What is VERAgene?
VERAgene is a comprehensive non-invasive prenatal test for the detection of fetal chromosomal aneuploidies, microdeletions and a selected panel of 50 monogenic disorders. VERAgene is available for singleton and twin pregnancies. VERAgene is developed using NIPD Genetics’ proprietary NIPT technology platform.
VERAgene uses Target Capture Enrichment Technology with unique technical characteristics that powers the test’s high sensitivity and specificity, and unparalleled accuracy in fetal fraction measurement. VERAgene captures and analyses cfDNA fragments from selected genomic regions using targeted enrichment and next generation sequencing (NGS) in combination with a multi-engine analysis pipeline (Koumbaris et al. Clinical Chemistry, 62:6, 848-855, 2016).
VERAgene’s features
Targeted Genomic Analysis
VERAgene uses patented Target Capture Sequences (TACS) designed to capture cfDNA fragments while avoiding copy number variations, repetitive DNA elements, and complex genomic architecture.
High Read Depth
Read-depth is the number of times a nucleotide in the genome is read during analysis. VERAgene captures DNA fragments only from targeted regions on chromosomes of interest. These fragments are then counted hundreds of times using NGS to achieve very high accuracy and precision.ια.
Fetal Fraction Measurement
VERAgene uses the high read depth of informative loci to accurately measure the fetal contribution to cell-free DNA (cfDNA). Accurate fetal fraction measurement protects from false results.
Comparison of prenatal testing methodologies
| VERAgene | First Trimester Screening | |
| Type of Test | Type of Test | Type of Test |
| Testing Method | Genetic analysis of cell-free DNA from mother and DNA from father to determine the fetal risk for the tested conditions. | Biochemical analysis of maternal blood ultrasound, and other parameters (e.g. maternal age) are used to estimate chance of being fetus affected by trisomies. |
| Testing Sample | Blood sample from biological mother and buccal swab from biological father | Blood sample from mother |
| Testing Accuracy | Higher than 99% for trisomy 21, 18 and 13 sex chromosome aneuploidies and microdeletions. Higher than 99% (CI: 96% – 100%) PPV in detecting monogenic disorders. | 80-95% for trisomy 21, 18 and 13. |