Description

Fulgent KNOVA NIPT

During your pregnancy, your blood contains your own DNA as well as DNA from your baby’s placenta. Fulgent KNOVA NIPT is a screening test that examines the placental DNA from your blood to see if there are signs of genetic conditions that could affect your baby’s health. This type of analysis is called Prenatal Cell-Free DNA (cfDNA) Screening, sometimes also called Non- Invasive Prenatal Testing (NIPT) or Non-Invasive. Prenatal Screening (NIPS). Fulgent KNOVA NIPT can also tell you the sex of your baby if you wish.

Fulgent KNOVA NIPTis not a diagnostic test and should not be used alone to make decisions about your pregnancy. Instead, Fulgent KNOVA NIPT can help you learn whether your pregnancy is at a higher-than-average risk for a severe disorder, giving you the option to pursue diagnostic testing as a next step. Because the Fulgent KNOVA NIPT test is non-invasive, it is considered relatively low-risk and can be a great first option for testing. Any decision to pursue diagnostic testing or any medical treatment or procedure should be made in consultation with your doctor. The Unique Benefits of Fulgent KNOVA NIPT We believe more knowledge means more informed choices for you and your family. That’s why our test covers more conditions than other similar tests, including:

What Can Fulgent KNOVA NIPT Screen For?

• Common Genetic Conditions such as Trisomies such as Trisomy 21 (Down Syndrome), Trisomy 18 (Edward Syndrome) and Trisomy 13 (Patau Syndrome) and others such as Trisomy 15, 16 and 22
• Sex Chromosome Conditions such as Turner Syndrome (45,X; 47,XXX; 47,XXY; 47,XYY
• Microdeletions (12):  1p36 del, 2q33 del, 4p16 del, 5p15 del, 8q23q24 del, 9p del, 11q23q25 del, 15q11.2-q13 del, 17p11.2 del, 18p del, 18q22q23 del, 22q11.2 del
• Single Genes Disorders (56 genes, associated with 30+ monogenic conditions):
• ASXL1, BRAF, CBL, CD96, CDKL5, CHD7, COL10A1, COL11A1, COL1A1, COL1A2, COL2A1, EBP, EFNB1, ERF, FGFR1, FGFR2, FGFR3, FLNB, FREM1, GLI3, HDAC8, HNRNPK, HRAS, KAT6B, KMT2D, KRAS, LMNA, MAP2K1, MAP2K2, MECP2, NIPBL, NRAS, NSD1, NSDHL, PTPN11, RAD21, RAF1, RIT1, RUNX2, SHOC2, SKI, SLC25A24, SMC1A, SMC3, SNRPB, SOS1, SOS2, SOX9, SPECC1L, STAT3, TCF12, TRAF7, TSC1, TSC2, TWIST1, ZIC1

KNOVA also screens for severe conditions that are not included on standard NIPTs (identifying 60% more pregnancies with severe genetic conditions compared to standard NIPT)  –*Based on a study of high-risk patients (PMID: 38253798). Fulgent KNOVA NIPT is appropriate for singleton pregnancies only; testing cannot be performed for cases with a history of egg donor, fetal demise, vanishing twin, or multiple pregnancy reduction.

Click this link for detailed clinician information about the test!

Targetted Versus Genome Wide NIPT Testing

Genome-wide NIPTs look at a larger portion of your baby’s DNA, but they have two main weaknesses:

• Because they use a low-detail (low-resolution) approach, they are more likely to miss small but important genetic changes that are known to cause severe disorders.
• They often pick up unclear changes that may lead to unnecessary anxiety.

In contrast, KNOVA closely targets critical areas, helping you get the most vital information for your baby’s health

 

Why Do I Need a Scan Before the NIPT Blood Draw?

If you wish to have your NIPT performed before week 12, we would advise that a viability scan be conducted prior to your blood draw to ensure the health of your pregnancy, to confirm a heartbeat is present and to exclude a multiple pregnancy. This scan is complimentary if you are attending our Cardiff clinic but if not you can arrange this locally. If you do not require a scan and do not live locally we can arrange for a private phlebotomist to take your blood sample at home or at work or anywhere in the UK and Northern Ireland FREE of charge.

 

What Can I Expect?

First Steps

Your doctor can order this test for you as early as 10 weeks into your pregnancy. It only requires a simple blood draw. If you have a personal or family history of a chromosomal or single gene disorder ,or an abnormal scan this information should be reviewed with your healthcare provider to ensure the most appropriate test is ordered. Innermost Healthcare provide a complimentary scan in out Cardiff Clinic or a complimentary phlebotomy service anywhere in the UK at no extra cost.

Results

KNOVA results will be reported to your provider approximately 7-10 days from the time the sample is received at our laboratory. 

What does a low-risk result mean?

A low-risk result means that your baby has a very low chance of having one of the conditions tested for by KNOVA. KNOVA is a screening test and is not diagnostic.

What does a high-risk result mean?

A high-risk result means your baby has a higher chance of having one of the conditions tested for by KNOVA. As a screening test, KNOVA identifies pregnancies at high risk for certain conditions. KNOVA is not diagnostic – if a high-risk pregnancy is identified, further diagnostic testing (during pregnancy or postnatally) is required to know whether the baby is affected. Decisions about a pregnancy should not be made using the KNOVA test alone. Rather, this test should be used to help identify risk at an early stage. If you have an abnormal or inclusive result we will arrange a consultation with Dr Bryn Beattie, Consultant in Fetal Medicine. If appropriate you will be offered or referred for a CVS or Amniocentesis test either via the NHS or on a private basis with Dr Bryan Beattie.