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FDA-approved companion diagnostic

PGDx elio tissue complete CDx

A comprehensive genomic profiling assay used as a companion diagnostic to select patients for targeted therapies across multiple solid tumors.

IVD-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: BRAF, MEK
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P250036
Supplements
Manufacturer
Personal Genome Diagnostics, Inc. (Labcorp)
Approval date
July 30, 2026
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
BRAF, MEK
What this test is

PGDx elio tissue complete CDx is an in vitro diagnostic test that uses next-generation sequencing to identify genomic alterations in solid tumors. It is approved by the FDA as a companion diagnostic for multiple targeted therapies across tumor types.

Results from this assay help determine whether a patient is eligible for specific therapies based on the genomic profile of their tumor.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
MelanomaBRAFV600ETAFINLAR, ZELBORAF

IVD Manufacturer

Personal Genome Diagnostics, Inc. (Labcorp)

This companion diagnostic is performed exclusively at Foundation Medicine's CLIA-certified, CAP-accredited laboratory.

Order this test

If your organization is connected to Casandra, you can place an electronic order for PGDx elio tissue complete CDx directly from your existing workflow.

Order via Casandra

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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