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Do you have published research demonstrating that the sample collection process (and the 80uL specifically) is sufficiently precise to detect and quantify these

Do you have published research demonstrating that the sample collection process (and the 80uL specifically) is sufficiently precise to detect and quantify these metabolites into clinically meaningful ranges? This was the core problem with Theranos IIRC. I've quickly reviewed your sources below and they seem to be related to the clinical value of metabolites, I haven't seen one describing precision of the device itself. I see you mention Theranos, but to be honest, this won't be the last time you get asked these questions. Every partner, news interview, and many potential customers will bring it up. So much so, that I would create a page specifically addressing these issues (in more detail than the FAQ).

danielgomari 4y ago
Yes, mass-spectrometry-based metabolomics can be performed on as little as 20ul in certain cases, and 80ul is certainly enough. Below are a few studies from other authors and platforms, and there are many more out there. https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-022-02852-4#Sec2 https://arthritis-research.biomedcentral.com/articles/10.118... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340475/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340475/ Specifications by an academic metabolomics facilty: https://www.embl.org/groups/metabolomics/faq/ https://www.embl.org/groups/metabolomics/faq/ Regarding your Theranos comment: You are absolutely right. This is something we will have to deal with, and where are actively working on our messaging.
- samstave 4y ago
  Does one do a benchmark by running the same tests, at different volumes with the same blood across multiple testing machines/methods, and then compare the results for accuracy/variance?
  - danielgomari 4y ago
    Yes, exactly. We are running internal validation tests to (a) compare the quality of the measurements with larger amounts of blood collected the "regular" way, and (b) validate that the storage and transportation at room temperature does not have detrimental effects on the measurements.
- nradov 4y ago
  The blood test accuracy problem that Theranos ran into wasn't so much about the specimen volume, but rather that they drew the blood from capillaries too close to the skin and thus it wasn't representative of blood circulating in larger veins. For some tests where they were just looking for any presence of certain substances that was good enough, but it couldn't work reliably for any test that needs consistent, quantitative results.

danielgomari 4y ago

Yes, mass-spectrometry-based metabolomics can be performed on as little as 20ul in certain cases, and 80ul is certainly enough. Below are a few studies from other authors and platforms, and there are many more out there. https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-022-02852-4#Sec2 https://arthritis-research.biomedcentral.com/articles/10.118... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340475/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8340475/ Specifications by an academic metabolomics facilty: https://www.embl.org/groups/metabolomics/faq/ https://www.embl.org/groups/metabolomics/faq/ Regarding your Theranos comment: You are absolutely right. This is something we will have to deal with, and where are actively working on our messaging.

samstave 4y ago
Does one do a benchmark by running the same tests, at different volumes with the same blood across multiple testing machines/methods, and then compare the results for accuracy/variance?
- danielgomari 4y ago
  Yes, exactly. We are running internal validation tests to (a) compare the quality of the measurements with larger amounts of blood collected the "regular" way, and (b) validate that the storage and transportation at room temperature does not have detrimental effects on the measurements.
nradov 4y ago
The blood test accuracy problem that Theranos ran into wasn't so much about the specimen volume, but rather that they drew the blood from capillaries too close to the skin and thus it wasn't representative of blood circulating in larger veins. For some tests where they were just looking for any presence of certain substances that was good enough, but it couldn't work reliably for any test that needs consistent, quantitative results.