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TOMORROW NON-INVASIVE PRENATAL TEST

tomorrow_info_medicos_ING
ABOUT

TOMORROW is the prenatal test of the Medical Genetics Laboratory of Unilabs (CGC Genetics) which, from a sample of maternal blood and in a non-invasive way, detects in the fetal DNA the presence of the trisomies 21,18 and 13, the fetal sex and sex chromosome aneuploidies (Monosomy X, XXX, XXY, XYY).

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Exames

Early Detection

TOMORROW can be performed from the 10th week of pregnancy (inclusive). 

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Laboratorio

Safe

The performance of the test has no risk of miscarriage, ususally associated with invasive methods. 

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Analises Clinicas

Simple

Only a simple blood collection is required, without prior preparation. 

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Genética

High Detection Capacity 

Detects the most common syndromes: trisomies 21,18 and 13, identifies fetal sex and aneuploidies of sex chromosomes  (Monosomy X, XXX, XXY, XYY).

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Verificar

Confidence Analysis 

False positive and false negative rates below  0,5% 1,2,3.

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Rápido

Answer

Average response time of working days (maximum 6). 

WHO IS FOR

WHO IS TOMORROW FOR? 

FOR PREGNANT WOMEN OF ANY AGE AND RISK CATEGORY 

TOMORROW, a non-invasive prenatal test, has been clinically validated for use in pregnant women of any age or risk category. 

TOMORROW IS INTENDED FOR ALL PREGNANT WOMEN, SPECIALLY RECOMMENDED TO: 

  • Pregnant women who wish to rule out the presence of these chromosomal changes in the fetus, without putting the pregnancy at risk through an invasive test. 
  • Pregnant women over 35 years old. 
  • Pregnant women at high risk for trisomies 21,18 and 13. 
  • Pregnant women with trisomy diagnosed in a previous pregnancy. 
  • Pregnant women with a historiy of recurrent abortion. 
  • Pregnant women with echographic results suggestive of the chromosomal disorders. 
  • Pregnant women who want to know more information abouth their baby. 

 

TOMORROW CAN ALSO BE PERFORMED IN: 

• IVF/Egg Donation

TOMORROW DETERMINES

TRISSOMIAS ANEUPLOIDIAS SEXUAIS SEXO FETAL
  • Trisomy 21

  • Trisomy 18

  • Trisomy 13

  • Monosomy X

  • XXX

  • XXY

  • XYY

  • Boy / Girl

 

Gravida Tomorrow

TOMORROW IN TWINS

Tomorrow can also be performed on twin pregnancies (2 fetuses). The study of fetal sex is performed by the presence or absence of the Y chromosome in maternal blood. In case of detection of the Y chromosome in twin pregnancies (2 fetuses), it is not possible to confirm whether one or both fetuses are male. Likewise, in twin pregnancies it is not possible to search for aneuploidies of sex chromosomes, so only the T21, T18, T13 can be performed.  

Please note that non-invasive prenatal tests are less sensitive when performed in twin pregnancies. 

METHODOLOGY

THE IMPORTANCE OF A NON-INVASIVE PRENATAL TEST 

There are several options for prenatal screening available. Compared to the non-invasive prenatal TOMORROW test, traditional screening methods have lower accuracy and higher false positive rates. 

On the other hand, invasive diagnoses, such as amniocentesis or chorionic villus biopsy (CVS), imply a risk of miscarriage of 0.5% or 1-2%, respectively. 

Risco de abortamento

TEST PERFORMANCE IN THE MOST COMMON CHROMOSOMIC ANEUPLOIDS 2,4

 

 

Sensitivity 

 

95% IC 

 

Specificity 

 

95% IC 

 

T21 > Down Syndrome 

 

99,14% 

 

98,0 - 99,7 

 

99,94% 

 

99,90 - 99,97 

 

T18 > Edwards Syndrome 

 

98,31% 

 

95,0 - 99,6 

 

99,90% 

 

99,86 - 99,93 

 

T13 > Patau Syndrome 

 

98,15% 

 

90,0 - 99,9 

 

99,95% 

 

99,91 - 99,97 

 

MX > Turner Syndrome 

 

95,0% 

 

75,1 - 99,9 

 

99,0% 

 

97,6 - 99,7 

 

 

 

 

 

 

 

 

 

 

 

 

 

WHAT IS THE METHODOLOGY USED?

  • From a blood sample, fragments of circulating DNA are obtained, both maternal and fetal. 
  • This is because, during pregnancy, small fragments of the fetus-placental unit enter the mother's bloodstream. These fragments of DNA from the fetal-placental unit are usualy referred to only as fetal DNA. 
  • The circulating fragments corresponding to both the mother's and fetus' DNA are analyzed by the TOMORROW Prenatal Test. 
  • The fraction of Fetal DNA present in the analyzed sample is quantified. 
metodologia

 

A DEEPER APPROACH TO SEQUENCING

  • The fragments of maternal and fetal DNA present in the bloodstream are analyzed by New Generation Sequencing technology (NGS). 
  • Then, through a complex bioinformatics analysis using the ILLUMINA platform, the number of sequences corresponding to each chromosome is "aligned" and analyzed.
  • The identification of fetal sex is determined by the presence or absence of the Y chromosome. 
  • Aneuploidies are detected by comparing the chromosomal material (maternal and fetal DNA) with reference values.  
  • Sequanciacao

     

 

 

Process

WHAT IS THE TOMORROW PROCESS?

The TOMORROW test adapts to any practice, providing the flexibility they need to schedule the test with other prenatal procedures, including ultrasounds. 

