Liquid biopsy · Compact panel

HP2 — a 32-gene panel for liquid biopsy

Hedera Profiling 2 is a compact liquid biopsy test for the most common solid tumours: lung, breast, colon, prostate and others. Its 32 genes cover over 80% of ESCAT Level I recommendations, including ESR1, MET ex14 and MSI status. Hybrid capture with UMI keeps sensitivity high even at low variant fractions.

  • 32 Genes in the panel
  • 10 ng Minimum cfDNA input
  • 5 days From sample to clinical report
  • 0.5% Limit of detection
About the test

A compact ctDNA panel for the most common solid tumours

HP2 is built on a simple principle: a smaller panel that contains only what matters. The selected genes cover treatment decisions in the tumours that ESMO recommends testing from ctDNA. As a result, the panel is only 90 kb and sequencing costs less.

The key markers for treatment selection remain in the panel: ESR1 for endocrine resistance in breast cancer, MET ex14 skipping in lung cancer and MSI status for immunotherapy. All in a single protocol with UMI-based error correction.

Specifications

What the HP2 panel covers in one test

32 genes, 90 kb

A compact panel that balances the most clinically important genes against the cost of sequencing.

> 80% ESCAT Level I

Covers over 80% of ESCAT Level I genes.

SNVs, indels and CNVs

Point mutations, small indels and copy-number variations. Plus fusion detection directly from ctDNA and MSI status.

ESR1, MET ex14, MSI

Markers that drive treatment decisions: endocrine resistance in breast cancer, MET skipping in lung cancer and MSI for checkpoint inhibitors.

UMI

Molecular identifiers correct read errors. The result is higher accuracy at low variant fractions.

10 ng cfDNA from 5 ml of plasma

Minimum input 10 ng, 30 ng recommended. Collection into Streck cfDNA BCT tubes.

Panel content

The complete list of genes in the panel

Based on the original Hedera Dx specification. The panel also covers METex14 skipping and the EGFR vIII variant. MSI status is determined from 36 markers. The CNV detection method is currently being validated.

Gene list of the HP2 panel, divided into SNVs and indels, CNVs, fusions and MSI
Workflow

From sample to report in 5 days

The entire workflow takes place in your laboratory. Hedera Dx supplies the kit, the library preparation protocol, hybrid capture and the Hedera Prime software. The output is a clinical report for the oncologist or molecular pathologist.

  1. 1

    Blood draw and cfDNA extraction

    5 ml of plasma from a Streck cfDNA BCT tube. Library preparation requires a minimum of 10 ng of cfDNA, with 30 ng recommended.

  2. 2

    Library preparation with UMI

    Twist Bioscience technology. Uses UMI to increase the accuracy of low-frequency variant detection. Runs on standard laboratory equipment, with nothing extra to buy.

  3. 3

    Hybrid capture

    Hybrid capture of 32 genes (90 kb), including fusion detection directly from DNA.

  4. 4

    Sequencing

    The panel runs on standard Illumina and Element Biosciences sequencers.

  5. 5

    Report in Hedera Prime

    Complete data analysis through to the clinical report. The final analysis takes less than five minutes.

Implementation support

Hedera Comply — tailored implementation under IVDR

HP2 comes with the Hedera Comply programme. It takes your laboratory all the way from installation to operation under IVDR.

  • Hands-on training on site in your laboratory
  • Laboratory procedures and software training
  • Review of the first runs and validation
  • Ready-made technical documentation for IVDR
  • Ongoing support, including after implementation
Let's get started

Want HP2 in your lab?

We will walk you through the technical requirements, the sample specifications and how to use the Hedera Prime software. We can offer you a trial kit on favourable terms.