Non-diagnostic designations (n = 17) were considered neither positive nor negative, and the results were excluded from the analysis.
Merck has received a "breakthrough" designation, designed to speed approval for using Keytruda with a PDL1 diagnostic made by Agilent – and Perlmutter says he does not think it could be revoked because of the Bristol results.
iRhythm and Preventice are going a step further offering interpretation of remote cardiac monitoring data via their data center configuration and individual diagnostic treatment facility (IDTF) designation.
When one reads Virginia Woolf's "Mrs. Dalloway, James Baldwinn's "Giovanni's Room," Jeanette Winterson's "Written on the Body," or even a work generically encoded as "lesbian," like Patricia Highsmith's "Price of Salt," as "gay" texts, this designation derives from diagnostic practices that readers bring to the texts rather than from the texts themselves.
This is followed by a lowercase letter designating the order of publication, and a numerical designation indicating the number of diagnostic sites that differentiate it from the subfamily consensus.
The presence of brain invasion is a feature considered to predict aggressive clinical behavior and recurrence, and is more recently used as a diagnostic criterion for WHO grade II designation [ 39].
Nevertheless, few studies have examined the prevalence of retinopathy across the spectrum of A1C levels, which could assist in the designation of ideal A1C diagnostic cut points (2, 3).
Pritchardia lanaiensis and P. elliptica were recently synonymized into P. glabrata [ 29], yet our results are inconsistent with this designation because of the diagnostic grouping of all P. glabrata sensu stricto individuals in PAA (Additional file 2).
Evaluation was limited to a simple designation of: acceptable or not acceptable (i.e. diagnostic, or non-diagnostic).
Finally, the schedule of drug development and diagnostic development can get confusing if the drug obtains a breakthrough therapy designation – a designation that allows pharma to submit an NDA on earlier stage data.
