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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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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
At present, the FDA lists over forty emergency-use approved at-home COVID tests on its website from over thirty different brands. Some tests are rapid at-home antigen tests that give results in as ...
KN95 masks that are approved with the FDA’s emergency-use authorization are actually hard to find these days. So stick with best practices and secure some Powecom KN95 masks for higher-risk ...