looking for insight? the non-invasive screen you can …...feb 21, 2017  · the lowest of any nipt...

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THE NON-INVASIVE SCREEN YOU CAN RELY ON Looking For Insight? REPRODUCTIVE GENETIC SCREENING NXGEN INFORMED PRENATAL TEST

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Page 1: Looking For Insight? THE NON-INVASIVE SCREEN YOU CAN …...Feb 21, 2017  · The lowest of any NIPT on the market. ... • Lowest failure rate of any NIPT available: (0.1%.) • Requires

THE NON-INVASIVE SCREEN YOU CAN RELY ON

Looking For Insight?

REPRODUCTIVE GENETIC SCREENING

NXGEN INFORMED PRENATAL TEST

Page 2: Looking For Insight? THE NON-INVASIVE SCREEN YOU CAN …...Feb 21, 2017  · The lowest of any NIPT on the market. ... • Lowest failure rate of any NIPT available: (0.1%.) • Requires

CONGRATULATIONS ON YOUR

PREGNANCY!

WITH THE NXGEN INFORMED PRENATAL

TEST, YOU CAN GAIN A CLOSER

UNDERSTANDING OF THE DEVELOPMENT

OF YOUR BABY

Page 3: Looking For Insight? THE NON-INVASIVE SCREEN YOU CAN …...Feb 21, 2017  · The lowest of any NIPT on the market. ... • Lowest failure rate of any NIPT available: (0.1%.) • Requires

The Trusted Tools for Insight Into Your Pregnancy

It is a non-invasive prenatal screen that can determine with a high degree of accuracy whether your baby may be at risk for certain conditions. With the NxGen Informed Prenatal Test, you will know more about your baby’s risk in order to make an informed decision and weigh the benefits and risks of an invasive procedure.

The lowest of any NIPT on the market.

WHAT DOES THE NXGEN INFORMED PRENATAL TEST SCREEN FOR?

• You are of advanced maternal age at time of delivery (35 years or older at delivery for a singleton pregnancy or 32 years or older at delivery for a twin pregnancy).

• Your maternal serum screen is “positive” or abnormal.

• Your ultrasound reveals abnormalities suggestive of a common chromosome condition.

• You have a personal or family history that indicates a higher risk for trisomies 21, 18, 13, or other sex chromosome aneuploidies.

Your results will tell your health care provider whether there is an increased risk result for the non-inherited chromosomal disorders that were tested.

In the instance of an “abnormal” result, your health care provider will discuss diagnostic testing options and further management of pregnancy.

0.1%Failure Rate

What is the NxGen Informed Prenatal Test?

Why Has My Doctor Recommended This Test?

Down Syndrome

Edwards Syndrome

Patau Syndrome

21

18

13

Caused by an extra copy of Chromosome 21. By age 35, a woman’s risk of having a child with Trisomy 21 is about 1 in 230 in the first trimester.

Caused by an extra copy of Chromosome 18. By age 35, a woman’s risk of having a child with Trisomy 18 at delivery is about 1 in 1000.

Caused by an extra copy of Chromosome 13. By age 35, a woman’s risk of having a child with Trisomy 13 at delivery is about 1 in 2000.

Disorder Trisomy Notes

The NxGen Informed Prenatal Test sheds much-needed light on the risk for certain chromosomal conditions for your pregnancy—providing the reassurance of reliable answers no other screening test can. It does not carry the risk of complications that invasive procedures do.

Why should I choose the NxGen Informed Prenatal Test over another test?

What happens next?

Page 4: Looking For Insight? THE NON-INVASIVE SCREEN YOU CAN …...Feb 21, 2017  · The lowest of any NIPT on the market. ... • Lowest failure rate of any NIPT available: (0.1%.) • Requires

I have read, or had read to me, the information in this brochure, and I understand it. Before signing this form, I have discussed the NxGen Informed Prenatal Test further with my doctor, an individual my doctor designated, or with a genetics professional.

I have all the information I want, and all my questions have been answered. I decided that:

Please check the box next to your choices.

