Liquid biopsies provide better therapy options for more patients
Hedera Dx liquid biopsy solution radically streamlines tumor profiling and cancer treatment monitoring for all patients, enabling every hospital laboratory to run CE-IVDR compliant and clinically actionable liquid biopsies in-house.
With a simple blood draw, liquid biopsies profile circulating tumor DNA (ctDNA) for the vast majority of patients
Traditional tissue biopsy might fail or be unfeasible for up to 40%1 or more of the cancer patients (e.g. NSCLC patients), thus limiting their chance to receive a treatment tailored to their tumor’s molecular makeup.
With a consistent very high success rate, insights from ctDNA found in the blood enable a more personalized patient journey and treatment plan, for many patients to benefit from better outcomes.
However, in-house adoption of NGS-based liquid biopsies is difficult
Assay validation, CE-IVDR compliance and local regulation, as well as privacy infrastructure are challenging to achieve; and even if these obstacles are overcome, existing software workflows are inefficient to run and lack essential features to ease reporting in daily practice.
In addition, there is still a paucity of clinical trials conducted or actively recruiting globally in hospital centers to investigate the clinical validation and clinical utility of ctDNA markers in cancers in a decentralized context.
High R&D and compliance hurdles
Time intensive laboratory, bioinformatics, and reporting workflows
Limited clinical evidence readily available for in-house molecular testing for many cancer types
liquid biopsy solution expands treatment options for patients — without the hurdles
Our liquid biopsy solution for the hospital laboratories
Our liquid biopsy solution, powered by the registered CE-IVD medical device software, Hedera Prime, together with our pan-cancer targeted assay, Hedera Profiling 2 ctDNA test panel, integrates swiftly into your existing laboratory setting with unrivaled simplicity.
Clinical Applications of ctDNA-based liquid biopsies for patients with cancer are broad
Hedera Dx launched its first solution for biomarkers-guided treatment selection in advanced disease.
How it works
A radically streamlined biopsy process
Our solution integrates swiftly into existing settings of molecular pathology laboratories with unrivaled simplicity.
Blood draw
When a physician decides to do a liquid biopsy test to find the best treatment option for the patient, a simple blood draw is ordered.
Sequencing
After the patient’s blood sample is sent to the hospital lab, ctDNA is extracted from the plasma and Next Generation Sequencing (NGS) is performed with the Hedera Dx assay.
Clinical report
Using our software, a report is generated that provides options of regulatory-approved therapies to the patient’s tumor ctDNA sequence.
Therapy options
The physician discusses the report results within his institution to ultimately determine the best path forward for treatment in alignment with the patient’s preferences.
We’re united by a vision to make liquid biopsies globally accessible for patients
October 28, 2024
Hedera Dx Announces Publication of International, Multicenter, Pan-Cancer Liquid Biopsy Test Panel Analytical Validation in medRxiv
October 28, 2024
Hedera Dx Announces Publication of International, Multicenter, Pan-Cancer Liquid Biopsy Test Panel Analytical Validation in medRxiv
- Malapelle, U et al. Liquid Biopsy for Biomarker Testing in Non-Small Cell Lung Cancer: A European Perspective. J. Mol. Pathol. 2021, 2, 255-273. https://www.mdpi.com/2673-5261/2/3/22
- Pascual, J et al. “ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group.” Annals of oncology : official journal of the European Society for Medical Oncology vol. 33,8 (2022): 750-768. doi:10.1016/j.annonc.2022.05.520