SAN DIEGO, March 27 /PRNewswire-FirstCall/ -- Sequenom, Inc. announced today that two proof-of-concept molecular diagnostic studies using Sequenom's MassARRAY system have concluded successfully.
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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. (Valencia, California), and bioscientia Institut fur Medizinische Diagnostik GmbH (Ingelheim, Germany), 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, both leading CLIA-certified reference laboratories, tested approximately 1,500 DNA samples for Factor V Leiden and Specialty tested more than 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."
About Siemens Medical Solutions
Siemens Medical Solutions of Siemens AG , with headquarters in Malvern, PA and Erlangen, Germany, is one of the largest suppliers to the healthcare industry in the world. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting and support services to help customers achieve tangible, sustainable clinical and financial outcomes.
About Specialty Laboratories
Specialty Laboratories, Inc. performs highly advanced clinical tests used by physicians to diagnose, monitor and treat disease. Offering an extensive menu of specialized testing options for more than ten major medical specialties, Specialty provides hospitals, laboratories and specialist physicians a single-source solution to their non-routine testing needs. Specialty's website address is http://www.specialtylabs.com.
About bioscientia
bioscientia Institut fur Medizinische Diagnostik GmbH, based in Ingelheim, Germany, is an international reference laboratory founded in 1970. Today, it is one of the largest purpose built reference laboratories in Europe with a staff in excess of 900 professional and technical personnel. With more than 25 years experience in the international market, bioscientia provides a pathology reference service to a wide range of institutions including universities, military, and Ministry of Health hospitals, clinics, laboratories and pharmaceutical companies worldwide. bioscientia's website address is http://www.bioscientia.com.
About Sequenom
Sequenom is committed to providing the best genetic analysis products that translate genomic science into superior solutions for non-invasive prenatal testing, biomedical research, molecular medicine and agricultural applications. The Company's proprietary MassARRAY system is a high-performance DNA analysis platform that efficiently and precisely measures the amount of genetic target material and variations therein. The system is able to deliver reliable and specific data from complex biological samples and from genetic target material that is only available in trace amounts. The Company has exclusively licensed intellectual property rights for the development and commercialization of non-invasive prenatal genetic tests for use with the MassARRAY system and other platforms.
Sequenom(R) and MassARRAY(R) are trademarks of Sequenom, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the potential benefits of the MassARRAY system, MassARRAY technology's potential as a single platform for a consolidation of many genetic tests, opportunities and the value potential for MassARRAY technology in molecular diagnostics, and the application of MassARRAY technology for the development and commercialization of non-invasive prenatal diagnostic tests, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks detailed from time to time in Sequenom's SEC filings, including Sequenom's Annual Report on Form 10-K for the year ended December 31, 2004, and its most recently filed quarterly report on Form 10-Q. These forward-looking statements are based on current information that is likely to change. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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