G-NIPT

Safe and Accurate Solution,
For Every Pregnant Woman and Baby

Powered by highly proprietary AI Technology,
G-NIPT delivers the best care solution for your little one.

FAST

Test completed within 3-5days
After sample received

ACCURATE

AI Algorithm

SAFE

Simple Blood Draw

What is NIPT ?

NIPT is a screening test during pregnancy that detects certain genetic conditions in the fetus by analyzing the mother’s blood. It can be done after the 10th week of gestation and screens for major chromosomal abnormalities. It utilizes cell-free fetal DNA from the placenta, which increases in amount as the gestational age progresses.

NIPT screens for major chromosomal aneuploidies like Down syndrome, Edward syndrome, and Patau syndrome. While NIPT provides high accuracy, it is a screening test, not a diagnostic test. If higher risk is indicated, additional diagnostic testing such as amniocentesis or chorionic villus sampling may be recommended for confirmation.

What does G-NIPT screen for?

Genome wide scanning method: Screens all 23 chromosomes and reporting major microdeletion syndromes with high clinical significance.
In the case of twins, the sex chromosome aneuploidy is not reported the result will tell you the female twin case and whether the Y chromosome is detected or not and cannot determine if one or two of the fetuses are male.

GC Genome Provides 3 options for you to choose from

Lite Basic Premium
T21/18/13 ✔ ✔ ✔
Fetal Gender ✔ ✔ ✔
Sex Chromosome Aneuploidy – ✔ ✔
T9/16/22 – – ✔
Other Chromosome – – ✔
Microdeletions – – ✔
Genome wide CNVs(>7Mb) – – ✔

How is it different from other screening and diagnostic tests?

Safer than the invasive amniotic fluid test
Accurate than other screening options

Other Prenatal Screening for chromosomal abnormalities G-NIPT Confirmatory Diagnostic Tests
Purpose Screening Screening Diagnostic
Sensitivity 80~97% 99% 99%
False-positive rate ~5% Below 1% Below 1%
Risk of moscarriage Almost none Almost none Exists
Testing timing After 11weeks At 10~22 weeks At 15~20 weeks
Testing method Biochemical marker test NGS mothod Karyotyping

* The information above is lased onDown Syndrome.
1) Raw Obstet Gynecol, 2013; 6(2); 48-62. 2) Am J Obstet Gynecol, 2015 Aug; 213(2); 214

Who should consider to have G-NIPT?

NIPT is ESSENTIAL for mothers who meet ANY of below criteria.

『

According to ACOG guideline,
NIPT is recommended regardless of Age or Risk factors

』

Any mothers regardless of age or other risk factors, who are worried about birth defects

Mothers wishing to receive a more accurate result from a screening test.

Any high-risk pregnancies according to their 1st and 2nd trimester biochemical screening tests

Mothers with abnormal ultrasound findings, or a fetus with increased NT

Mothers who want to select a safer screening option before the invasive amniotic fluid test (AFT)

Mothers with a pregnancy history of chromosomal abnormality

How does NIPT works?

Clear answers in just three simple steps.

After consulting with your doctor about necessity of genetic test, little amount of blood will be drawn.

Your blood sample will go through microarray and interpretation from specialized medical doctors at GC Genome Laboratory.

Your results are sent to your healthcare provider in 5 days.

Test Performance

  • Analysis of over 57,000 NIPT cases for G-NIPT performance evaluation
  • G-NIPT has proven the accuracy of the test through the analysis of multiple clinical samples and it provides reliable results.
Sensitivity Specificity NPV PPV
Trisomy 21 99.73% 99.99% >99.99% 98.92%
Trisomy 18 99.22% 99.98% >99.99% 95.49%
Trisomy 13 >99.99% 99.99% >99.99% 87.50%
Sex chromosome aneuploidy
(XO,XXX,XXY)		 >99.99% 99.86% >99.99% 48.65%
Other Chromosomes The clinical sensitivity was not determined due to low incidence.
Microdeletion Syndrome The Clickcal sensitivity was not determied due to low incidence, and the sensitivity may be significantly affected by factors such as fetal DNA fraction and microdeletion size

