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Ortho Clinical Diagnostics Announces Availability of Seven Manufacturer-Validated Applications for Thermo Fisher Scientific (TMO) Immunoassays

7/26/2011 10:07:43 AM

RARITAN, N.J., July 26, 2011 /PRNewswire/ -- Ortho Clinical Diagnostics (OCD) today announced availability of seven manufacturer-validated applications for the VITROS® 5,1 FS and 4600 Chemistry Systems. These applications will allow customers to run immunosuppressant drug assays, Therapeutic Drug Monitoring (TDM) assays and Drugs of Abuse Test (DAT) assays from Thermo Fisher Scientific and marks the first time the company is supporting applications for assays validated by an external third party-manufacturer to run on open channels on select VITROS® Instruments. The immediate availability of these applications broadens the VITROS® menu, providing customers with the flexibility to meet their individual laboratory needs with easy-to-use testing options.

OCD is collaborating with Thermo Fisher Scientific in its initiative to commercialize these assays with applications for VITROS® Systems to expand testing solutions to meet customer needs. The immunosuppressant, TDM and DAT assays include: CEDIA® Cyclosporine PLUS Low Range, CEDIA® Cyclosporine PLUS High Range, CEDIA® Tacrolimus, CEDIA® Mycophenolic Acid, DRI® Oxycodone Enzyme, DRI® Ecstasy and QMS® Amikacin. The immunosuppressant assays are used for monitoring immunosuppressant drug therapy in patients with transplanted organs or certain autoimmune disorders, while the Drugs of Abuse Test and Therapeutic Drug Monitoring assays are used for qualitative and semi-quantitative determination of drug presence in patients. The availability of these new applications provides VITROS® System customers with the ability to consolidate testing onto fewer platforms with service and support from both companies for their respective products.

"By actively listening and responding to customer feedback, Ortho Clinical Diagnostics identified a need to expand its testing menu to best meet the unique and evolving needs of the modern clinical laboratory," said Peter Hoehn, Vice President, Worldwide Marketing, Clinical Laboratories and Donor Screening. "We are committed to providing access to the most comprehensive testing menus by continually evaluating and updating our assay offerings to meet customer needs. The availability of these applications underscores our commitment to our customers and the patients who benefit from these critical tests."

Ortho Clinical Diagnostics has a broad, world-class menu of assays offering clinical chemistry tests that cover major disease states including cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions and anemia. The VITROS® assay menu covers up to 90 percent of the top 100 assays and 99 percent of laboratory test volume, with numerous other assays in development. In addition, standardized VITROS® reagents enable laboratories to better manage inventories and costs in addition to producing consistent test results from platform-to-platform. This is particularly beneficial for laboratories with multiple VITROS® platforms in their facilities.

About Manufacturer Validated Applications

Manufacturer Validated Applications utilize commercialized assays that have been adapted for use and validated by the reagent manufacturer for use on the VITROS® Systems using the "User Defined/Open Channel" function.

About the VITROS® 5,1 FS Chemistry System

The VITROS® 5,1 FS Chemistry System provides clinical laboratories the unique ability to manage difficult samples and ensure high result integrity by continually verifying key steps of the process. Key features of the VITROS® 5,1 FS Chemistry System include an intuitive, easy-to-use graphical user interface; disposable tip metering; up to 6-month calibration stability; and parallel processing of routine and special tests for uncompromised workflow. The VITROS® 5,1 FS Chemistry System also incorporates core state-of-the-art features offered to VITROS® customers, including Intellicheck Technology, MicroSensor Technology and e-Connectivity® Interactive System Management.

About the VITROS® 4600 Chemistry System

The VITROS® 4600 Chemistry System is Ortho Clinical Diagnostics' most recent addition to the VITROS® x600 family of analyzers. It offers standardized, high quality test results using common technologies across our continuum of integrated and stand-alone systems. Beginning with dry slide technology, the VITROS® 4600 System leverages OCD's core technologies that maximize patient result quality and promote ease of use and productivity. Key features of the VITROS® 4600 Chemistry System include an intuitive, easy-to-use graphical user interface that is standardized across our family of analyzers; disposable tip metering; up to 6-month calibration stability; parallel processing of routine and special tests for uncompromised workflow; reduced maintenance requirements, adjustable thresholds for onboard inventory management and calibration expiration. The VITROS® 4600 Chemistry System also incorporates state-of-the-art features including MicroSlide Technology, MicroTip Technology, MicroSensor Technology, Intellicheck Technology and e-Connectivity® Interactive System Management. In addition, the VITROS® 4600 Chemistry System provides a comprehensive chemistry menu including therapeutic drugs, special proteins, and DAT/Toxicology.

About Ortho Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc. delivers the high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit

VITROS is a registered trademark of Ortho Clinical Diagnostics. CEDIA is a registered trademark of Roche Diagnostics. All other trademarks are the property of Thermo Fisher Scientific, Inc. and its subsidiaries.

SOURCE Ortho Clinical Diagnostics

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