×

Quotient Limited Announces Positive Serological Disease Screening Results and Provides MosaiQ™ Development Program Update

JERSEY, Channel Islands, Jan. 11, 2016 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, will present the following update on the MosaiQ™ development program during its company presentation at the J.P. Morgan 2016 Healthcare Conference. MosaiQ™ is at an advanced stage of development and commercial scale-up and represents a truly novel testing platform for transfusion diagnostics. Current development efforts are focused on final assay optimization for the blood grouping and serological disease screening applications; commissioning the initial manufacturing system for MosaiQ™ consumables; and completing development of the MosaiQ™ instrument.

“Considerable progress has been made on the development and commercial scale-up of MosaiQ™ over the past year,” said Paul Cowan, Quotient’s Chairman and Chief Executive Officer. “During 2015, we completed construction of our MosaiQ™ consumable manufacturing facility in Eysins, Switzerland; locked the design of the initial MosaiQ™ instrument; and selected the final probe set to be included on the MosaiQ™ blood grouping consumable. We also made substantial progress on expanding the panel of intended assays to be included on the MosaiQ™ serological disease screening consumable. Additionally, we announced today a planned major expansion for the intended use of MosaiQ™ to include nucleic acid testing for donor disease screening. This natural extension of the unique capabilities of MosaiQ™ increases our addressable global market opportunity within transfusion diagnostics to over $3.4 billion.”

MosaiQ™ Development Program Update

Assay Development – Blood Grouping Panel

The final probe set for the blood grouping panel has now been defined. During the fourth quarter of 2015, Quotient continued the transfer of individual blood grouping assays to production, which is expected to be completed in the second quarter of 2016.

Assay Development – Serological Disease Screening Panel

During 2015, meaningful progress was made on the optimization of individual assays intended to be included on the serological disease screening panel. Quotient intends to initially launch MosaiQ™ into the donor testing market with a partial serological disease screening panel comprising assays for the detection of Cytomegalovirus (“CMV”) and Syphilis. Following commercial launch, Quotient plans to expand the test menu to include assays for the detection of Hepatitis B (“HBV”), comprising Hepatitis B Surface Antigen and Hepatitis B Core Antibody; Hepatitis C (“HCV”); human immunodeficiency virus (“HIV”), comprising HIV Type 1 and HIV Type 2; Human T-Lymphotropic Antibodies (“HTLV”); and Chagas disease.

Quotient completed a series of internal validation studies on individual assays being developed to detect CMV, Syphilis, HBV Surface Antigen, HIV Type 1 and HIV Type 2. The results of all of these validation studies exceeded the Company’s internal performance targets for this stage of the development process. For these studies, Quotient used commercially available, pre-characterized samples that are designed to test and challenge the full range of sensitivity and specificity for each assay. In terms of the limits of detection, these validation studies demonstrated that MosaiQ™ can detect less than 0.2 International Units of Hepatitis B Surface Antigen and less than 2.0 International Units of HIV p24 antigen, delivering an equivalent analytical sensitivity to comparable commercially available diagnostic systems (and in line with regulatory requirements).

The results of these internal validation studies are summarized in the following tables:

Target ComparatorMosaiQ™Concordance
PositiveNegativeTotalTrue
Positive
False
Positive
True
Negative
False
Negative
Syphilis291041332901040 100.0%
CMV114271411130271 99.3%



TargetSample
Size
SensitivitySpecificity
HBV Surface Antigen588 93.9% 99.8%
HIV Type 1600 99.0% 98.1%
HIV Type 2600 100.0% 99.0%


During the fourth quarter of 2015, Quotient commenced development of the remaining assays intended to be included on the serological disease screening panel to detect HBV, HCV, HTLV and Chagas disease and expects to report preliminary sensitivity and specificity data in the first quarter of 2016.

Based on results achieved to date, Quotient expects to transfer to production assays for the detection of CMV and Syphilis in the first quarter of 2016 and the remaining serological disease screening assays in the second half of 2016.

Manufacturing System – Commissioning

Commissioning of the initial manufacturing system for MosaiQ™ consumables is expected to be completed in the first quarter of 2016. The Company plans to manufacture both the MosaiQ™ blood grouping and the initial MosaiQ™ disease screening consumables for European field trials in the second quarter of 2016.

Instrument Development

Design of the MosaiQ™ instrument has been completed, with the current focus on software development and manufacturing scale-up. Quotient has received final prototype instruments, which are processing assays for development purposes, and field trial instruments are expected to be delivered in the first quarter of 2016. The field trial instruments will be subject to final software development, which we expect to complete in the second quarter of 2016, prior to the commencement of field trials.

Forecast Regulatory and Commercial Milestones

Quotient expects to commence field trials in Europe for both the MosaiQ™ blood grouping and initial MosaiQ™ serological disease screening consumables in the third quarter of 2016. The Company expects to file necessary regulatory submissions for Europe in the fourth quarter of 2016 to obtain required marketing clearances for MosaiQ™. Field trials in the United States are expected to commence in the fourth quarter of 2016 and regulatory submissions are planned to be filed in the first half of 2017 to obtain required marketing clearances in the United States. Field trials for the serological disease screening test menu expansion are expected to commence in the first half of 2017, both in the United States and in Europe.

Quotient expects to begin marketing MosaiQ™ in Europe during the fourth quarter of 2016. If approved for sale, the Company anticipates commercial launch in the United States in the first quarter of 2018. The Company also anticipates commercial launch of the expanded MosaiQ™ disease screening consumable in Europe during the second half of 2017 and in the United States during 2018, if approved for sale.

Paul Cowan will be presenting at the J.P. Morgan 2016 Healthcare Conference at 8:00 a.m. PT on Wednesday, January 13.

About MosaiQ™

MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms. Once approved, it will be the first fully automated solution for blood grouping, providing for the comprehensive characterization of both donor and patient blood, with turnaround times significantly quicker than existing methods. Widespread adoption of MosaiQ™ is expected to improve patient outcomes through better and easier matching of donor and patient blood, given cost-effective extended antigen typing offered by MosaiQ™. Improved patient outcomes from the use of MosaiQ™ include the potential for reduced incidence of adverse events associated with transfusion, particularly alloimmunization, where patients develop antibodies to foreign antigens introduced through transfused blood. MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories, including:

  • elimination of the need for routine manual testing typically undertaken by highly skilled technicians;
  • simplification of required consumables and testing processes;
  • consolidation of multiple instrument platforms in donor testing laboratories;
  • significant reduction in sample volume requirements;
  • reduction in the number of patient/donor samples required, consumables and reagent waste; and
  • more streamlined processes for matching donor units to patients.

Quotient expects to develop additional applications for MosaiQ™, starting with nucleic acid testing for donor molecular disease screening, upon completion of assay development for the blood grouping and serological disease screening applications.

About Quotient Limited

Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland 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 and 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 our expectations of continued growth and the development, regulatory approval, commercialization and impact of MosaiQTM and other new products. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the company's filings with the Securities and Exchange Commission. 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.

The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

INVESTORS: Stephen Unger, Chief Financial Officer – stephen.unger@quotientbd.com; (212) 228-7572

MEDIA: Michelle Thaler, MSLGROUP – quotient@mslgroup.com; (781) 684-6219

Source:Quotient Limited