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FDA-approved companion diagnostic

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

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

IVD-developed CDxMethod: FISHBiomarker: KMT2A
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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
DEN240067
Supplements
Manufacturer
Cytocell Limited (Oxford Gene Technology IP Limited)
Approval date
September 19, 2025
Test specifications
Methodology
FISH
Turnaround (typical)
Not specified
Report format
Comprehensive report PDF
Biomarker(s)
KMT2A
What this test is

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) 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)
Acute LeukemiaKMT2ARearrangements on chromosome 11 at location 11q23.3REVUFORJ

IVD Manufacturer

Cytocell Limited (Oxford Gene Technology IP Limited)

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 KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) 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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