PATIENT INFORMATION


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Results

  •   Hereditary Cancer Risk Analysis
  •   Genetic Carrier Screening
  •   Pharmacogenomic Analysis

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Inherited Cancer Genetics Consent and Disclosure

Description and Purpose of Test

This test uses ion-semiconductor sequencing technology for the detection of inherited, pathogenic or likely pathogenic variants in genes associated with several hereditary cancer syndromes (HCS). HCS are a group of inherited conditions associated with an increased risk for one or more types of cancers. The results of this test are designed to provide physicians with personalized genetic information for the consenting individual regarding genetic predisposition to developing certain cancers that are associated with HCS.

Meaning of a Positive Test Result

A positive test result means that a pathogenic or likely pathogenic variant* in one or more genes that are associated with an increased risk for a HCS was detected. These results DO NOT mean that you will develop cancer, just that your risk for developing certain cancers is increased over the general population risk. If you receive a positive result, you may wish to pursue further independent testing and/or consult with your physician and/or a genetic counselor.
*Pathogenic variants are known to increase the risk of developing one or more cancers associated with HCS. Likely pathogenic variants are likely to cause or increase the risk of developing one or more cancers associated with HCS; however, there is currently insufficient clinical and scientific evidence to definitively consider this kind of variant as fully pathogenic.

Meaning of a Negative Test Result

A negative test result means that sequencing and bioinformatic analysis did not detect any clinically relevant results in the targeted genetic regions. This means that no pathogenic or likely pathogenic variants were identified, but that benign, likely benign, and/or variants of uncertain significance (VUS) may have been identified in the target genetic regions. Because this test does not detect all regions and all possible sequence variations in all the genes tested, it is possible that you may have an undetected genotype which affects your hereditary cancer risk.

Test Limitations

The results of this test should be interpreted with caution and in the context of your complete personal and familial medical history. This test should not be used to diagnose or cure any disease and/or medical condition(s), nor should it be used as the sole source for determining the risk of developing cancers associated with HCS for the tested individual. This test does not indicate your risk for all cancer types.
This test does not exhaustively cover every gene, and it is possible to have a pathogenic variant in a gene not targeted by this test. Due to limitations in technology, certain genomic regions are more difficult to sequence than others. This test does not fully cover all bases in the following exons for the following genes: BRCA2 (exon 15), CHEK2 (exon 3), HRAS (exon 4), MSH2 (exon 3), MSH6 (exon 3), MUTYH (exon 3), NF1 (exons 1, 5, and 11), PALLD (exon 2), PMS2 (exons 2 and 11), PTCH1 (exon 1), RAD50 (exon 21), RAD51 (exon 4), and RET (exons 1 and 14). For more detail on the targeted and non-targeted regions, please contact LifeBrite.This test does not detect somatic (acquired after birth) mutations which cause sporadic, non-hereditary cancers.This test does not report on benign variants, likely benign variants and VUS.
As scientific research is an ongoing process, the clinical interpretation of the results provided by this test may change over time. As such, you may wish to periodically review your results with the guidance of a physician, genetic counselor or other individual trained in genetics.
These test results should not be incorporated into any genetically related individuals’ medical records, nor should they be used to infer the genotype of genetically related individuals. This test should not be used on children younger than the age of 18, unless there is an immediate medical reason that will impact the child’s current medical care.

Possible Risks

The Genetic Information Nondiscrimination Act of 2008 (GINA) makes it illegal for health insurers to request or use one’s genetic information to deny health insurance or to alter how much one pays for health insurance. This means that your genetic information cannot be used to determine if a condition is considered pre-existing. GINA also protects individuals from genetic discrimination by employers. However, in some states, this protection does not apply to life, long-term care, or disability insurance.

Possible Benefits

Benefits of this test are the inclusion of genetic knowledge into a personalized health care plan. Depending on the genetic variants identified, this test may provide guidance to your physician regarding your genetic predisposition to several HCS. Potential benefits of detecting a pathogenic variant when a HCS is suspected include proactive and preventative interventions vs reactive interventions, earlier diagnosis vs later diagnosis and knowledge for family planning.

Genetic and Physician Counseling

You may wish to seek professional genetic counseling before signing the informed consent form and at any time before or after receiving your test results. You may also wish to pursue further testing, genetic or otherwise, and/or request additional physician consultation. Do not make changes to your health plans before consulting your doctor, as there are other non-genetic factors which will influence your risk of developing cancer. You may request that the results of this test are only shared with your physician and not shared directly to you. The results of this test should be interpreted with caution and in the context of your complete personal and familial medical history.

