Maternal Serum Screening - LabCorp Serum...screening. This will serve as their final screening...

As your partner for genetic testing, Integrated Genetics offers a wide array of maternal serum screening options to meet the needs of each individual patient.

FirstScreen®

SequentialScreenSM

IntegratedScreenSM

SerumIntegratedScreenSM

Afp4®

The Right Test at the Right Time for the Right Patient.

Maternal Serum ScreeningProduct Offerings

Key parameters of test performance

Our full range of options enables you to provide your patients with the right test at the right time.

Detection rate: Percentage of affected pregnancies correctly identified

False positive rate (FPR): Percentage of unaffected pregnancies incorrectly called positive

Odds of being affected given a positive result (OAPR):

Provides the risk of having an affected pregnancy given a positive result

Allows you to compare the differences in the number of diagnostic procedures required to identify one affected pregnancy using each screening test

Integrated Genetics’ Maternal Serum Screening Options

Options FirstScreen® SequentialScreenSM IntegratedScreenSM Serum IntegratedScreenSM

Afp4®

BenefitsA high detection

rate in the first trimester

Early answers and high

detection rates

A high detection rate

A high detection rate without nuchal translucency (NT)

Our best second trimester screen

>90% Detection Rate ✓ ✓

Lowest FPR ✓

Early Answer ✓ ✓Detects Open Neural Tube

Defects (ONTD)✓ ✓ ✓ ✓

CVS ✓ ✓

Amniocentesis ✓ ✓ ✓ ✓ ✓

www.integratedgenetics.com

Maternal Serum Screening

Product Offerings

Affected

OAPR =1 in 23

Detection Rates

Disease Detection Rate

Down Syndrome 83%,1 with a 5% FPR

Trisomy 18 80%

Test Specifics

Markers NT, PAPP-A, hCG

Timing 10w 3d -13w 6d

NT Requirements

CRL is 39 mm to 84 mm Sonographer/M.D. certified through the Nuchal Translucency Quality Review(NTQR) program or the Fetal Medicine Foundation

Provides a high first trimester detection rate and allows for more diagnostic testing options.

Integrated Genetics 800-848-4436

FirstScreen®

Weeks of Pregnancy: 10–13

Provides early answers for patients at highest risk for Down syndrome and trisomy 18.

Part 1

“Final result pending second trimester sample”

Patients who receive this result will be recommended to return in the second

trimester for the second part of this screen.

“Screen positive”Patients who receive this result will not

be recommended for second trimester screening. This will serve as their final

screening result.

Diagnostic testing recommended.

Test Specifics

Markers NT, PAPP-A, hCG


NT RequirementsCRL is 39 mm to 84 mm Certified sonographer/M.D.

OAPR =1 in 7

Detection Rates


Down Syndrome 70%,2 with a 1.2% FPR

Trisomy 18 80%


Affected

SequentialScreenSM

Part 1 – Weeks of Pregnancy: 10–13

Part 1 – (10w 3d – 13w 6d)Integrated Genetics will analyze NT, PAPP-A,

hCG, and provide a pregnancy-specific risk assessment for Down syndrome

and trisomy 18.

Affected

Part 2

OAPR =1 in 16

“Screen negative”

“Screen positive”

Detection Rates


Down Syndrome 90.4%,2 with a 3.7% FPR

Trisomy 18 90%

ONTD 80%

Test Specifics

Markers NT, PAPP-A, AFP, hCG, uE3, inhibin


Detects 90.4% of fetuses with Down syndrome.


SequentialScreenSM

Part 2 – Weeks of Pregnancy: 15–21

Diagnostic testing recommended.

Part 2 – (15w 0d – 21w 6d)Integrated Genetics will analyze NT, PAPP-A,

AFP, hCG, uE3, and inhibin, and provide a pregnancy-specific risk assessment

for Down syndrome, trisomy 18, and open neural tube defects.

Affected

OAPR =1 in 21

Detection Rates



Trisomy 18 90%

ONTD 80%

Test Specifics

Markers NT, PAPP-A, AFP, hCG, uE3, inhibin

Timing 10w 3d -13w 6d and 15w 0d -21w 6d

NT RequirementsCRL is 39 mm to 84 mmCertified sonographer/M.D.

ReportA single report will be issuedin the second trimester

Detects 92% of fetuses with Down syndrome.


IntegratedScreenSM

Weeks of Pregnancy: 10–13 and 15–21

OAPR =1 in 22

Provides a high detection rate without NT measurements.

Detection Rates



Trisomy 18 90%

ONTD 80%

Test Specifics

Markers PAPP-A, AFP, hCG, uE3, inhibin

Timing 10w 3d -13w 6d and 15w 0d -21w 6d

ReportA single report will be issuedin the second trimester


Serum IntegratedScreenSM

Weeks of Pregnancy: 10–13 and 15–21

Affected

Integrated Genetics – a leading provider of reproductive genetic testing services, driven by its commitment to physicians and patients. Learn more by visiting www.integratedgenetics.com or calling Integrated Genetics Client Services at 800-848-4436.

If you are interested in genetic counseling services, please call 855-GC-CALLS or 855-422-2557.

ReFeRenCeS1. Wald, NJ et al., First and second trimester antenatal screening for Down’s syndrome: the results

of the Serum, Urine and Ultrasound Screening Study (SURUSS). Health Technol Assess 2003; 7(11).2. Palomaki, Glenn E et al., Comparing three strategies for combining first- and second-trimester

Down syndrome markers. Obstetrics & Gynecology 2006; 107:367-375.

©2016 Laboratory Corporation of America® Holdings. All rights reserved. rep-046-v5-0516

L15519-0516-5


First Trimester First and Second Trimesters Combined Second

Trimester

Options FirstScreen® SequentialScreenSM IntegratedScreenSM Serum IntegratedScreenSM

Afp4®

BenefitsA high detection

rate in the first trimester

Early answers and high

detection rates

A high detection rate

A high detection rate without nuchal translucency (NT)

Our best second trimester screen

Down Syndrome Detection Rate 83% 90.4% 92% 87% 81%

FPR 5% 3.7% 5% 5% 5%

OAPR 1 in 231 in 71 in 16

1 in 21 1 in 22 1 in 23

Trisomy 18 Detection Rate 80% 90% 90% 90% 80%

ONTD Detection Rate – 80% 80% 80% 80%

Markers NT, PAPP-A, hCGNT, PAPP-A, hCG,

AFP, hCG, uE3, inhibin

NT, PAPP-A, AFP,hCG, uE3, inhibin

PAPP-A, AFP, hCG, uE3, inhibin

AFP, hCG, uE3, inhibin

Timing 10w 3d – 13w 6d10w 3d – 13w 6d15w 0d – 21w 6d

10w 3d – 13w 6d15w 0d – 21w 6d

10w 3d – 13w 6d15w 0d – 21w 6d

15w 0d – 21w 6d

The Right Test at the Right Time

High Detection Rates and Low False Positive Rates

Maternal Serum Screening - LabCorp Serum...screening. This will serve as their final screening...

Documents

Transcript of Maternal Serum Screening - LabCorp Serum...screening. This will serve as their final screening...