QIAGEN Expands Clinical Decision Support for NGS in Oncology Labs

QIAGEN N.V. has announced enhancements to its QIAGEN Clinical Insight® (QCI™) clinical decision support solution, which streamlines the annotation, interpretation and reporting of next-generation sequencing results (NGS) for clinical laboratories.

The QCI bioinformatics platform, launched earlier this year, has been expanded from interpreting NGS data on somatic mutations in solid tumor cancers to add leukemia and lymphoma testing, as well as testing for hereditary cancer indications.

Designed and validated in collaboration with clinical testing laboratories such as the Memorial Sloan Kettering Cancer Center, the Baylor College of Medicine, Virginia Commonwealth University (VCU) and LabCorp, QCI enables labs to efficiently and accurately provide the valuable molecular insights made possible by next-generation sequencing.

“While instrument and assay costs have declined, clinical testing laboratories still face bottlenecks from the complexity and cost of interpreting and reporting NGS data. Our team took a customer-centered approach to solving these challenges, collaborating with more than 50 labs to develop and validate QIAGEN Clinical Insight for each test indication. QCI has launched very successfully and is today recognized as the best-in-class decision support platform,” said Dr. Laura Furmanski, Ph.D., Executive Vice President and Head of QIAGEN’s Bioinformatics Business Area. “Our bioinformatics are having an impact in diagnostics and personalized medicine using NGS, particularly in oncology. The user-friendly QCI platform provides valuable, clinically relevant insights to help guide the treatment of patients.”

For somatic cancer indications, the QCI enhancements include insights for diagnostic testing as well as monitoring and progression, support for copy number variations (CNVs) and fusion genes, and additional prognostics data from the literature.

QCI now provides comprehensive cover of FDA- and EMA-approved drug labels, NCCN, ASCO and ESMO professional guidelines, and active genotype-related clinical trials to compliment comprehensive coverage of literature references and a wide range of reported case databases.

“We have been collaborating with QIAGEN on the design, development and validation of QIAGEN’s new Clinical Insight (QCI) platform in support of NGS-based Oncology testing”, said Dr. Andrea Ferreira-Gonzales, Ph.D., Chair, Molecular Diagnostics Division and Director of the Molecular Diagnostics Laboratory at Virginia Commonwealth University. “We recently completed our validation work with the QCI platform that demonstrated results compliant with our manual methods and reporting policies for test interpretation and reporting, with the added benefits of enabling a more scalable and repeatable standards and levels of evidence based approach. The QCI platform enables us to quickly assess biological significance, clinical relevance and actionability of observed alterations at scale and to identify treatment and trial options based upon the available levels of evidence. QCI’s comprehensive coverage of literature, reported cases and drug labels, professional guidelines and trials enables VCU to provide its ordering physicians with more insightful decision support information.”

The enhancements also add 32 hereditary cancer genes to QCI’s coverage, providing a more complete solution for laboratories to interpret and report on germline variants, including support for NGS comprehensive cancer panels testing for both somatic and inherited cancers. QCI now includes comprehensive curation of the hereditary cancer literature and curated clinical case counts for common heritable cancers including breast and ovarian cancer, Lynch syndrome, Peutz-Jegher syndrome, ataxia telangiectasia, neurofibromatosis, hereditary diffuse gastric cancer, familial prostate cancer, polyposis, and many more.