Illumina Inc, San Diego, has signed a definitive agreement to acquire Verinata Health Inc, Redwood City, Calif, among the leading providers of noninvasive tests for the early identification of fetal chromosomal abnormalities.
The terms include a consideration of $350 million plus up to $100 million in milestone payments through 2015.
When the deal is complete, Illumina will have access to Verinata’s verifi® prenatal test, a broad noninvasive prenatal test (NIPT) for high-risk pregnancies, and to the company’s intellectual property portfolio.
Noninvasive prenatal testing is one of the most rapidly growing areas using next-generation sequencing, Illumina notes.
Available through a physician, the verifi test analyzes cell-free fetal DNA naturally found in a pregnant woman’s blood to look for missing or extra copies of chromosomes (referred to as aneuploidies). Specifically, the test detects Down syndrome (trisomy 21 or T21), Edwards syndrome (trisomy 18 or T18), and Patau syndrome (trisomy 13 or T13). It is the first noninvasive prenatal test that offers the option to include evaluation of sex chromosome aneuploidies, such as Turner syndrome (Monosomy X), Triple X (XXX), Klinefelter syndrome (XXY), and Jacobs syndrome (XYY) – the most common fetal sex chromosome abnormalities, according to the company.
The verifi test will continue to be offered through Verinata’s CLIA-certified and CAP-accredited laboratory, which will continue to act as a reference laboratory to gather some of the necessary clinical data for future regulatory submissions.
Illumina recent acqured BlueGnome Ltd, UK, a provider of genetic solutions for the screening of chromosomal abnormalities in cytogenetics and in vitro fertilization. “The synergies between Verinata’s and Illumina’s capabilities, combined with the expertise in reproductive health gained from the acquisition of BlueGnome, enable Illumina to provide a compelling portfolio of offerings across the spectrum of reproductive health,” says Greg Heath, senior vice president and general manager of Illumina’s Diagnostics business.
Based on ACOG and SMFM guidelines for high-risk pregnancies in the United States, the addressable NIPT market is estimated to be more than $600 million in 2013, according to the company. The total domestic market is estimated to grow to 1.5 to 2 million tests performed annually within the next 5 years.