“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. “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.
According to Greg Heath, SVP and General Manager of Illumina’s Diagnostics business, “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.” He added, “We look forward to integrating Verinata into our organization and leveraging the combined knowledge and resources.”
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. Working with our partners in this space, Illumina expects to service a significant portion of that market. Including the impact of synergies, the transaction is expected to be approximately $0.20 dilutive to Illumina's non-GAAP earnings per share in 2013 before turning accretive beginning in 2014 and beyond. Fiscal year 2013 guidance, including the impact of this transaction, will be provided during the Company's fourth quarter and fiscal year 2012 earnings call. The transaction will be financed primarily with cash on hand and is expected to close after the satisfaction of customary regulatory approval.
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