A Medical Device Daily

Sequenom (San Diego) reported a collaboration with Qiagen, a wholly-owned subsidiary of Qiagen NV (Venlo, the Netherlands), to jointly develop a “gold standard” preanalytical solution for small-molecule (fetal) DNA enrichment for prenatal diagnostics.

Sequenom will retain exclusive distribution rights to the technology for enriching short nucleic acids developed under the collaboration.

The companies said the collaboration will combine Qiagen’s expertise in preanalytical sample preparation technologies in life sciences and molecular diagnostics with Sequenom’s capabilities in genetic analysis technology.

The goal of the collaboration is to develop what Sequenom termed “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 preanalytical solutions for research use with compatibility for potential future use in conjunction with in vitro diagnostics.

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. The companies call robust fetal DNA enrichment “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, Sequenom said it is required for quantitative genomic tests such as tests for Down syndrome, cystic fibrosis and other phenotypes, conditions or disease states.

“We are looking forward to contributing our expertise toward developing this important preanalytical technology for Sequenom’s prenatal diagnostics program,” said Peer Schatz, Qiagen CEO. “[Our] 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.”

Harry Stylli, PhD, president/CEO of Sequenom, said, “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.”

He said the company’s 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.”

Separately, Sequenom reported that through its South Korean distributor, Bioneer, the company sold three MassArray genetic analysis systems in the region during 1Q06, including a sale to the Republic of Korea’s National Cancer Center.

Bioneer was named as the exclusive distributor and promoter of Sequenom’s genetic analysis products for South Korea in September. Bioneer also operates a core facility that provides contract services for human, livestock and agricultural applications throughout South Korea using Sequenom’s MassArray system and consumable products.

Under its relationship with Sequenom, Bioneer offers MassArray-based product and service solutions for fine mapping genotyping, gene and biomarker discovery, validation, screening, DNA methylation marker pattern analysis (epigenetic studies) and quantitative gene expression analysis.

“These sales represent the increased demand we are seeing in South Korea for fine mapping genetic analysis solutions and for life sciences research tools in general,” said Dr. Han-Oh Park, president/CEO of Bioneer. “Sequenom’s products and our service offerings . . . are especially well suited for fine mapping genotyping, a market that is emerging in South Korea as researchers complete their whole genome studies.”

He added: “Sequenom’s products are similarly attractive for DNA methylation pattern and gene expression analysis projects being conducted by prominent cancer research centers.”

Qiagen, U.S. firm in co-marketing plan

In other Qiagen news, the company and Pathway Diagnostics (Malibu, California), a firm developing biomarker and testing services for the pharma industry, reported entering into a co-marketing partnership that allows customers in the biotech and pharma industries to use Qiagen’s sample and assay technologies in combination with Pathway Diagnostics’ clinical development and testing service capabilities.

The Dutch company’s global pharmaceutical sales channel and resource network will develop opportunities addressed together with the service capabilities of Pathway Diagnostics.

The companies said the global pharma industry is accelerating its focus on the co-development and co-validation of biomarker assays intended to improve drug development via patient selection and clinical trial outcomes, accelerating time-to-market cycles for new drugs and reducing clinical trial costs.

Biomarker development also may lead to companion diagnostic products used as a prerequisite for therapeutic intervention.

“This partnership with Pathway Diagnostics . . . offers a novel and unique value proposition for our customers,” said Peer Schatz, CEO of Qiagen. “[We] share the vision that biomarker development and testing is at the forefront of accelerating drug development and providing clinical diagnostic value, leading to improved patient care and associated therapeutic intervention.”