TOP2A Fish Pharmdx

FDA-Cleared Indications

• Change in auxiliary material and supplier used in production of the probe mix to eliminate enzyme-related stability problems.

Clinical Applications

Reported off-label uses

• Assessment of TOP2A gene amplification or deletion in tumor specimens as a research or clinical laboratory test.
• Investigation of possible associations between TOP2A status and response to selected cancer therapies, when performed outside the device labeling.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• This is an in vitro diagnostic assay for laboratory use on appropriately prepared tumor specimens; it is not an implantable or injectable device.
• Testing requires fluorescence microscopy and validated laboratory procedures, including specimen preparation, probe hybridization, washing, and signal interpretation.
• Results should be interpreted by trained pathology or molecular-diagnostics personnel together with tumor morphology and other clinical and laboratory findings.
• The FDA indication provided for this record concerns probe-mix manufacturing and stability; it does not independently establish a specific treatment-selection indication.
• MRI safety, device sizing, and implantation considerations do not apply because the assay is not placed in the body.