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Verinata Enters Supply Deal with Illumina for Prenatal Dx

NEW YORK (GenomeWeb News) – Verinata Health today said that it has entered into a three-year supply deal with Illumina, under which it will purchase sequencing instruments and consumables for use in commercializing its prenatal diagnostics offerings.

Verinata is developing tests for detecting multiple aneuploidies. The San Carlos, Calif.-based firm said that in addition to the supply deal it will collaborate with Illumina on gaining regulatory approval for the testing service.

"With our proprietary technology and Illumina's sequencing prowess, it is our intention to advance and improve the testing methods of today for the determination of fetal aneuploidy," Verinata CEO Caren Mason said in a statement. "This supply agreement is designed to provide uninterrupted access to Illumina's HiSeq sequencing instrument and consumables including certain updates and improvements applied to current technology."

Verinata is currently conducting a prospective, blinded pivotal study to validate sensitivity and specificity of its first prenatal test. It expects to obtain results of the study before the end of this year. The firm has previously said that it expects to launch its test late this year or early next year.

Verinata is set to compete with Sequenom, which also is using the Illumina HiSeq as its instrument platform. Sequenom officials last week reiterated their timeline for launching a trisomy 21 test. The firm expects to launch a laboratory developed test through its Sequenom Center for Molecular Medicine either at the end of this year or during the first quarter of 2012. It also still plans on an FDA filing for the test in late 2012 or early 2013.

Ron Lindsay, Sequenom's executive vice president of research and development, recently told GenomeWeb Daily News sister publication Clinical Sequencing News that if Verinata launches a sequencing-based fetal trisomy test, it would infringe US Patent No. 6,258,540, "Non-invasive prenatal diagnosis," a broad patent that Sequenom licensed from Dennis Lo of the Chinese University of Hong Kong.

But Verinata also has licensed rights to non-invasive fetal genetic testing patents from Stanford University. Most recently, it licensed a patent recently issued to Stephen Quake of Stanford for the use of next-generation sequencing to diagnose fetal aneuploidies.

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