Verifi™ and Verifi™ Plus are the manufacturer’s names for Generation and Generation Plus. Verifi™ is validated for aneuploidy of chromosomes 21, 13, and 18 in both singleton and twin pregnancies, with gestational age of at least 10 weeks 0 days. Aneuploidy of sex chromosomes are validated only for singleton pregnancies, while presence/absence of Y chromosome material is validated for twin pregnancies. Verifi™ Plus is validated for trisomies of all chromosomes, including 21, 13, 18, sex chromosome aneuploidies and for specific deletions in chromosomal regions 1p36, 4p16.3, 5p15.2, 15q11.2, 22q11.2, in singleton pregnancies, with gestational age of at least 10 weeks 0 days. Both Verifi™ and Verifi™ Plus are screening tests that look only for specific chromosomal abnormalities. A normal result does not eliminate the possibility that the pregnancy is associated with other full or partial chromosomal or abnormalities, birth defects, genetic conditions, or other conditions, such as open neural tube defects or autism. There is a small possibility that the test results might not reflect the chromosomes of the fetus but may reflect chromosomal changes of the placenta (confined placental mosaicism, CPM) or of the patient (chromosomal abnormalities in the patient). Examples include sex chromosome status (eg. XXX), or benign and malignant neoplasm in the patient. Some cases of CPM may be associated with a higher chance for pregnancy complications or for uniparental disomy (UPD), which may affect the growth and development of the fetus. Some of these rare chromosomal aneuploidies may only occur in mosaic form. Clinical consequences depend on the chromosome involved and cannot be predicted prenatally. This test, like many tests, have limitations, including false negative and false positive results. A negative test result does not eliminate the possibility of chromosomal abnormalities for the tested chromosomes or microdeletions. In the case of vanishing twin, the test result may reflect the DNA of the vanishing twin, leading to a higher probability of false positive, false negative results, or sex discordance. No irreversible clinical decision should be made based on these screening results alone. If definitive diagnosis is desired, chorionic villus sampling or amniocentesis would be necessary. In some cases, other testing may also be necessary.
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