TOMORROW IN THREE SIMPLE STEPS

  1. Order the test after 10 weeks of gestation.
  2. Send the blood sample (7-10 mL) for analysis using the kit provided.
  3. Receive test results within 4 to 6 business days. 
Processo Tomorrow

WHAT INFORMATION IS OBTAINED FROM TOMORROW?

TOMORROW provides clear information on the most common fetal aneuploidies, which can minimize material anxiety and guide invasive procedures for definitive diagnosis. in the case of a positive result. 

Possible Results:

  • Not detected”, in case there is a very low probability for tested aneuploidies; 
  • Detected”, in case there is a very increased probability for the tested aneuploidies. 

In case of a positive result ("detected"), according to the recommendations pf ACOG, ACMG and SMF, confirmation by invasive prenatal diagnosis, in amniotic fluid (amniocentesis) or by chorionic villus biopsy, through FISH is advised, QF-PCR or karyotype. 

In this case, our Laboratory offers, without any additional cost, the performance of a quick analysis by QF-PCR, available in 24 to 48 hours and also the chromosomal analysis (karyotype). 

 

It is recommended that no irreversible clinical decision be taken based solely on the result of this test. 

 

ADDITIONAL INFORMATION

  • The test cannot be performed before 10+0 weeks of gestation, determined by LMP, CRL or other clinically appropriate method (equivalent to 8 weeks of fetal age, if determined by conception date). 
  • The test is not considered a diagnostic test, although all recent studies on the characteristics of this test demonstratess its high accuracy (99%) and low rate of false positives/negatives (<0.5%).
  • False negatives: in rare cases, a tested chromosomal alteration may be present, even if the test result is "undetected".
  • False positives: a "detected" result for a given tested aneuploidy may not be present in the fetus but, for example, be identified only in the placenta. 
  • Tests with "undetected" results do not eliminate the possibility of the fetus having other chromosomal changes besides those mentioned and within the limitations of the technique (less than 1%), birth defects or health problems.  
  • If the pregnant woman has recently received a blood transfusion, transplant, cell therapy or immunotherapy, an accurate assessment of fetal DNA is not possible. 

 

ACOG - American College of Obstetricians and Gynecologists; ACMG - American College of Medical Genetics and Genomics; SMFM - Society for Maternal-Fetal Medicine.

 

WHERE IT TAKES PLACE

The collection of the TOMORROW test is done in all Units of the Unilabs own network that have the Medical Genetics Specialty.

You can consult the contacts and schedules of these Units with the Specialty of Medical Genetics here.

 

PRICE

WHAT DOES TOMORROW INCLUDE?

Two types of TOMORROW Non-Invasive Prenatal Test are available: 

  • Tomorrow

Research of trisomies 21,18 and 13, identification of fetal sex and aneuploidies of sex chromosomes (Monosomy X, XXX, XXY, XYY)

495€

  • T21, T18, T13 only

Research of trisomies 21,18 and 13 and identification of fetal sex. 

370€

Regarding possible co-payments, check with the Health Insurance Companies. 

Please contact us for more information. 

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References

REFERENCES

• 1 - Futch T, Spinosa J, Bhatt S, et al., Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn. 2013. 33:569 574.

• 2 - Bhatt S, Parsa S, Synder H, et al., Clinical Laboratory Experience with Noninvasive Prenatal Testing: Update on Clinically Relevant Metrics. ISPD 2014 poster.

• 3 - Bianchi D, Parsa S, Bhatt S, et al., Fetal Sex Chromosome Testing by Maternal Plasma DNA Sequencing: Clinical Laboratory Experience and Biology. Obstet Gynecol. 2015. 125(2):375 382

• 4 - Verinata Health, Inc. Analytical Validation of the verify Prenatal Test: Enhanced Test Performance For Detecting Trisomies 21, 18 and 13 and the Option for Classification of Sex Chromosome Status. 2012. Redwood City, CA.

 

ADDITIONAL REFERENCES 

ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007. 109:217 227.

American College of Obstetricians and Gynecologists (ACOG) Committee on Genetics. Committee Opinion No. 545: Noninvasive prenatal testing for fetal aneuploidy. Obstet Gynecol. 2012. 120:1532 1534.

Gregg A, Gross S, Best R, et al. ACMG statement on noninvasive prenatal screening for fetal aneuploidy. Genet Med. 2013. 15:395 398.

Benn P, Borell A, Chiu R, et al. Position Statement from the Aneuploidy Screening Committee on Behalf of the Board of the International Society for Prenatal Diagnosis. Prenat Diagn. 2013. 33:622 629.

Devers P, Cronister A, Ormond K, et al. Noninvasive prenatal testing/noninvasive prenatal diagnosis: the position of the National Society of Genetic Counselors. J Genet Couns. 2013. 22:291 295.

Bianchi D, Platt L, Goldberg J, et al. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012. 119:890 901.

Rava P, Srinivasan A, Sehnert A, et al. Circulating fetal cell-free DNA fractions differ in autosomal aneuploidies and monosomy X. Clin Chem. 2014. 60:243 250.

Sehnert A, Rhees B, Comstock D, et al. Optimal detection of fetal chromosomal abnormalities by massively parallel DNA sequencing of cell-free fetal DNA from maternal blood. Clin 

Chem. 2011. 57:1042 1049.

Srinivasan A, Bianchi DW, Huang H, et al. Noninvasive detection of fetal subchromosome abnormalities via deep sequencing of maternal plasma. Am J Hum Genet. 2013. 92(2):167 176.

Liao C, Zhengfeng X, Zhang K. DNA sequencing versus standard prenatal aneuploidy screening. 

N Engl J Med. 2014. 371(6):577 178.

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