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PRS form

    Informed Consent Form for PRS Service

    The informed consent form (ICF) gives an overview of the PRS service and describes its purposes, benefits, and
    limitations. Please read the information carefully before providing your consent for testing. Taking the test is voluntary.

    I, (FIRST NAME and FAMILY NAME in capital letters), request and permit The Bio Arte Ltd. to analyze my DNA and other personal information to perform the PRS service/s that I have selected.

    I UNDERSTAND THAT:
    1. A polygenic risk score (PRS) is a genetic test to assess my personal risk of developing a chronic condition, such as cancer or heart disease, based on the combined effect of a large number of common variants (termed single nucleotide polymorphisms, or SNPs) found in my DNA. These variants have been found to increase or decrease the risk of the particular condition in my population.
    2. My genetic ancestry may be assessed by comparing my genome to a set of 26 global populations to provide a more accurate PRS. In such a case, the results of this assessment will be included in the risk report.
    3. Apart from genetic factors, environmental and lifestyle factors will have a strong effect on my lifetime risk of developing the selected condition/s. These factors are included in the questionnaire that I will proceed to answer. Only my contact details, genetic (biological) sex, age (date of birth), and ethnicity are required. The rest of the questions are optional and will help The Bio Arte in providing me with a tailor-made report and lifestyle risk mitigation advice.
    4. A PRS test cannot be used for the diagnosis of any condition.
    5. An elevated risk estimate does not mean that I will develop any of the tested conditions during my lifetime, while a moderate or lower risk does not mean that the probability of developing the disease is zero.
    6. A PRS test does not directly assess the risk of my family and relatives, i.e. polygenic risk score-based disease risks do not transfer directly from parents to children.
    7. The risk score tests have the following limitations:
    • They do not analyze rare pathogenic mutations in single genes predisposing to the condition/s of interest, especially cancers, that significantly increase the risk of developing the disease.
    • The risk score tests are based on the most up-to-date scientific data, which may, however, be supplemented and changed in the future as additional information becomes available. The field of genetics is constantly evolving, which may lead to changes in risk assessments over time, as well as changes in test selection recommendations and clinical recommendations based on test results.
    • Different polygenic risk scores predicting risks of the same trait may give different estimates of the individual’s risks due to differences in the genetic variants included in the models and their weights.
    • The results of this test should be applied in context with other relevant clinical data and family history.
    8. The buccal swab sample is necessary to collect and extract my DNA to perform the analysis.
    9. My sample may be transmitted to another laboratory as pseudonymized (i.e., samples are labeled only with a unique code precluding direct identity identification), for testing purposes. Second-generation genotyping is carried out in adequate ISO17025-accredited centres in the European Union (EU).
    10. My personal data will be processed in compliance with the EU General Data Protection Regulation (GDPR) and all the regulatory requirements in its effect.
    11. The Bio Arte Ltd. is not responsible for any misinterpretation of the results or subsequent actions/decisions.
    12. I have the right to receive a copy of this consent form.

    BY SIGNING BELOW, I ATTEST TO THE FOLLOWING:
    1. I have read, understood and agreed to the information provided on this form and have had an opportunity to have any questions answered by The Bio Arte or their representative (https://thebioarte.com/contact/).
    2. I acknowledge that I have read, understand and agreed to The Bio Arte’s Privacy Policy (https://thebioarte.com/privacy-policy/).

    Your signature:

    Kindly fill out the questionnaire below:

    Personal data

    Your PRS report will be sent to this email address.

    Date of Birth:

    Genetic Sex:

    Your genetic sex, as opposed to gender, is required in order to calculate certain sex-specific risk factors.

    Ethnicity has a considerable impact on genetic risk. Your ethnicity is required to factor in certain ethnicity-specific risk factors and compare your risk to that of ethnically similar populations.


    Diet & Lifestyle


    Do you drink alcohol?

    On average how many drinks do you have and how often?


    Glass of Wine (175ml)

    Pint of Beer / Lager / Cider (568ml)

    Bottle of Beer (Standard 330ml)

    Alcoholic Pop Drink (275ml)

    Shot of spirits (25 ml) includes Gin, Rum, Vodka, Whisky, Tequila, Sambuca

    Are you a present or past smoker (i.e. have you smoked at least 100 cigarettes)?

    Have you smoked a cigarette, cigar or pipe in the last 12 months?

    Would you describe yourself as:

    Vigorous physical activity is any activity that makes you breathe much harder than usual, such as aerobic exercise or fast bicycling.
    Moderately intense physical activity makes you breathe somewhat harder than usual, such as bicycling at a regular pace or doubles tennis.

    How many servings of the following foods do you typically eat in a day?
    Base your answers on your eating habits of last month.

    Fruits & vegetables (one serving is about the size of a small apple or small potato):

    Saturated (animal) fats (not including low-fat dairy, white and skinless turkey, white and skinless chicken, or fish):

    Serving sizes of common foods with saturated fat: Hamburger, steak, bacon, ham, sausage (85g or the size of a deck of cards); butter (1 teaspoon); whole milk (1 cup); ice cream (1/2 cup); cheese (1 prepackaged slice, about 30g).

