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Ortho Clinical Diagnostics Gets FDA Clearance for Advanced Integrated Chemistry Test System

NEW YORK (360Dx) – Ortho Clinical Diagnostics said today that it has received US Food and Drug Administration clearance for its Vitros XT 7600 Integrated System, which enables high-throughput clinical chemistry and immunoassay testing for mid- and high-volume labs.

Ortho said that with the FDA clearance, it is introducing Digital Chemistry technology to clinical lab management in the US by combining its MicroSlide technology — testing on a postage stamp-sized piece of film — with digital imaging and the potential to perform two separate lab tests simultaneously. The system's advanced optics for digital imaging enables it to obtain additional information from testing than has been previously possible and allows "powerful data analysis," the firm said.

Further, Digital Chemistry brings powerful data intelligence, operational improvements, and heightened quality to the lab to help clinical laboratories keep pace with a rapidly evolving global healthcare environment without requiring additional lab space, Ortho said.

Unlike traditional wet chemistry systems, which require highly purified water and complex plumbing systems to operate, the XT 7600 uses dry slide technology that doesn't require water and eliminates the risk that poor water quality could impact test results, the firm said.

Jennifer Paine, Ortho’s chief product portfolio officer, said in a statement that the new system is "a fundamental improvement in the way labs can operate, now and in the future."

Jaime Calnan, laboratory manager at Central Ohio Primary Care Physicians in Columbus, Ohio, said that MicroSlide technology paired with Intellichek monitoring enables accurate reporting of results for more than 1,000 patients nightly.

Earlier this year, when the firm submitted the system for FDA review, it said that the XT 7600 is suitable for running a broad range of tests with thin film, dry slide technology that also speeds throughput for selected assays.

The new system leverages multi-test processing — the potential to offer two tests per slide instead of one — and can simultaneously perform tests that are frequently ordered for the same patient. This saves time and space in the lab and requires less patient sample for testing, which is an important advantage for vulnerable patients or those with venous access issues, Ortho said.

The firm said that the new system will be available for purchase in the first quarter of 2019. The product is currently available for purchase in numerous countries in Europe, the Middle East, Africa, Asia, Latin America, and Canada.