Hedera Dx, an oncology company specializing in liquid biopsy testing, has unveiled a fully streamlined solution that allows hospitals to adopt liquid biopsy testing locally for their patients with minimal efforts. The solution is a combination of laboratory reagents and a software platform.

Liquid biopsies provide rapid, precise, non-invasive ways of assessing tumors and matching a patient with different targeted treatments. Currently, tumor tissue biopsies are considered a ‘gold standard’, however they are invasive and the process of obtaining a tissue biopsy is risky, painful and expensive. Most importantly, in up to 40% of cases, the patient can be ineligible for obtaining the biopsy or the actual biopsy can fail.

A liquid biopsy, using a simple blood draw, allows to draw insights and profile the patient’s tumor from circulating tumor DNA (ctDNA) found in the blood. This way hospital laboratories can efficiently acquire information about multiple sites and metastasis in one single sample. Liquid biopsies are also easily repeatable, potentially providing new options for monitoring disease progression and response to treatment through the patient journey.

The adoption of liquid biopsies could unlock the promise of transformative personalized cancer care. For example, there are over a dozen molecularly defined lung cancer entities and a wide range of possible treatments. A precise understanding of the tumor allows pathologists and clinicians to identify effective strategies and ensure that patients don’t suffer unnecessarily from the effects of interventions that are unlikely to help them.

Christian Meisel, Co-Founder and Chief Medical Officer of Hedera Dx said: “The widespread adoption of liquid biopsies in oncology will be a game-changer for patients. As a former clinician, I know firsthand how powerful the combination of routine non-invasive testing and personalized therapeutics will be for people struggling with one of the most challenging periods in their lives.”

Christian Meisel, Co-Founder and Chief Medical Officer of Hedera Dx

Hedera Dx’s comprehensive solution provides a streamlined and local alternative to the handful of liquid biopsy tests that are currently on the market.
The solution is called Hedera Profiling 2 ctDNA Test Panel and it integrates easily with the existing instrument infrastructure of a hospital lab. The test is built on actionability, in other words focusing on finding a potential treatment. Actionability is driven by the recognized ESCAT* framework, and the test covers over 80% of ESCAT Level I genes, providing a robust connection between the test results and targeted treatments that are already on the market. A key strength of the test is also the ability to simultaneously detect all of the four major kinds of genetic alterations, and in addition a genetic signature called MSI**.

A cornerstone of the solution is Hedera PrimeTM, a registered IVD medical device platform built on the feedback of over 140 laboratories to save them time while shaping the analysis report. Hedera Prime rapidly interprets DNA sequencing results and allows to quickly generate reports with actionable results connected to therapy options approved by the US and European regulators. Combined with the assay, this cuts the time to reach results
significantly, which is crucial in cancer care.

‍Tommi Lehtonen, Co-Founder and CEO of Hedera Dx said: “At Hedera Dx, we believe that the best way to unleash the power of liquid biopsy is to make adoption as smooth as possible for hospitals. This means introducing several comprehensive tests, intuitive software, and helping hospitals to navigate compliance. This whole platform approach, rather than trying to capture all of the complexity with an individual test, is central to ourphilosophy.”

Hedera Dx’s full biopsy solution has already been deployed in hospital laboratories across three countries and is about to be implemented in an increasing number of laboratories in the coming months.

About Hedera Profiling 2 ctDNA test panel
The Hedera Profiling 2 ctDNA Test Panel* is at the forefront of clinical actionability, providing a compact yet comprehensive 32-gene assay optimized to run ctDNA samples with NGS technologies commonly used in routine by hospital laboratories. The panel enables simultaneous detection of Single Nucleotide Variants (SNVs), Insertions and Deletions (Indels), Copy Number Variations (CNVs), Fusions, and Microsatellite Instability (MSI) across more than six common solid tumor types in a single DNA-only liquid biopsy assay.

Seamlessly integrating into routine NGS workflows, precise results can be obtained within a swift 5 calendar days, utilizing just 30 ng of cell-free DNA and empowering laboratories to expedite testing timelines without compromising on data accuracy with an overall panel sensitivity > 97% and specificity > 99% at 0.5% VAF for clinically relevant variants classified ESCAT Level I across multiple cancer types in the guidelines.

Each kit includes all the reagents for cfDNA extraction, library preparation and target enrichment, as well as the software, Hedera PrimeTM, required to analyze sequencing data and generate customizable reports within a few clicks with suggestions of therapy options. Hedera Prime is a registered IVD medical device software featuring, as a fully integrated component, the expertly curated OncoKBTM knowledge base for well-informed therapy decisions based on guidelines-related biomarkers. The software expedites the reporting process in an unprecedented resource-saving and comprehensive way and associates tumor gene alterations with regulatory-approved therapy options from FDA and EMA, facilitating the identification of effective and ineffective treatments for patients.

The cornerstone ESMO guidelines now recommend that genomic reports include ranking of the genomic alterations for clinical actionability by valid ranking systems such as the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) or OncoKBTM. Hedera Profiling 2 ctDNA test panel is the first product of our assay portfolio, with more to come on the horizon.

Read original news