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These technologies generally can be grouped into three approaches: polymerase chain reaction (PCR), hybridization, and next-generation sequencing (NGS). [22] Currently, a lot of PCR and hybridization assays have been approved by FDA as in vitro diagnostics. [47] NGS assays, however, are still at an early stage in clinical diagnostics. [48]
Moreover, for pathogen sequencing the use of controls is of fundamental importance ensuring mNGS assay quality and stability over time; PhiX is used as sequencing control, then the other controls include the positive control, an additional internal control (e.g., spiked DNA or other known pathogen) and a negative control (usually water sample). [2]
In January 2014, the Food and Drug Administration approved Affymetrix's postnatal blood test, CytoScan Dx Assay, looking at whole-genome correlates of congenital abnormalities and other causes of childhood developmental delay. [15]
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Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or through biochemical analysis to measure specific protein output. [1]
And then the FDA approval for our Ion Torrent Oncomine Dx Target Test, that's another example of our customer partnerships. ... This is a next-generation sequencing-based assay to be used as a ...
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