The new generation of
Non-Invasive Prenatal Test

From SYNLAB one of Europes leaders in Diagnostic testing.

Introduction

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Chromosomal abnormalities, such as trisomy 21 (Down's syndrome), occur in 1-2% of all fetuses. A large range of prenatal tests are available to evaluate the healthy development of the future baby prior to birth. SYNLAB has pioneered prenatal screening by incorporating new scientific advances to offer a state-of-the-art non-invasive prenatal test, backed by the expertise and reliability of one of Europe’s leading laboratories.

Cell-free DNA

  • The maternal blood contains cell-free DNA from both the fetus and the mother.

  • Cell-free DNA are small fragments of genetic material with a size of less than 200 base pairs.

  • Cell-free fetal DNA primarily comes from apoptotic trophoblast cells from the placenta.

  • The concentration of cell-free DNA from the fetus is much less than the concentration of cell-free DNA from the mother.

  • Advances in DNA sequencing technology makes it possible to detect fetal chromosomal abnormalities in a sample of maternal blood.

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neoBona

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  • Is the new generation of non-invasive prenatal test (NIPT), developed by integrating advanced technology and the experience of SYNLAB, a European leader in prenatal diagnosis.

  • The test only requires a blood sample and the analysis is performed through NGS (Next Generation Sequencing) of cell-free DNA with paired-end reads instead of standard single-reads. This technology allows a deeper study of the cell-free DNA, improving both the distinction between maternal and fetal cell-free DNA, and also the performance and accuracy of the chromosomal alterations analysis. This technology is offered exclusively by SYNLAB.

  • The fetal fraction is a crucial parameter which influences the precision of the analysis, all cell-free DNA prenatal tests require a minimum of fetal fraction to provide a result with appropriate accuracy. neoBona is able to issue a result even at low fetal fraction.

  • The technique used by neoBona to determine the fetal fraction is highly advanced and it provides greater accuracy, ensuring the reliability of the result.

 

neoBona is the new generation NIPT that integrates the technology of a world leader in DNA sequencing and the experience of a European leader in prenatal diagnosis.

With increased performance and sensitivity, neoBona significantly reduces the number of samples in which it is not possible to issue a result due to a low concentration of cell-free fetal DNA, and the high degree of automation allows to significantly reduce the turnaround time.

neoBona is highly effective to determine the risk of common chromosomal abnormalities during pregnancy with no risk for the mother and the fetus, determining also the fetal fraction.

neoBona is a genetic screening test and as such, must be prescribed by a clinician. 

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A union of expertise and technology

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SYNLAB a leading provider of prenatal testing and Illumina a world leader in DNA sequencing, have collaborated to develop neoBona, the latest generation NIPT. neoBona integrates the power of cutting-edge paired-end next generation sequencing and exclusively from SYNLAB know-how to offer an innovative non-invasive prenatal screening test. neoBona is offered and performed exclusively from our European laboratory.

The test can be performed on women who are at least 10 weeks into their pregnancy for both singleton and twin pregnancy (2 fetuses), including cases of egg donation.

Types of tests

There are three options of analysis in order to adapt the prenatal screening to each patient.

neoBona Advanced

Trisomies 21, 18, and 13 + Fetal sex + Sex chromosomes (X and Y)
Paired-end NGS technology
Fetal fraction 

Prenatal Test Extended Panel *

Trisomies 21, 18, and 13 + Aneuploidies X, Y + Fetal sex +  Microdeletions panel 
Conventional single-read NGS technology
Fetal fraction

Prenatal Test Extended Panel + All Chromosomes *

Trisomies 21, 18, and 13 + Aneuploidies X, Y + Fetal sex + Microdeletions panel: DiGeorge, Angelman, Prader-Willi, 1p36 deletion, Wolf-Hirschhorn and Cri-du-chat Syndromes + Aneuploidies in all chromosomes
WGS technology
Fetal fraction  ?