* Test performance is based in the G-NIPT test result conducted between 2015.12~2022.10 and may be changed in the future

Disease Information

Babies with Down syndrome have three copies of chromosome 21 and have intellectual disabilities that range from mild to severe. Children with Down syndrome will need extra medical care depending on the child’s specific health problems. Early intervention has allowed many individuals with Down syndrome to lead healthy and productive lives. The presence of medical conditions, like heart defects, can affect the lifespan in these children and adults; however, most individuals with Down syndrome will live into their 60s. Miscarriage occurs in about 30% of pregnancies with Down syndrome while overall about 1 in 700 babies are born with Down syndrome.
Babies with trisomy 18 have three copies of chromosome 18 and have severe intellectual disabilities and birth defects typically involving the heart, brain, and kidneys. Babies with trisomy 18 can also have visible birth defects such as an opening in the lip (cleft lip) with or without an opening in the roof of the mouth (cleft palate), a small head, clubbed feet, underdeveloped fingers, and toes, and a small jaw. Unfortunately, most pregnancies with trisomy 18 will miscarry. If born alive, most affected babies with trisomy 18 will pass away within the first few weeks of life. About 10 percent survive to their first birthday. Trisomy 18 occurs in approximately 1 in 3,000 live births.

Babies with trisomy 13 have three copies of chromosome 13 and have severe intellectual disabilities. They often have birth defects involving the heart, brain, and kidneys. Visible abnormalities include extra fingers and/or toes or an opening in the lip, with or without an opening in the palate. Given the severe disabilities, most pregnancies affected by trisomy 13 will miscarry. If born alive, most affected babies with trisomy 13 will pass away within the first few weeks of life. About 10 percent survive to their first birthday. Trisomy 13 occurs in approximately 1 in 5,000 live births.

Microdeletion is a group of genetic disorders characterized by the deletion of a small piece of DNA within a chromosome. These deletions typically involve multiple genes and can result in various health conditions and developmental issues. Microdeletion syndromes are usually caused by spontaneous mutations that occur during the formation of reproductive cells (sperm or egg) or early fetal development. They can also be inherited from a parent who carries the specific chromosomal deletion

Trisomy 9
Babies with trisomy 9 can lead to various symptoms and birth defects, including developmental delays, intellectual disabilities, facial abnormalities, heart defects, and kidney problems. The severity of symptoms can vary widely among individuals with trisomy 9
Trisomy 16
Babies with trisomy 16, they usually have severe birth defects and may not survive for long. These defects can include heart abnormalities, brain malformations, skeletal abnormalities, and other structural abnormalities throughout the body.
Trisomy 22
Trisomy 22 is a rare chromosomal disorder characterized by the presence of an extra copy of chromosome 22. Like trisomy 16, it is typically associated with miscarriage, and surviving individuals with full trisomy 22 are extremely rare. When present, trisomy 22 can cause a range of abnormalities, including developmental delays, intellectual disabilities, growth problems, heart defects, and skeletal abnormalities.

Powered by highly proprietary AI Technology,
G-NIPT delivers the best care solution for your little one.

FAST

Test completed within 3-5days
After sample received

ACCURATE

AI Algorithm

SAFE

Simple Blood Draw

What does G-NIPT screen for?

Copy Number Variation Reporting

  • Reporting CNVs(deletion/duplication) which size is more than 7Mb.
  • Reporting deletion/duplication showing “Sufficient evidence for pathogenicity” in the ClinGenDB curated by the Clinical Genome Resource(ClinGen) in the US.
  • The sex chromosome aneuploidy is not reported in the case of twins.
  • In the case of twins, the result will tell you the female twin case and whether the Y chromosome is detected or not and cannot determine
  • if one or two of the fetuses are male.

GC Genome Provides 3 options for you to choose from

Lite Basic Premium
T21/18/13 ✔ ✔ ✔
Fetal Gender ✔ ✔ ✔
Sex Chromosome Aneuploidy – ✔ ✔
T9/16/22 – – ✔
Other Chromosome – – ✔
Microdeletions – – ✔
Genome wide CNVs(>7Mb) – – ✔

Why G-NIPT for your patients ?

