Testing for genetic conditions can be complex. If warranted, obtain professional genetic counseling prior to giving consent, to fully understand what the risks and benefits are, after having the testing completed.
I hereby consent to participate in testing for GENETIC TESTING FOR INHERITED CANCER using a genetic test. I understand that a biologic specimen (blood, tissue, amniotic fluid, or chorionic villi) will be obtained from me or members of my family. I understand that this biologic specimen will be used for the purpose of attempting to determine if I and members of my family are carriers of a disease gene, or are affected with, or at increased risk to someday be affected with this genetic disease.
It has been explained to me and I understand that:
This test is specific for (write the disease):
• A positive result is an indication that I may be predisposed to or have the specific disease, or condition. Further testing may be needed to confirm the diagnosis. I understand I will be given the opportunity to talk with my physician or a genetic counselor about these results.
• There is a chance that I will have this genetic condition but that the genetic test results will be negative. Due to limitations in technology and incomplete knowledge of genes, some changes in DNA or protein products that cause the disease, may not be detected by the test.
• There may be a possibility that the laboratory findings will be uninterpretable or of unknown significance. In rare circumstances, findings may be suggestive of a condition different than the diagnosis that was originally considered.
• At this time, it is standard practice for the laboratory to systematically re-review likely pathogenic variants, and variants of uncertain significance that have been detected and reported. If the classification of a particular variation changes over time, the laboratory will inform the healthcare provider.
• In many cases, a genetic test directly detects an abnormality. Molecular testing may detect a change in the DNA. Cytogenetic testing may identify whether there is extra, missing or rearranged genetic material. Biochemical methods are sometimes used to look at abnormalities in the protein products that are produced by the genes. Most tests are highly sensitive and specific. However, sensitivity and specificity are test dependent.
• The accuracy of the test depends on correct family history. An error in diagnosis may occur if the true biological relationships of the family members involved in this study are not as I have stated.
• An erroneous clinical diagnosis in a family member can lead to an incorrect diagnosis for other related individuals in question.
• The tests offered are considered to be the best available at this time. This testing is often complex and utilizes specialized materials. However there is always a small chance an error may occur.
• Because of the complexity of genetic testing and the important implications of the test results, results will be reported only through a physician, genetic counselor, or other identified healthcare provider. The results are confidential to the extent allowed by law. They will only be released to other medical professionals or other parties with my written consent or as otherwise allowed by law. Participation in genetic testing is completely voluntary.
• I understand that MICRODIAGNOSTICS Ltd is not a specimen banking facility and my sample will not be available after 60 days or for future clinical studies. I understand that my specimen will only be used for the genetic testing as authorized by my consent and that my sample will not be used in any identifiable fashion for research purposes without my consent.
• Additional testing information can be found at: www.molediagnostics.gr
My signature below acknowledges my voluntary participation in this test.
In case the sample belongs to a member of my family, I declare responsibly that I have the authorization of the main examinee for the present consent. I understand that the genetic analysis performed by microDiagnostics Laboratories is specific only for this disease and in no way guarantees my health, the health of an unborn child, or the health of other family members.
Applicant's details (completed in the case of kinship with the examinee):
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