Use non-NY doctor for lab test not authorized yet in NY?

July 9, 2021 6:44 PM

I’m fascinated by the Galleri early “liquid biopsy” genetic screening cancer test. However, I’m an NYC resident; these tests cannot be performed in NY state due to state regulatory limits . Insurance doesn’t cover this test; medical providers in any other state can order the test for ~$950, which seems reasonable - I’d be willing to pay that much out of pocket. Could I register with an out-of-state doctor and have the test done through them (I'd be happy to travel)? Does anyone have any info beyond a hunch that this is possible/impossible?
posted by anonymous to Health & Fitness (4 answers total)

(a) The issue is specimens originating from NY. If I'm understanding the process, an out-of-state doctor willing to perform the blood draw should be able to order it.

(b) They are operating under the exact same regulatory loophole as Theranos (CLIA clearance rather than FDA approval). While the test is unlikely to do you actual harm (most likely adverse outcome is a false positive that causes you to waste money and stress on further tests, which is not good in the aggregate but may or may not be very harmful to you personally), I invite you to consider whether everything about the site doesn't say "VC-funded scam."
posted by praemunire at 7:09 PM on July 9, 2021 [4 favorites]

(I will not argue that this is a good test because I don't know much about it but I would like to contradict that they are somehow as shady as Theranos because of how they are operating a non-cleared/approved test in a CLIA-regulated lab (which is totally legal and common). Theranos may have initially operated under a similar track, but they then moved into doing illegal and unethical things. Just because this or any test is not FDA-cleared or approved does not mean there is something shady going on.). I'd agree with the rest though - if you can get a provider to draw blood in a state where the lab is licensed (not in NYS) and order the test (you can't order it yourself), and you're willing to pay full price, you can probably get the test. NYS is well-known to have the strictest lab regulations and the test may just not have gotten through yet (or the lab may be lazy and didn't bother with the paperwork or the test may not have met criteria, etc).
posted by Tandem Affinity at 7:32 PM on July 9, 2021

Mod note: One deleted. Sorry, but this isn't the spot for having a general discussion of the test (if people want to talk about it, a post to the blue would be the way to do that). OP is asking if anyone has solid information on whether they can register with an out-of-state doctor in order to take the test.
posted by taz (staff) at 11:09 PM on July 9, 2021

This is so new I can't find any doctors on ZocDoc who are advertising it. I don't know how kosher this is to say, but I'd look for doctors in Jersey (if it is approved there) or anything in the area you're willing to travel for. You'll probably okay with a PCP but if you're having trouble I'd search on the terms "luxury" or "discrete/anxiety" or something similar. These are legitimate doctors, but they're all cash ~$500 on top of the $949 fee. In my experience they're very quick, as in same day, with little or no waiting. I learned this the hard way when I lost medication and it was forever getting an appointment for a doctor.
posted by geoff. at 7:12 PM on July 11, 2021