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Ortho Clinical Dx Collaborating With Chinese IVD Firm

NEW YORK (360Dx) – Ortho Clinical Diagnostics and Beijing Leadman Biochemistry have collaborated to launch four assays for the Chinese market today.

The assays are cystatin C for the early diagnosis of chronic kidney disease; α-hydroxybutyrate dehydrogenase for the diagnosis of a heart attack; homocysteine for assessing risk factors for coronary atherosclerosis, Alzheimer's disease, venous embolism, neonatal defects, and habitual abortion; and total bile acids for the early detection of liver injury.

The tests are approved for use in China on Ortho's Vitros 4600 chemistry system and Vitros 5600 integrated system. They are Microtip Partnership Assays (MPA), which have been validated for use on Microtip-capable Vitros systems through a collaboration between Orthos and contracted strategic partners. Leadman, an in vitro diagnostics firm headquartered in Beijing, will offer the tests as reagents in prefilled packages for use specifically with the Vitros systems.

The assays are not cleared for use in the US.

The alliance with Leadman will help Orthos "accelerate our presence in China, and most importantly, to offer a new portfolio of MPA assays that will help to make hospital STAT lab more flexible and efficient," said Heidi Casaletto, head of clinical labs menu business field at Ortho, in a statement.

"This collaboration will expand our important assays on closed systems with open channels, which will increase our market penetration in key markets and will improve our R&D, production, and quality control continually," added Leadman President Haitao Zhang.