4 ms·

My doctor requested one for me, and I just got it in the mail (USA), which is nice for me. I suspect that this will remain a niche product. It would, in theory

My doctor requested one for me, and I just got it in the mail (USA), which is nice for me. I suspect that this will remain a niche product. It would, in theory, be applicable to most people on earth. Such wide spread screenings simply aren't viable in a world of massive compliance costs and subsidized health care. It took an act of god for simple COVID testing to become somewhat inexpensive. I look forward to getting this test every few years until it is killed by our regulatory apparatus.

johnnyApplePRNG 1y ago
Doctors can simply request these now? The article made it read like it was some trial that just completed. Does anyone know if (or when) these are regularly available in Canada? And the costs associated?
- bitwize 1y ago
  It could be that GP participated in a study, or simply had a cool doctor willing to pull a few strings.
- epistasis 1y ago
  They always could! Diagnostics are a bit different than therapeutics, which need that big Phase 3 trial before you can start selling a new therapy. There are two regulatory regimes for diagnostics in the US: 1) Lab developed tests (LDTs) licensed under the CLIA legislation (I think from the 1980s). These are verified by a Lab Director with a professional license in diagnostics, that allows them to sign out clinical results from the test. There are professional organizations that perform regular inspections of the lab, its condition, its paperwork, its tests, the SOPs, and the internal validations that have been performed at the lab director's direction to assess performance of the tests. These are limited to a single site, the kits for the test can not be sold except for Research Use Only, and if a second site wants to start doing a similar test the lab director at the other site needs to do all the same validation all over again as at the first site. 2) FDA approval for diagnostic medical devices. These can be simple and straightforward for Class 1/2 devices, which do not directly provide medical advice but mere physical readouts (to greatly bastardize the distinction between Class 1/2 and 3). Or the device approval can be quite complex for Class 3 devices, and would require a huge trial like the one described here. If you want to sell the device for others to use, rather than just testing as service, you want to go this route. Though there are still single-site "devices" especially for DNA sequencing tests, that want the FDA label. Neither of these will result in getting reimbursement for a test. For that, you need to pursue coverage determinations from all the payers, basically one on one. For complex sequencing tests like this that mostly affects older populations, getting CMS coverage (Medicare) can pave the path for others. For other conditions... well... get all your trials and papers together and hope that your patient population is super sympathetic or you can show the insurance company some savings. A large clinical trial like this one can help with getting coverage for the test, but it has to either show a big medical benefit, or show economic benefits within five years for the payor. Or ideally both. Early cancer detection has potential for this, but I have not heard optimistic things up until now at Galleri's chance for reimbursement any time soon.
toomuchtodo 1y ago
I think it’ll become an add on to an annual physical blood panel for the 50+ age cohort. Volume might push prices down faster. I paid the $950 rate (it’s occasionally discounted to $800, such as now until the end of the year, and you might be able to use FSA/HSA funds depending on plan administrator) and thought it was worth it (to detect potentially asymptomatic early stage cancer). (no affiliation)

johnnyApplePRNG 1y ago

Doctors can simply request these now? The article made it read like it was some trial that just completed. Does anyone know if (or when) these are regularly available in Canada? And the costs associated?

bitwize 1y ago
It could be that GP participated in a study, or simply had a cool doctor willing to pull a few strings.
epistasis 1y ago
They always could! Diagnostics are a bit different than therapeutics, which need that big Phase 3 trial before you can start selling a new therapy. There are two regulatory regimes for diagnostics in the US: 1) Lab developed tests (LDTs) licensed under the CLIA legislation (I think from the 1980s). These are verified by a Lab Director with a professional license in diagnostics, that allows them to sign out clinical results from the test. There are professional organizations that perform regular inspections of the lab, its condition, its paperwork, its tests, the SOPs, and the internal validations that have been performed at the lab director's direction to assess performance of the tests. These are limited to a single site, the kits for the test can not be sold except for Research Use Only, and if a second site wants to start doing a similar test the lab director at the other site needs to do all the same validation all over again as at the first site. 2) FDA approval for diagnostic medical devices. These can be simple and straightforward for Class 1/2 devices, which do not directly provide medical advice but mere physical readouts (to greatly bastardize the distinction between Class 1/2 and 3). Or the device approval can be quite complex for Class 3 devices, and would require a huge trial like the one described here. If you want to sell the device for others to use, rather than just testing as service, you want to go this route. Though there are still single-site "devices" especially for DNA sequencing tests, that want the FDA label. Neither of these will result in getting reimbursement for a test. For that, you need to pursue coverage determinations from all the payers, basically one on one. For complex sequencing tests like this that mostly affects older populations, getting CMS coverage (Medicare) can pave the path for others. For other conditions... well... get all your trials and papers together and hope that your patient population is super sympathetic or you can show the insurance company some savings. A large clinical trial like this one can help with getting coverage for the test, but it has to either show a big medical benefit, or show economic benefits within five years for the payor. Or ideally both. Early cancer detection has potential for this, but I have not heard optimistic things up until now at Galleri's chance for reimbursement any time soon.

toomuchtodo 1y ago

I think it’ll become an add on to an annual physical blood panel for the 50+ age cohort. Volume might push prices down faster. I paid the $950 rate (it’s occasionally discounted to $800, such as now until the end of the year, and you might be able to use FSA/HSA funds depending on plan administrator) and thought it was worth it (to detect potentially asymptomatic early stage cancer). (no affiliation)