Test prenatal no invasivo – Verifi

VerifiTM Plus based on cell-free DNA analysis from maternal or pregnant patients’ blood is a screening test. False positive and false negative results do occur. Test results must not be used as the sole basis for diagnosis. Further genetic counseling and confirmatory diagnostic testing is necessary with a positive test result. Test results might not reflect the chromosomal status of the fetus but may reflect chromosomal changes of the placenta (CPM) or of the patient, which may or may not have clinical significance. CPM may be associated with a higher chance for pregnancy complications or for uniparental disomy (UPD), whichmay 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. A negative test result does not eliminate the possibility of chromosomal abnormalities for the tested chromosomes or microdeletions. In addition, microdeletion conditions caused by other molecular mechanisms cannot be detected with this assy. This test does not screen for polyploidy (e.g. triploidy), birth defects such as open neural tube defects, single gene disorders, or other conditions, such as autism.

VerifiTM and VerifiTM Plus were developed by, and their performance characteristics were determined by Verinata Health, Inc. (VHI) a wholly owned subsidiary of Illumina, Inc. The VHI laboratory is CAP-accredited and certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. They have not been cleared or approved by the U.S. Food and Drug Administration.