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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]
Illumina claimed that Oxford Nanopore infringed its patents on the use of a biological nanopore, Mycobacterium smegmatis porinA (MspA), for sequencing systems. [64] [65] In August 2016 the parties settled their lawsuit. [66] In February 2020, Illumina filed a patent infringement suit against BGI relating to its "CoolMPS" sequencing products. [67]
The proximity extension assay (PEA) is a method for detecting and quantifying the amount of many specific proteins present in a biological sample such as serum or plasma. [1] The method is used in the research field of proteomics , specifically affinity proteomics, [ 2 ] where in one searches for differences in the abundance of many specific ...
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Exact Sciences Corp. is an American molecular diagnostics company based in Madison, Wisconsin specializing in the detection of early stage cancers. The company's initial focus was on the early detection and prevention of colorectal cancer; in 2014 it launched Cologuard, the first stool DNA test for colorectal cancer.
The TaqMan assay can be multiplexed by combining the detection of up to seven SNPs in one reaction. However, since each SNP requires a distinct probe, the TaqMan assay is limited by the how close the SNPs can be situated. The scale of the assay can be drastically increased by performing many simultaneous reactions in microtitre plates.
The widespread use of whole genome bisulfite sequencing has been primarily limited by its excessive cost, complex data output, and minimal required coverage. Due to the high amount and subsequent cost of DNA input, many studies using whole genome bisulfite sequencing assays occur with few or no biological replicates. [15]