Sequenom and Lenetix Collaborate on Prenatal Diagnostic

(San Diego, CA, USA) and Lenetix Medical Screening Laboratory, Inc. (Mineola, NY, USA) have entered into a collaboration and license agreement to develop and commercialize a proprietary non-invasive prenatal Rhesus D (RhD) incompatibility test based on Sequenom patent rights and real-time polymerase chain reaction (RT PCR) methodology. The RhD test, Sequenom's first non-invasive prenatal test, is expected to be marketed in the U.S. in the first half of 2007. Financial terms of the agreement were not disclosed.

The non-invasive characterization of fetal Rh genotype and other fetal genetic information has the potential to transform the practice of prenatal risk assessment, said Leonard Kellner, President of Lenetix. This new approach to non-invasive evaluation of a baby in utero is a very exciting scientific and commercial development, and may significantly reduce the need for invasive fetal diagnostic tests such as amniocentesis or chorionic villus sampling.

RhD blood group incompatibility between a pregnant woman and her fetus is a significant health problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of newborns. Although the pregnancy in which alloimmunization first occurs results in an unaffected child, future children are at substantial risk of anemia and, in the worst cases, fetal death. In the United States alone, RhD incompatibility occurs in more than 10% of all pregnancies, translating into more than 400,000 cases of RhD incompatibility annually.

This collaboration marks a significant milestone in our strategy to commercialize non-invasive prenatal diagnostic tests and we believe Lenetix's quality reputation and established position in prenatal testing will provide a solid foundation for our market entry, said Harry Stylli, Ph.D., president and CEO of Sequenom. We expect physician and patient adoption of the RhD test could pave the way for greater acceptance of our broader portfolio of non-invasive prenatal diagnostic tests in development.




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