Sequenom, Inc. has announced that its wholly-owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has completed several international distribution agreements that will expand access to the MaterniT21 PLUS testing service outside the United States.
Agreements in Asia cover Japan and Hong Kong; in Europe cover the Czech Republic and Slovakia, and the Netherlands; and in the Middle East, cover Israel.
The announcement of these agreements follows recent news that Sequenom's current licensee in Europe, LifeCodexx, gained CE Marking for their trisomy 21 test, the PraenaTest®, using the Sequenom-licensed technology and has made it available as a testing service at prenatal clinics and hospitals in Germany, Austria, Liechtenstein and Switzerland.
"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," said Harry F. Hixson, Jr., Ph.D., Chairman and CEO, Sequenom, Inc.
Hixson continued, "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 further support total volume increases and goals for the company for 2012.
As of August 18, 2012, Sequenom CMM had accessioned nearly 27,000 MaterniT21 PLUS test samples since the beginning of the year, and the company increased its 52-week run rate from 65,000 to 70,000 total samples.
The company has also completed its previously announced sales force expansion, with more than 70 field representatives now active across the United States.
Sequenom CMM has also completed a number of steps designed to improve functionality and enhance capacity of the MaterniT21 PLUS test.
The test now includes a report on the presence of "Y" chromosomal material, which was validated in the same original clinical cohort as trisomies 21, 18 and13.
Other new features of the MaterniT21 PLUS test include increased multiplexing - the new 12-plex process should more than double sequencing capacity per instrument - and the use of upgraded bioinformatics and automated library preparation processes.
To ensure maintenance of the high precision of the MaterniT21 PLUS test, all modifications have been rigorously validated in an equivalency study.
In addition, Sequenom CMM now employs new reagents made available through Sequenom's agreement with Illumina, all contributing to a more streamlined, efficient testing process.
The MaterniT21 PLUS test is intended for use in pregnant women at increased risk for fetal aneuploidy and can be used as early as 10 weeks gestation.
Estimates suggest there are an estimated 750,000 pregnancies at risk for fetal aneuploidy each year in the United States.
The test detects an increased amount of chromosomal material for trisomies 21, 18 and 13, as well as fetal sex.
The MaterniT21 PLUS test is available exclusively through Sequenom CMM as a testing service to physicians.