Non-invasive prenatal screening (NIPS) is a non-invasive, convenient, accurate, and rapid technology for detecting fetal chromosome abnormalities, such as trisomy 21 (Down's syndrome), trisomy 18 (Edward's syndrome) and trisomy 13 (Patau's syndrome).
NON-INVASIVE
NIPS only requires venous blood drawnfrom the pregnant women
ACCURATE
Accuracy is above 99%
EARLY DETECTION
NIPS can be performed as early as 12 weeks of gestation.
RAPID
The assay results will be available within 7~10 workdays after a blood draw.
Annoroad is one of the first clinical application trail units of high-throughput sequencing approved by National Health Commission, as well as the manufacturer of a high-throughput non-invasive prenatal DNA sequencer (NextSeq 550AR) and reagents approved by NMPA. Annoroad has carried out extensive cooperation with major hospitals in China, accumulating a large amount of clinical data and project experience. The company has gained increasing acclaim for its first-class testing quality and service from cooperative hospitals and pregnant women.
NIPS is a vital project for Annoroad closely related to human health and people’s livelihood. Supported by the national policies and regulations, the company will provide clinicias with more accurate and effective tests for fetal chromosomal aneuploidy.
SCIENTIFIC RESEARCH
Annoroad developed an independent cell-free fetal DNA (cffDNA) fragments enrichment technology for NIPS, which can effectively increase the concentration of cffDNA and the accuracy of the tests.
TECHNOLOGY
Annoroad established a CAD analytical workflow for NIPS, which can effectively eliminate maternal CNV interference and reduce the false positive rate.
DEVICE
NextSeq 550AR is an upgraded version of Illumina NextSeq 500, with improved data quality and NIPS results.
COMPANY QUALIFICATION
One of the first national trail units for NIPS, with extensive project experience and accurate results interpretation.
NextSeq 550AR gene sequencer（Medical Device Registration Certificate of the People‘s Republic of China: 20173400330）
Fetal chromosomal aneuploidy (T21, T18, T13) detection kit (Medical Device Registration Certificate of the People‘s Republic of China: 20173400331)
Non-invasive prenatal analysis software for fetal chromosomal aneuploidy (Beijing Medical Device Registration Certificate: 20192210692)
ANNOSTAR automatic sampling system (Zhejiang Medical Device Registration Certificate: 2020220056)
NIPS is suitable for singleton or twin pregnant women from 12 to 22 weeks of gestation. The target diseases include three common fetal chromosomal aneuploidies, i.e. trisomy 21, trisomy 18, and trisomy 13.
- Pregnant women at moderate risk by serological screening.
- Pregnant women with contraindications to invasive prenatal diagnosis (such as threatened abortion, fever, bleeding tendency, the active phase of chronic infection, Rh-negative blood type of pregnant women, etc.).
- Pregnant women miss the optimal time of serological screening due to beyond 20+6 weeks, but still require evalsuation of the risk of trisomy 21, trisomy 18 and trisomy 13.
Pregnant women who have any of the following situations should be treated with caution, including:
- High-risk of serological prenatal screening in the first and/or second trimester.
- The expected delivery age is ≥ 35 years old.
- Severe obesity (BMI>40).
- Conception through in vitro fertilization - embryo transplantation
- A couple have had a fetus with chromosomal abnormalities, but they themselves do not have chromosomal abnormalities
- Twin or multiple pregnancy.
- Other situations that clinicians consider can significantly affect the accuracy of NIPS results.
- The gestation week is<12+0.
- One partner in a couple has chromosomal abnormalities.
- The pregnant women have received allogeneic blood transfusion, transplantation, or cell therapy within 1 year.
- Fetal ultrasound examination indicates structural abnormalities that require invasive prenatal diagnosis.
- One or both partners in a couple have a familial history of genetic disease， or，there are other high-risk indications of genetic disease.
- Combined with malignant tumor during pregnancy.
- Other situations that clinicians consider can significantly affect the accuracy of NIPS results.
Except for the inapplicable situations mentioned above, pregnant women and their families can choose NIPS with fully informed consent.
