ImmunArray Enters Partnership with Kindstar Global
Tuesday, July 11, 2017
ImmunArray, a privately held molecular device company dedicated to the development of novel, blood-based in vitro diagnostic tests, and Kindstar Global Co., Ltd., a specialty clinical testing company based in Wuhan, China with locations throughout mainland China, have forged a partnership involving shared clinical studies and the launch of ImmunArray’s lupus rule-out test in China as the initial product offering.
The companies will undertake joint clinical testing of up to 500 serum samples from Chinese patients who are healthy as well as those with symptoms consistent with systemic lupus erythematosus (SLE) or lupus. The study will support the clinical implementation of ImmunArray’s SLE-Key Rule-Out® test, which was introduced in U.S. markets in 2016. Previous clinical trials have found the test delivers a differential diagnosis with >90% sensitivity and >70% specificity.
ImmunArray will provide training to Kindstar staff in ImmunArray’s Richmond facility and onsite in the first two labs in China. The detection platform on which the ImmunArray manufactured iChip® test has been cleared by the CFDA which will facilitate the introduction of the first of the tests planned for the market.
The diagnosis and treatment of lupus is not simply an American challenge but one that affects populations around the world. The Chinese population has the second largest incidence of lupus in the world with over 1 million patients identified with lupus in that country today.
“This partnership with Kindstar combines the resources of two innovative diagnostic companies that are focused on finding solutions to the diagnosis of autoimmune diseases, and we are extremely excited about the possibilities that this alliance can afford both parties,” said Donna Edmonds, CEO of ImmunArray.
“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,” said Shiang Huang, M.D., Kindstar founder and CEO. “We are focused on providing testing to a growing number of specialists as they support patient care. This expanded product line for rheumatologists is another demonstration of that commitment.”
As part of the agreement, Kindstar will acquire the exclusive rights to market ImmunArray’s SLE-Key Rule-Out test in China. The launch of the product into the Chinese market is tentatively set for November 2017 and will be formally announced at the internationally attended American College of Rheumatology annual meeting in San Diego.