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.
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.