SAN DIEGO—Life-sciences company Sequenom, Inc. has announcedthis week that its wholly own subsidiary, the Sequenom Center for MolecularMedicine (Sequenom CMM), has completed several international distributionagreements. These agreements will serve to expand access to the MaterniT21 PLUStesting service outside of the United States. The agreements cover severalcontinents, including Asia, covering Japan and Hong Kong; Europe, covering theCzech Republic and Slovakia, as well as the Netherlands; and the Middle East,covering Israel.
"We believe the completion of these internationalagreements represents an important advance in access to and future adoption ofour 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 thesecountries and to continuing our efforts to further expand access for expectantparents around the world."
The distribution agreements also support total volumeincreases as well as goals for Sequenom for 2012. As of August 18, Sequenom CMMwas reported as having accessioned approximately 27,000 MaterniT2 PLUS testsamples since the beginning of 2012, and the company has boosted its 52-weekrun rate from 65,000 to 75,000 total samples. In addition, the company has alsocompleted the sales force expansion it announced previously, increasing itsnumber of field representatives to more than 70 across the United States.
In addition to the agreements, Sequenom CMM has completedseveral 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 trisomies21, 18 and 13. Additionally, the MaterniT21 PLUS test now includes increasedmultiplexing as well, with a new 12-plex process expected to more than doublesequencing capacity per instrument, as well the use of upgraded bioinformaticsand automated library preparation processes. All of the new features have beenvalidated in an equivalency study to ensure the test maintains a high level ofprecision. Sequenom CMM has also begun using new reagents, which are madeavailable as a result of Sequenom's agreement with Illumina, Inc., for a morestreamlined and efficient process.
Sequenom's MaterniT21 PLUS test is indicated for use inexpectant women who face an increased risk for fetal aneuploidy, and can beused as early as 10 weeks into the pregnancy. It is estimated that in theUnited States alone, approximately 750,000 pregnancies are at risk for thecondition each year. Aneuploidy is a chromosomal abnormality in which an extraor missing chromosome leads to a genetic disorder. MaterniT21 PLUS determinesfetal sex as well as detecting increased chromosomal material for trisomies 21,18 and 13, which are associated with Down syndrome, Edwards syndrome and Patausyndrome, respectively.
The agreements come on the heels of an announcement thatLifeCodexx, Sequenom's licensee in Europe, had gained CE Marking for theirtrisomy 21 test, the PraenaTest. The test has been made available as a testingservice at prenatal clinics and hospitals in Germany, Austria, Liechtensteinand Switzerland.
SOURCE: Sequenom press release