Use Cases
Genialis works with pharma and biopharma, diagnostics companies and clinical researchers to build and commercialize our RNA Biomarkers.
In addition to our proprietary biomarker pipeline, we can tailor biomarker programs to meet the needs of each collaborator and partner, whether supporting translational decision making, clinical trial design, new assay development or patient care. A few examples are highlighted below.
The Xerna TME Panel is a novel biomarker panel for therapies targeting the tumor microenvironment (TME), such as immune checkpoint inhibitors (ICIs) and anti-angiogenic agents. Using RNA-sequencing and machine learning, the Xerna TME Panel classifies solid tumor samples into four subtypes based on the dominant biology of the TME. Each subtype represents a phenotype with a distinct therapeutic hypothesis and probability of response to treatment.
Watch a summary of the Xerna TME panel (1 minute)
Highlights
Training and validation
- The model was trained on microarray data, and since has been validated on 5 gene expression platforms and RNA-seq chemistries.
- Biomarker performance has been examined retrospectively on over 10,000 patient samples.
- The panel has been accepted by the FDA as an IDE for prospective validation in an upcoming Phase III clinical trial.
Pan cancer, pan modality
- The panel has been shown to stratify patients in a dozen different solid tumor types.
- In retrospective analyses, the panel has enriched for clinical benefit to 3 approved and 3 investigational drugs, matching or outperforming the performance of industry-standard biomarkers.
- More information about this biomarker can be found in our posters and papers.
Availability
- The Xerna TME Panel is under commercial development by several global diagnostics companies (Qiagen, Exact Sciences, Kindstar) for future use as a Cdx and RUO test.
References
The machine learning-based Xerna score is obtained from RNA gene expression levels of ~100 genes. The score reflects the dominant cellular micro-environment of the tumor, along immune and angiogenic axes, and may be useful for predicting response to particular therapies, thus informing therapy decisions.
The Xerna™ TME Panel has been licensed to Exact Sciences and integrated into their oncoExTra™ platform. This biomarker complements the oncoExTra comprehensive genomic and transcriptomic sequencing that interrogates both DNA and RNA. Genialis led the technical transfer and supported the implementation and validation of the panel within Exact’s clinical data analysis workflow.
Genialis and Exact Sciences have performed retrospective analyses to examine the distribution of actionable oncogenic driver mutations across Xerna TME subtypes in multiple cancer indications:
Immune and vascularization biologies define four subtypes: immune active (IA), immune suppressed (IS), angiogenic (A), and immune deficient (ID). Based on the gene expression patterns in the input RNA-seq data, the TME Panel classifies patient samples into one of these categories with a certain probability.
Genialis works with academic research centers and hospitals around the world to test and validate our biomarkers in different patient populations. These collaborations are based on the sharing of data, models, and clinical expertise, and may include sponsored research.
In 2023, Genialis announced a collaboration with Cancer Research Horizons (CRH), the innovation arm of Cancer Research UK. CRH has made anonymized and curated datasets with ‘omics and clinical metadata available to Genialis. This data will support the training and validation of ResponderID algorithms on diverse patient populations to better predict responses to KRAS inhibitors, immunotherapies, and other emerging classes of therapeutics.
