HARMONY PRENATAL TEST is a new DNA-based blood test for Down syndrome. Harmony is more accurate than traditional tests and can be performed as early as 10 weeks in pregnancy.© 2014 Ariosa Diagnostics, Inc. All Rights Reserved.

ARIOSA, the Ariosa Logo, ARIOSA DIAGNOSTICS, the Ariosa Diagnostics Logo, HARMONY PRENATAL TEST and HARMONY are trademarks or registered trademarks of Ariosa Diagnostics, Inc. in the U.S.A. and other countries. All other trademarks are the property of their respective owners. mm-00315-080414-Rev2.1

Clear ANSWERS to Questions that MatterVisit us at harmonytest.com, where you can find

more questions to ask your doctor about Harmony.

What can I learn from the Harmony test?

How does Harmony differ from other Down syndrome tests?

What are the advantages of using Harmony rather than traditional tests?

Do you offer the Harmony test in your office or through a laboratory?

How can I find out how much the Harmony test costs?

When and how will you notify me of the Harmony test result?

ASK Your Prenatal Healthcare Provider

Three Simple Steps to Clarity1. At 10 weeks or later, you get a simple blood test.

2. Your blood sample is sent to the Harmonylaboratory, where it is analyzed.

3. Your results are sent to your healthcare provider

Your ResultsThe test result will give you a clear answer about the risk to your pregnancy of having any of the genetic conditions included in the test.

Once you have your Harmony test results, you can discuss your pregnancy care with your healthcare provider.

Information on the test is available from www.ariosadx.com or www.pathwest.com.au/nipt

Please note:The laboratory is unable to issue results directly to patients.

Results will be sent to your doctor. Please contact your doctor for requlst enquiries.

What is Harmony? When you’re pregnant, your blood contains fragments of your baby’s DNA. Harmony Prenatal Test is a new type of test that analyzes this DNA in a sample of your blood to predict the risk of Down syndrome (trisomy 21) and two other genetic conditions, trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome).

For All WomenTraditional blood tests can miss as many as 15% of Down syndrome cases in pregnant women.

Harmony was developed to be a more accurate prenatal Down syndrome test for all women, regardless of age or risk. It is a new DNA-based blood test that has been extensively tested in pregnant women both over and under 35.

A More Accurate TestHarmony has been shown in clinical testing to identify 99% of Down syndrome cases and to have a false-positive rate of less than 0.1%.

Introduction During your pregnancy, your healthcare providers will offer various tests to help you assess the baby’s health. As part of your care, you will be given the option to test for Down syndrome, a rare genetic condition that affects physical and mental development.

Experts Support Down Syndrome TestingSome genetic conditions run in families. Others, like Down syndrome, typically do not. They can happen in any pregnancy.

Although the risk of Down syndrome increases with age, most babies with Down syndrome are born to women under 35.

Clarity EarlyHarmony Prenatal Test requires a single blood draw and can be done as early as 10 weeks or later in pregnancy.

Results are usually available in about seven business days. Other commonly used tests for Down syndrome are performed later in pregnancy and require multiple office visits.

Minimizes Need for Follow-up TestsThe greater accuracy and low false-positive rate of Harmony compared to traditional tests minimizes the chance further testing would be recommended due to a positive result. Follow-up testing might include an invasive procedure, such as amniocentesis.

Fetal Sex ChromosomesHarmony Prenatal Test can also be used as early as 10 weeks to evaluate X and Y sex chromosomes.

You have the option to test for conditions caused by having an extra or missing copy of the X or Y chromosomes, including Turner and Klinefelter syndromes.

Harmony versus Traditional Down Syndrome Tests

* Reports a high risk for Down syndrome when it is NOT actually present** Correctly indicates a high risk for Down syndrome when it IS present

CONGRATULATIONSon your pregnancy! Now that you are pregnant, supporting your baby’s development is your top priority.

