6 ms·

Here's the test on NMS: https://www.nmslabs.com/tests/3427SP https://www.nmslabs.com/tests/3427SP NMS does not list consumers as their customers, and none of t

by w10-1 3y ago

Here's the test on NMS: https://www.nmslabs.com/tests/3427SP https://www.nmslabs.com/tests/3427SP NMS does not list consumers as their customers, and none of their customers make medical decisions based on their lab work. NMS claims CLIA certification. This is the older law where labs self-certify compliance. Congress left CLIA in place alongside FDA IVD regulations to protect small pharmacists, but obviously Quest Diagnostics and LabCorp run fleets through that loophole, and most labwork is CLIA-certified, not FDA-approved. Paying to test for highly-prevalent, possibly-toxic, pervasively-feared, under-studied chemicals is an ideal recipe for fleecing people with no real benefit. Perhaps worse, if people get burned because it is corrupt, it puts people off trusting good providers. This is not just "Hey I made an app/web-site to track your period! How cool is that?" Some chemicals may be toxic, but so is fear. So yes, it's super important to enable people to concretely understand their risks, protect themselves, and advocate for health policies. All the more reason to do it right. So I hope you know what you're doing. Somehow the website needs to convey the organization behind it, and why that organization can be trusted to do this right, and not to mislead people.

mdrew 3y ago
Ok, a few thoughts. Direct to consumer lab testing is offered in ~47 states in the country. It has been available for years with thousands of tests available. To date, there has been no apocalypse from empowering consumers to know about their own personal health. NMS is one of the preeminent toxicology labs in the country. This test is Liquid chromatography–mass spectrometry which is known, quantifiable, extremely accurate and repeatable test methodology. National Academies of Science, Engineering and Medicine explicitly references this lab in their report. Further, they go on to elucidate the risks and benefits of offering PFAS testing to people. "Harms of PFAS testing include fear induced by blood draw, a small risk of injury or infection at the draw site, difficulties in interpreting results, and psychological stress that may occur when people who are tested learn that they or their family members have high levels of PFAS exposure. On the other hand, biomonitoring for PFAS blood levels may also alleviate fears associated with not knowing one’s PFAS levels. Another potential benefit is increasing awareness of exposure so that exposures can be reduced. If sources of exposure are identified, actions taken to reduce these exposures, such as using a water filter, may also benefit family members in addition to the person who was tested. Community-level benefits may be associated with PFAS testing as well, such as empowering communities to respond to contamination and providing a baseline with which to evaluate the impact of community-level interventions to reduce exposure. Additionally, biomonitoring for PFAS in the context of epidemiologic studies could provide more information about PFAS-associated health effects." Also a couple of quotes from the same paper. "Kristen Mello of Westfield Residents Advocating for Themselves (WRAFT) said to the committee: You don’t have a problem getting an insurance assessor when your car is hit, you don’t have a problem getting an insurance assessor when you have a tornado, but this slow motion unfolding environmental and public health disaster … is intentionally keeping the information from us so that we cannot take action. Furthermore, Emily Donovan of Clean Cape Fear, said: Sadly it feels like guinea pigs are treated better, because at least their exposures are thoroughly studied for the betterment of humanity. And Cathy Wusterbarth of Need Our Water said: We’ve tested the fish; we’ve tested the deer; we’ve tested the groundwater, the waterways, and the foam. When are we going to test the people?… The only risk [of testing] is to the polluters who do not want us to link them to our exposure." Make what you will. Source: https://www.ncbi.nlm.nih.gov/books/NBK584705/ https://www.ncbi.nlm.nih.gov/books/NBK584705/
- xracy 3y ago
  I don't think the previous commenter was saying "don't test people" but there are a few comments on here about how sketchy this website/company looks. So instead, the question is, if I pay $400 what meaning/value am I getting from this. And what can I get above and beyond the given 98% certainty I have that I've already ingested one of these chemicals?
  - mdrew 3y ago
    I get it. I think it's right there in the post itself. If you have certain occupations, live in certain zip codes, or have medical problems, a test like this can prove invaluable. If you're just curious, your mileage may very. I do push back on the idea that not knowing is somehow better. Or people cannot handle learning new information about themselves. It's an old idea from medicine I hope we can move past as it just entrenches the power dynamic between caregivers and patients.
    - vkou 3y ago
      > I think it's right there in the post itself. If you have certain occupations, live in certain zip codes, or have medical problems, a test like this can prove invaluable. Invaluable, as in, worthless? Invaluable for what? What are you going to do if you test positive?
      - mdrew 3y ago
        I encourage you to read the rest of the discussion.
        xracy 3y ago
        Uhh, you haven't answered this person's question in the rest of the discussion. What is the value of this test over assuming that I have this? What treatment exists that I can get if I know my blood contains PFAs?
deleted 3y ago
[deleted]
azinman2 3y ago
But I cannot order this test myself from NMS, right?
- mdrew 3y ago
  NMS does not offer tests direct to consumers.
  - azinman2 3y ago
    Are there labs where I can go in and order arbitrary tests?
    - codingdave 3y ago
      Yep, search for "direct lab testing" and you'll find some vendors, and possibly some local clinics. But the thing with ordering your own tests is that it is not the only way to get these results. You can simply ask a doctor. They'll order it and help you understand the results and insurance can cover it. Depending on your insurance, that might be cheaper or it might not. There are pros and cons to both approaches mostly centered around how self-driven you want your care to be and whether or not you have a cooperative doctor. But I would add a general word of warning - raw lab results do need some broader understanding of what the expected results are. They'll typically tell you what numbers are too low/high, but will not tell you what it means if you are outside those limits. For some things, being a slight bit out of the norms is a big deal. For others, unless you are at a few multiples beyond the limits, there is northing to fret over. Knowing which is which is critical to know how to react to test results. I'm not saying you've gotta work with doctors - I'm saying that they do have a point that self-educated and self-diagnosed patients who learn the info off the internet are not always well-informed. If you are going to go the self-directed route for your health care, take the time to learn deeply and do it well.
      - mdrew 3y ago
        Well said. If you're not well informed, this isn't for you.
mdek 3y ago
> NMS claims CLIA certification. This is the older law where labs self-certify compliance. Congress left CLIA in place alongside FDA IVD regulations to protect small pharmacists, but obviously Quest Diagnostics and LabCorp run fleets through that loophole, and most labwork is CLIA-certified, not FDA-approved. This is highly misleading. CLIA and the associated federal regulations are the standard to which diagnostic clinical laboratories are held, not an "older" or "loophole" regulation. All laboratories in the US that provide patient results for clinical use are regulated by CLIA. There are FDA-approved test systems and "Lab-developed tests" (LDTs) that are BOTH subject to CLIA obligations, which are unbelievably complex (and in my opinion are a source of regulatory capture in laboratory medicine, but that's not directly relevant). Most high complexity lab tests are LDTs. FDA-approved tests go through a formal FDA process such that the performing lab only has to "verify" the performance characteristics prior to patient testing. An LDT requires a much more stringent lab-level validation plan prior to patient testing. Both requiring strict ongoing quality control and quality assurance. And while the validation plan for an LDT can be self-designed, there are still strict requirements for what it most contain. Compliance is NOT "self-certified," instead there are routine, extremely intensive compliance inspections (scheduled and unscheduled), either by a regional CLIA office, or by an organization accredited by CMS to provide such verification of compliance (such as CAP or COLA). These are not cursory inspections but a deep dive into all lab operations and personnel, equipment, maintenance and quality records, and other documentation. I'm not a huge fan of Quest or Labcorp's presence in the field, and I don't know the specifics of NMS and this PFAS testing (CLIA compliance isn't required for research or non-clinical). If NMS has CLIA certification and they state the methodology and limitations of their LDT it's generally perfectly valid to provide the test, and the burden is generally on the downstream physician or provider to ensure the results are properly interpreted and applied.

