Frequent Questions

Customer Care

How to order TOMORROW Prenatal Test and where to send?

Medical counselling is advised prior to any screening and/or diagnostic test.

To order TOMORROW Prenatal Test:

• 7-10 mL maternal blood sample in STRECK tube, without prior preparation.
• Requisition Form TOMORROW Prenatal Test fully completed and signed by the ordering healthcare professional.
• Patient’s signature after careful reading of Patient Informed Consent.
• Send sample up to 4 days after collection to CGC Genetics PORTO, Rua Sá da Bandeira 706-1º, 4000-432 Porto, Portugal.

 

What are the sampling instructions?

Maternal blood sample can be collected from 10+0 weeks of pregnancy, at any time of the day and without prior preparation, respecting the following instructions:

1. Collect the blood sample into a  STRECK tube (ref.: Cell-Free DNA BCT© CE)

2. Identify the Streck Tube with at least 2 identifications, for example, patient’s name and date of birth;

3. Clean the region of sampling and harvest by venipuncture between 7–10 mL of blood into the Streck tube (the test cannot be performed if sample is less than 7 mL);

4. Immediately after sampling, carefully rotate the tube 8-10 times (inadequate or late mixture may affect the test result);

5. Sample should be stored and shipped at room temperature (20‑25°C, 68‑77°F);

6. Make sure delivery arrives within 4 days after blood sampling and that is addressed to:

CGC Genetics

Rua Sá da Bandeira, 706-1º

4000-432 Porto, Portugal

For more information on this please download our BLOOD SAMPLING INSTRUCTIONS

 

What is the price for TOMORROW Prenatal Test?

TOMORROW

Single pregnancy:

• Most frequent chromosomal alterations: Down syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13);

• Fetal gender identification (female or male);

• Sex chromosome numerical changes: Turner syndrome (Monosomy X), Klinefelter syndrome (XXY), Triple X syndrome (XXX) and Double Y syndrome (XYY).

RRP: 495 €

 

T21, T18, T13 only

Single pregnancy:

• Detection of trisomies 21, 18, 13 and fetal gender identification.

Twin Pregnancy:

• Most common fetal chromosomal disorders: Down syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13);

• Fetal gender identification (fetal gender identification is performed by detecting the presence or absence of Y chromosome in maternal blood. In case of Y chromosome detection in twin pregnancy (2 fetuses), it is not possible to confirm if one or both fetuses are male).

RRP: 395 €

 

 

Healthcare Professionals

What is TOMORROW Prenatal Test?

TOMORROW Prenatal Test, is the new CGC Genetics test that with a non-invasive technique and from a simple blood sample detects, as early as 10 weeks of pregnancy:
• The most common fetal aneuploidies: trisomies 21, 18 and 13;
• Fetal gender identification;
• Sex chromosome aneuploidies: Monosomy X, XXX, XXY and XYY.

 

Can TOMORROW Prenatal Test be performed in case of a twin pregnancy?

Yes, in case of a twin pregnancy (2 fetuses), TOMORROW Prenatal Test analyses the presence of trisomies 21, 18 and 13, but it is not able to detect sex chromosome aneuploidies.

TOMORROW Non Invasive Prenatal Test cannot be performed in case of pregnancies with more than two fetuses.

Fetal gender identification is performed by detecting the presence or absence of Y chromosome in maternal blood. In case of Y chromosome detection in twin pregnancy (2 fetuses), it is not possible to confirm if one or both fetuses are male.

If there is a history of vanishing fetus, please indicate in the appropriate section on the Requisition Form.

 

Can TOMORROW Prenatal Test be performed in case of an IVF pregnancy?

Yes, TOMORROW Prenatal Test can be performed in case of pregnancies by IVF, both with self-donation of eggs or not.
If there is a history of vanishing fetus, please indicate in the appropriate section on the Requisition Form

 

What are the requirements needed to perform TOMORROW Prenatal Test?

TOMORROW Prenatal Test is clinically validated to be performed from 10 weeks and 0 days of pregnancy, as estimated by LMP, CRL or other clinically appropriate method (equivalent to 8 weeks of fetal age, if determined by date of conception).

What type of sample is needed to perform TOMORROW Prenatal Test and what are the shipping conditions?

A simple maternal blood sample (7-10 mL) in STRECK tube (ref: Cell-Free DNA BCT© CE) is needed, collected at any time of the day and without prior preparation.

