Delivering Clinically Relevant Gene Therapy Analysis for Cancer Patients

Agendia’s TheraPrint^® is a microarray-based gene expression panel of 56 genes that have been identified as potential targets for prognosis and therapeutic response to a variety of therapies. Although these genes are still in a research phase, in the future they may hold the key to a greater level of personalized prognosis and therapy for breast cancer patients.

The genes used by TheraPrint and their potential involvement in cancer therapy have been investigated in research studies and have been described in scientific publications. Some of these genes are directly targeted by existing drugs or drug types, certain other genes have been shown to be involved in resistance or response to therapy or to be prognostic. The results are available in the public domain.  

Any breast cancer patient may potentially benefit from the genomic information captured by the Symphony^TM profile and TheraPrint^®. By acquiring the gene expression levels of these potential targets, in advance of any adjuvant therapy, you are in essence documenting the “fingerprint” of the patient’s tumor.  

Although there are scientific publications that discuss the involvement of these genes with regard to response or resistance to specific therapies, Agendia has not performed any studies that suggest, or support, the use of the TheraPrint results as a tool for therapeutic decision-making at the present time.  Agendia, as well as other independent research centers, are actively investigating the roles these genes play in disease progression and therapeutic response with the goal of enabling more individualized medicine.  Agendia will be regularly updating its database to provide you with additional information.

Decisions regarding care and treatment should not be based on a single test such as this test. More investigation is required to fully understand, and validate, how the expression levels of these genes are linked to therapeutic response.

Using DNA microarray technology, the TheraPrint measures the mRNA level of genes that are of potential interest in the context of cancer therapy.  For each gene assessed, the gene expression is shown as an absolute gene expression and a relative gene expression percentile.  There are no established cutoffs to determine whether a given result is high/low or active/inactive.  To provide a relative indication whether a gene expression is rather low or rather high, the patient’s absolute gene expression is compared to the gene expression of a reference population.  The TheraPrint reference distribution was established using 373 samples from newly diagnosed untreated breast cancer patients.

The absolute gene expression result is the log2 intensity of each gene as measured on the array ranging from 0 to 19. The value is dimensionless and cannot be directly translated to RNA concentration or copy number.  The relative gene expression readout compares the expression of a given gene to expression of the same gene in the reference distribution comprised of other breast cancer samples.  The relative expression of the patient's gene is given as a percentile score. This percentile score indicates the percentage of reference samples with a lower intensity.

For example, if the absolute expression of a gene is 2 and the expression of the reference ranges from 0 to 10, then the relative gene expression percentile of this gene is 20, indicating that 20 percent of the reference samples have a lower expression, and 80% of the reference samples have a higher expression.

Agendia assumes that physicians ordering this test understand the meaning of the individual gene expression result in the context of their research.

TheraPrint

The TheraPrint panel will be performed using the same quality control measures with the other tests in the Symphony profile.  Your Agendia representative, or Customer Care, can provide you with the test requisition form at your request.

Agendia will perform the test on the tumor sample submitted for the Symphony profile. The tissue sample should be obtained fresh, prior to formalin fixation, and placed into Asuragen’s FDA-cleared, room temperature RNARetain^® molecular fixative provided within the Specimen Transportation kit.  For detailed instructions on obtaining a tumor sample for testing, please refer to Agendia’s Sampling Instructions provided within the Specimen Transportation kit.

Once the sample is received, Agendia will perform the analysis and provide a report of the quantitative results within 10 working days.  Agendia performs testing at its state-of-the-art CLIA (Clinical Laboratory Improvement Act) certified and CAP (College of American Pathologists) registered and compliant genomics laboratories in Irvine, California and Amsterdam, The Netherlands.

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For Sampling Instructions or to order test requisition forms and specimen transportation kits please visit: Ordering