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June 30, 2015 9:07 AM ET

Healthcare Equipment and Supplies

Company Overview of Ortho-Clinical Diagnostics, Inc.

Company Overview

Ortho-Clinical Diagnostics, Inc. provides solutions for screening, diagnosing, monitoring, and confirming diseases for the transfusion medicine community and laboratories worldwide. It offers integrated clinical chemistry and immunoassay testing systems, chemistry systems, immunodiagnostic systems, and automation solutions that streamline and standardize laboratory workflow. The company also provides donor screening solutions, such as Ortho Summit System, a system for screening assays, automation, and information management; T-cruzi ELISA test system, an enzyme-linked immunosorbant assay for the qualitative detection of antibodies to trypanosoma cruzi in human serum and plasma specimens; and...

1001 US Highway 202

Raritan, NJ 08869

United States

Founded in 1974

Phone:

908-218-8137

Fax:

908-218-8168

Key Executives for Ortho-Clinical Diagnostics, Inc.

Chairman and Chief Executive Officer
Age: 54
Chief Financial Officer
Age: 49
Chief Operating Officer
Executive Vice President for Commercial
General Counsel
Compensation as of Fiscal Year 2014.

Ortho-Clinical Diagnostics, Inc. Key Developments

Ortho-Clinical Diagnostics, Inc. Receives FDA 510k Clearance for VITROS Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay

Ortho-Clinical Diagnostics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the VITROS Chemistry Products HbA1c Reagent Kit to be used on the VITROS 5600 Integrated System, VITROS 4600 Chemistry System, and the VITROS 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in the diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The VITROS Chemistry Products HbA1c Reagent Kit offers operational and performance enhancements over the company's currently marketed VITROS Chemistry Products d%A1c Reagent Kit, including higher throughput and simplified calibration. The design of the VITROS HbA1c assay allows its use in patients with hemoglobin variants S, C, D, and E traits. The new assay is now available and will replace the VITROS Chemistry Products d%A1c Reagent Kit, which will eventually be discontinued. A false high or low HbA1c value caused by a clinically silent hemoglobin variant may lead to over or under treatment. The design of the VITROS HbA1c assay allows its use in patients with hemoglobin variants S, C, D and E traits. In addition, the method is unaffected by the presence of chemically modified hemoglobin. Approximately 7% of the world's population are heterozygous carriers of hemoglobinopathies. Among diabetic patients, more than 12 million worldwide are estimated to have a hemoglobin disorder. In the U.S., the four most common variants are Hb S, C, E, and D. HbE is found primarily in people from Southeast Asia and is now encountered quite commonly in the U.S. HbD Punjab is found most commonly in the Punjab region of India and is also encountered in the U.S.

Ortho-Clinical Diagnostics, Inc. Receives Health Canada Approval for ORTHO VISION™ Analyzer

Ortho-Clinical Diagnostics Inc. (OCD) announced that it obtained Health Canada approval for the ORTHO VISION™ Analyzer, a highly interactive, fully automated analyzer for transfusion medicine laboratories. The ORTHO VISION™ Analyzer for ORTHO Column Agglutination Technologies will be commercially available in Canada in the second quarter of 2015. Although transfusion medicine has evolved to enhance safety and establish critical efficiencies, today’s automation solutions lack the ability to anticipate and respond to individual user needs and ever-changing conditions within the laboratory. The introduction of the ORTHO VISION™ Analyzer represents an advanced system able to meet these needs through automation that is responsive, representing the next evolution in transfusion medicine. The ORTHO VISION™ Analyzer’s unique pairing of secure monitoring technologies and dynamic work flow management is an advance that offers labs the ability to address unpredictable demands when needed and have confidence in the results. Designed with secure monitoring technologies for responsive safety checks and balances, the ORTHO VISION™ Analyzer gives transfusion medicine professionals the ability to track critical automated steps in the immunohematology testing process. Through Ortho Clinical Diagnostics’ proprietary Intellicheck® Technology, the ORTHO VISION™ Analyzer verifies and documents diagnostic checks throughout the sampling process; while e-Connectivity® Technology provides 24/7 remote data tracking that monitors and ensures instrument performance while maximizing uptime. Laboratory personnel can also log on anytime, anywhere to collaborate on interpreting results in real time for an extra level of confidence. In addition to multiple safety advancements, the ORTHO VISION™ Analyzer also delivers dynamic workflow management, providing the adaptability to respond to unpredictable lab demand. Now lab personnel will be able to focus on prioritizing tests as they are requested, including STAT requests, making informed decisions and re-establishing a natural flow in the lab, all while automating more tests than ever before. Building on its market leadership position, Ortho Clinical Diagnostics is reinforcing its commitment to the transfusion medicine industry with innovations such as the ORTHO VISION™ Analyzer, designed to meet the needs of labs and their patients. A version of the ORTHO VISION™ Analyzer is commercially available in Europe, Japan and Australia.

Ortho-Clinical Diagnostics, Inc. Enters into Distribution and Supply Agreement with Quotient Limited

Ortho-Clinical Diagnostics, Inc. announced it has entered into an exclusive agreement with Quotient Limited to distribute and sell Quotient's transfusion diagnostics platform MosaiQ. MosaiQ, which is currently in development, is being designed with Quotient's proprietary technology platform. This technology promises to allow improved time to test results and more comprehensive matching of donor and patient blood, beyond what is available in current transfusion diagnostic instruments. Under the terms of the Distribution and Supply Agreement, Quotient is responsible for the development and launch of MosaiQ, while OCD will leverage its worldwide commercial capabilities to sell the product to customers. OCD has exclusive rights to distribute MosaiQ for the global patient testing market (for blood grouping) and the donor testing market in the developing world and Japan (for blood grouping and serological disease screening). Quotient will be responsible for the manufacture of all products (instruments, consumables and ancillary products) associated with MosaiQ and has retained all other commercial rights to MosaiQ with OCD receiving a right of first offer where Quotient decides to commercialize MosaiQ with a third party for an application other than blood grouping. The agreement also allows Quotient and OCD to explore opportunities to develop and commercialize MosaiQ for other diagnostics applications outside of patient testing and donor screening.

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