Services

 The Sirona Dx Research and Development team is  technology agnostic and works closely with our pharma clients to select  the most appropriate methods and platforms. Our team applies  cutting-edge technologies to develop and validate high-complexity  genomic assays.

Sirona Dx offers a variety of clinical trial services including assay  development, customized reporting, trial site training, and  investigator support. We undertake studies of various scale and scope  ranging from Phase I to Phase IV clinical trials. We apply the highest  level of control including 21 CFR part 11 (Federal Regulation for  Electronic Records and Signatures) to obtain the most consistent and  highest quality data.

The Sirona Dx team works closely with our clients to select the most  appropriate reporting format to meet the needs of the sponsor, trial  investigators, and regulators. We offer customized report designs and  distribution capabilities.

The Sirnoa Dx Information Technology (IT) infrastructure has a fully  validated data management system that complies with 21 CFR part 11 and  21 CFR part 58 regulations. Our laboratory maintains a comprehensive  disaster recovery plan to ensure data security.

Our Laboratory will identify the best analytical approach for data  interpretation. Our bioinformatics team has the skills, understanding  and tools to help you successfully manage large NGS data sets. Whether  contracted in conjunction with an NGS clinical trial project or as a  stand-alone service, we can tailor our Bioinformatics Services to your  project.

R&D / Assay Development

The Sirona Dx Research and Development team is  technology agnostic and works closely with our pharma clients to select  the most appropriate methods and platforms. Our team applies  cutting-edge technologies & a wide range of platforms in the  development of high-complexity genomic assays.

Our Cancer Hotspot Panel allows the interrogation of hotspot regions  of 50 oncogenes and tumor suppressor genes, with wide coverage of the  KRAS, BRAF, and EGFR genes. This panel requires only 10 ng of  DNA facilitating the sequencing of challenging samples like FFPE tissue.


We combine demanding clinical validation with the flexibility to  customize assay parameters and reporting formats based on the sponsor's  clinical study requirements. We use a variety of molecular approaches  tailored to the client's needs, including Next Generation Sequencing,  exome sequencing, bioinformatics, targeted resequencing, RT-PCR for gene  expression, SNP analysis, and Capillary Electrophoresis. Our laboratory  offers multiple platforms for the detection of mutations, copy number  variations, and expression levels. Our extensive clinical validation  guarantees robust performance and accuracy.

Clinical Trial Services

Sirona Dx offers a variety of clinical trial services  including assay development, customized reporting, trial site training,  and investigator support. We undertake studies of varied scale and scope  ranging from Phase I to Phase IV clinical trials. We apply the highest  level of control including 21 CFR part 11 (Federal Regulation for  Electronic Records and Signatures) to obtain the most consistent and  highest quality data.


Customized Reporting

The Sirona Dx team works closely with our clients to select the most  appropriate reporting format to meet the needs of the sponsor, trial  investigators, and regulators. We offer customized test report designs  and distribution capabilities. Our project managers deliver the data  reports on target and on time. Frequently, graphical displays and  interpretation guidelines are required to ensure proper patient  management and clear communication among sponsors and trial  investigators.


Investigator and Trial Site Support

Sirona Dx is committed to exceed your expectations. We  provide comprehensive services to investigator sites including custom  sample collection kits, one-on-one counseling, training services, and  protocol-specific support. In addition, our experienced project  management team will answer questions throughout the life cycle of your  clinical trial - from site initiation, testing, reporting, data  transfer and interpretation. A designated team of CT specialists  maintains a detailed ongoing knowledge of all aspects of the trial, from  contract, protocol, statement of work, sample collection and shipping  protocols to data reporting.


Investigator Education

Sirona Dx offers educational programs during investigator meetings  that include testing protocols, platform & methodologies, and data  interpretation.


Data Management Program

The Sirona Dx Information Technology (IT) infrastructure has a fully  validated data management system. The trials' data are 21 CFR part 11 as  well as 21 CFR part 58 compliance. Our laboratory maintains  comprehensive disaster recovery plans to ensure data security.

Bioinformatics Services

Our bioinformatics team will identify the optimal analytical approach  for data interpretation, and has the skills, understanding and tools to  help you successfully manage large NGS data sets. Whether contracted in  conjunction with an NGS clinical trial project or as a stand-alone  service, we can tailor our Bioinformatics Services to your project.


Sirona Dx offers:

  • Analysis of exome or targeted sequencing data
  • Variant calling and annotation
  • Analysis of microbial communities using sequences of 16s rRNA
  • Testing for statistical significance of treatment effects
  • Visualization of data (clustering, PCoA plots, heatmaps, bar charts)

Clinical Laboratory Services and assays

Sirona Dx is an Ion Torrent Certified Service Provider,  offering an extensive suite of Next Generation Sequencing capabilities  with the Ion PGM and proton systems.

Targeted resequencing enables the interrogation of specific genomic regions in a high throughput and cost-effective manner.

Sirona Dx CLIA Laboratory is a Life Technologies certified service  provider for Ion Ampliseq Exome Sequencing. This certification indicates  that our sequencing data is of the highest quality and is generated  with the fastest possible turnaround time.

Sirona Dx provides state of the art SNP Genotyping (single-nucleotide  polymorphism) services using the Life Tech Quant Studio Real-Time PCR  instrumentation. This platform not only detects the amount of  fluorescence through each cycle of polymerase chain reactions, it  confidently distinguishes between more ambiguous genotypes. It also  provides the option of real-time data, allowing for higher sensitivity  with lower DNA input, more accurate analysis of results, and faster  turnaround time.

Pharmacogenomics involves detection of variations in genes that helps  identify sources of inter-individual variability in drug response, both  effectiveness and toxicity. These genetic differences in metabolic  pathways that affect the individual's response to various therapeutic  drugs make it possible to individualize therapy.

image10