At HIST, our mission is simple and urgent: get lifesaving diagnostics to patients faster. Today, we’re beyond excited to announce our partnership with HederaDx, a Swiss oncology company pioneering hospital-run, next generation sequencing liquid biopsy solutions.

We would like to give a special appreciation to the HederaDx team. Paola Castelli, VP of Sales and Damian Lapray, Co-Founder & COO for diligently working with us to make this partnership possible. We have immense pleasure to be working with them as they utilize their brilliance to accelerate a technology that is much needed in the MENA market.

Together, we will help health systems across the Middle East & North Africa (MENA) stand up in-house ctDNA testing so oncologists can act sooner, with more precision, and closer to the patient.

Why this partnership matters

Cancer outcomes hinge on timing. Traditional testing models often rely on distant reference labs, stretching turnaround times when every day counts.

HederaDx’s approach enables hospital laboratories to run clinically actionable liquid biopsies themselves, supported by a purpose-built software layer and an implementation program that helps labs validate and operate in compliance with IVDR where applicable.

For patients, this means a simple blood draw can inform therapy selection and disease monitoring—**with results moving from “weeks away” to a sample-to-report target of about five calendar days.

Who is HederaDx?

HederaDx develops a clinic-ready, next-generation sequencing (NGS) liquid biopsy solution that combines an optimized ctDNA panel with intuitive software for reporting and quality control. Rather than centralizing everything in one mega-lab, HederaDx decentralizes testing so hospitals can provide precision oncology on-site—and keep clinical data within their own walls.

The technology at a glance

• Hedera Profiling 2 (HP2) ctDNA panel: a 32-gene, DNA-only liquid biopsy assay for solid tumors, designed to detect SNVs, indels, copy-number changes, gene fusions, and MSI from plasma. Independent, international multicenter work has documented its analytical performance for decentralized hospital settings. (hederadx.com)

• Hedera Prime software: transforms raw NGS data into clinician-friendly reports, with QC dashboards to confirm run performance and configurable sections that link genomic findings to regulatory-approved therapy options. (hederadx.com)

• Comply implementation program: step-by-step support—on-site training, validation guidance, and technical documentation—to help hospital labs reach local compliance for routine, in-house liquid biopsy. (hederadx.com)

What this means for health systems in MENA

Faster answers, closer to the bedside. By enabling hospital-run testing, we aim to reduce logistics friction and shorten time to treatment decisions for oncology teams across the region. HederaDx’s workflow is engineered for rapid integration into routine NGS environments and is supported by software that streamlines reporting for busy pathology and molecular teams.

Evidence-based precision care. HP2’s multicenter analytical validation and Hedera’s growing clinical-evidence program (e.g., EMPATHY NSCLC) support the shift to in-house liquid biopsy and help broaden access to targeted therapies—particularly where central lab dependence has limited adoption.

Capacity building and compliance. HIST will partner with hospitals to plan deployment, coordinate local validation, and facilitate training—working hand-in-hand with HederaDx’s Comply program so labs can meet their regulatory and quality obligations.

Designed for real-world oncology

• Turnaround time goal: ~5 days sample-to-report to help clinicians act on molecular insights within standard treatment windows.

• Actionability: the panel emphasizes ESCAT Level I biomarkers to guide therapy selection where benefit is most established.

  
  

• Run-level confidence: Hedera Prime includes QC dashboards to verify performance before reports are issued.

  
  

• Built for hospital labs: A decentralized model that supports ownership of data and avoids sole dependence on remote labs—key for sustainable precision oncology programs. (Air Street Press)

A shared mission

“Every week we delay the right test is a week a patient waits for the right treatment. With HederaDx, now MENA hospitals can bring world-class liquid biopsy in-house—shrinking timelines and opening doors to targeted therapies for patients across MENA.” — Talha, COO

This partnership is about closing the access gap—so that a patient’s postal code doesn’t decide their odds.

By uniting HIST’s regional implementation expertise with HederaDx’s hospital-ready platform, we’re building capacity where it’s needed most: inside the health systems that care for patients every day.

About HederaDx

HederaDx is a Swiss company focused on clinic-ready NGS liquid biopsy for tumor profiling and treatment monitoring. Its offering pairs the Hedera Profiling 2 (HP2) ctDNA panel with Hedera Prime software and a comprehensive Comply program for local validation and IVDR-aligned implementation in appropriate jurisdictions. The company is advancing a body of clinical and real-world evidence to support hospital adoption.

About HIST

HIST partners with innovative diagnostics and biotechs to accelerate market entry and scale across MENA through AI compliance & distribution. We integrate regulatory, training, medical affairs, distribution, and post-market support so technologies reach clinicians and patients years faster than traditional routes.

Get involved

• Hospitals & laboratories: Interested in in-house liquid biopsy? Let’s discuss readiness, validation, and go-live timelines.

• Oncology leaders & tumor boards: Explore how hospital-run ctDNA testing can streamline therapy decisions for your patients.

• Payers & health authorities: Work with us on value frameworks and real-world evidence to support adoption at scale.

Contact HIST to bring HederaDx to your institution.

admin@histgroup.org

References & further reading

• HederaDx Solution & Comply program (panel, actionability, 5-day TAT, implementation). (hederadx.com)

• Hedera Prime software (reporting and QC). (hederadx.com)

• Why Liquid Biopsies (patient/physician benefits; sample-to-report). (hederadx.com)

• International multicenter analytical validation of HP2 (32-gene ctDNA assay). (MedRxiv)

• Decentralized, hospital-run model context. (genomeweb.com)

Note: Availability and regulatory status vary by country. Solutions are implemented in accordance with local requirements.