    How often do you generally eat:
    Raw, smoked or cooked (not fried) fish and/or seafood:

    Fried fish or seafood:

    Do you regularly take dietary supplements (e.g. multivitamins)?

    Kindly specify what dietary supplements you take:


    Medical history


    Have you been told by a doctor, nurse or other healthcare provider that you have diabetes?

    If Yes, what type of diabetes were you told you had/have?

    Do you know your fasting blood glucose level?

    Fasting blood glucose level: (if known)

    Do you currently take medication for diabetes?

    Have you been told by a doctor, nurse or other healthcare provider that you have high cholesterol levels?

    If Yes, what is your Total cholesterol level:

    Do you know your total cholesterol and “good” cholesterol (high-density lipoprotein, HDL) levels?

    If Yes, what is your HDL level:

    Have you been told by a doctor, nurse or other healthcare provider that you suffer from hypertension (high blood pressure)?

    Do you know your blood pressure measurements?

    If Yes, what is your Blood pressure measurements:

    Do you currently take blood pressure medication?


    PRS test/s


    Which PRS test/s have you purchased?

    Comprehensive Men's Health

    Comprehensive Women's Health

    Cancer PRS for Genetic sex Female


    Women's Health


    How old were you when you had your first period?

    Have your periods now stopped completely?

    That is, have you now gone at least 6 months without having a period and you are not pregnant or using any form of hormonal contraception?
    Have you ever taken the oral contraceptive pill?

    Have you ever (currently or in the past) used any form of oral contraceptive - this includes both the combined pill and the progesterone-only/mini pill. It does not include other forms of hormonal contraception such as the contraceptive implant, injection or Mirena coil.
    Have you ever used hormone replacement therapy (HRT) for the menopause?

    Have you had any children?

    Have you ever had a mammogram?

    Female Medical History


    Have you ever been diagnosed with endometriosis?

    Have you had your tubes tied (tubal ligation)?

    Have you ever had any of the following operations?

    Have you ever had any of these cancers?

    If you selected to having had breast cancer, kindly provide more details about the specific type of cancer, if you have them (e.g. ER/PR/HER2 status).

    If you had any other cancer, kindly provide more details.

    Cancer PRS for Genetic sex Male


    Male Medical History


    Have you ever had any of these cancers?

    If you selected to having had breast cancer, kindly provide more details about the specific type of cancer, if you have them (e.g. ER/PR/HER2 status).

    If you had any other cancer, kindly provide more details.

    Genetic & Family History


    Do you have any Ashkenazi Jewish ancestors?

    Kindly provide as much information as possible about your family history of cancer. For each affected individual, kindly provide their sex, their relationship to you (e.g. mother, sister), and the estimated age at diagnosis of the cancer.

    Cardiovascular PRS


    Personal & Family History


    Have you ever had any of the following conditions or procedures?

    Have your parents, siblings or children had any of the following at an early age (younger than age 55 for men and younger than age 65 for women)?

    Dementia PRS


    Education


    Please write down the number of years of education you have at each level:
    Primary school
    Secondary school
    Technical college/higher secondary
    University
    Other education

    Personal & Family History


    Have you ever been told by a doctor or other health professional that you suffer from any of the following conditions?

    Have you ever had a head injury where you lost consciousness or were told by a doctor or other health professional that you suffered a concussion?

    Have you ever been told by a doctor or health professional that you suffered from depression?

    Have you ever taken medication for depression?

    Please read each question carefully, then indicate how you felt or behaved during the past week, including today.
    During the past week:
    1. I was bothered by things that usually don't bother me.

    2. I did not feel like eating; my appetite was poor.

    3. I felt that I could not shake off the blues even with help from my family and friends.

    4. I felt that I was just as good as other people.

    5. I had trouble keeping my mind on what I was doing.

    6. I felt depressed.

    7. I felt that everything I did was an effort.

    8. I felt hopeful about the future.

    9. I thought my life had been a failure.

    10. I felt fearful.

    11. My sleep was restless.

    12. I was happy.

    13. I talked less than usual.

    14. I felt lonely.

    15. People were unfriendly.

    16. I enjoyed life.

    17. I had crying spells.

    18. I felt sad.

    19. I felt that people disliked me.

    20. I could not get "going".

    Do/did you have any first-degree relatives (natural/biological mother or father, siblings) with dementia?

    Social Engagement


    Do you live:

    How often, on average, do you socially interact in the below environments/with the below people:
    1. At work

    2. With family members

    3. With friends

    4. In religious, social, political or community groups

    Cognitive & Leisure Activities


    How much time, on average, do you spend reading each day, including online reading?

    In the past year, how many times did you:
    1. Visit a museum

    2. Attend a concert/play/musical

    3. Visit a library

    4. Read a newspaper, including online

    5. Read a magazine

    6. Read a book

    7. Wrote an email/letter

    8. Posted on social networks

    9. Played a word or board game, puzzle, or similar games including online

    10. Carried out "brain training" activities such as Sudoku, crosswords and computer memory games

    11. Engaged in other cognitive activities such as art & crafts, coding, etc.

    Environmental factors


    Have you ever been involved with mixing, applying or loading any pesticides, herbicides, weed killers, fumigants or fungicides?