Molecular Diagnostics Ushers In New Era Of Prenatal Testing
The recent launch of several noninvasive gene-based tests for Down syndrome and other fetal chromosomal abnormalities is poised to upend current prenatal screening practices and potentially usher in a new, multibillion-dollar market opportunity in the process. These new tests employ next-generation gene sequencing, along with advanced, risk-based computer algorithms, to detect and characterize fetal genetic abnormalities using the DNA present in a maternal blood sample. And because they are actually able to “interrogate” the DNA, they represent a huge technological advance over the current standard-of-care for prenatal screening.
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Four companies have brought noninvasive prenatal testing to the market within the past two years. Its dramatic, rapid uptake has triggered a backlash among many geneticists, who fear the consequences of a poorly understood – and overhyped – technology.
The prospective medical device tax, the continuing decline of venture investing, pricing challenges, austerity measures in Europe, and other headwinds continued to push against the medtech industry in 2012. But emerging clinical and geographic markets, along with an active M&A market, are providing the industry with some momentum going into 2013.
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”