Things to Look for When Performing a Hereditary Cancer Risk Assessment

A hereditary cancer risk assessment is performed to help determine if you may have an increased genetic predisposition for a HCS. If your risk assessment has multiple indicators suggestive of a hereditary cancer syndrome, a genetic test may help further define your genetic predisposition. Please list all indicators on your RELEVANT CLINICAL INFORMATION form†. Such indicators include:

  • A personal history including several kinds of cancer and/or cancer diagnosed at a young age (≤ age 50)
  • A family history especially if:
    • Three or more relatives, on a single side of the family, have/had the same type of cancer
    • Two or more relatives, on a single side of the family, had cancer diagnosed at a young age (≤ age 50)
    • A single relative developed two or more types of cancer
    • A HCS diagnosis has been made in one or more relatives
  • A pathogenic variant associated with a HCS is present in a relative
  • Unusual cases of cancer (such as male breast cancer)
  • Other features such as:
    • Presence of birth defects including benign skin growth and/or skeletal abnormalities
    • Belonging to an ethnic group that is at an increased risk for a HCS (ex-Ashkenazi Jewish ancestry)

You may choose to provide your risk assessment in a different format, so long as all relevant clinical information is included. For example, one acceptable alternative option is the Surgeon General's "My Family Health Portrait," a free and easy-to-use internet-based tool (https://familyhistory.hhs.gov/FHH/html/index.html).

Please review the regions not covered in the TEST LIMITATIONS to determine if the pathogenic variant is covered by this assay. Your physician may request assistance in determining this information by contacting LifeBrite. Please provide all details regarding the pathogenic variant (include gene name, nucleotide location, and description of variant).

Privacy and Confidentiality

Your specimens will only be used to generate a report for the test specified on your requisition form. Any portion of your DNA specimens that are not used for the test will be destroyed by LifeBrite within sixty days following specimen receipt unless a longer retention period is expressly authorized in your consent form. LifeBrite will not release your genetic information to any persons or organizations not specifically authorized by you except in cases where we are legally required to do so. LifeBrite will retain your genetic test results for a period of 2 years following report generation, after which all electronic and hard-copies will be destroyed.

Billing and Consent

By signing the requisition form, you agree to the following statement: “I understand that I am responsible for payment for the requested genetic test(s), and that any cost not reimbursed by insurance is my responsibility to pay. I authorize LifeBrite to bill my insurance company(ies), and to take all necessary steps on my behalf to secure payment from my insurers. I authorize any holder of my medical information to release it to LifeBrite and to my insurers as required for insurance billing. I further authorize LifeBrite to retain any insurance payments for the requested genetic test(s).”

Once you have reviewed and consent to this information and filled-in the RELEVANT CLINICAL INFORMATION form (or provide a separate HCS risk assessment), please sign the requisition form to indicate your consent.

Carrier Screening Genetics Consent and Disclosure

Description and Purpose of Test

This test is designed to detect targeted genetic variants (or alleles) associated with recessive disorders. This information can be used to determine if the tested individual(s) may be a carrier(s) for these alleles.

Meaning of a Positive or Negative Test Result

Positive test result means that genotyping detected one or more targeted disease-causing alleles for one or more conditions. If only one diseasecausing allele was identified (per condition), this means you are a “carrier” for that condition and have a 50% chance of passing down the allele to your child. Two copies of recessive alleles are required for a child to develop a recessive condition.

Negative test result means that genotyping did not detect one of the targeted disease-causing alleles. There may still be a chance that you carry a non-targeted, undetected disease-causing allele.

Test Limitations and Disclaimer

The results of this test should be interpreted in the context of your complete personal and familial medical history. This test does not detect all possible sequence variations or de novo mutations, so it is possible to be a carrier for a non-targeted, undetected disease-causing allele, resulting in a false negative result. The results of this test do not guarantee the health of unborn children or specific pregnancy outcomes. Do not make changes in your family planning before consulting your doctor and a genetic specialist (such as a genetic counselor).

Possible Benefits

Benefits of this test include genetic knowledge to provide guidance for family planning, help to decrease the chance of having an affected child, and/or knowledge of potential opportunities for antenatal intervention to improve perinatal outcomes.

Possible Risks

The Genetic Information Nondiscrimination Act of 2008 (GINA) protects you from genetic discrimination by health insurers and employers but does not extend this protection to life, long-term care, or disability insurance (expect in certain states). There may be emotional distress associated with genetic testing. The results of this test may have implications beyond the intended purpose, such as results that are inconsistent with assumed parentage or familial relations.

