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This document is a Declaration of Conformity by Illumina, asserting that the TruSight Oncology Comprehensive (EU) in vitro diagnostic devices meet the required standards outlined by the EC Directive 98/79/EC and its amendments. It includes details about the manufacturer, authorized representative, device model numbers, classification, and the components of the device.
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How to fill out trusight oncology comprehensive eu

01
Obtain the Trusight Oncology Comprehensive EU kit from a certified supplier.
02
Read the accompanying instructions and guidelines to understand the workflow.
03
Collect the tissue or blood sample following the standard collection procedures.
04
Prepare the sample for processing, ensuring it is kept in the correct storage conditions until analysis.
05
Follow the kit's protocol to perform the necessary assay steps, including any extraction or amplification processes.
06
Load the prepared samples onto the appropriate sequencer as described in the instructions.
07
Monitor the sequencing process and ensure all quality control measures are met.
08
Analyze the sequencing data using the provided software tools to interpret the results.
09
Review the output report for comprehensive insights into the genomic alterations present in the sample.
10
Consult with a clinical team or genetic counselor to understand the implications of the findings.

Who needs trusight oncology comprehensive eu?

01
Patients diagnosed with cancer who require comprehensive genomic profiling.
02
Oncologists seeking to tailor treatment plans based on specific genetic mutations.
03
Research institutions studying the genetic basis of cancer.
04
Pharmaceutical companies developing targeted therapies based on genetic information.
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TruSight Oncology Comprehensive EU is a genomic profiling test designed to identify genetic mutations associated with various types of cancers, providing insights for personalized treatment plans.
Healthcare providers and laboratories that utilize the TruSight Oncology Comprehensive test for cancer patients are required to file the results and data generated from the test.
To fill out the TruSight Oncology Comprehensive EU, healthcare providers must follow the specific guidelines set by the manufacturer, which typically include entering patient information, test results, and relevant clinical data into the designated reporting system.
The purpose of TruSight Oncology Comprehensive EU is to help clinicians understand the genetic makeup of a patient's tumor, guiding treatment decisions and improving patient outcomes in oncology.
The information required includes patient demographics, tumor characteristics, genetic mutations identified, and any recommendations for targeted therapies.
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