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top2a fish pharmdx
Dako Denmark A/S
Summary: The top2a fish pharmdx is a diagnostic device used to detect genetic markers in cancer cells. It is primarily utilized by oncologists and pathologists to guide treatment decisions.
FDA Clearance Information
Pathway
PMA
Number
P050045 ↗
Decision Date
March 26, 2008
Product Code
NXG
Device Class
Class 3
Evidence
0 studies
The top2a fish pharmdx was cleared through the FDA's premarket approval (PMA) process on March 26, 2008. Manufactured by Dako Denmark A/S, it is classified as a Class 3 device.
What It Is
The top2a fish pharmdx is a fluorescence in situ hybridization (FISH) diagnostic test designed to detect the topoisomerase II alpha (TOP2A) gene in cancer cells. This test helps identify genetic abnormalities that may influence cancer prognosis and treatment strategies. By using fluorescent probes, it allows for the visualization of specific DNA sequences in tumor samples, providing critical information for personalized cancer therapy.
Clinical Applications
This device is commonly used in oncology and pathology settings to assess genetic markers in breast cancer and other malignancies. It aids in determining the likelihood of response to certain chemotherapeutic agents, particularly in patients with aggressive cancer types. The test is typically performed in specialized laboratories equipped to handle molecular diagnostics and is an integral part of personalized medicine approaches in cancer care.
Indications for Use
The FDA indications highlight a change in auxiliary materials to improve the stability of the probe mix used in the test. Clinically, this means the device is intended for use in detecting genetic markers in cancer patients, ensuring reliable and stable test results.
Practical Considerations
When using the top2a fish pharmdx, it is important to ensure compatibility with existing laboratory equipment and protocols. The test requires precise handling and interpretation by trained personnel. It is crucial to follow the manufacturer's guidelines for sample preparation and analysis to achieve accurate results.
Frequently Asked Questions
What is top2a fish pharmdx used for?
It is used to detect genetic markers in cancer cells to guide treatment decisions.
What specialties typically use this device?
Oncologists and pathologists typically use this device in cancer diagnostics.
What are the FDA-cleared indications?
The device is indicated for use in detecting genetic markers in cancer patients, with improved stability in the probe mix.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.