well you are talking about this i think https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf
while looking for some price data i stumbled on this website here - https://www.medicalnewstoday.com/articles/fit-test#fit-products
also this one -https://www.testing.com/tests/at-home-colon-cancer-test/
Now, this home based test if i am not wrong but the price is cheap except for Cologurd so basically if RHY has to enter as private test then they need to have price around the cheaper one in my opinion initially at-least to get foot into market... !
however, imagine going to get FDA approval would allow them to get price even higher as competitor is only cologuard at the moment if i am not wrong.
so what it is worth in my opinion, if TGA approval is positive and price spike then do what AVH did i.e. capital raise to cover cost of full FDA approval EU reimbursement approvals, TGA reimbursement approvals so roughly $100m to $200m whatever management think is required, feasible and obviously how much price rise it get's on news but go maximum figure so no more dilution in future until steady income derived from TGA, EU and FDA in my opinion.... !
please note i have not checked what is the quality or reliability of other test below or their approvals etc. etc. etc.... so DYOR. i will leave weblinks below for this test for information only.
https://www.pblabs.com/products/second-generation-fit-fecal-immunochemical-test-2-pack
https://www.everlywell.com/products/fit-colon-cancer-screening-test/?utm_source=affiliate&utm_medium=affiliate&utm_campaign=CJ
https://www.letsgetchecked.com/home-colon-cancer-test/
https://www.ondemand.labcorp.com/at-home-test-kits/colorectal-cancer-home-test
