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What is Clarigo

Clarigo is a safe, accurate non-invasive prenatal test (NIPT). The test has obtained a CE-mark, supported by a large multi-center study comprising more than 1,500 test results. The test can be performed from as early as 8 weeks into your pregnancy. This risk-free blood test analyzes the circulating cell-free DNA of your unborn baby for 3 most common chromosome abnormalities:

  • Down syndrome also known as trisomy 21
  • Edwards syndrome also known as trisomy 18
  • Patau syndrome also known as trisomy 13

In rare cases, there is an increased risk for chromosomal abnormalities of your unborn baby. The most frequent and well-known type is Down syndrome, caused by an extra copy of chromosome 21. Patau syndrome caused by an extra copy of chromosome 13 and Edwards syndrome caused by an extra copy of chromosome 18 occur less often than Down syndrome.

Developed in Europe, Clarigo analyzes the circulating cell-free DNA (cfDNA) of your baby with state-of-the-art technology. Throughout the pregnancy, a small percentage of placental cfDNA is released into the mother’s bloodstream. As a result, a standard blood sample of a pregnant women contains a mixture of fetal and maternal cfDNA. Clarigo analyzes cfDNA for the presence of trisomy 21, 18, or 13 in the fetus.

The test is developed for local implementation in a laboratory. This means that your blood sample does not have to be shipped abroad. In the unlikely event of a positive result, your healthcare provider will provide you more information.

How it works

Clarigo can be performed as early as 8 weeks into the pregnancy. It is safe for you and your baby. This NIPT test involves a standard blood draw from your arm by your doctor. Your blood sample is then sent off to a local laboratory, where an expert will analyze the fetal cfDNA for signs of abnormalities of chromosome 21 (Down syndrome), chromosome 18 (Edwards syndrome), and chromosome 13 (Patau syndrome).

Once the results of your test are available, you and your doctor will discuss whether more testing is needed. If the test is positive, your doctor may recommend following up with an invasive procedure, amniocentesis or chorionic villus, to confirm the result.

Step 1:

A blood sample is drawn from your arm, the sample contains cell-free DNA partly from yourself and partly originating from the placenta of your unborn baby.

Step 2:

The blood sample is sent to the local laboratory for analysis on:

  1. Down syndrome (T21)
  2. Edwards syndrome (T18)
  3. Patau syndrome (T13)
  4. Optionally, the gender of the fetus can be analyzed
Step 3:

Results are sent from the laboratory to your doctor.

Step 4:

Your doctor will explain your result and provide you counselling about the next steps regarding your further pregnancy care options.

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Why

Clarigo is the first CE-marked NIPT in Europe for local implementation, supported by a large multi-center study on more than 1,500 blood samples. Clarigo provides a helpful option in prenatal screening to screen your unborn baby for Down syndrome, Edwards syndrome, or Patau syndrome. It gives you and your healthcare provider accurate answers to your pressing questions.

For many years, prenatal testing choices were limited and could be stressful for the expecting parents. Conventional methods, like serum screening or combined testing, do not score well on accuracy and therefore result in a large number of unnecessary invasive procedures. Clarigo provides you and your healthcare provider with significant benefits over these conventional screening methods.

Key Features
Added Values
Reliable
  • Clarigo has proven accuracy based on extended studies in more than 1,500 samples
  • Fewer false alarms, requiring risky invasive procedures that can result in miscarriages
  • More accurate and fewer missed cases.
Safe
  • Non-invasive test, reduces risk of miscarriage as compared to traditional methods.
Affordable
  • Clarigo is the NIPT with the most competitive price available. Clarigo makes NIPT affordable and accessible to a broader public. The lower price is achieved through the adoption of state-of-the-art technology.
Rapid
  • Clarigo has a fast turnaround time. Labs can deliver test results to your healthcare provider in just a couple of days from when your sample is taken.
  • Early in pregnancy
  • Reliable result from as early as week 8 into the pregnancy
Local
  • Unlike most NIPT tests, Clarigo can be performed in a laboratory in your country, allowing a fast turnaround time
Simple
  • Clarigo only requires a safe maternal venous blood sample
  • Clear results

For more information, contact your healthcare professional or. mail us.

For In Vitro Diagnostic Use.