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 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.