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
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 prevalence of
lupus in the world with over 1 million patients identified with lupus in that country today.
ImmunArray is working closely with AMPEL BioSolutions, co-founded by Drs. Peter Lipsky and
Amrie Grammer, with whom ImmunArray announced a Strategic Partnership on World Lupus
Day in May 2017. Dr. Lipsky 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
“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.
For further information please contact:
Kelsey Leavey (U.S)
The Hodges Partnership