Quotient announces initial MosaiQ SDS field trial data
Quotient reported EU field trial performance data for its initial MosaiQ Serological Disease Screening, or SDS, Microarray. 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 marked MosaiQ instrument. The field trial results represent a step in advance of the company's CE marking submission for the initial SDS microarray, which is currently planned for later this quarter. In the field trial, in excess of 4600 samples were tested for CMV and for Syphilis. "The SDS microarray performance in a clinical setting gives me added confidence in its position as an important complement to the Company's initial MosaiQ Immunohematology (IH) Microarray, which was submitted for CE mark approval late in September 2018. We also continue to believe it demonstrates the effectiveness of MosaiQ for high-performance immunoassays required in both transfusion diagnostics and in the larger clinical diagnostics market place," said Franz Walt, CEO.