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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
Timing 10w 3d -13w 6d
NT RequirementsCRL is 39 mm to 84 mm Certified sonographer/M.D.
OAPR =1 in 7
Detection Rates
Disease Detection Rate
Down Syndrome 70%,2 with a 1.2% FPR
Trisomy 18 80%
www.integratedgenetics.com
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
Disease Detection Rate
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
Timing 15w 0d -21w 6d
Detects 90.4% of fetuses with Down syndrome.
Integrated Genetics 800-848-4436
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
Disease Detection Rate
Down Syndrome 92%,1 with a 5% FPR
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.
www.integratedgenetics.com
IntegratedScreenSM
Weeks of Pregnancy: 10–13 and 15–21
OAPR =1 in 22
Provides a high detection rate without NT measurements.
Detection Rates
Disease Detection Rate
Down Syndrome 87%,1 with a 5% FPR
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
Integrated Genetics 800-848-4436
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
www.integratedgenetics.com
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