Sequenom Announces Publication of Study Manuscript on Noninvasive Detection of Fetal RHD Genotyping in Maternal Plasma
SAN DIEGO, June 7, 2011 /PRNewswire/ — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced the acceptance for publication of the manuscript titled, “Fetal RHD Genotype Detection from Circulating Cell-Free Fetal DNA in Maternal Plasma in Non-Sensitized RhD Negative Women.” The article is currently available online and will appear in the next issue of Prenatal Diagnosis.
The study, conducted by the company’s wholly-owned subsidiary, Sequenom Center for Molecular Medicine (Sequenom CMM), evaluated the performance of the SensiGeneÃ‚® Fetal RHD Genotyping Laboratory Developed Test (RHD Genotyping LDT) using circulating cell-free fetal DNA (ccff DNA) extracted from maternal blood plasma. Results showed that fetal RHD genotyping can be accurately determined using ccff DNA in the first and second trimester of pregnancy.
The study was performed using two cohorts, a first trimester serotype reference group of 207 cases obtained from the Fetal Medicine Foundation in London, England and a combined first and second trimester genotype reference group of 199 patients. The serotype cohort had a test accuracy of 97.1% (sensitivity of 97.2%; specificity of 96.8%) and the genotype reference cohort had a test accuracy rate of 99.5% (sensitivity of 100.0%; specificity of 98.3%).
“This study demonstrates that the SensiGene Fetal RHD Genotyping LDT using MALDI-TOF mass spectroscopy is effective in the detection of specific RHD gene exons in maternal blood plasma with a high degree of accuracy during the early stages of pregnancy,” said Dr. Allan T. Bombard, Chief Medical Officer of Sequenom, Inc. “It also demonstrates that the presence of fetal DNA can be determined in the instance of an RHD negative female fetus in a mother who is also RhD negative phenotypically.”
Other contributing principal investigators included Kypros Nicolaides, MD and Rnajit Akolekar, MD, both from the Fetal Medicine Foundation, London, United Kingdom.
SensiGeneÃ‚® Fetal RHD Genotyping is a laboratory developed, noninvasive prenatal blood test for the direct detection of fetal RHD genotype in RhD (-) mothers. Utilizing SEQureDx(TM) technology, DNA material is extracted from the blood of the mother, enabling direct genetic testing to assess fetal status in the first trimester. This test method is designed to detect circulating cell-free fetal (ccff) DNA from maternal blood and examine multiple regions of the gene that is known to be the most common genetic basis of RhD negative phenotypes.
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
Sequenom Center for Molecular Medicine
Sequenom Center for Molecular Medicine (Sequenom CMMÃ‚®) is a CAP accredited and CLIA-certified molecular diagnostics laboratory dedicated to the development and commercialization of laboratory-developed genetic tests for prenatal and ophthalmic conditions. Utilizing innovative proprietary technologies, Sequenom CMM provides test results that can be used as tools by clinicians in managing patient care. Testing services are available only upon request by physicians. Sequenom CMM scientists work closely with key opinion leaders and experts in obstetrics, retinal care and genetics. Our scientists use a variety of sophisticated and cutting-edge methodologies in the development and validation of tests. Sequenom CMM is helping to advance patient care with the power of molecular diagnostics. Visit www.SequenomCMM.com for more information on laboratory services.
Ã‚©2011 Sequenom Center for Molecular Medicine.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the expected publication of the manuscript in the next issue of Prenatal Diagnosis, the expected performance and impact of the RHD Genotyping LDT, and Sequenom’s commitment to improving healthcare through revolutionary genetic analysis solutions and dedication to development and commercialization of laboratory-developed genetic tests for prenatal and ophthalmic conditions, 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 and uncertainties associated with reliance upon the collaborative efforts of other parties, Sequenom’s ability to develop and commercialize new technologies and products, particularly new technologies such as prenatal and other diagnostics and laboratory developed tests, Sequenom’s ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory developed tests, obtaining or maintaining regulatory approvals, ongoing litigation and investigations and other risks detailed from time to time in Sequenom, Inc.’s most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and 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, Inc. undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
SOURCE Sequenom, Inc.