8 ms·

I think you're missing the point - at least how I'm reading it - the idea is the user friendliness, not that the techniques themselves are novel. You're absolu

by nmjohn 12y ago

I think you're missing the point - at least how I'm reading it - the idea is the user friendliness, not that the techniques themselves are novel. You're absolutely correct that PCR and DNA/RNA amplification tech is nothing new and is (relatively) very simple - to the point where I did it in high school biology (AP) 6 years ago and then a number of times in undergrad labs. However I am not aware of anything that makes it this easy for a nurse/doctor to do in the hospital - as they put it "without the need of a specialized technician or expensive lab machinery." There isn't enough information provided to know how useful it will be though. I can see some potentially interesting use cases where a nurse being able to take a blood sample and run a plate with results in an hour could save a lot of time and money. At the same time, it really comes down to the "patented biochemistry" and what specific markers are on the plates. > On top of that, doesn't anyone else think this is a bad idea to try to test everyone for low incidence diseases? miRNA and sRNAs are OK markers for disease, not great and certainly not definitive. You're guaranteeing that most of your positives are false positives. That is highly dependant on the disease in question, no?

icegreentea 12y ago
Given their careful choice of wording, its likely that intermediary processing between getting the blood sample and running the test is needed. In fact, simply be requiring the pipetting, they are already saying that they do no intend doctors or nurses to use this device - this is purely meant to be used in a laboratory context (note: there are lots of hospital labs). This device as it is is clearly meant 'For Research Use' only. The benefit of this device for their use will be relatively narrow. In a patient setting, the benefits of fast, on demand testing is obvious (for certain tests). In a research environment, where they will likely already have bulk PCR processes ready, the benefit is less clear. I work at a company that works in this field - we target DNA instead, and only look at one gene. We have FDA approval for high complexity lab use (https://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx https://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx). From my experience, getting this down to the doctor/nurse level is ridiculously hard, and getting approval for 96 different tests will require a ridiculous amount of capital. My guess is that this is a first gen product designed to work as proof of concept and generate some cash flow so they can bootstrap and move down the complexity chain towards the patient. One thing to note is that 'specialized personnel' are actually pretty cheap given the recent surge in underemployed biochem graduates.
aroch 12y ago
I'm not missing the point. It's a company cashing in on Silicon Valley's recent health disruption bullshit. A well established miRNA testing protocol has been around for about 8 years now and there's an open database of markers. This testing isn't being used because it isn't "user friendly", it isn't being used because there are better methods or the information provided is useless. There are some 1800 'neoplasm associated' miRNAs (abnormal growths), being positive for many of them means next to nothing. Every person has hundreds and thousands of cells undergoing abnormal growth that doesn't mean they have bona fide cancer but they will, after non-specific PCR amplification, ping as "Has Cancer". They have a sample prep that likely involves several chemicals that no layperson should ever work with and no nurse/doctor has any business dealing with. At most they would what they already do, a blood draw and the hospital lab will do the rest.
- nmjohn 12y ago
  I'm curious where you're getting any of that information from the linked page - I very well may be missing something, but you are making a ton of assumptions [0] whereas I was giving them the benefit of the doubt until more information is known. Additionally, there are uses extending beyond cancer that are much more "binary" in nature which is where I see the value. [0]: * They have a sample prep that likely involves several chemicals that no layperson should ever work with * what they already do, a blood draw and the hospital lab will do the rest.
  - aroch 12y ago
    It's step 1 of their "3 easy steps"[0].... If you read their Wired profile[1], it's clear there's sample prep involved. I do RNA work quite frequently, (high quality) RNA preparation is finicky and involves reagents you can't buy as a normal person and equipment that may not be "specialized" but isn't in your standard Gen practitioners office and definitely in effectively 0 homes. High throughput RNA extraction -- which is what their Mastermix is -- yields OK-ish quality RNA but works fairly well if you have well optimized RT-primers. There are several caveats to quick extractions though, the two big ones for this product are it doesn't work well for human tissue or blood samples and they're either not doing very much testing (literally only 96 specific tests) or they're doing broad range testing and not using optimized primers because there's not a lot of RNA in any given sample. My guess is a combination of the two, there's a reason why the real microarrays we run for research are both expensive and time consuming. Doctors already "test" for things, and by that we mean the doctors have nurses do a blood draw and that blood draw is sent the the hospital lab. And the hospital lab does the testing. Even with this device, it's still the hospital lab that's going to do the testing. Your lab results don't necessarily take a while to come back because they're hard or cumbersome or take a ton of time to do, they take a while because the lab is running more than just your samples and your doctor has more than one patient (and also might like to sleep at some point). Most labs (that don't need something like culturing) can easily come back in less than 24hours and assuming you were the only one could come back in just a few hours. I see no reason to give them the benefit of the doubt, they've shown nothing to merit it. Mass producing what appears to be a hotplate with a non-tunable $5 laser inside a sleek, shiny baby blue case and making a companion iPhone app is gimicky. There aren't that many diseases that present as binary and those that do have existing, proven tests. [0]: "1. Extract the total RNA from the patient's blood sample and pipette it in a standard 96 well plate " [1] http://www.wired.com/2014/10/miroculus/ http://www.wired.com/2014/10/miroculus/ "You can prepare the blood sample, for instance, using a standard off-the-shelf RNA extraction kit, as well as a Miroculus 'master mix'"

