Transforming Oncology

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.

Woman with illustration of lung overlay showing tumor

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.

Solution

Growing clinical body of evidence for in-house liquid biopsy testing

EMPATHY NSCLC

Real-world utility and clinical validation study

EMPATHY NSCLC is the first European, Prospective, Multicenter Clinical Validation study for the in-house liquid biopsy testing, enabling Real-World assessment of current NGS-based liquid biopsies practices in hospital laboratories.

Partnerships

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.

About

We’re united by a vision to make liquid biopsies globally accessible for patients

References
  1. 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
  2. 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