RE: Funding14 Feb 2025 08:02
Similar to STX. IF they get the uptake. Approval Q2 now. If it ever comes.
T he Company's submission has completed FDA substantive review (July 2024) and following further discussions with the FDA is expected to progress to approval in early Q2 2025. FDA approval of CARDIO inCode would enable the test to be provided as a medical device (kit) format which the directors expect would substantially expand the market for the test.
In January 2025, the Company announced that its CARDIO inCode test had been included in the U.S. Centres for Medicare and Medicaid Services (CMS) 2025 Clinical Lab Fee Schedule with a median price of approximately $500 per test. This development is an important step in facilitating reimbursement from Medicare and Medicaid across the United States. In addition, the Company is preparing a MolDx submission for US state-based reimbursement following receipt of FDA approval.
LIPID inCode has an average reimbursement of $1,229, reflecting the Clinical Laboratory Fee Schedule for the test and the broad Familial Hypercholesterolemia Panel of tests to identify FH genetic variants.
In assessing the future financial drivers of the business, the Company has made the following assumptions about revenues:
· In the US, LIPID inCode is expected to reach on average 100 tests per month by mid 2025, increasing to 275 tests per month by mid 2026, and sold at circa £625 each (blended price of Insurance and self-pay). CARDIO inCode tests are expected to reach on average 120 tests per month from mid 2025 (post FDA-approval), increasing to 250 tests per month by mid 2026 and sold at circa £300 each (blended price of distributor and self-pay).
· In the UK, the Company estimates that each new NHS region would add approximately £650k of revenue annually and assumes the addition of one new region expected in 2025 and two more in 2026.
· In addition, in Spain, the Company expects the launch of CARDIO inCode Public Health and a new partnership would add £400k in each of 2025 and 2026 on top of the normalised 20% annual organic growth.