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 Type | A | B | D | C | c | E | e | K | Cw |
Concordance | 100% | 100% | 99% | 99% | 99% | 100% | 100% | 100% | 100% |
Antigen Type | k | Kpa | Fyb | Jka | Jkb | S | Leb | Antibody Screen | |
Concordance | 100% | 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.