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1

GENTIS launches the non-invasive prenatal screening package GenEva 92

Created date : 12-06-2024

Updated date: 05-09-2024

Author: Gentis

Recently, GENTIS announced the launch of the GenEva 92 non-invasive prenatal screening package (NIPT IVD), committing to provide the highest quality service for expectant mothers. "With the GenEva 92 test meeting CE-IVD standards and achieving high accuracy of over 99%, GENTIS is confident that this service will become a regular test for expectant mothers in Vietnam in the near future," said Mr. Do Manh Ha, General Director of GENTIS.

GenEva 92 - A New Advancement in Non-Invasive Prenatal Screening

GenEva 92 is a non-invasive prenatal screening test that screens for syndromes related to fetal genetic abnormalities by analyzing cfDNA from the fetus in the maternal blood starting from the 10th week of pregnancy, ensuring safety and achieving an accuracy rate of over 99%.

NIPT testing is recommended by global medical associations (ACOG, ISPD) for all expectant mothers. In Vietnam, in April 2020, the Ministry of Health issued Decision 1807, officially incorporating the NIPT method into the prenatal screening process. Following this decision, NIPT has become a highly accurate screening test that is trusted and utilized by expectant mothers.

In practice, NIPT testing is becoming increasingly popular in Vietnam, significantly aiding in pregnancy management. As a result, GENTIS continues to enhance its services, utilizing sequenced data analyzed with proprietary software certified CE-IVD to ensure high accuracy. Notably, GenEva 92 is a CE-IVD certified non-invasive prenatal screening solution for the entire process

GenEva 92 - A New Advancement in Non-Invasive Prenatal Screening

Several innovations of the GenEva 92 Test at GENTIS

To implement the GenEva 92 test, GENTIS has invested in and installed advanced equipment and machinery, along with technical training based on rigorous standards. Currently, GENTIS has fully mastered the technology and integrated it into regular testing procedures.

With adopting the GenEva 92 test, expectant mothers will benefit from comprehensive, safe, and accurate screening that minimizes risks for both mother and fetus. Additionally, the testing process is quicker and more efficient, providing peace of mind and significant support for obstetricians and families. GenEva 92 is regarded as an essential tool in modern prenatal care due to its outstanding advantages, including:

The process is fully automated from sample extraction to result analysis, significantly reducing the need for direct technician intervention. As a result, human error is minimized, leading to more accurate and stable outcomes, with sensitivity and specificity proven to exceed 99%.
The GenEva 92 test utilizes IVD-certified reagents for the entire process, from the chemicals used to extract cfDNA from maternal blood to the next-generation sequencing reagents.
The proprietary result analysis software is CE-IVD certified, ensuring high accuracy. This is a significant advantage that currently sets GenEva 92 apart from other NIPT testing packages available on the market.
The GenEva 92 test offers an expanded testing solution capable of identifying the following abnormalities:
Three common aneuploidy syndromes: Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome).
Four syndromes: XO (Turner syndrome), XXX (Triple X syndrome), XXY (Klinefelter syndrome), and XYY (Jacobs syndrome).
Aneuploidy across all other chromosomes.
Ninety-two microdeletions/duplications associated with common genetic syndromes, including Prader-Willi/Angelman (15q11.2), DiGeorge (22q11.2), and Cri-du-chat,...

With the GenEva 92 test, GENTIS hopes this will mark a significant turning point in the journey to enhance the quality of healthcare services in Vietnam. GENTIS is committed to continuing research and development to provide the most effective and advanced healthcare solutions for Vietnamese people.