypeABDCcEeKCw
Concordance100%100%99%99%99%100%100%100%100%
Antigen TypekKpaFybJkaJkbSLebAntibody Screen
Concordance100%98%98%99%96%99%99%97%

The preliminary field trial data were obtained in testing laboratories using microarrays manufactured in Quotient’s ISO certified manufacturing facility in combination with the CE marked MosaiQ instrument.

The Company plans to make a CE mark submission for the Expanded IH microarray around year end. “We decided to seek two separate CE Marks - one covering all the tests included in the expanded IH menu and one with a more basic menu. This will allow us to respond more flexibly to individual tenders in Europe. We are on track to have the first powerful commercial combination, Expanded IH and Initial SDS, available for sale in Europe during the second quarter of calendar year 2021,” said Franz Walt, Chief Executive Officer of Quotient.

Quotient also reported that it expects to shortly begin a US field trial for the Expanded IH Microarray and that initial results from that trial are expected by mid-2021.

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 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 create operational cost savings to laboratories around the world. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.

Contact: Peter Buhler, Chief Financial Officer, IR@quotientbd.com; +41 22 545 52 26


FAQ

What are the preliminary results of Quotient Limited's MosaiQ Expanded Immunohematology Microarray?

Quotient Limited's preliminary results indicated high accuracy, with a 100% concordance rate for several antigen types tested during EU field trials.

When does Quotient Limited expect to submit for the CE mark for its Expanded IH Microarray?

Quotient Limited plans to submit for the CE mark around year-end 2020.

What is the significance of the 4000 blood donor samples tested in Quotient Limited's trial?

The testing of over 4000 blood donor samples demonstrates the reliability and accuracy of Quotient's MosaiQ technology in real-world applications.

What is the expected timeline for Quotient Limited's US field trial?

Quotient Limited expects to begin its US field trial shortly, with initial results anticipated by mid-2021.

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