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Sequenom completes distribution agreements
SAN DIEGO—Life-sciences company Sequenom, Inc. has announced this week that its wholly own subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has completed several international distribution agreements. These agreements will serve to expand access to the MaterniT21 PLUS testing service outside of the United States. The agreements cover several continents, including Asia, covering Japan and Hong Kong; Europe, covering the Czech Republic and Slovakia, as well as the Netherlands; and the Middle East, covering Israel.
"We believe the completion of these international agreements represents an important advance in access to and future adoption of our technology in the international prenatal care market," Harry F. Hixson, Jr., Ph.D., chairman and CEO of Sequenom, said in a press release. "We look forward to working closely with each of our partners in these countries and to continuing our efforts to further expand access for expectant parents around the world."
The distribution agreements also support total volume increases as well as goals for Sequenom for 2012. As of August 18, Sequenom CMM was reported as having accessioned approximately 27,000 MaterniT2 PLUS test samples since the beginning of 2012, and the company has boosted its 52-week run rate from 65,000 to 75,000 total samples. In addition, the company has also completed the sales force expansion it announced previously, increasing its number of field representatives to more than 70 across the United States.
In addition to the agreements, Sequenom CMM has completed several steps intended to improve the functionality and capacity of the test, such as the inclusion of a report on the presence of Y chromosome material, which was validated in the same original clinical cohort along with trisomies 21, 18 and 13. Additionally, the MaterniT21 PLUS test now includes increased multiplexing as well, with a new 12-plex process expected to more than double sequencing capacity per instrument, as well the use of upgraded bioinformatics and automated library preparation processes. All of the new features have been validated in an equivalency study to ensure the test maintains a high level of precision. Sequenom CMM has also begun using new reagents, which are made available as a result of Sequenom's agreement with Illumina, Inc., for a more streamlined and efficient process.
Sequenom's MaterniT21 PLUS test is indicated for use in expectant women who face an increased risk for fetal aneuploidy, and can be used as early as 10 weeks into the pregnancy. It is estimated that in the United States alone, approximately 750,000 pregnancies are at risk for the condition each year. Aneuploidy is a chromosomal abnormality in which an extra or missing chromosome leads to a genetic disorder. MaterniT21 PLUS determines fetal sex as well as detecting increased chromosomal material for trisomies 21, 18 and 13, which are associated with Down syndrome, Edwards syndrome and Patau syndrome, respectively.
The agreements come on the heels of an announcement that LifeCodexx, Sequenom's licensee in Europe, had gained CE Marking for their trisomy 21 test, the PraenaTest. The test has been made available as a testing service at prenatal clinics and hospitals in Germany, Austria, Liechtenstein and Switzerland.
SOURCE: Sequenom press release