Sequenom, Inc. has announced that two proof-of-concept molecular diagnostic studies using Sequenom's MassARRAY system have concluded.
Performed at two separate, CLIA-certified laboratories, the studies yielded absolute equivalence of analytical results generated by the MassARRAY Compact system when compared with well established systems in current use.
The studies also demonstrated significant comparative advantages in the MassARRAY platform's throughput capabilities and overall performance.
The studies tested for cystic fibrosis (CFTR), and for Factor V Leiden, a marker associated with predisposition for deep vein thrombosis.
Conducted and evaluated by joint working group members Siemens Medical Solutions of Siemens AG, Specialty Laboratories, Inc., and bioscientia Institut fur Medizinische Diagnostik GmbH, these research studies are part of the molecular diagnostics benchmarking study that was initiated in late 2004 by Siemens and Sequenom for the purpose of evaluating the analytical data quality and workflow of the MassARRAY Compact system in a certified clinical laboratory environment.
Specialty Laboratories and bioscientia tested approximately 1,500 DNA samples for Factor V Leiden and Specialty tested 1,000 DNA samples for CFTR, in their research studies.
"The analytical results generated in our laboratory from CFTR and Factor V Leiden testing using Sequenom's MassARRAY system were 100% in agreement with the results we generated using a well-established competing technology," said James B. Peter, M.D., Ph.D., Chief Science Officer of Specialty.
"The MassARRAY system demonstrated clear benefits, including rapid assay design, high throughput, and platform flexibility. These benefits contribute to the overall cost-effectiveness of the platform."
"We performed Factor V Leiden testing in our laboratory on the MassARRAY system and compared the results to data that we generated using another well-established, but different technology than that used by Specialty," said Markus Nauck, CEO and Medical Director of bioscientia.
"We also achieved 100% concordance in our results and concluded that MassARRAY technology presents numerous benefits including the potential to be able to consolidate many of our genetic tests onto a single platform."
"It was critical to evaluate MassARRAY technology against gold standard technologies and rewarding to complete the analytical studies with such high quality results. The MassARRAY platform demonstrated the ability to run multiple genetic assays on the same platform with proven accuracy," said Mohammad Naraghi, M.D., Ph.D., Head of Business Development at Siemens Medical Solutions.
"As the number of diseases that incorporate genetic analysis into patient management increases, the opportunity for MassARRAY technology in development of molecular diagnostics becomes greater."
"Obviously, we are very pleased with the results and the findings of our joint working group, especially since our standard, commercially available research MassARRAY Compact system was used for the study," stated Harry Stylli, M.B.A., Ph.D., President and Chief Executive Officer of Sequenom.
"The conclusions of the benchmarking study confirm our belief that the MassARRAY platform has compelling potential value for molecular diagnostic applications."
"Furthermore, internally we have generated promising data that suggests our MassARRAY technology may offer unique technical advantages for the development and commercialization of non-invasive prenatal diagnostic tests."