RICHMOND, Va.--(BUSINESS WIRE)--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. ImmunArray is working closely with Peter Lipsky, M.D., co-founder of AMPEL with whom ImmunArray announced a Strategic Partnership on World Lupus Day in May 2017. Dr. Lipsky and AMPEL co-founder Dr. Amrie Grammer, has had the good fortune to provide training to some of the leaders of the Chinese academic rheumatology community and maintains active collaborations with many. He will be a co-chair of the Scientific Advisory Board with leading Chinese academic rheumatologists, making recommendations to ImmunArray and Kindstar concerning their joint venture.
“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.
Founded in 2006 and co-located in Rehovot, Israel and Richmond, Va., ImmunArray’s novel blood-based testing platform supports the diagnosis and management of complex acute and chronic immune and neurodegenerative diseases. The company designs and analyzes sets of biomarkers known to be linked to a particular condition and develops tests on platforms that are most appropriate to facilitate the adoption of additional tests. The company’s first commercial test, the SLE-Key® Rule-Out Test, is used to assist physicians in ruling out Systemic Lupus Erythematosus (SLE) or lupus as part of a differential diagnosis. The company has a pipeline of products in development to support diagnosis and management of other auto-immune and neurological diseases.
About Kindstar Co., Ltd.
Founded in 2003 and based in Wuhan, China, Kindstar Global Co., Ltd. provides specialty clinical testing services throughout China. The company offers esoteric diagnostic testing and laboratory testing services to Chinese hospitals, including tertiary care hospitals. The company has a long standing partnership with the Mayo Clinic and has laboratory facilities in Beijing, Shanghai and Wuhan. It was formerly known as Wuhan Kindstar Diagnostics Co., Ltd.