Genetic and Physician Counseling

You may wish to seek professional genetic counseling before consenting to and/or after receiving your genetic test results. You may also wish to pursue further testing, genetic or otherwise, after receiving your results.

Privacy and Confidentiality

Your specimens will only be used for the requested test(s) and will be destroyed within 60 days following report generation. Your genetic test results will be retained for a maximum of 2 years. LifeBrite will not release your genetic information to any persons or organizations not specifically authorized by you, except if we receive a court order or other legal processes to release them.

Billing

You are responsible for payment of the requested genetic test(s). You authorize LifeBrite to bill your insurance company(ies) and to take all necessary steps on your behalf to secure payment from your insurers. You authorize any holder of your medical information to release it to LifeBrite and to your insurers, as required for insurance billing. You authorize LifeBrite to retain any insurance payments for the requested genetic test(s).

Consent

By signing the requisition form, you indicate that you reviewed and understand the information provided on this consent form, had the opportunity to voice questions and concerns regarding this test, and voluntarily consent to providing your DNA sample to be used for the genetic test(s) indicated on your requisition form

Pharmacogenomics Consent and Disclosure

Pharmacogenomics Panels

Cardiovascular
Psychotropic
Pain
Anti-Cancer Agents
Diabetes & Gastrointestinal
Infectious Disease
Immunology & Urology
Comprehensive (all panels)

Description of Test

This test uses a quantitative Real-Time PCR System for the detection of genetic variants in genes specific to the panel(s) selected on your requisition form. The results of this test are designed to provide physicians with personalized genetic information for you regarding clinically actionable and informative gene-drug-disease relationships. Genes and medications covered by each panel are indicated on the requisition form.

Principle/Purpose of Test

The purpose of the LifeBrite Pharmacogenomic Panels is to detect specific genetic variants in several drug metabolizing enzyme (DME) genes to determine if you (the consenting individual) has a genetic make-up (genotype) which alters your metabolic response to the cardiac, pain, psychotropic, pain, anti-cancer, diabetes, gastrointestinal, infectious disease, immunological, and/or urological medications indicated on the requisition form.

For the Cardiovascular and Comprehensive Panel options, this test will also identify genetic variants which indicate your genetic predisposition to thrombosis, hyperhomocysteinemia, and dyslipidemia. For the Psychotropic and Comprehensive Panel options, this test will also identify genetic variants which indicate your genetic predisposition to hyperhomocysteinemia and to antipsychotic-induced hyperprolactinemia, tardive dyskinesia, and weight gain.

Indications for Testing

Diagnostic (symptomatic) - For when you are experiencing adverse drug reactions (ADRs) and/or not experiencing therapeutic benefits of a drug(s). Testing may reveal if your specific responses (or lack of response) is due to genetic variants which alter drug metabolism, absorption, excretion, etc.
Pre-symptomatic pre-dispositional (predictive prescribing) - For when you have not been prescribed any medications. You may have a family and/or personal history of ADR and/or lack of therapeutic benefits for a drug. Testing may reveal if you should receive higher/lower/normal dosing of a drug, if you may be a non-responder to a drug, or if you are pre-disposed for ADRs. Additionally, for some drugs, the FDA requires this testing before you physician may prescribe the medication.

Meaning of a Positive Test Result

A positive test result means that genotyping detected an actionable and/or informative genotype, which may be used to predict drug dosing, drug response, and/or genetic predisposition to ADR(s) that is different from standard label-recommended dosing and administration guidelines. It may also mean you have a genetic predisposition for one of the specific conditions tested. As such, you may wish to consider further independent testing and/or consultation with your physician or a genetic counselor.

Meaning of a Negative Test Result

A negative test results means that genotyping did not detect an actionable and/or informative genotype, which may be used to predict drug dosing, drug response, and/or genetic predisposition to ADR(s). Based on these results, medications should be prescribed based on standard label-recommended dosing and administration guidelines. Because this test does not detect all possible sequence variations in all the genes tested, it is possible that you may have an undetected genotype which affects your response to specific drugs.

Test Limitations

The results of this test should be interpreted by your physician with caution and in the context of your complete personal and familial medical history. This test does not indicate your response to all medications, nor does it identify all possible genetic variants for the covered genes. Therefore, the presence of rare variants may not be detected and may result in a false positive or false negative result.

As scientific research is an ongoing process, the clinical interpretation of the results provided by this test may change over time. As such, you may wish to periodically review your results with the guidance of a physician, genetic counselor, or other individual trained in genetics.

