CLINIC NAME CLINIC ID

REFERRING CLINICIAN

PHONE FAX EMAIL

ADDRESS

CITY POST CODE COUNTRY

CLINICAL AND TEST DETAILS

NAME SURNAME

DATE OF BIRTH (DD/MM/YY) ID

PHONE EMAIL

ADDRESS

CITY POST CODE COUNTRY

PATIENT INFORMATION REFERRAL INFORMATION

AFFIX BARCODE LABEL — SIF

HERE

I hereby grant consent for my referral doctor for the collection and transport of a blood sample to NIPD Genetics laboratories. I also grant permission to NIPD Genetics to use this blood sample for the test requested on this form. I attest that I have read, or have had read to me, the Patient Informed Consent and that I understand it. I have had the opportunity to have counseling about the VERACITY test and to discuss with my referral doctor any aspect of this consent form including the benefits, risks and limitations of the VERACITY test, as well as the reasons for performing the test and availability of alternative testing options to my satisfaction.I agree that my referral doctor collects my personal and clinical details such as is needed to complete the sample information form and that such details are provided to NIPD Genetics for the purposes of performing the VERACITY test. I affirm that all information provided is true to the best of my knowledge and that I will not hold NIPD Genetics responsible for any consequences as a result of untrue or inaccurate information.I authorize NIPD Genetics to code, store and use leftover sample and test data for quality improvement and/or research purposes.

I do not authorize NIPD Genetics to store and use my coded sample and test data as described above.

PATIENT CONSENT

CLINICIAN ATTESTATION

I certify that the patient has been counseled about the test and informed of the content of the informed consent including the benefits, risks, and limitations of the VERACITY test, and have obtained informed consent from the patient for performing the VERACITY test.I attest the need to perform the VERACITY test to determine the risk for trisomies of 13,18,21, and upon request aneuploidies of X,Y, select microdeletions (DiGeorge, 1p36 deletion, Smith-Magenis, Wolf Hirschhorn) and fetal gender as part of the patient’s medical care.

PATIENT SIGNATURE DATE

CLINICIAN SIGNATURE DATE

FOR LABORATORY USE ONLYORDER NUMBER LAB ID NUMBER KIT LOT NUMBER

COMMENTS

Neas Engomis 31, Nicosia, 2409 Cyprus Phone: +357 22266888 Fax: +357 22266899

Web: http://www.nipd.comEmail: info@nipd.com

SAMPLE INFORMATION FORM

CLINICIAN COMMENTS

TICK ONLY ONE BOX BELOW

FOR SINGLETON PREGNANCIES

TICK APPROPRIATE BOX & ADD COMMENTS

PATIENT/FAMILY HISTORYABNORMAL ULTRASOUND

ADVANCED MATERNAL AGESERUM SCREEN RISK

OTHER

REQUESTED TEST TEST INDICATIONS

T21 RISK SCORE: 1 in

COLLECTION DATE (DD/MM/YY)TEST INFORMATION

REDRAW TEST: YES NO

TRISOMIES 13, 18, 21TRISOMIES 13, 18, 21; PRESENCE OF YTRISOMIES 13, 18, 21; PRESENCE OF Y; ANEUPLOIDIES X, YTRISOMIES 13, 18, 21; PRESENCE OF Y; ANEUPLOIDIES X, Y; MICRODELETIONS

FOR TWIN/VANISHED TWIN PREGNANCIES

TRISOMIES 13, 18, 21TRISOMIES 13, 18, 21; PRESENCE OF YTRISOMIES 13, 18, 21; PRESENCE OF Y; MICRODELETIONS

T18 RISK SCORE: 1 in

T13 RISK SCORE: 1 in GESTATIONAL AGE (WEEK + DAY) HEIGHT (CM)WEIGHT (KG)MATERNAL INFORMATION

CLINICAL INFORMATIONCOMPLETE ALL SECTIONS BELOW

IVF PREGNANCY: YES NO

SELF DONOR AGE AT EGG RETRIEVAL

IVF INFORMATION

SURROGATE: YES NO

IF IVF, EGG USED:

1 FETUS

MONOCHORIONIC TWIN DICHORIONIC TWIN

NUMBER OF FETUSES

1 FETUS – VANISHED TWIN

2 FETUSES

Collect 4 weeks after the vanishing event

RECEIVED BYDATE & TIME OF RECEIPT(DD/MM/YY HH:MM)

PATIENT INFORMED CONSENT

VERACITY is a laboratory-developed Non-Invasive Prenatal Test (NIPT) for trisomies of 13,18,21, and upon request

aneuploidies of X, Y, select microdeletions (DiGeorge, 1p36 deletion, Smith-Magenis, Wolf Hirschhorn) and fetal

gender. The test is safe for both the fetus and the mother. It requires two tubes of blood (20ml) from the pregnant

woman using standard phlebotomy practices.

VERACITY is available for singleton and twin pregnancies including in-vitro fertilization (IVF) pregnancies of at least

10 weeks of gestation. Singleton pregnancies conceived by IVF with egg donation are also eligible. Twin pregnancies

in which loss of one fetus (vanished twin) occurred are eligible for testing after the 10th week of gestation and 4

weeks after the vanishing event. Information related to the number of fetuses and IVF status is mandatory and affects

testing. Twin pregnancies and vanished twin pregnancies are not eligible for X and Y aneuploidy detection. Patients

with malignancy or a history of malignancy, patients with bone marrow or organ transplant are not eligible for the

test. Twin pregnancies and vanished twin pregnancies conceived through in-vitro fertilization (IVF) with egg donation

or use of a surrogate mother are not eligible for the test. In a small number of cases the amount of fetal DNA present

in maternal blood (fetal fraction), is not sufficient for analysis and a redraw may be requested.

The VERACITY non-invasive prenatal test is not intended and is not validated for the detection of mosaicism,

triploidy, partial trisomy or translocations. A positive result for twin pregnancies indicates high risk for the presence

of at least one affected fetus. In twin pregnancies, detection of Y indicates the presence of at least one Y chromosome.

Although this test is highly accurate, there is still a possibility for false positive and false negative results. This is due

to technical limitations and/or biological limitations, including but not limited to confined placental mosaicism (CPM)

or other types of mosaicism, maternal constitutional or somatic chromosomal abnormalities, residual cfDNA from

a vanished twin or other rare molecular events. The test will not identify all deletions associated with each

microdeletion syndrome. This test has been validated on full region deletions and may be unable to detect smaller

deletions. The VERACITY test is not diagnostic but a screening test and results should be considered in the context

of other clinical criteria. The referring health professional is responsible for counselling before and after the test

including the provision of advice regarding the need for additional prenatal invasive genetic testing. It is recommended

that a positive result is confirmed by amniocentesis.

Samples collected will be used for the purposes of performing the VERACITY test as requested on the sample

information form. No additional clinical testing will be performed by NIPD Genetics. However, some sample may

remain. As NIPD Genetics requires samples and test data for quality improvement and/or ongoing research efforts,

an option is available in ‘Patient Consent’ to grant permission to ‘code’ the remaining sample and test-data for such

use. This means upon completion of the test; all personal information and details are removed, and the sample and

test results are anonymized. No personal information will be associated with studies or publications.

NIPD Genetics Public Company Ltd, 31 Neas Engomis Street, 2409 Engomi, Nicosia,

Customer service: Tel. + (357) 22266888; Fax. + (357) 22266899; Email: info@nipd.com;

Web page: www.nipd.com