The Value of Diagnostic Testing: What it is and Why it’s Important to a Patient

Diagnostic testing is essential to the basic management of patient care, allowing physicians to detect disease earlier, make accurate diagnoses, prescribe therapies and monitor results. Whether it's a routine lab test such as blood work, or one of the most technologically advanced tests for detecting genetic deletions and mutations, diagnostic testing provides the medical community with the most comprehensive information available today.

Due to advancements in genomics, proteomics, and laboratory developed tests, a new class of diagnostics is starting to emerge – IVDMIAs. IVDMIA stands for In Vitro Diagnostic Multi-Variate Index Assay. They are considered a subset of laboratory developed tests (LDT) that combine multiple variables (i.e. gender, age, weight, clinical lab results, etc.) using an interpretation function (i.e. an algorithm) to generate a patient-specific result (i.e. risk assessment, classification) for the purpose of diagnosing, treating, or mitigating a disease.

This type of test now enable doctors to better predict your risk for metastasis or your tumor recurring. Based on your individual risk of recurrence, whether or not your cancer has the potential to spread, your doctor will determine the best therapy for you. If you are at low risk for recurrence, hormonal therapy alone may be recommended. Conversely, if you are at high risk, your doctor may recommend more aggressive treatment that may include chemotherapy.

In the past, the only way doctors could determine treatment decisions was to use physical and hereditary traits in a patient to determine the most likely outcome based on how other patients had fared. This often led to patients enduring serious treatments like chemotherapy that may not have been needed. With IVDMIAs designed specifically for breast cancer patients, doctors can make crucial decisions in determining the best possible treatment plan specifically for you based on the results of these tests.

MammaPrint®

There are only a few IVDMIAs on the market today that focus on breast cancer. MammaPrint is the only FDA-cleared gene expression profile test validated to assess your individual risk of breast cancer recurrence. Truly a next generation diagnostic test, MammaPrint leverages advances made by the Human Genome Project and the newest developments in microarray technology to analyze the complex biology of your tumor and provide you and your doctor with powerful insights into the aggressiveness of your cancer.

To learn more on how you can individualize your treatment and learn your likelihood of recurrence with MammaPrint, click here.

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