by w10-1 3y ago

mdrew 3y ago

Ok, a few thoughts. Direct to consumer lab testing is offered in ~47 states in the country. It has been available for years with thousands of tests available. To date, there has been no apocalypse from empowering consumers to know about their own personal health. NMS is one of the preeminent toxicology labs in the country. This test is Liquid chromatography–mass spectrometry which is known, quantifiable, extremely accurate and repeatable test methodology. National Academies of Science, Engineering and Medicine explicitly references this lab in their report. Further, they go on to elucidate the risks and benefits of offering PFAS testing to people. "Harms of PFAS testing include fear induced by blood draw, a small risk of injury or infection at the draw site, difficulties in interpreting results, and psychological stress that may occur when people who are tested learn that they or their family members have high levels of PFAS exposure. On the other hand, biomonitoring for PFAS blood levels may also alleviate fears associated with not knowing one’s PFAS levels. Another potential benefit is increasing awareness of exposure so that exposures can be reduced. If sources of exposure are identified, actions taken to reduce these exposures, such as using a water filter, may also benefit family members in addition to the person who was tested. Community-level benefits may be associated with PFAS testing as well, such as empowering communities to respond to contamination and providing a baseline with which to evaluate the impact of community-level interventions to reduce exposure. Additionally, biomonitoring for PFAS in the context of epidemiologic studies could provide more information about PFAS-associated health effects." Also a couple of quotes from the same paper. "Kristen Mello of Westfield Residents Advocating for Themselves (WRAFT) said to the committee: You don’t have a problem getting an insurance assessor when your car is hit, you don’t have a problem getting an insurance assessor when you have a tornado, but this slow motion unfolding environmental and public health disaster … is intentionally keeping the information from us so that we cannot take action. Furthermore, Emily Donovan of Clean Cape Fear, said: Sadly it feels like guinea pigs are treated better, because at least their exposures are thoroughly studied for the betterment of humanity. And Cathy Wusterbarth of Need Our Water said: We’ve tested the fish; we’ve tested the deer; we’ve tested the groundwater, the waterways, and the foam. When are we going to test the people?… The only risk [of testing] is to the polluters who do not want us to link them to our exposure." Make what you will. Source: https://www.ncbi.nlm.nih.gov/books/NBK584705/ https://www.ncbi.nlm.nih.gov/books/NBK584705/

