What is NIPT?

1. Comprehensive view of the fetal genome

• Screens entire fetal genome* and not just trisomies in chromosomes 21, 18, and 13

2. Test Performance

• Sensitivity and specificity of >99.9% for Trisomy 21, 18, 13
• >99% call rate

3. Low Test Failure Rates

NIPT test failure or no call rates vary significantly based on the test methodology used. Tests that use a targeted approach have demonstrated higher rates of test failure than WGS-based tests, in both validation and clinical experience studies. WGS assays provide ample data across the entire diploid genome. This coverage produces an analytical reference that current analytical techniques can use to reduce assay- and sample-specific biases. These normalization steps lead to high sensitivity when working with low fetal fraction samples, which means correct aneuploidy calls can be made in the range of fetal fractions that typically requires QC rejection when using targeted approaches^1.

4. Low Test Failure Rates

• The Claria NIPT offers a fast three-step automated workflow for NIPT
• The turn around time is less than or equal to 7 working days

5. Extensive Validation on Indian Samples

Claria NIPT is validated using 303 clinical samples from Indian population which included both known high risk samples and samples tested with cross platform. The validation successfully identified 51 high risk cases and the low risk cases.

6. Accuracy of Claria NIPT detecting Rare Autosomal Aneuploidies