What is Vistara?

Vistara is a non-invasive prenatal test (NIPT) which screens cell-free DNA (cfDNA) for monogenic mutations. Vistara screens 30 genes involved in a number of severe diseases including: skeletal diseases, cardiovascular diseases and neurological diseases. Conditions screened by Vistara have a combined incidence of 1 in 600 – higher than that of Down syndrome.

Diseases meet at least one of the following criteria:
• Causes cognitive disabilities
• Requires surgical or medical interventions
• It affects the quality of life

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Why is this important?

Vistara identifies risk for single-gene disorders that may have otherwise gone undetected prenatally.
• No other non-invasive prenatal screening (NIPT) test can identify these diseases, and invasive tests do not guarantee a diagnosis.
• Family history is usually not a good indicator of risk for these diseases which are, in most cases, caused by de novo mutations.
• Ultrasound investigations are not reliable indicators for these diseases.

Prenatal screening with Vistara can lead to improved delivery management and targeted neonatal care
•Early testing with Vistara allows patients to be guided toward to the maternal-fetal morphology specialist or other specialists for specific tests, as follows: fetal echocardiograms, NMR and targeted anatomical evaluations.
•Prenatal fetal diagnosis allows doctors and patients to plan the child delivery in specialized clinics which are properly equipped in order to ensure immediate assessment of the condition of the baby and administration of the necessary treatment.
•Understanding these complex genetic conditions before birth allows families to plan their resources, ask more questions and anticipate future needs.

Ultrasound identification of the diseases

A significant number of diseases can’t be detected through ultrasound.
Where there is no indication of a fetal disease during the pregnancy, doctors and patients are not prepared for the birth of an affected child.
Very often, ultrasound findings occur at advanced pregnancy ages
These diseases can be identified only in third pregnancy quarter when confirmation through an invasive test can lead to spontaneous abortion.

Many diseases have non-specific identifiable ultrasound features
Non-specific findings such as nucal translucency and cardiac malformations may have a variety of causes.

How is Vistara different from other NIPTs?

Vistara screens for serious conditions across 30 genes that are not screened for by standard NIPTs. Other NIPTs screen for chromosomal abnormalities, such as Down syndrome, rather than looking for small changes, or single-gene mutations, in DNA from the placenta.
Vistara does not test for chromosomal abnormalities such as extra chromosomes (e.g. Down syndrome), or test for the baby’s gender. However, results from standard NIPT and Vistara together can help reduce the chance for a wider range of genetic abnormalities.

How does information about genetic abnormalities affect the pregnancy care plan?
Information from genetic screening helps parents to make the best decisions for their families.
Many conditions screened by Vistara may require specialized medical care prenatally, at birth, and into childhood. Knowing about genetic conditions sooner can empower patients to learn about options to care for an affected child.

Results from Vistara will show whether a disease-causing or likely disease-causing single-gene mutation has been identified. Results will provide valuable information to help patients and doctors plan prenatal care and delivery. Like other screening tests, Vistara is not a diagnostic test and does not provide a definitive diagnosis of any conditions screened. Amniocentesis or CVS can be performed before birth, or the baby can be tested with a blood sample at or after delivery.