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JERSEY, Channel Islands, April 21, 2020 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today reported positive performance data for its SARS-CoV-2 antibody test. Based on these results, under applicable regulations, the Company can now offer the MosaiQ COVID-19 Antibody Microarray as a research-use-only (RUO) product in Europe and the US. MosaiQ COVID-19 Antibody…
JERSEY, Channel Islands, April 06, 2020 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today announced the completion of the development phase of a microarray based SARS-CoV-2 (COVID-19) antibody test for the fully automated high throughput MosaiQ system in response to the global COVID-19 pandemic. One MosaiQ instrument can process up to…
JERSEY, Channel Islands, Feb. 14, 2020 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today announced that it has received the Conformité Européene (CE) Mark approval for the Initial Serological Disease Screening (SDS) Microarray. “We are very pleased to report the CE Mark approval of the Initial SDS Microarray ahead of our…
“We are very encouraged by these results. The Initial SDS and the Expanded Immunohematology Microarray will be the first powerful commercial combination to hit the market. These results continue to demonstrate the effectiveness of the MosaiQ™ platform,” said Franz Walt, CEO of Quotient. Mr.Walt added, “We remain committed to our previously stated commercialization plans and expect…
“The timely submission of our initial SDS microarray is yet another major step for the Company, advancing our efforts to demonstrate the effectiveness of MosaiQ in the transfusion diagnostics marketplace. The next steps include the submission of the initial SDS microarray for FDA approval by November this year,” said Franz Walt, the Company’s Chief Executive Officer. Microarray…
Initial IH Microarray Approval in Europe Following the successful conclusion of its first EU field trial in July 2018 and the subsequent submission of the technical dossier for CE Mark approval in late September 2018, on April 30, 2019, the Company was informed that it had received CE Mark clearance for its initial IH Microarray for use in transfusion diagnostics. Franz…
Initial SDS Microarray – Field Trial Assay Performance Field trial results for the initial MosaiQ SDS Microarray used for the detection of CMV and Syphilis achieved the required clinical performance. The field trial data was obtained by donor center testing laboratories using microarrays manufactured in Quotient’s ISO audited manufacturing facility and run on the CE…