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ImmunArray, Kindstar Partner on Lupus Test in China

NEW YORK (360Dx) – In vitro diagnostics firm ImmunArray and Kindstar Global today announced a partnership focusing on shared clinical studies, as well as the launch of ImmunArray's lupus rule-out test in China.

As part of the deal, Kindstar has been granted exclusive rights to market the SLE-Key Rule-Out test in China, which will be the initial product offering stemming from the partnership. The test is scheduled for launch in that country in November, the firms said. It became available in the US last year.

Additionally, the partners will run joint clinical testing of up to 500 serum samples from both healthy Chinese subjects and patients displaying symptoms consistent with systemic lupus erythematosus, or lupus. The studies will support the clinical implementation of the SLE-Key Rule-Out test. Previous clinical trials found the test has greater than 90 percent sensitivity and greater than 70 percent specificity.

The firms said that the platform on which the ImmunArray-manufactured iChip test has been cleared by the Chinese Food and Drug Administration, paving the way for the introduction of the lupus test in that country. More than 1 million patients in China have been identified as having lupus, making it the second-largest market for lupus testing, they added.

"The business relationship and expanded market opportunity this provides to Kindstar is an important part of our strategy to be the premier specialty laboratory in China," Kindstar Founder and CEO Shiang Huang said in a statement.

Financial and other terms of the deal were not disclosed.