* Test available only on request

Advantages compared to other techniques

CONFIDENCE

neoBona offers parents confidence that chromosomal abnormalities in the fetus can be detected early during pregnancy. A non-invasive test does not carry the same risk to the mother of the future baby as amniocentesis.

INNOVATION THROUGH TECHNOLOGY

Developed with Illumina, a world leader in DNA sequencing, integrating state-of-the-art technology and know-how to offer an innovative non-invasive prenatal test.

FETAL FRACTION

Unlike conventional screening, neoBona measures the presence of fetal DNA in the blood sample from the mother, improving the reliability of the result.

PROFESSIONAL COUNSELLING

neoBona is the only prenatal test available that has the support of SYNLAB and their specialist team of more than 600 medical professionals and genetics experts to support your clinician. 

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EXPERIENCE

SYNLAB has performed over 500,000 prenatal diagnostic tests to date, neoBona is the next evolution test resulting from over a decade of experience supporting doctors & parents.

ACCURACY

The traditional first-trimester combined screening test (1TT) provides a statistical risk of trisomy based on biochemical testing, maternal age and ultrasound examination. The accuracy of neoBona is much higher as it is based on the study of the cell-free fetal (placental) DNA.

SPECIFICITY

The specificity of conventional first-trimester screening is 95% with a 5% false-positive rate, leading to counselling, further examinations and possible prenatal diagnosis. The very high specificity of neoBona (>99.9%) means that less than 1/1000 tests have false positive results, significantly reducing anxiety and unnecessary follow-up.

INCREASED SENSITIVITY

The sensitivity of conventional screening is 90%. This means that out of every 100 fetuses with Down’s Syndrome, traditional screening would not detect 10 cases. The sensitivity of neoBona is higher than 99%, meaning that it detects practically all cases of Down’s Syndrome.

NEXT GENERATION BIOINFORMATICS

The innovative TSCORE algorithm integrates the depth of sequencing, the fetal fraction and the fragment size distribution of the cell-free DNA, to generate reliable results even at a low fetal fraction.

WHAT TYPES OF CHROMOSOMAL ABNORMALITIES DOES IT DETECT?

Frequent chromosomal abnormalities

Autosomal aneuploidies

Trisomy 21 or Down’s Syndrome is the most common trisomy at birth. Its appearance is closely related to the age of the mother, being the incidence greater in older mothers.  Down’s Syndrome is related to moderate intellectual disability, digestive abnormalities and congenital heart defects. It is estimated that trisomy 21 is present in 1 in every 750 newborns.

 Trisomy 18 or Edward’s Syndrome is less common and presents a high incidence of miscarriage. Babies born with trisomy 18 usually suffer from congenital heart problems in addition to other medical conditions, which significantly reduces life expectancy. About 1 in every 7,000 newborns presents this disorder.

Trisomy 13 or Patau’s Syndrome is related to a high incidence of miscarriage. Babies born with trisomy 13 usually have severe cardiac defects and other medical conditions. Survival after the first year is uncommon. Approximately 1 in every 15,000 newborns presents trisomy 13.

Aneuploidies of sex chromosomes

Women normally present two copies of the X chromosome, while men present one copy of the X chromosome and one copy of the Y chromosome. There are many different sex chromosomes aneuploidies (SCA), which are almost all significantly-TYPO less severe than the trisomies above. They are commonly present in mosaic and have an important clinical variability; some SCA can cause developmental problems or infertility, whereas others may be undetected or be associated only with slight or moderate symptoms.

Aneuploidies of sex chromosomes that affect girls:

Monosomy of the X chromosome or Turner Syndrome (45, X) is caused by the absence of the second copy of the X chromosome. Girls who present with this disorder may have learning difficulties. Approximately 1 in 2,500 newborn girls presents monosomy of the X chromosome.

Triple-X (47, XXX) is caused by the presence of an extra copy of the X chromosome. Most girls with triple-X lead normal lives and often go undetected; others may have premature ovarian insufficiency.  Approximately 1 in 1,000 newborn girls presents with triple-X.  