xracy 3y ago
I don't think the previous commenter was saying "don't test people" but there are a few comments on here about how sketchy this website/company looks. So instead, the question is, if I pay $400 what meaning/value am I getting from this. And what can I get above and beyond the given 98% certainty I have that I've already ingested one of these chemicals?
- mdrew 3y ago
  I get it. I think it's right there in the post itself. If you have certain occupations, live in certain zip codes, or have medical problems, a test like this can prove invaluable. If you're just curious, your mileage may very. I do push back on the idea that not knowing is somehow better. Or people cannot handle learning new information about themselves. It's an old idea from medicine I hope we can move past as it just entrenches the power dynamic between caregivers and patients.
  - vkou 3y ago
    > I think it's right there in the post itself. If you have certain occupations, live in certain zip codes, or have medical problems, a test like this can prove invaluable. Invaluable, as in, worthless? Invaluable for what? What are you going to do if you test positive?
    - mdrew 3y ago
      I encourage you to read the rest of the discussion.
      - xracy 3y ago
        Uhh, you haven't answered this person's question in the rest of the discussion. What is the value of this test over assuming that I have this? What treatment exists that I can get if I know my blood contains PFAs?

deleted 3y ago

[deleted]

azinman2 3y ago

But I cannot order this test myself from NMS, right?

mdrew 3y ago
NMS does not offer tests direct to consumers.
- azinman2 3y ago
  Are there labs where I can go in and order arbitrary tests?
  - codingdave 3y ago
    Yep, search for "direct lab testing" and you'll find some vendors, and possibly some local clinics. But the thing with ordering your own tests is that it is not the only way to get these results. You can simply ask a doctor. They'll order it and help you understand the results and insurance can cover it. Depending on your insurance, that might be cheaper or it might not. There are pros and cons to both approaches mostly centered around how self-driven you want your care to be and whether or not you have a cooperative doctor. But I would add a general word of warning - raw lab results do need some broader understanding of what the expected results are. They'll typically tell you what numbers are too low/high, but will not tell you what it means if you are outside those limits. For some things, being a slight bit out of the norms is a big deal. For others, unless you are at a few multiples beyond the limits, there is northing to fret over. Knowing which is which is critical to know how to react to test results. I'm not saying you've gotta work with doctors - I'm saying that they do have a point that self-educated and self-diagnosed patients who learn the info off the internet are not always well-informed. If you are going to go the self-directed route for your health care, take the time to learn deeply and do it well.
    - mdrew 3y ago
      Well said. If you're not well informed, this isn't for you.

mdek 3y ago

> NMS claims CLIA certification. This is the older law where labs self-certify compliance. Congress left CLIA in place alongside FDA IVD regulations to protect small pharmacists, but obviously Quest Diagnostics and LabCorp run fleets through that loophole, and most labwork is CLIA-certified, not FDA-approved. This is highly misleading. CLIA and the associated federal regulations are the standard to which diagnostic clinical laboratories are held, not an "older" or "loophole" regulation. All laboratories in the US that provide patient results for clinical use are regulated by CLIA. There are FDA-approved test systems and "Lab-developed tests" (LDTs) that are BOTH subject to CLIA obligations, which are unbelievably complex (and in my opinion are a source of regulatory capture in laboratory medicine, but that's not directly relevant). Most high complexity lab tests are LDTs. FDA-approved tests go through a formal FDA process such that the performing lab only has to "verify" the performance characteristics prior to patient testing. An LDT requires a much more stringent lab-level validation plan prior to patient testing. Both requiring strict ongoing quality control and quality assurance. And while the validation plan for an LDT can be self-designed, there are still strict requirements for what it most contain. Compliance is NOT "self-certified," instead there are routine, extremely intensive compliance inspections (scheduled and unscheduled), either by a regional CLIA office, or by an organization accredited by CMS to provide such verification of compliance (such as CAP or COLA). These are not cursory inspections but a deep dive into all lab operations and personnel, equipment, maintenance and quality records, and other documentation. I'm not a huge fan of Quest or Labcorp's presence in the field, and I don't know the specifics of NMS and this PFAS testing (CLIA compliance isn't required for research or non-clinical). If NMS has CLIA certification and they state the methodology and limitations of their LDT it's generally perfectly valid to provide the test, and the burden is generally on the downstream physician or provider to ensure the results are properly interpreted and applied.