Sequenom has signed a supply agreement with Illumina related to its noninvasive sequencing-based trisomy 21 test and will collaborate with the instrument vendor to submit an in vitro diagnostic test for approval.
Under the three-year supply agreement for Illumina's HiSeq 2000 platform, Sequenom and its subsidiaries will purchase sequencing equipment and consumables for use in the development of the Down syndrome test, which detects an overabundance of chromosome 21 in pregnant women.
"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," said Sequenom CEO Harry Hixson in a statement.
Sequenom and Illumina will also jointly work toward submitting an in vitro diagnostic product for the detection of fetal chromosomal abnormalities for regulatory approval.
Last month, Sequenom said that it had begun the process of obtaining pre-market approval for an IVD version of the T21 test from the US Food and Drug Administration (CSN 6/15/2011). The company plans to launch it as a laboratory-developed test by the end of this year or early next year.
Hixson said at the time that he was hoping for a supply agreement with Illumina in order to bring the consumables costs of the test to less than $200 per sample.