Quotient Limited Provides Status Update on the Initial SDS Microarray and MosaiQ Instrument for the US Market

Rhea-AI Summary

Quotient Limited (NASDAQ:QTNT) has received a request from the U.S. FDA for additional testing data for its 510(k) application for the Initial Serological Disease Screening Microarray (SDS) and MosaiQ instrument. The company plans to re-submit its application in early 2021 and aims for FDA clearance by mid-2021. Quotient does not anticipate this request to impact the commercial launch of the MosaiQ platform in the U.S. significantly. The MosaiQ technology is designed to enhance diagnostic testing efficiency and is being utilized in COVID-19 antibody testing, which has received Emergency Use Authorization.

Positive

• The company plans to resubmit its 510(k) application with additional data in early 2021.
• Quotient targets FDA clearance for its MosaiQ platform by mid-2021.
• The MosaiQ technology offers increased efficiency and workflow improvements for laboratories.

Negative

• The request for additional testing data from the FDA could indicate potential regulatory scrutiny.
• Uncertainties remain regarding market conditions and potential delays in the commercial launch.

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."

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 operational cost savings to laboratories around the world. In response to the global effort to combat COVID-19, Quotient developed the MosaiQ COVID-19 Antibody Microarray which is CE marked and has received the U.S. FDA Emergency Use Authorization. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.

Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements regarding the underwritten public offering, including the anticipated net proceeds to be raised in the offering and expected closing date of the offering. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially, including: market conditions; Quotient's ability to satisfy closing conditions related to the offering; unanticipated expenses associated with the offering; and other risks set forth in Quotient's most recent Annual Report on Form 10 K and Quarterly Report on Form 10 Q, as well as other documents that Quotient files with the Securities and Exchange Commission, including the Registration Statement on Form S 3 (File No. 333 248235), as amended by Amendment No. 1, for the offering. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements because of new information, future events or circumstances or other factors. The Quotient logo, Quotient MosaiQ and MosaiQ are trademarks or registered trademarks of Quotient Limited or its subsidiaries in various jurisdictions.

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

FAQ

What is the latest news about Quotient Limited (QTNT)?

Quotient Limited announced it received a request from the FDA for additional data for its 510(k) application regarding the MosaiQ instrument, with plans to resubmit in early 2021.

When is Quotient Limited expecting FDA clearance for its MosaiQ platform?

Quotient Limited is targeting mid-2021 for FDA clearance of the MosaiQ platform.

How will the FDA's request impact Quotient Limited's commercial launch?

Quotient Limited does not expect the FDA's request for additional data to materially delay the commercial launch of the MosaiQ platform.

What is the significance of the MosaiQ COVID-19 Antibody Microarray?

The MosaiQ COVID-19 Antibody Microarray has received Emergency Use Authorization from the FDA, contributing to Quotient's response to the pandemic.

What challenges does Quotient Limited face regarding its FDA application?

Quotient Limited faces uncertainties related to market conditions and the need for additional testing data for its FDA application.