Sequenom (San Diego) has once again expanded its noninvasive prenatal diagnostics portfolio. The company has acquired exclusive rights in the U.S., Europe, Australia, Canada and Japan as well as non-exclusive rights in China, to noninvasive prenatal diagnostic intellectual property from The Chinese University of Hong Kong.

The licensed intellectual property adds to Sequenom's portfolio of patents related to noninvasive prenatal genetic analysis methods using fetal nucleic acids obtained from maternal serum or plasma, the company said. The newly acquired rights include methods of fetal nucleic acid analysis using methylation marker and gene expression analysis on a maternal blood, serum, or plasma sample. Sequenom also obtained exclusive rights to a portfolio of methylation and nucleic acid markers. Financial terms were not disclosed.

Harry Stylli, PhD, Sequenom's president/CEO, told Medical Device Daily that the acquired rights are an important addition to the company's fetal nucleic acid technology.

"We continue to build our noninvasive prenatal diagnostic intellectual property portfolio on a platform-independent basis, and these licensed rights provide us with expanded opportunities," Stylli said. He said they are important "because they provide us with an opportunity to expand our technology offering beyond genetic analysis of fetal DNA to include epigenetic and expression analysis. In view of our pre-existing intellectual property, these additional methods of analysis may provide alternative or complementary paths to a sensitive and specific noninvasive prenatal aneuploidy solution, and more generally, may potentially reduce or avoid the technical hurdles for developing assays for a broad range of noninvasive prenatal tests."

Dennis Lo and others at The Chinese University of Hong Kong invented the technology, Sequenom said. Lo is a "world-renowned researcher" in the field of noninvasive prenatal genetic analysis, the company said.

Stylli said the technology "enables patients to be tested in their first trimester noninvasively with minimal or no risk to the mother and fetus." As a result, it could be useful in the early detection of Down syndrome, he said.

Stylli said that many women who need to undergo screening for genetic abnormalties avoid it because they perceive a level of risk associated with the testing. With this technology, doctors could diagnose fetal health by doing a simple blood test on the mother which "leads to a change in maternal and fetal health and I think that's ultimately the goal here," he said. "If you're able to diagnose diseases that affect the fetus . . . ultimately it could change clinical practice and open up therapies for these diseases."

Emphasizing the importance of this type of testing, Stylli noted that the American College of Obstetricians and Gynecologists (ACOG; Washington) in January mandated that all pregnant women, regardless of age, should be offered screening for Down syndrome. Previously, women were "automatically" offered genetic counseling and diagnostic testing only if they were 35 years of age or older (Medical Device Daily, Feb. 6, 2007).

These newly acquired intellectual property rights build upon the noninvasive prenatal diagnostic intellectual property rights that Sequenom previously licensed from Isis Innovation, the technology transfer company of the University of Oxford (Oxford, UK) (MDD, Oct. 26, 2006).

Sequenom says its MassArray system is a nucleic acid analysis platform that measures the amount of genetic target material and variations, to deliver specific data from complex biological samples and from genetic target material only available in trace amounts.

Stylli said Sequenom's first noninvasive prenatal test, the Rhesus D will be launched commercially in June as a "home brew" test in the U.S.