Hedera

Hedera Dx develops next-generation sequencing (NGS) based tumor profiling solutions designed to be run inside hospital molecular pathology laboratories rather than sent to a central reference lab. Its portfolio spans genomic profiling of FFPE tissue, circulating tumor DNA (ctDNA) liquid biopsy and RNA-only testing, combined with analysis and reporting software that matches detected tumor alterations to regulatory-approved therapy options. The company frames its mission around broadening access to advanced molecular testing for health systems, patients and drug development programs.

The commercial offering has three main components. Hedera Profiling 2 is a targeted, DNA-only ctDNA liquid biopsy assay covering 32 genes for detection of SNVs, indels, CNVs, fusions and microsatellite instability across more than ten common solid tumor types, including lung, breast and colorectal cancer; it is labeled for performance studies only and is not available in all countries, including the United States. Hedera Prime is the accompanying sample-to-report software, a registered CE-IVD/CE-IVDR medical device software manufactured by Limbus Technologies GmbH in Rostock, Germany, which performs pathogenicity and oncogenicity assessment using databases such as ClinVar, OncoKB, OMIM, gnomAD, dbSNP, Mastermind and BRCA Exchange, and outputs customizable clinical reports ranking EMA- and FDA-approved therapy options by OncoKB therapeutic levels of evidence. Hedera Comply is an implementation program providing onsite wet-lab and software training, run assessment, local validation support and pre-filled IVDR technical documentation so laboratories can reach compliance for routine in-house testing.

Alongside diagnostics, Hedera Dx operates a real-world evidence (RWE) business built on ethics committee-approved infrastructure with standardized informed consent and governance. It assembles longitudinal datasets that link clinical data, tissue and liquid biopsy molecular profiling over time, and validated patient-reported outcome instruments (EQ-5D-5L, PRO-CTCAE), positioned for uses such as regulatory submissions, HTA and HEOR analyses, biomarker discovery, model development and clinical trial optimization including external control arms. Its flagship study, EMPATHY NSCLC (ClinicalTrials.gov NCT07096258), is described as a European, prospective, multicenter clinical validation and real-world utility study of in-house liquid biopsy testing; the company also designs bespoke prospective RWE studies with partners. Patients are engaged directly through the myHedera app, which collects patient-reported outcomes and experience measures.

Founding story

Hedera Dx was established in Switzerland in 2021 by Tommi Lehtonen, Damien Lapray and Christian Meisel, who came from prior roles in genetic testing and precision oncology: Lehtonen co-founded Blueprint Genetics and led Specialty Genetics at Quest Diagnostics; Meisel, an MD PhD, held senior positions at Roche including Global Head Translational Medicine and was CMO of Molecular Health; Lapray was long-standing CCO of Sophia Genetics.

Business model

Hedera Dx sells products and services to hospital and molecular pathology laboratories: NGS tumor profiling kits, subscription/licensed analysis and reporting software (Hedera Prime, commercialized together with the kits or purchasable separately), and a paid implementation and IVDR-compliance program (Hedera Comply). A second line monetizes clinicogenomic real-world evidence generated through its study network for drug developers and health-system partners, including bespoke prospective studies.

Revenue derives from sales of tumor profiling kits (18 reactions per kit) and the Hedera Prime software, quoted on request, plus implementation, training and technical documentation services and partner-funded real-world evidence studies.

Traction

The Hedera Profiling 2 panel was analytically validated in an international multicenter study spanning 8 countries and 11 expert cancer centers using 78 reference samples and 137 clinical cfDNA samples across nine tumor types, with a preprint on medRxiv. The Hedera Prime report was developed with feedback from more than 140 experts and the software is a registered CE-IVD/CE-IVDR medical device. The prospective EMPATHY NSCLC multicenter validation study is registered as NCT07096258.

Latest developments

The company announced Tobias Silberzahn as a board member (July 2026) and scheduled symposia on liquid biopsy in molecular pathology (April 2026 and August 2026). Its EMPATHY NSCLC prospective multicenter clinical validation study is registered as NCT07096258, and the analytical validation of Hedera Profiling 2 is available as a medRxiv preprint pending publication.