If you are preparing for a NIPT screening, VeriSeq NIPT by Phacogen is a leading choice for reliability and safety. As the first NIPT solution in Vietnam to achieve CE-IVD certification for the entire workflow, it delivers high accuracy and total peace of mind throughout your pregnancy.
The Importance of Choosing IVD-Certified NIPT Screening
A fact that many expectant mothers are unaware of: Not all NIPT packages currently available in Vietnam are eligible for clinical use. According to Decree 98/2021/ND-CP and Circular 05/2022/TT-BYT, specialized medical tests must achieve IVD (In Vitro Diagnostic) certification—the highest standard ensuring the reliability, safety, and legal validity of the results.
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IVD is not just a "prestigious label"; it represents a rigorous evaluation by independent third-party organizations of the entire workflow—from sample collection to reporting. When a NIPT test is fully IVD-certified, its results are backed by international medical standards and hold official reference value in clinical practice.
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In reality, many current NIPT packages only achieve IVD certification for individual components (such as the machinery or the kits), while the entire integrated process remains uncertified. This poses a risk of inaccurate results, leading expectant mothers to have a false sense of the test's precision and safety.
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For a screening that directly impacts fetal health, prenatal care decisions, and subsequent diagnostic steps, the lack of comprehensive IVD certification is not a risk worth taking. IVD is not just an "added bonus"—it is a mandatory criterion.
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Expectant mothers have every right—and should—ask testing providers directly:
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Is this NIPT package IVD-certified?
- Does the IVD certification apply to the entire workflow or only to certain parts?
- Only when you receive a clear answer accompanied by a certificate from an independent organization can you truly be confident in your choice.
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VeriSeq NIPT – The First NIPT Solution in Vietnam with Comprehensive CE-IVD Certification
In Vietnam, VeriSeq NIPT marks a significant milestone as the first NIPT screening solution to achieve full CE-IVD certification for its entire workflow, officially implemented by Phacogen. This is not only an achievement for Phacogen but also a major leap forward for the field of prenatal screening in the country.
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CE-IVD—the most stringent European standard for In Vitro Diagnostics—ensures that every stage, from testing reagents and next-generation sequencing (NGS) systems to analysis protocols and quality control, is independently validated. As a result, VeriSeq NIPT provides superior accuracy, exceptional stability, and long-term reliability, serving as an official reference for clinical practice.
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Beyond screening for common abnormalities such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), and Patau syndrome (Trisomy 13), VeriSeq NIPT extends its analysis to all 23 pairs of chromosomes, including sex chromosome aneuploidies and large deletions/duplications (depending on the package). This minimizes the risk of missing critical genetic abnormalities—a limitation often found in traditional methods like the Double or Triple tests.
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Recommended Subjects for VeriSeq NIPT (According to Illumina VeriSeq NIPT guidelines and international medical recommendations):
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- Pregnant women from the 10th week of pregnancy (the ideal time for sampling).
- All expectant mothers, regardless of age or risk level (including singleton and twin pregnancies).
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Particularly suitable for mothers over 35, those with a family history of genetic disorders, suspicious ultrasound or Double/Triple test results, or those seeking a comprehensive, highly accurate screening to make safe and responsible clinical decisions.
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With a modern medical philosophy, VeriSeq NIPT at Phacogen does more than provide results; it supports expectant mothers and physicians in making the most optimal and safest prenatal care choices.
How to Register for Consultation and VeriSeq NIPT at Phacogen
To ensure that every pregnant woman receives accurate and sufficient counseling before testing, Phacogen has established a personalized and long-term support process for VeriSeq NIPT.
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To schedule a service consultation, please contact Phacogen: 1900 3200
