Tuesday, July 27, 2021

Get that assay to the clinic/regulated environment by moving it to a single quad!

I was watching a talk by Matthias Mann recently where he described his main focus right now as being clinical applications. Which is super cool for one of our field's top innovators to focus on boring practical work (where we desperately need new approaches!)  And with the work from this group that I've excitedly rambled about (example, example2) it's clear that the group isn't messing around. So far, these developments have utilized LC-high resolution accurate mass instruments (LC-HRAM) 

Last year I went through the process of ISO qualifying and getting Department of Health approval for an LC-HRAM assay. I'm excited to say that the assay I developed is still in use and has completed thousands of samples since the clearance about a year ago and is approved for continued use by both bodies for at least another year. There were 2 huge challenges with getting this assay through. 

1) Instrument cost! 

2) The extra steps necessary to qualify a Q Exactive for use in a regulatory environment. (I detailed a super important and expensive step here.)

If I had to develop another regulatory assay would I go the same route? Or would I try something with less of both challenges?  I'm not sure, I really like HRAM, but here is a really good argument! 

You can probably guess by some of the author names that this is small molecule focused, but it doesn't take much imagination to extend this to peptides and proteins.

This group investigates how good a single quad based assay can really be when you design the experiments and downstream analysis really well. The answer? In many cases almost as good as a triple quad! Now, this does assume that your single quad is designed to be good, rather than designed with silly limitations to make it clear that the vendor really wants you to buy the triple quad. 

In this case the authors puts a Waters TSQ up against an Agilent 6130 (which seems like a powerful little quad system). 

How does that effect the challenges that I mentioned above?

1) Cost? A COVID discount bundle on a stripped down Vanquish Q Exactive was still $275k. You can easily pick up a good LC-single quad for under $100k, even if your sales rep doesn't like you because maybe you talk too much. 

2) You can avoid LOTS of qualification steps because you can get a single quad that is an approved medical device. (Of course, I think every major vendor has triple quads that have been through CFAR and FD&C clearance as medical devices), but a good LC-QQQ is about the same price as an LC-HRAM. 

Here is an approved medical device single quad from Shimadzu that could speed your assay out of your lab and out into the world helping patients. 

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