Sequenom and Qiagen Target Prenatal Diagnostics

(San Diego, CA, USA) and Qiagen GmbH (Venlo, Netherlands), a wholly-owned subsidiary of Qiagen N.V., announced that they have entered into a strategic collaboration to jointly develop a gold-standard preanalytic solution for small molecule (fetal) DNA enrichment for prenatal diagnostics. Sequenom will retain exclusive distribution rights to the specific technology for enriching short nucleic acids developed under this collaboration.

The collaboration will combine Qiagen's expertise in preanalytic sample preparation technologies in life sciences and molecular diagnostics with Sequenom's capabilities in genetic analysis technology. The primary goal of the collaboration is to develop a robust and reliable set of reagents that optimize the enrichment of small nucleic acid fragments, such as circulating free fetal nucleic acids in maternal plasma or serum, as well as short nucleic acids in blood, plasma, or serum, for the analysis of cancer and other key disorders. The reagents are expected to provide complete and validated preanalytic solutions for research use with compatibility for potential future use in conjunction with in-vitro diagnostics (IVD).

Fetal DNA enrichment is the process of increasing the concentration of fetal DNA relative to maternal DNA from blood plasma or serum obtained from a simple blood draw from a pregnant woman. Robust fetal DNA enrichment is a key step for enabling certain non-invasive prenatal diagnostics. While robust enrichment of fetal DNA is not necessary for many non-invasive prenatal nucleic acid tests, such as tests for Rhesus D incompatibility, it is required for quantitative genomic tests such as tests for Down syndrome, cystic fibrosis, and other phenotypes, conditions, or disease states.

We are very much looking forward to contributing our expertise toward developing this important preanalytical technology for Sequenom's prenatal diagnostics program, said Peer Schatz, CEO at Qiagen. Qiagen's QIAamp product line is the clear standard for processing DNA from maternal plasma to analyze fetal Rhesus D. Through this collaboration with Sequenom we expect to tailor and expand existing capabilities of our DNA processing expertise to provide a solution to routinely address tests for conditions such as cystic fibrosis, Down syndrome, and Tay-Sachs, by non-invasive prenatal diagnostics.

Sequenom president and CEO Harry Stylli, Ph.D. commented, Non-invasive molecular diagnostics modalities will play an increasingly important role in supporting a new generation of diagnostic products for a range of critical disorders. Sequenom intends to develop a viable and robust platform initially for non-invasive prenatal diagnostics that can be leveraged to other applications based on the detection and characterization of small nucleic acids. Our MassArray technology's acutely high sensitivity and precision should be advantageous for enabling the development of the challenging tests that we are currently working on and plan to work on in the future. We are excited by the potential of this collaboration with Qiagen and look forward to jointly developing solutions as a critical step in our non-invasive prenatal diagnostic commercialization plans.



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