RE: RNS19 May 2026 15:53
Some interesting insights if you have a mess around with your AI of choice.
Reality check: typical CLIA timelines for a diagnostic test like an LDT are around 3 months post submission. Even with a "submission ready" package like CIZ have mentioned. Do not bet the farm on an immediate accreditation.
Approval is the starting gun, not the finish line. Most small cap biotech rallies into CLIA approval then pulls back; rerate will occur if revenue traction appears.
Bull case assumption on a $300 test at 10% royalties:
Year 1 = 1000 weekly tests / $1.6m royalties
Year 2 = 5000 weekly tests / $7.8m
Year 3 = 15000 weekly tests / $23.4m
Year 4 = 30000 weekly tests / $46.8m
What has to go right for the above to happen: Fast approval, physician adoption, reimbursement, operational scaling. Many tests stall at ~ 1000 per week. The bet is - will this become a widely used screening tool and not lose out to a newcomer or larger rival.