NEW YORK (GenomeWeb) – Noninvasive prenatal testing company NIPD Genetics of Cyprus has raised €5 million ($5.7 million) in a private financing round. The company recently expanded its Veracity test to cover sex chromosomal aneuploidies and has started offering it in additional countries, while its laboratory in Nicosia recently received accreditation from the College of American Pathologists.
The new funding comes from unnamed US investment firms and business angels, as well as an investment firm in Cyprus and UK investors, and will allow the company to expand its operations and sales, optimize testing processes, and develop additional tests.
NIPD Genetics, a 2010 spinout from the Cyprus Institute of Neurology and Genetics, has already expanded by moving into a new 13,000-square-foot facility and recently hired 10 sales and marketing experts, increasing its total headcount to about 40 employees. It currently has sufficient capacity to run several thousand samples per year, according to CEO Philippos Patsalis.
Last June, the company launched the Veracity test, its first clinical product, and has run several thousand tests so far in its laboratory. At the time, the assay — which employs a patented target-capture, deep-sequencing, and bioinformatics strategy and runs on lllumina sequencing platforms — was used to screen for fetal trisomies 21, 18, and 13 and determine fetal sex. A clinical validation study the company conducted prior to the launch that correctly identified all trisomy cases, with no false positive results, is scheduled for publication in a peer-reviewed journal later this month, Patsalis said.
In the meantime, the company has completed another validation study, for X and Y chromosome aneuploidy, which also identified all cases correctly and will be submitted for publication soon. Based on those results, NIPD Genetics just added X and Y chromosome aneuploidy testing to the Veracity test.
The company initially focused sales on several countries in Europe and the Middle East, but recently expanded these efforts following agreements with distributors in Greece, several Middle Eastern countries, Ukraine, Lithuania, India, and elsewhere, Patsalis said.
While he acknowledged considerable competition from other NIPT providers in some of these markets, he said the Veracity test provides a number of advantages, including very high accuracy, the ability to accurately measure and report fetal DNA fraction, and a "very competitive price."
As it expands Veracity sales, NIPD Genetics is developing additional noninvasive prenatal diagnostic tests to identify genetic disorders associated with small and large subchromosomal deletions and duplications. Validation studies for these are underway, Patsalis said, and the tests will be commercialized if they show sufficiently high accuracy that meet the company's standards.