Consent Form

For genetic testing following informed consultation

Testing for genetic disorders can be complex. If you consider it appropriate, seek professional genetic counseling before giving your consent, so that you fully understand the risks and benefits involved in undergoing the test.

By means of this form, I consent to be tested for HEREDITARY CANCER PREDISPOSITION SCREENING through the performance of a genetic test. I understand that a biological sample (blood, tissue, fluid) will be taken from me and/or members of my family. I understand that this biological sample will be used for the purpose of determining whether I and the members of my family are carriers of the disease-causing gene, are affected by the genetic disease, or are at increased risk of developing it at some point in the future.

It has been explained to me, and I understand, that this test specifically concerns (write the disease):

A positive result is an indication that I may be predisposed to the specific disease or condition, or that I may already be affected. Further testing may be required to confirm the diagnosis. I understand that I will be given the opportunity to speak with my physician or a genetics specialist regarding the results.

There is a certain probability that I have the specific disease or condition, but that the test results are negative. Due to limitations in the technology and incomplete knowledge of genes, certain changes in the DNA or in the protein products that cause diseases may not be detected by the test.

There is also a certain probability that the laboratory findings are non-interpretable or of unknown significance. In rare cases, the findings may indicate a condition different from the diagnosis originally suggested.

In the event that a variant of uncertain significance (VUS) is detected, your physician will recommend a re-testing plan based on your personal and family medical history, and should new information become available in the meantime regarding the variants of uncertain significance in your result, we will inform you and your physician.

In many cases, a genetic test detects an abnormality directly. The molecular test can detect an alteration in the DNA (mutation). The cytogenetic test can determine whether additional, missing, or rearranged genetic material is present. Biochemical methods are sometimes used to test for abnormalities in the protein products produced by the genes. The more specialized tests are particularly sensitive and specialized. However, sensitivity and specificity depend on each individual test.

The accuracy of the test depends on obtaining a correct family history. An error in the diagnosis may occur if the actual biological relationships among the family members participating in this study are not as I have declared.

An erroneous clinical diagnosis in one family member may lead to an erroneous diagnosis in other related individuals.

The tests offered are considered the best currently available. This test is often complex and makes use of specialized materials. Nevertheless, there is always a small probability of errors.

Due to the complexity of genetic testing and the significant implications of its results, the results will be provided only through a physician, genetic counselor, or other duly certified professional, in a manner that ensures their proper interpretation, within a confidential setting. The results will be confidential to the extent permitted by law. They will be made available to other professionals in the medical field or to other parties solely with my written consent or by another lawful means. Genetic testing is carried out on a voluntary basis for the patient.

I understand that MICRODIAGNOSTICS S.A. is not a sample bank and that my sample will not be available after 60 days, nor for future clinical studies. I understand that my sample will be used only for the genetic test approved by my consent, and that my sample will not be used in any identifiable manner for research purposes without my consent.

Signatures

Consent

By signing this form, I confirm my participation, or that of a member of my family, in this test on a voluntary basis. In the event that the sample to be tested belongs to a member of my family, I responsibly declare that I have the authorization of the principal examinee for this consent. I understand that the genetic analysis conducted by the MICRODIAGNOSTICS S.A. laboratory concerns only the specific disease and in no way guarantees the health of myself, of an unborn child, or of other members of my family.