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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]
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]
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]
In the United States, the Food and Drug Administration (FDA) has determined that while such tests qualify as medical devices, these products could enter the market without prior approval from the agency. In 2014, the FDA announced that it would start regulating some LDTs. [3] [4] In general, however, it has not done so, as of April 2019. [5]
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.
HIVE Logo. The High-performance Integrated Virtual Environment (HIVE) is a distributed computing environment used for healthcare-IT and biological research, including analysis of Next Generation Sequencing (NGS) data, preclinical, clinical and post market data, adverse events, metagenomic data, etc. [1] Currently it is supported and continuously developed by US Food and Drug Administration ...
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