Ortho Clinical Diagnostics (OCD) Announce Availability of Seven Manufacturer-Validated Applications for the VITROS® 5,1 FS and 4600 Chemistry Systems

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.