Sequenom, Inc. has secured exclusive rights to fundamental patent rights for digital PCR technologies and methods through a licensing agreement with Genomic Nanosystems, LLC, a wholly owned subsidiary of the Cytonix Corporation. The exclusively licensed rights include United States Patent Nos. 6,143,496 and 6,391,559 and pending applications.

The license provides Sequenom with the exclusive right to use digital PCR methods on any platform for non-invasive prenatal diagnostics and analysis for any sample (for example, fetal cells, amniocentesis fluids, plasma, urine, etc.). Sequenom also secured the exclusive right to use digital PCR methods in conjunction with mass spectrometry for any commercial, diagnostic or research purpose, excluding second generation sequencing. Financial terms were not disclosed.

"Sequenom's extensive intellectual property position in non-invasive prenatal diagnostic testing for the assessment of fetal Down syndrome and other fetal genetic conditions is enhanced by this partnership, enabling us to develop even more highly sensitive tests on our MassARRAY system, as well as other platforms of our choice in our fields of use," said Harry Stylli, Ph.D., president and chief executive officer of Sequenom. "We are particularly pleased to be chosen as an exclusive partner by Genomic Nanosystems. These exclusive rights, as well as the licensing agreement we announced last week, further strengthen the proprietary foundation upon which we will continue product development and commercialization in our SEQureDx diagnostics business. Furthermore, Sequenom intends to develop a MassARRAY platform-based digital PCR solution for our genomic analysis business and for cancer research and diagnostics."

Luke Ranasinghe, Ph.D., chief technical officer of Genomic Nanosystems, added, "Digital PCR and Genomic Nanosystems' portfolio of digital amplification methods provide for detection and quantification of rare and/or foreign genetic sequences. We are pleased to license these patents to Sequenom whose capabilities and innovation provide unprecedented opportunities for molecular genetic analysis in prenatal diagnostics, as well as cancer and infectious disease."

Conventional PCR methods have inherent inaccuracies, are unable to provide information about single molecules, and have limited dynamic range. Digital PCR, in contrast, comprises methods for amplifying and detecting individual nucleic acid molecules, leading to "needle in the haystack" detection capability with nearly unlimited dynamic range. Chromosomal counting is just one example of how digital PCR can be applied. Therefore, Digital PCR in combination with Sequenom's technology has the potential to enable the detection of prenatal genetic characteristics soon after conception, and early detection of cancer derived nucleic acids, in some cases months earlier than other diagnostic methods.