If you’re interested in offering noninvasive prenatal testing (NIPT) in your lab, we have 2 product offerings: an in-house solution and out-of-lab solution. For labs that want to bring a software solution in-house, the VeriSeq NIPT Analysis Software (16 Samples) is a EU CE marked in vitro diagnostic product and is now available in certain European Union countries. For those that want to offer NIPT as part of their product portfolio, but send the samples to the Illumina CLIA lab for processing, the verifi Prenatal Test is a great option.
Test requisition/signed consent form and blood sample are obtained.
Blood sample and test request form are sent back to lab.
Lab processes and analyzes the sample.
The lab reports test results.
The verifi Prenatal Test was developed by, and its performance characteristics were determined by Verinata Health, Inc. 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. It has not been cleared or approved by the U.S. Food and Drug Administration.