Qiagen, Hilden, Germany, has recently announced the commercial launch of its Qiagen Clinical Insight (QCI) bioinformatics content and software platform, enabling clinical testing labs to interpret and report on genomic variants identified in next-generation sequencing (NGS). The first two supported applications for the bioinformatics platform are in oncology, for somatic and hereditary cancer testing.

Furmanski

Laura Furmanski, PhD, Qiagen.

The Clinical Insight platform is an evidence-based decision support solution that evaluates genomic variants in the context of published biomedical literature, professional association guidelines, publicly available databases and annotations, drug labels and clinical trials. Using a powerful software platform, the secure QCI Web application, and Qiagen’s private data center, clinicians can rapidly classify variants, identify treatment options, and perform geographical clinical trial matching. QCI is instrument- and assay-agnostic, and currently supports both somatic and germline testing. It also provides access to the Allele Frequency Community, the world’s largest repository of ancestral and ethnic diversity data.

“Qiagen Clinical Insight is the most comprehensive, scalable bioinformatics platform for clinical labs to use in interpretation and reporting of genomic variants from next-generation sequencing data,” says Laura Furmanski, PhD, head of Qiagen’s bioinformatics business area. “In creating this platform, we gathered input from more than 100 clinical testing labs and worked with 50 of them to evaluate the QCI content and software in their workflows for laboratory-developed tests.

Tsongalis

Gregory J. Tsongalis, PhD, Dartmouth-Hitchcock Medical Center.

“The commercial rollout of QCI is the latest addition to Qiagen’s portfolio of sample to insight solutions, including universal sample and assay consumables, and a range of resources for bioinformatics that are driving the growth of next-generation sequencing for clinical research and diagnostic labs,” Furmanski adds.

“Getting from raw sequencing data to accurate and timely curation of clinically actionable variants, and reporting in a user friendly format for our ordering physicians, continues to be a significant challenge for complex molecular testing,” says Gregory J. Tsongalis, PhD, director of the molecular pathology and translational research program at the Dartmouth-Hitchcock Medical Center, and a clinical collaborator in evaluating QCI. “Working in collaboration with Qiagen on the development and validation of Qiagen’s new Clinical Insight platform in support of somatic cancer testing has resulted in scalable and reproducible results in addressing our labs unmet bioinformatics needs and challenges. We look forward to continued validation work with Qiagen, and realizing the full potential of the Clinical Insight platform.”

Hegde

Madhuri Hegde, PhD, Emory University.

“Clinical labs developing and offering NGS-based clinical tests are confronted with two key challenges: the complexity of translating genetic information into actionable insights for ordering physicians, and the time and effort it takes to interpret and report clinically relevant variants,” says Madhuri Hegde, PhD, professor of human genetics at the Emory University School of Medicine and executive director of the Emory genetics laboratory (EGL). “Through its collaboration with EGL and other leading labs on the design and validation of its new QCI offering, Qiagen has developed a deep understanding of these unmet needs.

“QCI supports both germline and somatic test indication which is important to labs offering diverse test indications,” Madhuri adds. “And it provides full platform- and assay-agnostic interpretation and reporting workflow support, which enables clinical testing labs to reduce time and cost associated with NGS-based testing.”

Bioinformatics is a key growth driver for Qiagen. The company’s integration of Ingenuity Systems, CLC bio, and Biobase has created an industry-leading provider of integrated bioinformatics solutions and expertly curated content for the analysis, interpretation, and reporting of biological data. For further information, visit Qiagen.