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Noninvasive Prenatal Diagnostics: How Will They Revolutionize the Industry?

Decision Resources, Inc, Dec 2006, Pages: 34


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Prenatal diagnostics have been used since the 1960s to help determine the health of a fetus in its mother’s womb. A key use of prenatal diagnostics is found in the diagnosis of infectious disease, such as group B streptococcus. Timely diagnosis and treatment of the infection can prevent preterm delivery and lower overall health care costs. The trend in prenatal diagnostics is moving away from invasive procedures, which reveal genetic abnormalities but can harm the mother and the fetus, toward noninvasive procedures.

Questions Answered in This Spectrum Report
Current invasive prenatal diagnostics such as amniocentesis and chorionic villus sampling (CVS) can definitively detect chromosomal abnormalities, but these procedures are costly and risky. What noninvasive techniques are gradually taking the place of amniocentesis and CVS? A movement is under way within the medical community to shift more prenatal testing to the fi rst trimester for earlier diagnosis. What are the benefi ts of earlier testing?
In order for new prenatal diagnostic products to be competitive in the prenatal care market, they must have four attributes. What are they?

Clinical Laboratory Improvement Amendments (CLIA) laboratories are important to companies with noninvasive prenatal diagnostics in development. What key role do they play? Numerous companies are working on molecular techniques such as DNA microarrays, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), and mass spectrometry (MS) to evaluate maternal blood and urine samples. Which companies will have an impact on the market?

Scope
Invasive prenatal procedures: amniocentesis, CVS, percutaneous umbilical blood sampling
(PUBS).
Current noninvasive procedures: ultrasound and maternal serum testing.
Noninvasive procedures under development: cellular techniques, molecular techniques, novel biomarkers.
Key players in noninvasive prenatal diagnostics: companies developing products to prevent preterm labor and companies developing products to detect genetic abnormalities.



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