Illumina and Kindstar Global announced last week that they have made an agreement that allows Kindstar to offer a set of Illumina products, including the Infinium Dx CytoSNP-12 BeadChip assay, to its Chinese clients.
According to Illumina, Kindstar offers a growing menu of molecular tests to members within a network of more than 3,300 hospitals across China. As part of the deal, Kindstar gains the right to validate and offer testing using the Infinium Dx assay, as well as Illumina's TruSight panels for targeted next-generation sequencing.
The Infinium Dx CytoSNP-12 is a 294,975-marker microarray test that relies on CytoSNP-12 assay kits and KaryoStudioDx analysis and reporting software. It is designed to detect chromosomal abnormalities and aid postnatal diagnosis of autism spectrum disorders, developmental delay, intellectual disability, congenital anomalies, and dysmorphic features in children.
Kindstar has previously partnered with a number of test developers including the Mayo Clinic, Insight Genetics, and BG Medicine to expand its portfolio of genetic and other tests.
In a statement, Shiang Huang, founder and CEO of Kindstar, said the company is excited to now offer services in China based on Illumina's products, and that "leveraging Illumina's technology will enable [the firm] to offer the highest quality and most specialized diagnostics."
Other array companies have indicated that the market for array-based clinical diagnostics is growing rapidly in China. Last November, Jun Hou, a member of Agilent Technologies' management team in China, told BioArray News that Agilent has seen demand pick up significantly for its menu of chromosomal microarrays in the country.
"To date, most business has been with academic customers, but in recent years demand has increased dramatically from the clinical community, including customers of independent labs," which are similar to CLIA-compliant labs in US, he said. (BAN 11/27/2012)
Chromosomal arrays must be run on platforms cleared by the China Food and Drug Administration, or SFDA, to be used officially for clinical diagnostics. And in order for an assay to be cleared for clinical use in China, it must have already been cleared in the company's country of origin.
Illumina said this week that it submitted the Infinium Dx CytoSNP-12 BeadChip assay to the US Food and Drug Administration for 510(k) review in first quarter.
In the firm's Q1 earnings call this week, CEO Jay Flatley said that Illumina considers the partnership with Kindstar a "very important step" toward reaching the Chinese clinical market.
"Kindstar is a very interesting organization in China," Flatley said. "It's a relatively young company, but funded well …. And they have some very powerful rights, we think, to take technology that's been initially developed here in the United States through some partnerships and to market those diagnostic tests in China," he said.
Representatives for Kindstar did not return emails seeking comment in time for this publication.