by nmjohn 12y ago

icegreentea 12y ago

Given their careful choice of wording, its likely that intermediary processing between getting the blood sample and running the test is needed. In fact, simply be requiring the pipetting, they are already saying that they do no intend doctors or nurses to use this device - this is purely meant to be used in a laboratory context (note: there are lots of hospital labs). This device as it is is clearly meant 'For Research Use' only. The benefit of this device for their use will be relatively narrow. In a patient setting, the benefits of fast, on demand testing is obvious (for certain tests). In a research environment, where they will likely already have bulk PCR processes ready, the benefit is less clear. I work at a company that works in this field - we target DNA instead, and only look at one gene. We have FDA approval for high complexity lab use (https://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx https://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx). From my experience, getting this down to the doctor/nurse level is ridiculously hard, and getting approval for 96 different tests will require a ridiculous amount of capital. My guess is that this is a first gen product designed to work as proof of concept and generate some cash flow so they can bootstrap and move down the complexity chain towards the patient. One thing to note is that 'specialized personnel' are actually pretty cheap given the recent surge in underemployed biochem graduates.

aroch 12y ago

I'm not missing the point. It's a company cashing in on Silicon Valley's recent health disruption bullshit. A well established miRNA testing protocol has been around for about 8 years now and there's an open database of markers. This testing isn't being used because it isn't "user friendly", it isn't being used because there are better methods or the information provided is useless. There are some 1800 'neoplasm associated' miRNAs (abnormal growths), being positive for many of them means next to nothing. Every person has hundreds and thousands of cells undergoing abnormal growth that doesn't mean they have bona fide cancer but they will, after non-specific PCR amplification, ping as "Has Cancer". They have a sample prep that likely involves several chemicals that no layperson should ever work with and no nurse/doctor has any business dealing with. At most they would what they already do, a blood draw and the hospital lab will do the rest.

nmjohn 12y ago
I'm curious where you're getting any of that information from the linked page - I very well may be missing something, but you are making a ton of assumptions [0] whereas I was giving them the benefit of the doubt until more information is known. Additionally, there are uses extending beyond cancer that are much more "binary" in nature which is where I see the value. [0]: * They have a sample prep that likely involves several chemicals that no layperson should ever work with * what they already do, a blood draw and the hospital lab will do the rest.
- aroch 12y ago
  It's step 1 of their "3 easy steps"[0].... If you read their Wired profile[1], it's clear there's sample prep involved. I do RNA work quite frequently, (high quality) RNA preparation is finicky and involves reagents you can't buy as a normal person and equipment that may not be "specialized" but isn't in your standard Gen practitioners office and definitely in effectively 0 homes. High throughput RNA extraction -- which is what their Mastermix is -- yields OK-ish quality RNA but works fairly well if you have well optimized RT-primers. There are several caveats to quick extractions though, the two big ones for this product are it doesn't work well for human tissue or blood samples and they're either not doing very much testing (literally only 96 specific tests) or they're doing broad range testing and not using optimized primers because there's not a lot of RNA in any given sample. My guess is a combination of the two, there's a reason why the real microarrays we run for research are both expensive and time consuming. Doctors already "test" for things, and by that we mean the doctors have nurses do a blood draw and that blood draw is sent the the hospital lab. And the hospital lab does the testing. Even with this device, it's still the hospital lab that's going to do the testing. Your lab results don't necessarily take a while to come back because they're hard or cumbersome or take a ton of time to do, they take a while because the lab is running more than just your samples and your doctor has more than one patient (and also might like to sleep at some point). Most labs (that don't need something like culturing) can easily come back in less than 24hours and assuming you were the only one could come back in just a few hours. I see no reason to give them the benefit of the doubt, they've shown nothing to merit it. Mass producing what appears to be a hotplate with a non-tunable $5 laser inside a sleek, shiny baby blue case and making a companion iPhone app is gimicky. There aren't that many diseases that present as binary and those that do have existing, proven tests. [0]: "1. Extract the total RNA from the patient's blood sample and pipette it in a standard 96 well plate " [1] http://www.wired.com/2014/10/miroculus/ http://www.wired.com/2014/10/miroculus/ "You can prepare the blood sample, for instance, using a standard off-the-shelf RNA extraction kit, as well as a Miroculus 'master mix'"