There are two broad categories of assays for HPV.
Such an approach has even greater relevance in all five categories of biomarker assays and especially in situations where QCs are usually less representative of clinical samples, such as in the case of relative quantitative techniques (Findlay, 2009).
There is a growing acknowledgement that these guidelines are not sufficiently flexible to accommodate the many different categories of PD assays that are employed during anticancer drug development of molecularly targeted agents (Lee et al, 2005).
As with all five categories of biomarker assays sample and reagent integrity should also be carefully assessed during method validation, including studies on sample stability during collection, storage and analysis (Nowatzke and Wood, 2007).
These capabilities are reviewed in this section, broadly dividing categories of imaging assays into functional/physiological properties, protein expression (with an emphasis on tumor receptors), the tumor microenvironment, and tumor gene expression.
The report consists of three categories: the type of assay used, the test results (positive/negative, pattern, and antibody level), and the advice for the clinician.
This category of biomarker assay lacks calibration against a certified standard, but reports numerical values as a characteristic of the sample.
Proving analytical and more importantly clinical specificity and sensitivity is the key to validation of this category of biomarker assay, but such a process can require access to resources which are not readily available, such as knock out mice, cell lines with overexpression of the target protein or clinical specimens.
A custom R script took two categories of inputs: a) assay lists provided by ToxCast (Judson et al. 2010; Kavlock et al. 2012; U.S. EPA 2013) with descriptive information about assays in ToxCast phase 1, ToxCast phase 2, and Tox21; and b) a file containing search keywords.
Table 2 lists the assay categories (major types of assays).