Aneuploidies of sex chromosomes that affect boys:

Klinefelter syndrome (47, XXY) is caused by an extra copy of the X chromosome. Most boys with Klinefelter syndrome are undetected, whereas up to one-third may suffer from hypogonadism and azoospermia or hypofertility. 1 in 500-1,000 newborn boys presents this aneuploidy.

Jacobs syndrome (47, XYY) affects boys who have an extra copy of the Y chromosome. The clinical effects are minor and approximately 85% of XYY males are never diagnosed. XYY males tend to be tall and behavioural and psychiatric disorders are common. About 1 in every 1,000 newborn boys presents this disorder.

SYNLAB, EXPERTS IN PRENATAL DIAGNOSTICS

SYNLAB Quality Diagnostics

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SYNLAB Quality Diagnostics is a European leader in diagnostic services, specialising in the management of laboratories for clinical analysis, pathological anatomy and genetics with over 10 years of experience.

The company carries out its activities to serve patients, doctors, insurance companies, hospitals, businesses, other laboratories and centres, both public and private, with the ultimate objective of providing high-value diagnostic information for patient care in any health environment.

SYNLAB assists over 25 million patients each year in over 500 laboratories and over 150 hospital centres across 40 countries in Europe: Belgium, Spain, France, Italy, Portugal, the United Kingdom, and Switzerland, as well as South America and the Middle East.

SYNLABs Experience in Prenatal Diagnostics

SYNLAB Quality Diagnostics stands out in prenatal diagnosis due to the extensive experience, and the performance of more than 60,000 molecular genetic studies and more than 14,000 prenatal diagnostic tests each year. The SYNLAB medical team has prestigious international professionals, specialists in non-invasive prenatal diagnosis, preimplantation genetic diagnosis, molecular genetics and medical genetics.

SYNLAB has 160 laboratories equipped with the most advanced technology in which more than 6,000 people work, including technicians, biologists, chemists, and physicians.

SYNLAB is a pioneer in the clinical use of molecular methods and in rapid molecular diagnostics of numerical chromosomal abnormalities, having published results and indications of over 43,000 QF-PCR tests, a technique incorporated and pioneered by the team of SYNLAB prenatal diagnostics experts.

SYNLAB has over 10 years' experience in prenatal diagnosis, always standing one step ahead, by incorporating the latest technology in this area.

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A Team of Professionals at your Service

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SYNLAB offers the specialist a team of more than 600 medical professionals and genetics experts, who can advise you clinically as a physician whenever you need it. The team collaborates in the development, evolution and improvement of the tests, applying the knowledge and experience in a project of continuous improvement and commitment to innovation.

The attention and support to the specialist is a priority, therefore SYNLAB develops tools and equipment designed for the training and support to the specialist in the different areas. SYNLAB together with the physician contributes to promote health, providing quality service and proximity and also participating in epidemiological and medical research programs at local, national and international levels.

The mission of SYNLAB is to offer the best laboratory clinic diagnosis by providing the highest quality using our technical and human resources. Our service is guaranteed by the high quality of all of our laboratories, which are accredited and certified for compliance with ISO 9001, ISO 17025 and/or ISO 15189, and by the experience and qualifications of the professionals involved within the SYNLAB network.

 

Innovative Technology

SYNLAB sees innovation as a way of constantly improving the services offered to its customers, mainly through agreements with biotech companies specialised in diagnostic testing and relying on the most advanced Next Generation DNA platforms, which are revolutionising approaches to preventive and personalised treatment.

The experience and knowledge of the expert team of SYNLAB, together with the incorporation of the latest technology, provide the most innovative diagnostic tools with the support of a European leader in prenatal diagnosis.

The SYNLAB prenatal diagnosis laboratory currently has a high degree of automation, through innovative platforms including Hamilton robotised platforms and Illumina's NextSeq 500 sequencing system.

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Contact

Synlab Nigeria Reference Laboratory
9A/B Egbeyemi Street Off Coker Road / Ilupeju
(+234) 8104607653

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