Events

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Specialized CRO offers high-definition tissue imaging services for pharmaceutical and clinical research

SOUTH SAN FRANCISCO, Calif. and PORTLAND, Ore., Nov.  01, 2018   (GLOBE NEWSWIRE) -- Sirona Dx, a leader in high-complexity genomics  and proteomics services, today announced the introduction of Imaging  Mass Cytometry™ services on the Fluidigm Hyperion™ Imaging System to  advance biomarker discovery and therapeutic development.
 

 Sirona Dx is a specialized contract research organization (CRO) that  provides high-quality clinical research services to pharmaceutical and  clinical research clients and focuses on offering early access to  advanced technologies.

With a goal of providing innovative approaches to expand drug  discovery pipelines and bring more effective therapies to market, Sirona  Dx decided to add multiplex tissue imaging to its growing technology  portfolio. Noticing impressive Imaging Mass Cytometry results from top  pharmaceutical companies and leading academic medical centers, Sirona Dx  engaged Akil Merchant, M.D., Assistant Professor at the University of Southern California Keck School of Medicine, as a Scientific Advisor to assess its full potential.

“After a comprehensive evaluation of different tissue imaging  technologies, Imaging Mass Cytometry was the clear choice. Imaging Mass  Cytometry will enable our clients to resolve complex cellular networks  and signaling pathways within tissue microenvironments with  unprecedented definition,” said Nasry Yassa, Ph.D., Chief Executive  Officer of Sirona Dx. “The early response from our pharma partners has  been extremely positive. Our clients are expressing significant interest  in using Imaging Mass Cytometry to advance their research goals and are  pleased to access this new technology through an experienced CRO.  Sirona Dx has exciting projects underway and additional requests coming  in from top pharmaceutical companies.”

Developed for research use, Imaging Mass Cytometry enables  simultaneous imaging of up to 37 protein markers from a single scan of  formalin-fixed, paraffin-embedded (FFPE) or fresh tissue sections at  subcellular resolution. Using proven CyTOF® technology, Imaging Mass  Cytometry surpasses the inherent limitations of fluorescence detection  by using high-purity metal tags that are separated by mass instead of by  wavelength. With an established global footprint and 18 scientific  publications to date, Imaging Mass Cytometry is rapidly setting a new  standard for highly multiplexed tissue imaging.

“By preserving tissue architecture and cellular morphology  information, Imaging Mass Cytometry is ideal for understanding complex  tissue microenvironments. It is especially useful for monitoring changes  in the immune system in a variety of disease states such as cancer or  auto-immunity,” said Dr. Merchant. “With easily customizable panel  designs using available pre-conjugated antibodies or metal conjugation  kits, Imaging Mass Cytometry is a valuable tool for translational and  clinical research across a range of disease areas.”

“Sirona Dx is our first Imaging Mass Cytometry CRO partner in the United States,” said Chris Linthwaite, President and CEO of Fluidigm.  “Expanding market accessibility is a top priority for unlocking the  full potential of Imaging Mass Cytometry. CRO partners play a critical  role in providing valuable expertise, accelerating new health insights.”     

PORTLAND, Ore., Oct. 30, 2018  /PRNewswire/ -- Sirona Dx, a leader in high complexity genomics and  proteomics services, announced today the launch of Oncocyst PD-L1, an  assay using IncellDx technology that detects and quantifies abnormal  bladder cells and immune cells from urine cytology specimens that  express the immune-oncology marker PD-L1 using multi-parameter flow  cytometry and bioinformatics. The algorithm also uses aneuploidy/DNA  content in cells from the bladder, markers often detected by  fluorescence in situ hybridization (FISH) and read using microscopy. The  new high throughput assay is non-subjective and can be performed in  less than 3 hours.

"The ability to batch large numbers of samples to determine the PD-L1  and DNA content status on abnormal urine cytology specimens represents a  major advantage over technologies that require subjective microscopic  assessment and dark rooms to read FISH," reports Dr. Nasry Yassa,  CEO, Sirona Dx. "We are committed to additional assay development  projects with InCellDx to leverage their innovative technology platform  that enables simultaneous cell classification and single cell analysis  of proteomic and genomic biomarkers."

"We are delighted to announce a partnership with Sirona Dx for our  novel platform of single cell proteomic and genomic assays using flow  cytometry and CTC platforms. With simultaneous 30+ marker capabilities  and DNA content on individual cells, we are driving personalized  medicine to the cellular level addressing the profound tumor  heterogeneity in cancer," added Bruce K. Patterson MD, CEO of IncellDx, Inc.

The two companies look forward to presenting the Oncocyst PD-L1 study data at the IncellDx Corporate Symposia, Wednesday, October 31st, at the Association of Molecular Pathology Meeting in San Antonio TX. 

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."

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."

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)