Building the clinical evidence for decentralized in-house oncology NGS testing
Precision oncology is a rapidly evolving field where patients are given therapies based on their unique genomic profile and disease trajectory, to ultimately improve their outcomes.
Difficulties in traditional RCTs and the recruitment challenge
Multigene panel–based genomic testing, including ctDNA analysis from the blood, has revealed an increasing number of molecular-based cancer subtypes with rare patient populations.
This has led to difficulties in executing and recruiting for traditional Randomized Clinical Trials (RCTs) that often require large patient populations to achieve statistical significance, with the escalating costs and clinical utility demonstration posing additional barriers.
Real-World Data (RWD) that describe the patient journey in routine clinical practice can help overcome obstacles and/or complement existing clinical datasets.
A unique decentralized global cancer evidence collection
Hedera Frame is a collection of evidence from both clinical and Real-World Data from patients with solid tumors who have undergone genomic profiling to inform on best practices for treatment decisions by clinicians, foster global collaborations between cancer centers, and enable robust conclusions regarding outcome data to be drawn.
Cancer genomics data assets and real-world data collection efforts provide insights into the clinical utility, cost-effectiveness and outcomes of genomic profiling in daily practice.
Genomic-based technologies and especially ctDNA testing generate a wealth of genomic data that can enhance our understanding of cancer biology, identify novel therapeutic targets, and uncover potential biomarkers for predicting treatment response and prognosis. This knowledge can drive further advancements in cancer research and personalized medicine.
EMPATHY NSCLC
The First Multicenter, Prospective Clinical Validation and Real-World Utility Study for In-House, NGS-based Liquid Biopsy Testing
Liquid biopsy has emerged as a powerful and repeatable diagnostic test, offering real-time profiling of cancer genomes with minimal invasiveness. By analyzing blood-circulating biomarkers, like circulating tumor DNA (ctDNA), it serves as a valuable solution to support oncological decision-making. While tissue biopsy currently remains the gold standard for diagnosis of advanced solid tumors, liquid biopsy already complements it in various clinical settings and is increasingly being adopted as an independent diagnostics solution for treatment selection, monitoring of treatment response, cancer clonal evolution and prognostic evaluation where tissue biopsy is not feasible, warranted or accepted by the patient. Several clinical validation studies have been conducted globally to assess the clinical sensitivity and specificity of liquid biopsy through concordance studies with matched tissue profiling. However, most of these studies were typically run for only a specific and narrow national setting, not necessarily in the real-world setting and with limited numbers of participating centres. On top, most of the assays assessed in these studies were performed by central, privately owned laboratories and often in a retrospective way. As a result, several questions remained open in the European decentralized liquid biopsy context, which is mainly driven by in-house usage of the assays by hospital laboratories, necessitating further clinical validation studies to support a broader integration of liquid biopsy into routine clinical practice.
EMPATHY NSCLC (European Molecular PlasmA profiling liquid-biopsy program in THE NSCLC patients) represents the first Prospective Clinical Validation study for the European decentralized liquid biopsy approach, enabling prospective Real-World assessment of current ctDNA-based liquid biopsies practices in hospital laboratories. It aims at addressing some of the unresolved questions in various oncological settings, namely:
Sensitivity
What is the sensitivity of NGS-based liquid biopsy compared to standard of care tissue biopsy when used in routine clinical practice across a representative population in Europe?
Real-world Utility
What is the real-world utility of liquid biopsy, assessed through the proportion of treatment decisions guided by ctDNA-based liquid biopsy in clinical routine?
Patient Outcomes
What are the resulting patient outcomes, when reported by both investigators and patients themselves?
First of its kind
First Prospective Clinical Validation for the European Decentralized Liquid Biopsy (NGS-based) approach assessing concordance “Liquid to Tissue” across 10+ centers
Lead by renowned experts
European, Multicenter, non interventional study lead by Prof. U Malapelle, Prof. S Novello and Prof. F Passiglia
Real-world outcomes collected
Prospective outcomes collected in the Real-World setting via a patient mobile app (PROMs, PREMs) in addition to investigators reported ones
Building clinicogenomics evidence
First element of Hedera Frame, a large clinicogenomics data collection aiming at collecting Real-Life testing patterns with liquid biopsies, to ultimately unleash the potential of this highly promising technology and develop the next generation of breakthrough personalized therapies
Investigators’ own research
Investigators will get access to the data collected in EMPATHY NSCLC for their own research
Enrollment ongoing
800+ patients planned to be enrolled starting from H1 2024
Participating Centers
10+ centers
Participating in 6 countries
H1 2024
1st patient in
myHedera App
Making data collection easier for patients & hospital personnel to give patients more insight and control over their health
Hedera Dx has developed myHedera, a clinical app dedicated to ease Patient-Reported Outcomes (PROs) as well as Patient-Reported Experience Measures (PREMs) regarding Quality of Life, physical and psychological well-being, and satisfaction with diagnostic procedures, therapeutics, and general cancer-related care.
myHedera app is intended to ease patient-reported outcome measures concerning Quality of Life, physical and psychological well-being, and satisfaction with diagnostic procedures, therapeutics, and general care. It aims at placing patients at the center of their own care and fostering a collaborative relationship between healthcare providers, patient groups and individuals, leading to better care and meaningful advancements in healthcare practices.
Simple Feedback Upload
myHedera App allows patients to upload PROs and PREMs for clinical registry studies and experiences in the context of clinical studies. Patients will not be forced to visit the hospital to report routine information needed by the studies, it can be done from mobile anywhere, anytime.
Growing Clinical Evidence
Initially, the app will be used within the frame of the EMPATHY NSCLC study sponsored by Hedera Dx.
