California Technology Assessment Forum Recommends Use Of Cell-Free DNA Technology As Advanced Prenatal Testing For Pregnant Women At High Risk For Fetal Chromosomal Anomalies
SAN DIEGO, Oct. 18, 2012 /PRNewswire/ — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced that the California Technology Assessment Forum completed an independent evaluation of the cell-free fetal DNA technology used in the Sequenom Center for Molecular Medicine’s (Sequenom CMM) MaterniT21 PLUS(TM) laboratory-developed test (LDT). CTAF recommended that the use of cell-free fetal DNA as a prenatal advanced screening test for fetal aneuploidy for Trisomy 21 and Trisomy 18 in high risk women meets all five CTAF criteria for safety and efficacy and improvement in health outcomes.
Blue Shield of California Foundation (BSCF) spearheads the California Technology Assessment Forum (CTAF), which was established to assess new and emerging medical technology. CTAF is one of the preeminent independent medical technology assessment organizations in the country. A multidisciplinary group of medical providers, researchers, ethicists, and consumer advocates work to discuss and formulate positions on the safety and effectiveness of new and emerging technologies. Approximately 15 new technologies are reviewed each year, including devices, procedures and diagnostics.
CTAF uses the following criteria in its assessment process: 1) the technology must have final approval from the appropriate government regulatory bodies; 2) the scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes; 3) the technology must improve net health outcomes; 4) the technology must be as beneficial as any established alternative(s); and 5) the improvement must be attainable outside the investigational setting.
“We are very pleased with the recommendation from CTAF. As one of the leading independent organizations in the biomedical field, CTAF recommendations support the broadened acceptance of novel technologies into clinical practice. We see it as further assurance for physicians and patients of the safety and efficacy of this non-invasive approach to detect fetal aneuploidies in appropriate high risk groups,” said Bill Welch, Senior Vice President, Diagnostics at Sequenom.
The following CTAF recommendations were unanimously approved at the October 17 review meeting:
- It is recommended that the use of cell-free fetal DNA as a prenatal advanced screening test for fetal aneuploidy for Trisomy 21 and Trisomy 18 in high risk women meets all five CTAF criteria for safety and efficacy and improvement in health outcomes.
- It is recommended that the use of cell-free fetal DNA as a prenatal advanced screening test for fetal aneuploidy for Trisomy 13 in high risk women does not meet CTAF criteria 4-5 for safety and efficacy and improvement in health outcomes.
- It is recommended that the use of cell-free fetal DNA as a prenatal primary screening test for fetal aneuploidy for Trisomy 21, Trisomy 18, and Trisomy 13 in average and high risk women does not meet CTAF criteria 3 through 5 for safety and efficacy and improvement in health outcomes.
The MaterniT21 PLUS test is intended for use in pregnant women at high risk for fetal aneuploidy and can be used as early as 10 weeks gestation. Estimates suggest there are about 750,000 pregnancies at high risk for fetal aneuploidy each year in the United States. The test detects an increased amount of chromosomal material for trisomies 21, 18 and 13, as well as fetal gender. The MaterniT21 PLUS test is available exclusively through the Sequenom Center for Molecular Medicine (Sequenom CMM) as a testing service provided to physicians. To learn more about the test, please visit www.Sequenomcmm.com.
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 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 CMM, LLC
Sequenom Center for Molecular Medicine® (Sequenom CMM), a CAP accredited and CLIA-certified molecular diagnostics laboratory, is developing a broad range of laboratory developed tests with a focus on prenatal and ophthalmic diseases and conditions. These laboratory-developed tests provide beneficial patient management options for obstetricians, geneticists and maternal fetal medicine specialists, and retinal specialists. Sequenom CMM is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding expectations, or the effect or impact of the CTAF recommendations, the Company’s commitment to improving healthcare through revolutionary genetic analysis solutions, and Sequenom CMM changing the landscape in genetic disorder diagnostics, 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 market demand for and acceptance and use of technology and tests such as the MaterniT21 PLUS test, reliance upon the collaborative efforts of other parties including without limitation any international distributors or licensees, the Company or third parties obtaining or maintaining regulatory approvals that impact the Company’s business, government regulation particularly with respect to diagnostic products and laboratory developed tests, publication processes, the performance of designed product enhancements, the Company’s ability to develop and commercialize technologies and products, particularly new technologies such as noninvasive prenatal diagnostics, laboratory developed tests, and genetic analysis platforms, the Company’s financial position, the Company’s ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, litigation involving the Company, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission, including without limitation its Current Report on Form 8-K filed on September 10, 2012, Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 and its Annual Report on Form 10-K for the year ended December 31, 2011. 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 the Company 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.