Benzinga | Dec 10, 2020 08:38AM EST

Quotient Limited Receives Request From FDA For Additional Testing Data Regarding 510(k) Application For SDS And MosaiQ Instrument; Intends To Re-Submit Its Application With Additional Data In Early 2021

JERSEY, Channel Islands, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today announced that it received a request from the U.S. Food and Drug Administration (FDA) for additional testing data regarding the 510(k) application for the Initial Serological Disease Screening Microarray (SDS) and MosaiQ instrument. The data the FDA has requested relates to specific individual performance characteristics of the assays on the microarray. In response to this request, the Company intends to re-submit its application, with the additional data requested by the FDA, in early 2021. Following that submission, the Company is targeting to receive the FDA 510(k) clearance in mid-2021.



The Company does not expect to be materially impacted by the need to submit additional data. Franz Walt, Chief Executive Officer of Quotient, explained, "We do not expect this development will delay the commercial launch of our MosaiQ platform in the US. As we always said, the commercialization of the initial SDS will only commence once the expanded Immunohematology microarray is available."