Genome Wide Scanning

Screens all 23 pairs of chromosomes to detect not only chromosomal aneuploidies in chromosome 21, 18, 13 and sex chromosome, but also other chromosomal aneuploidies and microdeletion syndromes.

Fetal Fraction Report

ACOG recommends NIPT providers to report the result only when the fetal fraction level (FF) is over 3~4%.
G-NIPT reports the exact fetal DNA fraction(%) every cases.

Twin Pregnancy Cases

Over 1,300 cases of twin pregnancy conducted, especially from university hospitals in South Korea where deal with difficult pregnancies.

G-NIPT is validated with > 99.4% accuracy and 99.07% sensitivity 1

  • In this study, we developed a novel NIPT method using cfDNA fragment distance (FD) and convolutional neural network-based artificial intelligence algorithm (aiD-NIPT).
  • In an analysis of 17,678 clinical samples, all algorithms showed >99.40% accuracy for T21/T18/T13.

Test Performance

  • Analysis of over 57,000 NIPT cases for G-NIPT performance evaluation
  • G-NIPT has proven the accuracy of the test through the analysis of multiple clinical samples and it provides reliable results.
Sensitivity Specificity NPV PPV
Trisomy 21 99.73% 99.99% >99.99% 98.92%
Trisomy 18 99.22% 99.98% >99.99% 95.49%
Trisomy 13 >99.99% 99.99% >99.99% 87.50%
Sex chromosome aneuploidy
(XO,XXX,XXY)		 >99.99% 99.86% >99.99% 48.65%
Other Chromosomes The clinical sensitivity was not determined due to low incidence.
Microdeletion Syndrome The Clickcal sensitivity was not determied due to low incidence, and the sensitivity may be significantly affected by factors such as fetal DNA fraction and microdeletion size

* Test performance is based in the G-NIPT test result conducted between 2015.12~2022.10 and may be changed in the future

How does NIPT works?

Discuss testing and collect
your patient’s blood sample and
send it to GC Genome Laboratory.

Receive results within
5 days and discuss
with your patient.

If you need genetic counseling
based on the result,
please contact your account manager.

Samples should be at least 8.5 ml(WB) of maternal blood and are stable for 7 days when stored at room temperature.
After collecting it in a dedicated container, shake it slowly 8 to 10 times. In the case of storage, so please do not open the plastic packaging so that the contents in the tube(preservative) do not dry out.

It is recommended to test G-NIPT at 10 to 22 weeks of gestation.

Resampling is usually required when the fetal fraction in the maternal blood is low. Causes of low Fetal fraction include early gestational age, high maternal weight, abnormalities in the fetus itself, and unknown causes.

The neural tube defects cannot be observed in all NIPT test.

Yes, it is possible. However, in the case of twins the results including T21, T18, T13, total chromosomal aneuploidy, and deletion and duplication syndromes (7Mbp or more) are reported, except for the sex chromosome aneuploidies.

The NIPT test for multiple fetuses is not recommended according to the literatures because the verification is not sufficient yet.

아직 답변이 없습니다.

Samples should be at least 8.5 ml(WB) of maternal blood and are stable for 7 days when stored at room temperature.
After collecting it in a dedicated container, shake it slowly 8 to 10 times. In the case of storage, so please do not open the plastic packaging so that the contents in the tube(preservative) do not dry out.

It is recommended to test G-NIPT at 10 to 22 weeks of gestation.

Resampling is usually required when the fetal fraction in the maternal blood is low. Causes of low Fetal fraction include early gestational age, high maternal weight, abnormalities in the fetus itself, and unknown causes.

The neural tube defects cannot be observed in all NIPT test.

Yes, it is possible. However, in the case of twins the results including T21, T18, T13, total chromosomal aneuploidy, and deletion and duplication syndromes (7Mbp or more) are reported, except for the sex chromosome aneuploidies.

The NIPT test for multiple fetuses is not recommended according to the literatures because the verification is not sufficient yet.

아직 답변이 없습니다.

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