CLEAR ANSWERS TO QUESTIONS THAT MATTER

FALSE-POSITIVERATE*

DETECTION RATE**

HARMONY Prenatal Test

Less than 1 in 1,000

More than 99 in 100

TRADITIONAL First Trimester

Screening1 in 20 85 in 100

Sequential Screening

SCREENING TEST

v Provides a risk assessment for Down syndrome and trisomy 18

DETECTION RATE:

v 90% of fetuses with Down syndrome

v 90% of fetuses with trisomy 18

v 3% (1 in 30) chance of receiving a “false positive” result

WHAT IS INVOLVED?

v Blood draw at 10-14 weeks AND

v Ultrasound to measure fetal nuchal translucency (NT) at 11-14 weeks AND

v Second blood draw at 15-20 weeks

WHEN DO I GET RESULTS?

v Initial result in first trimester

v Final result in second trimester

Harmony Prenatal Test

SCREENING TEST

v Provides a risk assessment for Down syndrome, trisomy 18, and trisomy 13.

v Optional: Can provide a risk assessment for other chromosomal conditions, such as Turner syndrome and Klinefelter syndrome. Fetal sex determination is also possible.

DETECTION RATE:

v >99% of fetuses with Down syndrome

v >98% of fetuses with trisomy 18

v 8 of 10 fetuses with trisomy 13

v 0.1% (1/1,000) chance of receiving a “false positive” result

WHAT IS INVOLVED?

v One blood draw any time after 10 weeks of pregnancy

WHEN DO I GET RESULTS?

v 8-10 days after blood draw

Amniocentesis

DIAGNOSTIC TEST

v Determines whether or not the fetus has a chromosome condition

v Tests for a wider variety of chromosome conditions than either screening test

DETECTION RATE:

v >99% of fetuses with Down syndrome

v >99% of fetuses with trisomy 18

v >99% of fetuses with trisomy 13 and other chromosome conditions

v Minimal risk for “false positive” result

WHAT IS INVOLVED?

v Removal of a small amount of amniotic fluid via a needle inserted in to the abdomen

v 16-22 weeks of pregnancy

v The risk for pregnancy complications, including miscarriage, is 1/300 to 1/500.

WHEN DO I GET RESULTS?

v 1-2 weeks following the procedure

NON-INVASIVE PRENATAL TESTPatient Information

Non-Invasive Prenatal Testing (NIPT) is a service provided by PathWest Laboratory Medicine WA. Your doctor will explain what NIPT is for and how it works; this information is provided to assist you in having a blood sample collected at a PathWest collection centre.

In order to access the HarmonyTM test through PathWest, you need to visit a collection centre on the day and time listed overleaf. Please phone the collection centre for further details and make an appointment if you feel it is necessary.

Your blood sample will be sent to Ariosa Diagnostics in San Jose, California, where the testing will be carried out. If you wish to find out more about Ariosa Diagnostics and the HarmonyTM test please see their website: www.ariosadx.com

How does NIPT process work?1. Your doctor counsels you on how the test works and whether it is appropriate for you.2. Read and sign the informed consent section on the Ariosa HarmonyTM request form, acknowledging that your consent has been given to have the test performed.3. Your doctor is required to complete and sign both the Ariosa and PathWest request forms.4. Take both signed and completed forms to your nearest PathWest collection centre.5. If you want to know the sex of your child please advise you doctor of this, to ensure this is reflected in the request form.

Please not that this test is only available on certain days, so please check the dates and times where this test is performed at your nearest collection centre.

Your specimen sample will not be performed without the completed documentation from your doctor. Check to ensure this prior to presenting to a collection centre.

The HarmonyTM NIPT test costs $525.00 and payment via VISA or MasterCard must be made prior to the sample being collected.

Test results are available within 14 days. PathWest will forward the results to your doctor as soon as they become available. Your doctor will then communicate the result to you.

In a small percentage of cases, the sample collected will contain too little of your baby’s DNA to provide a reliable test result. This will not be known until the test is run in the USA. You will then be asked to provide a new sample. New forms from your doctor will be required before you can have the re-collect, which again must be signed by both you and your doctor. There is no charge where a retest is required.

Disclaimer: PathWest will take all possible care when collecting and shipping samples but is not responsible for any aspect of the testing procedure, nor provides any guarantee of the quality of results. PathWest are not responsible for delays caused by transportation strikes or delays caused by public holidays in Australia or USA.

