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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.

Ongoing advances in molecular diagnostics and gene-sequencing technology are poised to fundamentally change the way a variety of diseases and disorders are diagnosed and managed, and one of the first clinical areas likely to feel the full impact of these changes could be the prenatal testing arena. (Also see Also see "In Vitro Diagnostics: The Quest for Growth" - Medtech Insight, 1 October, 2010. and Also see "Utility Before Profitability: The Evolving Evidence Paradigm For Molecular Diagnostics" - In Vivo, 12 September, 2012..)

In the late 1990s, researchers first discovered that fragments of cell-free DNA (cfDNA) from a developing fetus could be found in the mother’s blood early in pregnancy. This set off...

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