NEW YORK (GenomeWeb) – PerkinElmer said today that its Vanadis NIPT system has been CE-IVD-marked for marketing in Europe and other regions that recognize the CE designation.
The test, designed for noninvasive prenatal screening for trisomies 21, 18, and 13, with Y chromosome testing as an optional marker, has been validated in an external clinical study in France, which analyzed 80 samples from pregnancies affected by trisomy 21 and 670 samples from unaffected pregnancies. The Vanadis test correctly classified all cases, with one sample failing to generate a result, Waltham, Massachusetts-based PerkinElmer said. The firm has also conducted clinical studies to demonstrate high sensitivity and specificity for trisomies 18 and 13.
Vanadis uses targeted labeling and counting of specific cfDNA fragments in maternal plasma, offering a cost-effective, high-throughput, scalable platform to measure fetal chromosomal trisomies, PerkinElmer said, that eliminates the expensive and data-intensive steps necessary for next-generation sequencing- and microarray-based approaches used by other noninvasive prenatal tests. Â Vanadis
PerkinElmer and Women & Infants Hospital of Rhode Island are currently evaluating the Vanadis platform in a study, which aims to look at test samples from about 2,500 women to determine the performance of the test, including its detection rate and false-positive rate.
"NIPT has been previously limited by the complexity, cost, and capacity of existing commercially available technologies, which prevented many laboratories and obstetricians from offering reliable and cost-effective solutions for aneuploidy screening," Olle Ericsson, general manager at Vanadis Diagnostics, a PerkinElmer company, said in a statement. "With our Vanadis platform, we are taking the technical complexity out of NIPT while breaking down the cost barriers. This will enable more women to gain access to NIPT and improve the level of prenatal care on a global level."
Vanadis is currently not available in the US for clinical use.
According to Ross Muken of investment bank Evercore ISI, the CE-IVD mark for Vanadis will help "further transform [PerkinElmer's] diagnostic portfolio into more high-growth and complex testing markets and gives us more confidence in the management's ability to deliver on [high-single digit] growth targets in the medium term."
In the near-term, Vanadis could add about $5 million in sales in the fourth quarter and between $20 million to $25 million in 2019, Muken said, adding the trial with Women & Infants Hospital will be crucial for potential US Food and Drug Administration approval of the test, possibly in 2020 or later.