Abbott's Ibis Biosciences today introduced a new molecular assay to detect a wide variety of vector-borne microorganisms, including those known to cause Lyme Disease, Rocky Mountain Spotted Fever, Babesiosis, Ehrlichiosis and Anaplasmosis.
The PLEX-ID™ Vector-borne test, which is intended for non-diagnostic use, has been designed to support bioresearch, environmental surveillance, and other activities central to the detection and identification of vector-borne pathogens.
Dr. Eshoo led a study in which vector-borne disease surveillance researchers in New York and Connecticut collected 299 blacklegged ticks. The ticks were analyzed using the Ibis technology for a wide range of vector-borne microorganisms. Results showed that two-thirds of the ticks were infected with B. burgdorferi, the agent of Lyme disease, and a third of these positive ticks contained other tick-borne co-infections such as Babesia microti or Anaplasma phagocytophilum. The research demonstrated that the Ibis technology can detect and identify B. burgdorferi as well as co-infection in ticks with other vector-borne pathogens quicker than traditional lab methods.
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Does anyone have a clue -- other than a possibly long and drawn-out FDA approval process -- why PLEX-ID could not be used for diagnostic purposes?
ReplyDeleteIt certainly sounds like a versatile test.
Quote:
PLEX-ID is designed to identify a broad range of bacteria, viruses, fungi, certain parasites, and also provide information about drug resistance, virulence, and strain type. Anticipated public health and biodefense applications include epidemiologic research and identification of emerging or previously unknown agents. In addition, the system is being used for forensic characterization of human samples.
(end quote)
Rita,
ReplyDeleteCheck out the link for the product (and not just Abbott's link):
http://global.plex-id.com/static/gateway.html
Let me know if you select 'Canada' if you are also given multiple dialog boxes asking if you understand that PLEX-ID is a non-diagnostic test...
Rita,
ReplyDeleteThe FDA is part of the story, and recently they have been trying to rewrite and clarify their requirements for designating certain tests diagnostic versus those for research only.
As far as I know, nucleotide/molecular assays for research purposes only are used on a collection of large samples and not for individual testing on a per patient basis, but I have yet to review whether or not this is the case with PLEX-ID.
CO,
ReplyDeleteThere is just one statement (at the bottom of the video) that indicates "Not for Use in Diagnostic Procedures". I didn't see multiple dialog boxes, but then again it was difficult to see anything. There was something about redesigning the website that I could barely make out, so I may try again.
Okay, so there may be multiple reasons for PLEX-ID not being used for diagnostic purposes. It could still prove to be a very useful test.