By Bio-IT World Staff
January 7, 2013 | Illumina announced today that it has signed a definitive agreement to acquire Verinata Health for consideration of $350 million plus up to $100 million in milestone payments through 2015. Upon completion of the acquisition, Illumina will have access to Verinata’s verifi prenatal test, the broadest non-invasive prenatal test (NIPT) available today for high-risk pregnancies, and to what Illumina says is the most comprehensive intellectual property portfolio in the non-invasive prenatal test industry.
Verinata Health started as a company dedicated to microfluidic technology based on intellectual property from MIT and Harvard, Diana Bianchi, Executive Director of the Mother Infant Research Institute at Tufts Medical Center and chair of Verinata’s clinical advisory board, told Bio-IT World in November (see, In Conversation: Tufts Geneticist Diana Bianchi on Noninvasive Prenatal Testing). “Verinata has the exclusive license to [Stanford professor] Steve Quake’s patents in this space, which specifically discuss the use of massively parallel sequencing to detect fetal trisomy,” Bianchi said.
Non-invasive prenatal testing is one of the most rapidly growing areas utilizing next-generation sequencing, and Illumina believes the company is uniquely positioned to be at the forefront of providing superior prenatal testing options.
“This agreement with Verinata demonstrates Illumina’s commitment to developing innovative diagnostic solutions and providing our partners with the most advanced technologies for improved patient care,” said Jay Flatley, President and CEO of Illumina in a press release. “Building on the recent acquisition of BlueGnome Ltd. (see, Illumina Acquires Cytogenetics Company BlueGnome) and our expertise in next-generation sequencing, this announcement further establishes Illumina as a leader in reproductive health.”
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 non-invasive 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.
Compared to other testing options, the verifi prenatal test provides more definitive information than risk score-based tests (traditional protein serum screens), which calculate probabilities, and does not carry the risk of complications that an invasive procedure, such as an amniocentesis, can have. The robust technology behind the verifi test leverages the power of massively parallel next-generation sequencing with a highly optimized algorithm to provide accurate aneuploidy detection, with the ability to look across the entire genome.
“Together, Illumina and Verinata are well-suited to drive the adoption of the non-invasive prenatal testing market. With approximately 500,000 high-risk pregnancies annually in the United States and an estimated four million pregnancies in total, there is a clear need for such tests,” said Dr. Jeffrey Bird, Executive Chairman and CEO of Verinata Health in a statement. “Given the recent American College of Obstetrics and Gynecology (ACOG) and Society of Maternal and Fetal Medicine (SMFM) joint opinion that recommended cell–free DNA prenatal testing as a first or second trimester option for women at increased risk of aneuploidy, we believe more physicians will be adopting NIPT.”
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.
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. The total domestic market is estimated to grow to 1.5 to 2 million tests performed annually within the next five years.