This test should not be used to diagnose or cure any disease or medical condition(s), nor should it be used as the sole source for determining drug selection and dosing for the tested individual (you).

These test results should not be incorporated into any genetically related individuals’ medical records, nor should they be used to infer the genotype or used to guide drug selection or dosing for any genetically related individuals. This test should not be used on children younger than the age of 18, unless there is an immediate medical reason that will impact the child’s current medical care.

Possible Risks

The Genetic Information Nondiscrimination Act of 2008 (GINA) makes it illegal for health insurers to request or use one’s genetic information to deny health insurance or to alter how much one pays for health insurance. This means that your genetic information cannot be used to determine if a condition is considered pre-existing. GINA also protects individuals from genetic discrimination by employers. However, in some states, this protection does not apply to life, long-term care, or disability insurance. See the DISCLAIMER for information on genes that may be of concern in this regard.

Possible Benefits

Benefits of this test are the inclusion of genetic knowledge into a personalized health care plan. Depending on the genetic variants identified, this test may provide guidance to your physician regarding your current or future medication plans. In some cases, this may mean your physician is directed to alter dosing for a given drug(s), and/or to avoid prescribing a given drug(s) due to an increased risk of ADRs and/or lack of therapeutic response. This may allow you to avoid ADRs or the chance of receiving an ineffective medication.

For the Comprehensive and Cardiovascular Panels, this test will indicate your genetic predisposition to specific cardiac conditions. For the Comprehensive and Psychotropic Panels, this test will indicate your genetic predisposition to specific side effects associated with psychotropic drugs. Together, these test results may allow your physician to suggest lifestyle and medical interventions to decrease the risk of these conditions and side effects.

Disclaimer (for Cardiovascular, Comprehensive, & Psychotropic Panels Only)

The LifeBrite Cardiovascular and Comprehensive Panels offer genetic testing for alleles of APOE to assess genetic predisposition to dyslipidemia. The APOE alleles tested in these panels are also associated with varying risks for developing late onset Alzheimer’s disease. APOE allele status DOES NOT definitively predict onset or if an individual will ever develop Alzheimer’s disease. There are individuals without the “increased risk” APOE allele who develop Alzheimer’s, as well as individuals with the “increased risk” APOE allele who never develop the disease.

The Psychotropic Panel with SLC6A4 covers variants that are associated with aggressive behavior in Alzheimer disease patients, depression susceptibility in individuals experiencing stressful life events (including emotional trauma), and anxiety-related personality traits. SLC6A4 allele status DOES NOT definitively predict if such traits will manifest, and instead means there is variability in one’s “risk” or “chance” of developing such traits.

LifeBrite does not report on the variant associations with the behavioral and disease states described above for either APOE or SLC6A4. However, there may be un-anticipated anxiety or unforeseen concerns associated with knowing one’s APOE or SLC6A4 allele status. Therefore, it is important to consider this information before consenting to genetic testing for APOE or SLC6A4. You may wish to speak with a genetic specialist, such as a certified genetic counselor, BEFORE and AFTER genetic testing.

Genetic and Physician Counseling

You may wish to seek professional genetic counseling before signing the informed consent form, and possibly after receiving your genetic test results. You may also wish to pursue further testing, genetic or otherwise, and/or request additional physician consultation. Do not make changes to your medication(s) or health plans before consulting your doctor, as there are other, non-genetic factors which will influence your response and/or sensitivity to a given drug(s). You may share the results of this test with your physician and/or pharmacist. You may also request that the results of this test are only shared with your physician and not shared directly to you.

Privacy and Confidentiality

Your specimens will only be used to generate a report for the test specified on your requisition form. Any portion of your DNA specimens that are not used for the test will be destroyed by LifeBrite within sixty days following specimen receipt unless a longer retention period is expressly authorized in your consent form. LifeBrite will not release your genetic information to any persons or organizations not specifically authorized by you, except if we receive a court order or other legal processes to release them. LifeBrite will retain your genetic test results for a period of 2 years following report generation, after which all electronic & hard-copies will be destroyed.

Billing and Consent

By signing the requisition form, you agree to the following statement: “I understand that I am responsible for payment for the requested genetic test(s) and that any cost not reimbursed by insurance is my responsibility to pay. I authorize LifeBrite to bill my insurance company(ies) and to take all necessary steps on my behalf to secure payment from my insurers. I authorize any holder of my medical information to release it to LifeBrite and to my insurers as required for insurance billing. I further authorize LifeBrite to retain any insurance payments for the requested genetic test(s).”