Quotient Limited Reports First Quarter Fiscal 2016 Financial Results

JERSEY, Channel Islands, Aug. 3, 2015 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported financial results for its fiscal first quarter ended June 30, 2015.

"Commercial scale-up of MosaiQ™ continued at a rapid pace during the first quarter," said Paul Cowan, Chairman and Chief Executive Officer of Quotient. "Conversion of the Eysins, Switzerland facility for the manufacture of MosaiQ™ consumables is now largely complete and installation of the key manufacturing and bioprocessing systems has commenced. Assays to be incorporated on the MosaiQ™ consumables for both blood grouping and disease screening continue to generate positive performance data, as we begin their transfer to final manufacture. Overall, we remain on track for the commercial launch of MosaiQ™ in Europe during the second half of calendar 2016."

MosaiQ™ Status Update

MosaiQ^TM, our next-generation automation platform for blood grouping and serological disease screening, is at an advanced stage of development and commercial scale-up. Our current efforts are focused on the installation and validation of the initial MosaiQ™ manufacturing system at our Eysins manufacturing facility and completion of the MosaiQ™ instrument with Stratec Biomedical AG ("STRATEC"), our instrument development partner. We remain on plan to manufacture both the blood grouping and the initial disease screening consumables for European field trials in the first quarter of calendar 2016. Field trials in the United States are planned to commence immediately following completion of the European trials.

We have started the transfer of individual blood grouping assays to production, which we expect to complete by the end of calendar 2015. We expect to transfer the CMV and Syphilis assays to production for inclusion on the initial disease screening consumable in the fourth quarter of calendar 2015. The remaining disease screening assays (HBV, HCV, HIV, HTLV and Chagas) for inclusion on the full disease screening consumable are scheduled to be transferred to production in the first half of calendar 2016.

Design of the MosaiQ™ instrument is now largely complete, with the current focus on software development, including software integration, and manufacturing scale-up. We have received advanced prototype instruments from STRATEC for evaluation purposes, which have met our expected functional requirements. Utilizing these prototype instruments, we plan to complete an internal performance evaluation study for MosaiQ^TM (involving ~600 known samples) in the third quarter of calendar 2015. We expect to receive field trial versions of the MosaiQ™ instrument before the end of calendar 2015, which will be subject to further software upgrades prior to the commencement of field trials.

We plan to commence formal field trials in the first quarter of calendar 2016 and then file necessary regulatory submissions in the second half of calendar 2016, first in Europe and then in the United States, to obtain required marketing clearances. If licensed for sale, we continue to anticipate commercial launch for both the MosaiQ™ blood grouping and the initial MosaiQ™ disease screening consumables in Europe during the second half of calendar 2016 and in the United States during the second half of calendar 2017. We anticipate commercial launch of the full MosaiQ™ disease screening consumable in Europe during the second half of calendar 2017 and in the United States during calendar 2018.

Conventional Reagent Business Update

"Our conventional reagent business progressed largely to plan during the first quarter of fiscal 2016 and began to play a key role in the commercial scale-up of MosaiQ™ through the production of reagent antibodies for incorporation as assays on the MosaiQ™ blood grouping consumable," said Paul Cowan. "While the business continues to feel the impact of adverse exchange rate movements on both revenues and gross profit, we expect both growth and profitability to improve throughout the remainder of fiscal 2016."