Clarigo is an advanced and affordable CE-marked non-invasive prenatal test (NIPT). The test enables a rapid analysis of fetal cell-free DNA in the venous blood of the mother for the most common fetal trisomies (21, 18, and 13) early in pregnancy. Clarigo has great accuracy and significantly low false positive rate, resulting in improved confidence in the outcome for all risk groups and consequently a decrease in unnecessary invasive procedures and associated stress for the pregnant couple. It allows healthcare providers to offer a safe, fast and reliable screening to all pregnant women early in the pregnancy.
Clarigo screens for trisomies 21, 18, and 13 and includes optional gender calling. The test uses a single maternal blood draw from as early as 8 weeks of gestation. The blood of pregnant women contains a small amount of cfDNA, released by placental cells, that reflects the genetic blueprint of the fetus. The blood sample is sent to a local lab, where the cfDNA is further analyzed.
Clarigo uses Agilent’s proprietary Multiplex PCR technology and targeted Next-Generation Sequencing (NGS) to provide clear results. NGS enables the analysis of cfDNA to be performed with accurate sensitivity and precision. The Multiplex PCR approach allows the analysis of only those pieces of cfDNA that contribute to the answer.
Other available tests use shotgun sequencing whereby the whole cfDNA pool is sequenced randomly and where up to 20 M sequencing reads are needed. Clarigo requires almost 10 times less reads per sample. Taking advantage of this methods, less reads are needed, and only relevant DNA information is analyzed, which makes the assay faster and cheaper.
How it works
With Clarigo aneuploidy status of chromosome 21, 18 and 13 can be analyzed using cell-free DNA (cfDNA) prepared from a blood sample from a pregnant woman. This NIPT can be performed as early as 8 weeks gestational age, earlier than any other prenatal screening. Blood samples can be sent to a local laboratory where the cfDNA is analyzed for signs of abnormalities using Next-Generation Sequencing (NGS).
Blood sample from pregnant women as early as week 8 of gestation
NGS of cfDNA in local laboratory
Data processing by a specially designed software tool for analyzing and reporting results
Results available in 3-5 working days
After 3-5 working days from receipt of the sample in the laboratory, you will receive a clear report containing the fetal fraction and results for chromosomes 21, 18, and 13 and optionally fetal gender.
Pregnant women within one of the following categories, are not within the test criteria:
Less than 8 weeks pregnant
Maternal chromosomal abnormality
Pregnant of twins or multiples
Pregnant by oocyte donation
Underwent one of the following treatments in the previous 3 months: blood transfusion, immune therapy, stem cell therapy, transplantation, radiation therapy.
Thanks to Clarigo’s innovative method, a highly reliable and safe test for fetal screening has become available for all pregnant women.
Clarigo is a locally implementable and accurate non-invasive prenatal test (NIPT), accessible to a larger group of pregnant women. This reliable test gives a clear and accurate result for trisomy 21, 18, and 13 as early as 8 weeks of gestational. Furthermore, fetal gender calling is optional.
Highly accurate trisomy assessment
Proven sensitivity and specificity for T21, T18, T13
Fetal fraction included for both male and female fetus samples
Optional fetal gender calling
CE-mark supported by a multi-center study on more than 1,500 samples
Clarigo makes NIPT affordable and accessible to a wider group of pregnant women. The lower price is achieved through the adoption of state-of-the-art technology.
Early in pregnancy possible and reliable result from as early as week 8 of gestation
Clarigo has a fast turnaround time. Labs can deliver test results in just 3-5 days after the sample arrived in the lab.
Unlike most NIPTs, Clarigo can be implemented in a laboratory in your area. Blood samples do not need to be shipped abroad.
Clarigo only requires a safe maternal venous blood sample.
Non-invasive prenatal test is safe to the fetus and the mother.