Fluidigm Introduces Immuno-Oncology Gene Expression Assay for Translational and Clinical Research

Advanta Immuno-Oncology Gene Expression Assay enables efficient screening of 170 highly informative genes involved in human checkpoint therapeutic response

SOUTH SAN FRANCISCO, Calif., July 18, 2017 (GLOBE NEWSWIRE) -- Fluidigm Corporation (NASDAQ:FLDM) today announced the launch of the Advanta™ Immuno-Oncology Gene Expression Assay, an optimized qPCR assay that enables efficient interrogation of tumor immunobiology using proven Fluidigm® microfluidic technology. Designed for use with the Biomark™ HD system, the Advanta Immuno-Oncology Gene Expression Assay sensitively detects 170 gene expression markers involved in checkpoint therapeutic response from FFPE and fresh frozen tumor samples. With the capability to analyze biomarkers across defined T cell subsets, immune regulation, immune cell fate, cytokines, chemokines and more, this assay can enable translational researchers to accelerate the development of checkpoint immunotherapies and to identify predictive biomarker signatures for therapeutic response.

Tumor gene expression profiling has proven effective in measuring immune response during cancer progression and therapeutic response. Previous approaches using large preconfigured panels containing hundreds of genes or transcriptome analysis, however, are both costly and time-consuming. Large preconfigured panels can also be difficult to customize for specific experimental needs. The Advanta Immuno-Oncology Gene Expression Assay was developed in collaboration with leading researchers from academia and biopharma to provide the right balance of biomarker breadth, assay flexibility and workflow efficiency.

"Sirona Dx specializes in tumor expression profiling of challenging FFPE samples, and we welcomed the opportunity to partner with Fluidigm to offer the Advanta Immuno-Oncology Gene Expression Assay," said Nasry Yassa, CEO of Sirona Dx. "Our pharma clients are universally impressed with the extremely low input requirements and reduced cost compared to other approaches and are now able to screen more of their precious samples."

The Advanta Immuno-Oncology Gene Expression Assay is available as a two-panel set. The first panel includes 91 key markers of tumor immune response that were previously shown in a multicenter international clinical trial to inform tumor progression and checkpoint therapeutic response. The second panel includes 74 additional highly informative immuno-oncology markers and 17 open assay inlets for additional customization. Both panels contain the same five reference genes and can be purchased and used together or separately.

Combined with Fluidigm microfluidics technology, this Advanta assay uniquely offers significant workflow efficiencies over traditional gene expression profiling methods. Each reaction is miniaturized to nanoliter volume and controlled using precise automation to empower accurate and cost-effective qPCR testing across a large dynamic range. Since assay introduction into the microfluidics circuit is under user control, researchers have the flexibility to add or exchange gene assays within the panel to achieve experimental goals.

"Immunotherapeutic approaches that harness the body's own immune system to fight cancer provide great promise to change how cancer is treated and ultimately cured," said Chris Linthwaite, President and CEO of Fluidigm. "We are excited to announce the Advanta Immuno-Oncology Gene Expression Assay as an expansion of our growing portfolio of workflow solutions for the Biomark HD system to empower this great work. With the launch of this new assay, we are pleased to bring high-value innovation to the cancer research community to help advance the future of cancer care."

Sirona Dx Expands to include Oncomine Focus Assay

VANCOUVER, Wash. - (Nov. 10, 2016) - Sirona Dx, a leader in high complexity genomics and proteomics services, today announced it has adopted Thermo Fisher Scientific's Oncomine Focus Assay to run on the Ion PGM System and expand its drug development and next generation sequencing (NGS) services offered to pharmaceutical and clinical research clients.

Sirona Dx recognizes that pharmaceutical companies require access to genomic expertise as well as multiple platforms and technologies to support oncology clinical research studies. After its comprehensive evaluation and validation, Sirona Dx chose to complement its current service offerings with the Oncomine Focus Assay, which includes 52 solid tumor genes, many associated with current oncology therapies and published evidence.

"We are in a revolutionary time in the world of cancer research. The ability to understand the specific genomic makeup of a tumor and have that information drive drug development and eventually treatment is empowering," said Nasry Yassa, Ph.D., Chief Executive Officer of Sirona Dx. "The Oncomine Focus Assay represents the best of what is available in terms of content and technology."

The assay's content is driven by the Oncomine Knowledgebase, the world's largest curated compendium of cancer genomic information and confirmed with industry-leading pharmaceutical companies, to help enable a more unified approach to companion diagnostic and drug development. It is powered by proven Ion AmpliSeq technology to enable detection of single nucleotide somatic changes, inversions, insertions and deletions, as well as gene fusions and copy number variations using as little as 10ng of formalin-fixed paraffin-embedded (FFPE) DNA and RNA in a single workflow.

"We differentiate ourselves by securing early access to advanced technologies that align with pharma requirements in support of drug development programs," said Charles J. Sailey, MD, MS, FCAP, FASCP, Chief Medical Officer of Sirona Dx. "We are very encouraged by the ability of the Oncomine Focus Assay to enable routine analysis of FFPE samples. To further accelerate drug development programs, we're investigating Ion Torrent solutions for liquid biopsies and circulating tumor cells with plans to offer additional services in the future."

"Pharmaceutical companies are in the midst of a paradigm shift in their drug development strategy, which is leading to a pronounced need for targeted NGS tools that enable precision and efficiency," said Joydeep Goswami, president of clinical next generation sequencing at Thermo Fisher Scientific. "We are proud that Sirona Dx has joined the growing list of partners who have adopted our Oncomine technology in an effort to help the pharma industry develop new therapeutics."

About Sirona Dx

Sirona Dx was founded in 2014 with a strong dedication and focus to accelerate the pace of targeted therapy development to improve outcomes for cancer patients. The founders created a technology agnostic CRO to offer specialized high complexity genomics and proteomics services. Sirona Dx is keen to play a key role in the pharmaceutical companies' drug development programs and their efforts in transforming patient lives. The Sirona Dx laboratory operates out of a 35,000 sq ft CLIA and CAP accredited facility in Vancouver, WA, with its strategic partner, Molecular Testing Labs (MTL)