BALLETT Study will measure the impact of comprehensive genomic profiling on access to, and uptake of, personalized medicines and on clinical outcomes for patients
PierianDx, the global leader in clinical genomics knowledge, today announced a partnership with the Belgian Society of Medical Oncology (BSMO) to study the impact of comprehensive genomic profiling (CGP) on clinical outcomes of late-stage cancer patients. As part of the study, nine sites across Belgium will use the PierianDx interpretation and reporting solution, Clinical Genomics Workspace™ (CGW), to help determine the best therapeutic options for treatment.
Current approaches to precision medicine testing often mean that tests are outsourced to large international organizations or that they are run by independent regional labs, neither of which result in standardized clinical care systems or improved collective knowledge. In response to these challenges, the BSMO has established the BALLETT (Belgian Approach for Local Laboratory Extensive Tumor Testing) study to evaluate the impact of CGP.
CGP uses next-generation sequencing (NGS) to analyze hundreds of genes and biomarkers in tissue samples from biopsies or blood and detect those that are clinically relevant in driving cancer growth. Illumina will provide its CGP panel for tissue samples, TruSight™ Oncology 500 (TSO500), and NovaSeq™ 6000 and NextSeq™ sequencing platforms for the study. Clinical interpretation of the sequencing data will be carried out using the PierianDx Clinical Genomics Workspace™ (CGW) solution.
CGW provides a streamlined, standardized analysis platform in which EU drug approvals and guidelines are matched to complex genetic variants detected in patient tumor DNA and RNA, all within a GDPR-compliant environment. Using the platform, the nine participating Belgian laboratories can collaboratively review variant pathogenicity and clinical impact for their local samples while also benefiting from the knowledge of other clinical laboratory CGW users from around the world. At the same time, the nine Belgian laboratories will provide this standardized testing and analysis close to the patient’s home, where they receive cancer care, accelerating treatment initiation. As this study will also monitor the patient outcomes during and following treatment, a true indication of those longer-term clinical benefits will be derived.
Dr. Brigitte Maes of the Jessa Hospital in Belgium, Coordinator of BALLETT study said, "As part of Belgium’s broad approach to advancing precision medicine the study will generate valuable insights into the value of CGP versus currently reimbursed sequencing approaches. For example, in addition to genetic mutations that drive cancer formation, CGP will also identify cancers driven by the TMB biomarker which can guide patients towards immunotherapy treatments. This means that the study will give access to additional treatments which may not have been considered through more traditional diagnostic testing."
Dr. Rakesh Nagarajan, Founder of PierianDx states, "We are ecstatic to be part of this groundbreaking study. The CGW platform is in use by over 25 countries to share knowledge and facilitate better treatments and patient outcomes, and now the clinicians involved in this study will benefit from this collective knowledge while incorporating European-specific data sources, which are curated and maintained by PierianDx." He adds, "Not only will this study measure the impacts of CGP but it will provide a justification, framework, and a blueprint for other clinical laboratories around the world that wish to implement similar initiatives."
Founded in 2014 out of Washington University in St. Louis, PierianDx is focused on advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide. Its industry-leading clinical genomics technologies, CAP and CLIA accredited laboratory, IVD-ready knowledgebase and reporting solution, and expertise deliver the most integrated, trusted, and collaborative approach across the clinical care spectrum. From genomic sequencing and biomedical informatics in the laboratory to reporting and decision support at the patient’s bedside, PierianDx drives the adoption of genomics in clinical care and accelerates the fight against somatic cancer and hereditary germline diseases. For more information visit www.pieriandx.com.
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