Sequenom, Inc. has announced the New York State approval of noninvasive prenatal test based on Sequenom's SEQureDx™ Technology for Cell Free Fetal Nucleic Acid assessment.
The Laboratory Developed Test (LDT) performed on a real-time PCR (RT-PCR) platform to detect Rhesus D (RhD) incompatibility will be marketed by Sequenom's nonexclusive licensee, CLIA-certified, New York State Permitted laboratory Lenetix Medical Screening Laboratory, Inc., Mineola, New York.
"This will be the first commercially introduced noninvasive prenatal test in the United States to utilize the SEQureDx™ Technology and represents a significant step in our strategy to build a proprietary global portfolio of noninvasive prenatal products. RhD is our pioneering test and will serve in assisting in preparing us in developing and launching other tests such as FetalXY and Down syndrome," said Harry Stylli, Ph.D., Sequenom's President and Chief Executive Officer.
"Genetic-based noninvasive prenatal testing could complement and potentially present a paradigm shift from current invasive testing procedures such as amniocentesis. Tests based on our SEQureDx Technology can be performed from a simple maternal blood sample, which could allow obstetric and fetal maternal specialists to successfully intervene early in the pregnancy to improve outcomes," Stylli added.
The Company expects to introduce additional noninvasive prenatal tests, beginning in the first half of 2008 with a LDT application for FetalXY/Gender Screening, which may assist healthcare providers in the evaluation of high risk pregnancies with familial history of inherited disorders associated with the X chromosome.
In addition, the Company expects to migrate the RhD incompatibility and FetalXY/Gender Screening tests to the proprietary MassARRAY® system next year. The MassARRAY system offers unique multiplexing capabilities for complex genetic targets with outstanding sensitivity and precision, an important advantage for the development of additional noninvasive prenatal tests.
"Lenetix Medical Screening Laboratories is pleased to be the first commercial genetic testing company to offer the RhD/SRY to at-risk pregnant women in the United States," said Leonard H. Kellner, President and CSO of Lenetix.
"We have worked diligently over the last year with the regulatory and molecular experts in the New York State Department of Health to bring this innovative, high-quality, noninvasive prenatal assay to the United States. It will be clinically available to all Lenetix' customers effectively immediately," Kellner continued.