SLE-Key Rule-Out Test for Lupus Is One Step Closer to Entering the Chinese Market

ImmunArray and Kindstar Global, two companies focused on the development and marketing of diagnostic tools for acute and chronic immune and neurodegenerative diseases, have joined forces to launch the cost-effective SLE-Key Rule-Out Test for lupus in China.

The blood test, which helps clinicians accurately rule out lupus during diagnosis, is expected to enter the Chinese market by November 2017. The process will be formally presented at the American College of Rheumatology 2017 Annual Meeting, held Nov. 3-8 in San Diego.

“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,” Donna Edmonds, CEO of ImmunArray, said in a press release.

With over 1 million patients diagnosed with lupus, China has the second largest incidence of this autoimmune disease worldwide.

Available in the United States since 2016, the SLE-Key is based on ImmunArray’s proprietary iCHIP platform, which detects circulating systemic lupus erythematosus (SLE)-related antibodies in blood samples. The test has shown to be highly sensitive and a powerful tool.

“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, MD, founder and CEO of Kindstar. “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.”

Under the agreement, ImmunArray will provide training to Kindstar staff on the SLE-Key Rule-Out Test. Both companies will then evaluate ImmunArray’s blood-based diagnostic test using 500 blood samples from healthy volunteers and individuals in China with SLE symptoms.

Results of this analysis, together with previous clearance of the iCHIP platform by the China Food and Drug Administration (CFDA), are expected to provide the scientific and regulatory support required for bringing the SLE-Key Rule-Out Test to China.

The agreement also states that Kindstar will have exclusive marketing rights for ImmunArray’s SLE-Key Rule-Out Test in China.