Make sure delivery arrives within 4 days after blood sampling and that is addressed to:

CGC Genetics
Rua Sá da Bandeira, 706-1º
4000-432 Porto, Portugal

What type of result can be obtained with TOMORROW Prenatal Test?

TOMORROW Prenatal Test analyses the most common fetal aneuploidies: trisomies 21, 18 and 13, identifies fetal gender and detects sex chromosome aneuploidies (Monosomy X, XXX, XXY and XYY).

Possible results:
“Not detected”, in case there is a highly reduced probability for the tested aneuploidies;
“Detected”, in case there is a highly increased probability for the tested aneuploidies;
Fetal Gender: Female (XX), Male (XY).

 

What to do in case of a positive result?

In case of a positive result (“detected”), according to ACOG, ACMG and SMFM*, confirmation by invasive prenatal diagnosis is recommended by amniocentesis or chorionic villus sampling, and chromosomal analysis by FISH, QF PCR or karyotyping.

In this case, CGC Genetics offers at no additional cost, the analysis by QF-PCR, to detect numerical changes of chromosomes 21, 18, 13, X and Y, with results in the shortest time possible (24-48h), as well as cytogenetic chromosomal analysis, in a fetal sample.

IT IS RECOMMEND THAT NO IRREVERSIBLE CLINICAL DECISION IS TAKEN UNIQUELY BASED ON THE RESULT OF THIS TEST.

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

When can I expect TOMORROW Prenatal Test results to be available?

Average turnaround time: 6 business days (maximum 10) and the results will be sent directly to the ordering healthcare professional.

What is a false positive or false negative rate of TOMORROW Prenatal Test?

TOMORROW Prenatal Test, like any other test type has an inherent error rate, although it is much reduced. The combined rate of false positive and false negative is less than 0.5%.

A false positive result means that even though the test result is of highly increased risk (“detected”) for a specific tested aneuploidy, this in reality is not present in the fetus, but it might be present, for example, only in the placenta (placental mosaicism).

A false negative means that the test result has been presented as of highly reduced risk (“not detected”), but the fetus presents one of the tested aneuploidies. This error is the less frequent, having a probability of occurrence of 0.03% for trisomies 21, 18 and 13.

For more information on the clinical studies performed so far, please visit the publications list available

 

Do you have any other questions?

CONTACT US

customercare@cgcgenetics.com

+351 223 389 900

EXPECTING PARENTS

What is TOMORROW Prenatal Test?

TOMORROW Prenatal Test, is the new CGC Genetics test that with a non-invasive technique and from a simple blood sample detects, as early as 10 weeks of pregnancy:

• The most common fetal chromosomal disorders: Down Syndrome (trisomy 21), Edwards Syndrome (trisomy 18) and Patau Syndrome (trisomy 13).

• Fetal gender identification (female or male).

• Sex chromosome numerical changes: Turner Syndrome (Monosomy X), Klinefelter Syndrome (XXY), Triple X Syndrome (XXX) and Double Y Syndrome (XYY).

 

I´m pregnant with twins, can I do TOMORROW Prenatal Test?

Yes, in case of a twin pregnancy (2 fetuses), TOMORROW Prenatal Test analyses the presence of trisomies 21, 18 and 13, but it is not able to detect sex chromosome aneuploidies.

TOMORROW Prenatal Test cannot be performed in case of pregnancies with more than two fetuses.

Fetal gender identification is performed by detecting the presence or absence of Y chromosome in maternal blood. In case of Y chromosome detection in twin pregnancy (2 fetuses), it is not possible to confirm if one or both fetuses are male.

 

I got pregnant by in vitro fertilization, can I also do TOMORROW Prenatal Test?

Yes, TOMORROW Prenatal Test can be performed in case of pregnancies by IVF, both with self-donation of eggs or not.

Can my previous pregnancy interfere with TOMORROW Prenatal Test result?

No. Recent studies demonstrate that fetal cells may remain in the mother’s blood stream circulation years after birth. However, fetal DNA, which is what TOMORROW Prenatal Test test actually analyses, is eliminated from blood circulation in just a few hours after birth. Therefore, a previous pregnancy does not interfere with the test results of the next pregnancy.

Does interrupting a previous pregnancy has any influence TOMORROW Prenatal Test results?

No. Recent studies demonstrate that fetal cells may remain in the mother’s blood stream circulation years after interrupting a pregnancy. However, fetal DNA, which is what TOMORROW Prenatal Test actually analyses, is eliminated from blood circulation in just a few hours after pregnancy interruption. Therefore, even if a previous pregnancy has been interrupted, it does not interfere with the test results of the next pregnancy.

