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
Sequenom (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™ 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.
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