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GEN News Highlights : Jul 11, 2011

Sequenom Purchases Illumina Sequencing Platform to Develop Trisomy 21 Test

HiSeq 2000 and consumables are covered by three-year supply arrangement as company moves toward PMA application.

Sequenom and its subsidiaries will purchase Illumina's HiSeq 2000 platform and consumables for use in developing a noninvasive prenatal test designed to detect an overabundance of chromosome 21 in pregnant women, a result associated with fetal Down syndrome.

Under their three-year supply agreement, Sequenom and Illumina said they will work collaboratively toward a submission for regulatory approval of an in vitro sequencing-based diagnostic product for detecting fetal chromosomal abnormalities.

"This agreement is an important step in bringing our proprietary trisomy test to market, giving us the scalability, speed to market, and supply chain necessary to address the commercial opportunity of our noninvasive prenatal test for trisomy 21," states Sequenom chairman and CEO Harry F. Hixson Jr., Ph.D.

Last month Dr. Hixson said at a healthcare conference that Sequenom plans to submit a PMA application to the FDA for its SensiGene® Trisomy 21 (T21) test by the end of 2012. Sequenom representatives began talks with the FDA in January about the preclinical and clinical studies it would need to gain premarket approval.

Also in June Sequenom said it secured a $30 million credit facility—a $20 million term loan plus a $10 million revolving line of credit—to support the development and commercialization of new laboratory developed tests (LDTs).

Sequenom announced in May that its molecular diagnostics reference laboratory, the wholly owned subsidiary Sequenom Center for Molecular Medicine, completed testing samples from the pivotal Sequenom-funded Women and Infants clinical validation study to evaluate the clinical performance of its LDT. Study results are expected to be announced later this year following their submission and publication in a yet-to-be determined peer-reviewed journal.