When can I do TOMORROW Prenatal Test and when can I get the results?

TOMORROW Prenatal Test is clinically validated to be performed as early as 10 weeks and 0 days of pregnancy. It is only necessary to collect a maternal blood sample (7-10 mL) at any time of the day and without prior preparation. Average turnaround time: 6 business days (maximum 10) and the results will be sent directly to your ordering healthcare professional.

What type of results can be obtained with TOMORROW Prenatal Test?

TOMORROW Prenatal Test analyses the most common fetal chromosomal alterations: trisomies 21, 18 and 13, identifies fetal gender and detects sex chromosome numerical changes (Monosomy X, XXX, XXY and XYY).

Possible results:
“Not detected”, in case there is a highly reduced probability for the tested chromosome numerical changes;
“Detected”, in case there is a highly increased probability for the tested chromosome numerical changes.
Fetal Gender: Female (XX), Male (XY).

FREE OF CHARGE CONFIRMATION

In case of a positive result, CGC Genetics offers at no additional cost a quick analysis by QF‑PCR, available in 24 to 48 hours, and also chromosome analysis (karyotype), in a fetal sample.

What to do in case of a positive result?

In case of a positive result (“detected”), according to ACOG, ACMG and SMFM, confirmation by invasive prenatal diagnosis is recommended by amniocentesis or chorionic villus sampling, and chromosomal analysis by FISH, QF PCR or karyotyping.

In this case, CGC Genetics offers at no additional cost, the analysis by QF-PCR, to detect numerical changes of chromosomes 21, 18, 13, X and Y, with results in the shortest time possible (24-48h), as well as cytogenetic chromosomal analysis, in a fetal sample.

IT IS RECOMMEND THAT NO IRREVERSIBLE CLINICAL DECISION IS TAKEN UNIQUELY BASED ON THE RESULT OF THIS TEST.

 

Can the test result be a false positive or a false negative?

TOMORROW test, like any other test has an inherent error rate, although it is much reduced. according to recent studies, the rate of false positive and false negative is 0.1% and 0.02%, respectively.

A false positive result means that even though the test result is of highly increased risk (“detected”) for a specific tested aneuploidy, this in reality is not present in the fetus.

A false negative means that the test result has been presented as of highly reduced risk (“not detected”), but the fetus presents one of the tested disorders. This error is the less frequent, having a probability of occurrence of 0.02% for trisomies 21, 18 and 13, which means that one case may happen in every 5000 tests performed.

For more information on the clinical studies performed so far, please visit the publications list available. 

 

What is the difference between TOMORROW Prenatal Test and routine prenatal screening?

There are several prenatal screening options available. In comparison with the TOMORROW Prenatal Test, traditional screening methods have a lower precision and higher false positive/negative rate.

The screening test that combines both biochemical and ultrasound markers is part of the protocol used in pregnancy follow-up; however, this is based on an indirect method which allows only to indicate a probability of the presence of trisomies 21, 18 and 13, providing no information on sex chromosome number alterations or the fetal gender. Results are shown as a risk score (e.g. 1/600 or 1/75), which are not always easy to understand. In addition, these results have a false positive rate between 3 and 5% that need further confirmation by invasive prenatal screening diagnosis.

TOMORROW Prenatal Test, the new prenatal non-invasive test, analyses fetal-placental DNA directly for detection of numerical changes of chromosomes 21, 18, 13, X and Y (Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome, Klinefelter Syndrome, Triple X Syndrome, Double Y Syndrome) as well as the identification of fetal gender, with high sensitivity and specificity.

 

Does TOMORROW Prenatal Test substitute amniocentesis?

TOMORROW Prenatal Test is a high precision screening test with no risk of abortion associated, as a simple maternal blood sample is need. A test result of highly reduced risk for the tested chromosomal alterations may discourage invasive prenatal procedures, such as amniocentesis or chorionic villus sampling, which have a risk of abortion of 0.5 or 1-2%, respectively.

However, TOMORROW Prenatal Test is not a diagnostic test and therefore, in case of a result of highly increased risk, invasive prenatal diagnostic procedures are advised to confirm the result.

I have more questions, who should I ask?

Send us email to customercare@cgcgenetics.com or call +351 223 389 900, from Monday to Friday, from 09.00 to 18.00 (GMT/UTC + 00:00)