Agreement Establishes Patient Registry for Clinical Outcomes Data
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jul. 1, 2013-- Illumina, Inc. (NASDAQ: ILMN) today announced that Teva Pharmaceutical Industries Ltd. signed an exclusive agreement with Verinata Health, an Illumina company, for the commercialization of the verifi® non-invasive prenatal test1 in Israel. The MOR Institute for Medical Data Ltd., through its relationship with Teva, will provide the verifi® prenatal test to customers of Clalit Health Services who are at high risk of having a fetus with a chromosomal abnormality. The MOR Institute, which is a wholly-owned subsidiary of Clalit Health Services, will also establish a 9,000-patient clinical outcomes registry to collect performance data and will share the data with Verinata.
"We are extremely pleased to partner with Verinata in Israel, to bring pregnant women unprecedented access to what we believe is the superior non-invasive prenatal test to detect chromosomal abnormalities," said Ron Mayron, Chief Executive Officer of Teva Israel. "The verifi® prenatal test exemplifies our investment in the women's health segment and our commitment to offer clinically-validated, innovative new products to Israeli women to improve their health and quality of life."
Under the terms of the five-year agreement, Teva Pharmaceuticals will be the exclusive distributor of the verifi® prenatal test in Israel. All tests will be run in Verinata Health's CLIA-certified laboratory in California. Clalit Health Services will provide reimbursement for the verifi® prenatal test through supplemental insurance.
"We strongly believe that the verifi® prenatal test will have a lasting and positive impact on the Israeli community, and beginning July 1, MOR will provide a special nursing service, allowing pregnant women to have their sample collected for the test in the convenience of their homes, as well as in MOR clinics in the country," said Orit Jacobson, Ph.D., Chief Executive Officer of MOR Institute. "The patient registry developed through this collaboration will be the largest and most extensive of its kind, demonstrating our commitment to leadership in women's health."
"This collaboration brings together the top healthcare marketing and sales force in Israel with an established reimbursement infrastructure and long-term performance measurements. The unique collaboration emphasizes the value of the verifi® prenatal test," said Vance Vanier, M.D., Vice President of Global Commercial Operations for Verinata. "With the test now available in several international markets, we look forward to expanding our commercial presence by continuing to partner with leading organizations around the globe."
About Verinata Health
Verinata (www.verinata.com), a wholly-owned subsidiary of Illumina, Inc., is driven by a sole, extraordinary purpose - maternal and fetal health. Our initial focus is to develop and offer non-invasive tests for early identification of fetal chromosomal abnormalities using our proprietary technologies. We aim to reduce the anxiety associated with today's multi-step process, the unacceptable false-positive rates, the non-specific and sometimes confusing results of current prenatal screening methods, as well as the risk of current invasive procedures. We support national guidelines and the recent American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine Committee Opinion recommending cell-free DNA prenatal testing is one option that can be used as a primary or secondary screening test in women at increased risk of aneuploidy. We believe women who desire such testing should be offered a single blood draw test with a definitive result. The verifi® prenatal test is available through a physician.
About Illumina
Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative 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. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paying the way for molecular medicine and ultimately transforming healthcare.
Forward-Looking Statements
This release may contain forward looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.
1 The verifi® prenatal test is a non-invasive blood test that analyzes DNA found in a pregnant woman's blood to detect the most common fetal chromosome abnormalities, including Down syndrome (trisomy 21 or T21), Edwards syndrome (trisomy 18 or T18), Patau syndrome (trisomy 13 or T13) and sex chromosome abnormalities.
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