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PGDx, Qiagen Partner on Clinical Decision Support for Molecular Cancer Testing

NEW YORK – Personal Genome Diagnostics (PGDx) said on Wednesday that it is partnering with Qiagen to provide clinical decision support to users of its cancer genomic profiling tests.

Under the non-exclusive agreement, laboratories that purchase PGDx Elio oncology products will have an option to receive standardized reporting from Qiagen that is informed by professional guidelines to facilitate case review. In addition, laboratories will receive access to Qiagen's QCI Interpret One for rapid, evidence-based variant interpretation and reporting for next-generation sequencing (NGS) tests.

PGDx Elio Tissue Complete is a US Food and Drug Administration-cleared genomic profiling kit used to identify tumor alterations and inform treatment decisions for patients with advanced solid tumors. As a kitted test, Elio Tissue Complete can be performed by laboratories anywhere, and by pairing the kits with automated data-analysis and interpretation support, the companies hope to spur more widespread adoption of precision oncology testing.

"PGDx Elio Tissue Complete is a first-of-its-kind FDA-cleared kit to enable any molecular lab to perform comprehensive tumor profiling," PGDx CEO Megan Bailey said in a statement. "It is important for our customers to be able to stay up to date with clinical guidelines and evidence supporting variant interpretation to maximize the value of NGS data in improving clinical care. We've built the PGDx Elio software to deliver robust, high-quality variant calls. The addition of Qiagen clinical decision support software … provides labs an option for a comprehensive solution that will enable more informed treatment decisions for clinicians and patients."