NEW YORK (GenomeWeb News) — Sequenom today said that New York State health officials have approved a noninvasive prenatal test based on the firm’s SEQureDx technology for cell-free fetal nucleic-acid assessment.
The lab-developed test, performed on a real-time PCR platform, is designed to detect Rhesus D incompatibility. It will be marketed by Lenetix Medical Screening Laboratory, Sequenom’s CLIA-certified, nonexclusive licensee.
Sequenom’s SEQureDx technology determines the genetic status of the fetus by extracting fetal nucleic-acid material from a maternal blood specimen. The test for RhD incompatibility could avoid maternal alloimmunization and resulting hemolytic disease in the newborn, Sequenom said.
Alloimmunization most frequently occurs when an RhD-negative mother is exposed to red blood cells of an RhD-positive fetus, which produced maternal antibodies against the RhD antigen.
“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,” the company added.
In the US RhD incompatibility occurs in more than 10 percent of all pregnancies, according to Sequenom.
The approval, the first based on the SEQureDx technology, “represents a significant step in our strategy to build a proprietary global portfolio of noninvasive prenatal products,” Sequenom CEO Harry Stylli said in a statement. The test “will serve in assisting in preparing us in developing and launching other tests,” including screens for FetalXY and Down syndrome.
“Genetic-based noninvasive prenatal testing could complement and potentially present a paradigm shift from current invasive testing procedures such as amniocentesis,” said Stylli. “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.”
The Company expects to start introducing additional noninvasive prenatal tests in the first half of 2008.