I WANT I DO NOT WANT

NxGen Informed Prenatal Test

Patient Signature

Date

Informed Consent/Decline for NxGen informed Prenatal Test

Best-In-Class Testing• Lowest failure rate of any NIPT available: (0.1%.)

• Requires only a simple blood draw

• Can be drawn conveniently in your doctor’s office

as early as 10 weeks

• Provides reliable estimation of risk about the most

Fast Turnaround TimeHaving the information you need on time is

extremely important in providing insight into

your pregnancy. That’s why NxGen is focused on

providing your results as quickly as 5-7 days.

Access to Personal Genetic CounselorsGain more knowledge behind your results and

what they may mean for you and your family. Our

trained, professionally licensed, and certified genetic

counselors are here to assist in answering any

questions about your results and how they can affect

your pregnancy.

Talk to one of our genetic councelors when

it’s conveniet for you, at no cost, to gain a full

understanding of your results.

To schedule an appointment with one of our genetic

counselors, call 855-766-9436.

Supportive Resources:

National Down Syndrome Society (ndss.org)

Support Organization for Trisomy (trisomy.org)

Trisomy 18 Foundation (trisomy18.org)

You should be certain you understand the following points:

1. The purpose of this screening test is to determine the risk for my pregnancy to have common chromosomal abnormalities.

2. The decision to have non-invasive prenatal screening is completely mine.

3. The screening test does not detect all genetic conditions.

4. If the test detects certain common chromosome abnormalities, diagnostic testing would be necessary to determine a definitive answer.

5. If my screen result is negative, it is still possible that our pregnancy is affected with one of the common chromosome conditions screened for, but the risk is low.

6. If the screen notes an increased risk for one of the common chromosome conditions screened for, diagnostic prenatal testing can be done to find out whether or not the pregnancy is affected by a common chromosome condition.

7. The laboratory needs accurate information about my family history for the most accurate interpretation of the test results.

8. Leftover de-identified specimens (unless prohibited by law) as well de-identified genetic and other information learned from your testing may be used for purposes of quality control, laboratory test development, and laboratory improvement. All such uses will be in compliance with applicable law. Leftover specimens from New York State will be destroyed within 60 days.

9. The laboratory will disclose the test results only to my doctor or to his/her agent, unless otherwise authorized by me or required by law.

This consent form is provided by NxGen MDx LLC as a courtesy to

physicians and their patients.

Why the NxGen Informed Prenatal Test?

common non-inherited chromosomal abnormalities.

Page 5: Looking For Insight? THE NON-INVASIVE SCREEN YOU CAN …...Feb 21, 2017  · The lowest of any NIPT on the market. ... • Lowest failure rate of any NIPT available: (0.1%.) • Requires

INSIGHT INTO YOUR PREGNANCY

The NxGen Informed Prenatal Test is one

of the world’s most reliable tests that

screens for the most common chromosomal

abnormalities that can affect your baby’s

future health. With the lowest test failures in

its class of .1%, doctors rely on NxGen’s best-

in-class Prenatal Testing as a trusted tool for

early family planning, giving couples insight

and outlook for the years ahead.

The best preparation is knowing your risk.

Page 6: Looking For Insight? THE NON-INVASIVE SCREEN YOU CAN …...Feb 21, 2017  · The lowest of any NIPT on the market. ... • Lowest failure rate of any NIPT available: (0.1%.) • Requires

facebook.com/nxgenmdx

PRECISE REPRODUCTIVE CARRIER SCREENINGwww.nxgenmdx.com Customer Service: 855-776-9436

twitter.com/nxgenmdx

linkedin.com/company/nxgen-mdx

NxGen MDx LLC is a leading clinical molecular diagnostics laboratory delivering accurate and precise reproductive screening detection rates. Unlike other laboratories, NxGen MDx uses whole-genome sequencing (WGS) with next generation sequencing (NGS) which offers one of the most accurate, reliable, and quick screens for chromosomal abnormalities. We pride ourselves in the assurance we bring to the futures of families everywhere.

Ask your doctor about the NxGen Informed Prenatal Test today, and feel confident about tomorrow.