Non-Invasive Prenatal Testing (NIPT)Collection Centres and Times

Metro collection centres - Monday, Tuesday, Wednesday at times shownLOCATION ADDRESS TIME CONTACTARMADALE Armadale Hospital 11.00am - 1.00pm 9391 2030BELMONT 325 Abernathy Rd, Cloverdale 1.30pm - 3.30pm 9479 5108 BENTLEY Bentley Hospital 11.00am - 1.00pm 9416 3720FREMANTLE Fremantle Hospital, B Block 11.00am - 3.00pm 9431 2215HELENA VALLEY 160 Scott Street 11.00am - 12.30pm 9225 3768JANDAKOT Unit 1, 233 Berrigan Drive 10.30am - 12.00pm 9417 9078JOONDALUP Unit 1, 14 Reid Promenade 11.00am - 12.30pm 9301 5452KALAMUNDA Kalamunda Hospital 11.00am - 12.30pm 9257 8193MAYLANDS Unit 11, 168 Guildford Road 11.00am - 12.30pm 9471 9358MIRRABOOKA 29 Yirrigan Drive 11.00am - 12.30pm 9344 8063MURDOCH Fiona Stanley Hospital, B Block 10.00am - 4.00pm 6152 4011NEDLANDS QEII Medical Centre, J Block 8.00am - 3.00pm 9346 3000OSBORNE PARK Osborne Park Hospital 11.00am - 1.00pm 9244 2326ROCKINGHAM Rockingham Hospital 11.00am - 1.00pm 9599 4239SOUTH PERTH Unit 15, 38 Meadowvale Avenue 10.30am - 12.30pm 9474 6124SUBIACO King Edward Memorial Hospital 11.00am - 1.30pm 9340 2739SUBIACO Unit 4, 400 Barker Road 11.00am - 12.30pm 9381 6420PERTH Royal Perth Hospital, North Block 8.00am - 12.30pm 9224 1170PERTH Goderich Street Clinic 8.00am - 4.00pm 6477 5012WEMBLEY Unit 1, 178 Cambridge Street 11.00am - 12.30pm 9388 3653Regional collection centres - Monday and Tuesday, unless statedLOCATION ADDRESS TIME CONTACTALBANY Albany Hospital 11.30am - 1.00pm 9892 2240BRIDGETOWN Bridgetown Hospital (Monday ONLY) 10.00am - 11.00am 9782 1222 BROOME Broome Hospital 8.30am - 10.30am 9194 2286BUNBURY South West Health Campus 1.30pm - 3.00pm 9722 1280BUSSELTON Busselton Hospital 11.30am - 1.00pm 9754 0648CARNARVON Carnarvon Hospital (Monday ONLY) 10.00am - 11.30am 9941 0431COLLIE Collie District Hospital 11.30am - 1.00pm 9734 1132DENMARK Strickland (Monday ONLY) 10.00am - 11.30am 9848 2711DERBY Derby Hospital (Monday ONLY) 10.00am - 11.30am 9193 3371ESPERANCE Bay of Isles collection centre 11.30am - 1.00pm 9071 0839GERALDTON Geraldton Regional Hospital 8.00am - 3.00pm 9956 2254KALGOORLIE Kalgoorlie Regional Hospital 11.30am - 1.00pm 9080 5825KARRATHA Nickol Bay Hospital 11.30am - 1.00pm 9143 2338KATANNING Katanning Hospital (Monday ONLY) 10.00am - 11.30am 9821 6334KUNUNURRA Kununurra Hospital (Monday ONLY) 9.30am - 11.30am 9166 4245MANDURAH Unit 5, 2A Peel Street 11.00am - 1.00pm 9582 7988MANJIMUP Warren District Hospital 11.30am - 1.00pm 9777 0444MARGARET RIVER Station Road (Monday ONLY) 8.45am - 11.15am 9757 0405MERREDIN Merredin Hospital 11.30am - 1.00pm 9041 1532MIAMI Shop 2, Miami Village, Old Coast Road 11.00am - 12.30pm 9534 6040NARROGIN Narrogin Hospital (Monday ONLY) 10.00am - 11.30am 9881 0481NEWMAN Newman Hospital (Monday ONLY) 11.00am - 12.00pm 9175 2943NORTHAM Northam Regional Hospital 11.30am - 1.00pm 9690 1657PORT HEDLAND Hedland Health Campus 11.30am - 1.00pm 9174 1504Please ensure paperwork is completed by your practitioner and you prior to your visit to PathWest. 5/10/15