Hedera Dx Launches AI-Enabled RWD Capabilities with First Patients Recruited in EMPATHY NSCLC: a Prospective, International, Decentralized, Multicenter, Real-World Utility Study for Liquid Biopsy
September 13, 2024
- EMPATHY NSCLC is a multicenter, prospective real-world clinical utility study for in-house liquid biopsy testing in advanced NSCLC
- First patients have been enrolled to EMPATHY NSCLC across expert cancer centers in Europe, creating high quality real-world evidence for lung cancer treatment
- The study leverages Hedera Dx technology, including the myHedera app for PROs and PREMs
- The study combines genomics with deep clinical data
- EMPATHY NSCLC is designed to overcome traditional limitations and provide a representative view of management of NSCLC and patient outcomes in real-world clinical setting
Lausanne, Switzerland (September 13th, 2024). Hedera Dx, an oncology company specializing in liquid biopsies and real-world data (RWD), announces the launch of its Real-World Data Asset, Hedera Frame, alongside the recruitment of the first patients into EMPATHY NSCLC.
In June 2024, the first patients were recruited into the EMPATHY NSCLC study. The study contributes to Hedera Frame, the multi-omics data platform of Hedera Dx. "EMPATHY NSCLC marks a new era in real-world evidence generation. Our goal is to improve outcomes and the quality of life for NSCLC patients by significantly advancing the understanding of diagnostic and treatment realities in real-world clinical practice,” said Prof. Dr. Umberto Malapelle, Principal Investigator at the Lead Site, University Federico II of Naples, Italy.
In the study, genomic data is combined with clinical data to create rich clinico-genomics data, including patient-reported outcomes (PROs) and experiences (PREMs). "Unlike many datasets that only aggregate genomic findings, we combine this with rich clinical data, offering deeper and more fit-for-purpose insights." said Tommi Lehtonen, CEO of Hedera Dx.
EMPATHY NSCLC addresses the limitations caused by narrow inclusion criteria in clinical trials, creating an open RWD registry that also responds to global concerns over restricted clinical trial data access. The study evaluates molecular tumor profiling, treatment choices, and patient outcomes, providing a representative basis for NSCLC management. The initiative ensures data security while granting researchers access under approved protocols.
Patient advocacy groups like WALCE (Women Against Lung Cancer in Europe) play a vital role, with the Steering Committee overseeing responsible data use and protecting patient privacy. The study contributes to the Hedera Frame that covers multiomics data, data on a broad set of tumor types and biomarkers, addressing the needs of modern cancer care and drug development.
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For additional information:
Tommi Lehtonen, CEO
Hedera Dx
+41 21 561 35 45
tlehtonen@hederadx.com
Christian Meisel, Chief Medical Officer
Hedera Dx
+41 21 561 35 45
cmeisel@hederadx.com
About Hedera Dx
Founded in Switzerland in 2021 by Tommi Lehtonen, Damien Lapray and Christian Meisel, Hedera Dx aims to revolutionize cancer care through the global adoption of liquid biopsies. The company specializes on next-generation sequencing (NGS) technology and fit-for-purpose, large-scale real-world data (RWD) to enhance cancer patient outcomes. Their AI-driven platform, Hedera Frame, powered by the CE IVDR certified medical device, Hedera Prime, provides scalable solutions for the aggregation and analysis of clinicogenomics data. Hedera Dx supports healthcare professionals, including molecular pathologists and oncologists, in accelerating the adoption of precision oncology.