Fluidigm, Ascendas Genomics to Partner on MDx Systems and Assays in China

Ascendas Genomics will develop and commercialize molecular diagnostic systems and assays in China using Fluidigm’s Biomark™ HD and Juno™ microfluidic technologies, the companies said.

Fluidigm’s microfluidic technology is designed to detect somatic and genomic variations from patient samples. The company says its technology is intended to enable highly scalable and automated workflows for quantitative PCR, gene expression, copy number variation analysis and next-generation sequencing library preparation.

The Biomark™ HD system is designed to enable users to run entire projects, from research to validation to routine screening, on a single system that combines digital PCR with simultaneous real-time data for counting and validation. Fluidigm says Biomark HD is flexible yet consistent, offering reliable production-scale throughput and single-cell sensitivity, with a wide variety of sample types and chemistry choices for most genomic applications.

The Juno Targeted DNA Sequencing Library Preparation System, which includes Targeted DNA Seq Library Preparation reagents, is intended to let users produce dozens to hundreds of sample libraries daily, with each sample enriched for up to 4,800 specific amplicons covering user-defined genes or genomic loci.

According to Fluidigm, Juno is optimized for use with Illumina^® sequencing systems in combination with Fluidigm-supplied sample barcodes, allowing for accurate sequencing of more samples that is faster and more affordable than ever. Juno also serves as a universal controller to prepare integrated fluidic circuits for both gene expression and genotyping analysis when used together with Biomark HD.

“The Juno and Biomark HD systems demonstrate superior performance in automation and ease of use, and provide great potential to advance diagnostic testing for the clinical labs and hospitals in China to enable the future of precision medicine,” Ascendas Chairman and CEO Chengyong Yang, Ph.D., said in a statement.

Based in Zhongshan, China, Ascendas was established in 2014 and focuses on developing and applying genetic diagnosis-related products, especially newborn screening and oncology genetic tests.

Ascendas develops genetic solutions for diagnostic markets, and provides technical and consulting services to clinical research laboratories, academic institutions and biotechnology companies. The company also  offers immunodiagnostic and molecular diagnostic tests to hospitals and health care centers through its subsidiary company, Ruikang Diagnostics, a commercial reference lab.  

“We strongly believe our partnership with Fluidigm will make it possible to develop cost-effective and robust genetic diagnostic tests for more patients in China,” Dr. Yang added.

As a result, Fluidigm reasons, the partnership with Ascendas will help it expand its presence in the world’s most populous nation. “We are very pleased to partner with Ascendas Genomics to expand our market position in China,” added Fluidigm President and CEO Chris Linthwaite.

The strategic partnership, whose value was not disclosed, will expand Fluidigm’s presence in China, where the company saw its revenue drop to $2.4 million in Q1, down 27% from $3.3 million in Q1 2016. China’s share of total Fluidigm revenue fell from 11% to 10%, according to the company’s Form 10-Q filing for the first quarter.

The China decline helped lower Fluidigm’s total Q1 Asia-Pacific sales 17%, to $4.987 million from $6.008 million a year ago.

China sales “benefited in the year-ago period from multiple genomics instruments sold into applied customers adopting our technology for genetic testing,” Fluidigm CFO Vikram Jog told analysts on the company’s quarterly conference call, according to a transcript by Seeking Alpha.

During 2016, China sales nearly doubled, rising to $11.1 million—up $5.5 million or 97% from 2015. That surge brought total Asia-Pacific sales 18% above 2015, to $18.478 million, offsetting a reduction of sales in the rest of the region, primarily Japan.