Illumina Purchases Verinata and Acquires Prenatal Test for Chromosomal Abnormalities

Illumina, Inc. (San Diego, CA, USA) has signed an agreement to acquire Verinata Health, Inc. (Redwood City, CA, USA), provider of noninvasive tests for the early identification of fetal chromosomal abnormalities. As a result of the acquisition Illumina will have access to Verinata’s verifi broad noninvasive prenatal test (NIPT) for high-risk pregnancies, and to a comprehensive intellectual property portfolio in the noninvasive prenatal test industry. Illumina will pay USD 350 million for the acquisition plus up to USD 100 million in milestone payments through 2015.

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 or aneuploidies. The test detects Down syndrome (trisomy 21 or T21), Edwards syndrome (trisomy 18 or T18), and Patau syndrome (trisomy 13 or T13). It offers the option to include evaluation of sex chromosome aneuploidies, such as Turner syndrome (Monosomy X), Triple X (XXX), Klinefelter syndrome (XXY), and Jacobs's syndrome (XYY)–the most common fetal sex chromosome abnormalities.

The verifi test will continue to be offered through Verinata’s Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory, which will continue to act as a reference laboratory to gather some of the necessary clinical data for future regulatory submissions.

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.

Noninvasive prenatal testing is one of the most rapidly growing areas utilizing next-generation sequencing, and Illumina will be at the forefront of providing superior prenatal testing options. Dr. Jeffrey Bird, executive chairman and CEO of Verinata Health said, “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 NIPT market for high-risk pregnancies in the United States is estimated to be more than USD 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. Illumina expects to service a significant portion of that market.

Illumina develops, manufactures, and markets life science tools and integrated systems for large-scale analysis of genetic variation and function. The company provides sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein.

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