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GenEva

Non-invasive prenatal tesing GEN-EVA

GenEva (NIPT - Illumina) is a non-invasive prenatal DNA screening test (also known as cell free DNA - cfDNA test) that helps detect syndromes related to chromosome abnormalities (aneuploidy) of the fetus through maternal blood sample.

During pregnancy, a small amount of fetal DNA is released and moves freely in the mother's blood, called free DNA (cfDNA). With the advent of the new generation of DNA sequencing machines and supercomputer systems, American scientists have developed a method of analyzing cfDNA to diagnose genetic diseases of the fetus without having to carry out invasive interventions.

This test is recommended by the International Society for Prenatal Diagnosis (ISPD) as the first test for all pregnant women.

Decision 1807 of the Ministry of Health issued on April 21, 2020 recommended that the gestational week to perform NIPT test should be > 10 weeks.

GenEva is the American standard NIPT test. GENTIS technique is officially delivered from Illumina, USA. GenEva also achieved ISO 15189:2012 on laboratory quality management issued by BoA.

SCREENING RANGE

- Abnormal numbers of chromosomes cause common syndromes: Down syndrome, Edwards syndrome, Patau syndrome.

- Abnormal of chromosomes: Turner syndrome, Klinefelter syndrome, Trisomy XXX.

- Microdeletion: 22q11 (DiGeorge), 15q11 (Angelman/Prader - Willi), 1p36, Wolf - Hirschhorn, Cri-du-chat

- Abnormal number of all remaining chromosomes

WHO SHOULD TAKE A NIPT TEST (GEN-EVA)

The NIPT_GenEva test is recommended for all pregnant women from the 10th week of pregnancy, especially those at high risk of having a baby with genetic syndromes such as:

- High-risk Double and/or Triple test results
- Pregnant women aged 35 and above
- Have a history of having a baby with a birth defect / have had a miscarriage
- Malformed pregnancy, stillbirth of unknown cause
- Abnormal ultrasound results
- Undergoing assisted reproductive technology (IVF)
- Twin pregnancy...

ADVANTAGES OF NIPT TESTING (GEN-EVA) AT GENTIS

- Safe: Non-invasive, just take 7-10 ml of venous blood from pregnant women from the 10th week of pregnancy.
- Accurate: Directly analyse the free DNA (cfDNA) from the mother with the SAFeR algorithm, with an accuracy of up to 99.9%.
- Simple: The test is done from the 10th week of pregnancy and has no restrictions on ethnicity, BMI, ART, pregnancy from IVF and egg donation cases.
- Fast: Time to receive results from 4-5 working days since sample collection.
- International quality: GenEva test is performed at GENTIS international laboratory according to Veriseq NIPT technology solution of Illumina Corporation - USA officially transferred. GenEva testing at an international laboratory complies with ISO 15189:2012 issued by the BOA quality management office.

TEST PROCEDURE

NIPT TESTING TECHNOLOGY (GEN-EVA) IN GENTIS

GENTIS is the only unit that Illumina completely transfers non-invasive prenatal screening technology

GEN-EVA + ISO 15189
ABOUT US

- The Non-invasive Prenatal Screening Test (GenEva) combines next-generation sequencing and a proprietary algorithm with CE-IVD certification that is capable of detecting fetal abnormalities even in the case of low cfDNA in the mother's blood (>1.4%). This results in the lowest technical failure rate (0.1%) and eliminates unnecessary invasive testing like other NIPT tests.

- The method was evaluated in a clinical study with 86,658 cases worldwide

85,298 (98.4%) give accurate results
6% did not continue to participate in the study
1% failed due to technical limitations

NIPT TESTING TECHNOLOGY ensures the factors that determine test quality:

- Technology: Transfer of technology completely including equipment, processes, algorithms by Illumina

- Expert: The genetic consultants are experts in the fields.

- Testing Center: Performed at an international standard laboratory in Vietnam. Quality is strictly monitored, ensuring equivalent to a laboratory in the US. Limit many risks of errors when sending samples abroad, get quick results...

- International standards: NIPT testing service at GENTIS is certified by the quality public office - BOA Vietnam in accordance with ISO 15189:2012 (http://www.boa.gov.vn/en/ room-xet-ghiem-quoc-te-gentis). According to Decision No. 3148/QD-BYT, the condition for laboratories (laboratory) to be linked to recognize the results is that laboratories must be evaluated according to the set of "Criteria for assessing the quality of medical laboratories" and achieve quality from level 01 or higher or laboratories certified to ISO 15189:2012.

- The test is 99.9% accurate for Down syndrome

- Time to return results quickly from only 4-5 days.

- Screen for many common genetic syndromes and abnormal numbers of all remaining chromosomes.

- Support on-site sample collection: You can come to GENTIS for the test or call 1800 2010 for GENTIS to support sampling at your place. Currently, GENTIS has more than 50 sampling points, collecting samples in provinces and cities across the country.

More information at: https://nipt.com.vn/9-ly-do-chon-gentis

==>> Call the hotline 1800 2010 for detailed advice and register to use the service

The first unit in Vietnam to have a synchronous laboratory system, >2500m2 wide in Hanoi and Ho Chi Minh City meeting international standards ISO 9001:2015
Since 2010, Gentis has successfully performed analysis of more than 3,000,000 samples.
There are more than 50 sample collection points across the country, ensuring to provide customers with the most convenient, fast and accurate services.
Pioneer in applying advanced genetic analysis technologies in the world such as the United States, Europe, and Korea.
GENTIS is also a place to gather a team of scientists, experienced consultants in the field of genetics, and a team of professional, enthusiastic and thoughtful technicians and consultants to bring the best services to you. quality service to customers.