Wednesday, February 7, 2024

Proteomic Testing Act Passed! What it means!


The biggest news for proteomics for 2024 isn't some silly expensive new instrument. It isn't dueling labs trying to see who can throw the most money at a single cell. It is absolutely, without a doubt, this little tiny bit of legislation last week. More details here

For a decent analysis of what this could mean you can check out this paper from last year.  (It should be open access). 

The short story is that one of the biggest hurdles in getting proteomic diagnostics out there in the world helping people has been kicked right over. There is a billing mechanism so that labs performing these tests can get paid for said tests. 

If you're someone who filled out the recent Twitter survey on what "clinical proteomics" means last year and you selected "analyzed the proteomes of human samples" stop reading right here and go back to what you're doing. This news is not for you. This news is for the minority of people who got the answer correct. Despite the.....things.....that often manage to get published in the "journal" called "Clinical Proteomics", running HeLa dilutions is not what this is about.  

Clinical proteomics is the application of protein measurement technologies to inform a clinician of information to aid in patient diagnosis. Any sort of clinical assay needs to be rock solid. From a thorough (and special) validation of the instrument that you've purchased (if not a special approval from the design of the device to qualify it for medical testing) through the strict monitoring of where that sample is in your lab - at all times - and what has been done to it, it's serious stuff. Even your scales and pipettors have to be manufactured in a compliant environment with calibrations checked and monitored routinely. Randomly people will show up by surprise and try to find you slouching. Failed that 4pm QC? Cancel plans. You're recalibrating and then you are randomly pulling samples you ran between the last QC that passed. You slipped 2 standard deviations in more than 10% of the random samples? You're re-running every. single. one.  of them. That's what it's like in clinical chemistry. For real.

Whew. With that out of the way....


This is so huge for anyone with aspirations of really really doing clinical proteomics. This is the gateway to getting the attention of company's to take those biomarkers you found for early detection of disease A and condition B actually out there in the wild where they will really and truly do things. 

Self-serving entry time ---> if you've got biomarkers and you need help getting that panel out there in the world, I'm willing to talk. If you're an investor hoping to capitalize on this new market, I just got my DUNS. Clearly this blog is what everyone here knows me for, but I started doing clinical chemisty 21 years ago. What a lot of business people know me for is as the sole inventor of the very first (and still possibly only) high resolution LCMS assay to operate under ISO and US DOH regulatory compliance guidelines. No joke, I took a brand new quadrupole Orbitrap and made it a fully compliant testing device. Pain. In. The. Butt. But it would be easier to do it a second, third, or twelfth time. 

Either way, it's time to stop screwing around and help people! 

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