Multiple ways to obtain payment

Three payment channels
Payment for PancreaSure is obtained through three channels. These reflect different stages in the reimbursement process, from direct patient payment to full insurance coverage, and they differ in both the amount collected per test and the time it takes to collect it.

1. Direct payment from patients (cash pay)
The first payment channel is patients paying for the test directly through a cash pay program. This was the model in place from the launch of Pancreasure in September 2025. The program includes financial assistance that adjusts the cost of the test based on the patient's ability to pay. Cash payments may be zero, $100, $200 or $550 per test. The assistance program is an important part of building momentum behind adoption of the test in this early phase.

2. Billing insurers ahead of a coverage decision
The second channel is billing private insurance companies before they have made a formal decision to cover Pancreasure under their medical policy. Immunovia began submitting these claims in February 2026. The full list price of $995 per test is billed, though the portion that will ultimately be collected is not yet clear. These claims take insurers a long time to process, and initial claims are often rejected. Rejections are then appealed, which means the time to collection is considerably longer for this channel than for the others. Payers billed under this channel move into the third category as coverage decisions are secured.

3. Reimbursement following a coverage decision
The third channel, and the longer-term objective, is reimbursement from payers that have determined the test to be medically necessary and reasonable. Coverage is being pursued along two tracks: a Medicare submission planned for Q3 2026, and parallel work with commercial payers. There are a large number of commercial payers across the United States, each with its own medical policy, review timeline and assessment criteria, so this work will take time. Once coverage is secured, reimbursement per test is expected to be higher than under the other approaches, and the collection cycle shorter, since fewer steps are involved once a payer has agreed the test should be covered.

Two of the three steps toward Medicare coverage secured
Medicare reimbursement rests on three elements: a billing code, a price, and a coverage decision. Thus far, we’ve reached two of the three milestones:

• Code – secured. PancreaSure holds its own CPT code, the identifier used to bill the test.
• Cost – secured. Medicare’s Clinical Lab Fee Schedule lists PancreaSure at $897 per test.
• Coverage – in progress. What remains is Medicare’s determination that testing is reasonable and necessary, and for whom. Immunovia’s analytical validation and three clinical validation studies underpin the initial submission for coverage – clinical utility studies are underway to further strengthen the application. Submission to MolDX is planned for Q3 2026.
  
  

Milestones ahead

• Submission. Immunovia plans to file its Medicare coverage request – a scientific summary anchored by the pooled analysis in high-risk individuals with pancreatic abnormalities (83.3% sensitivity, 91.6% specificity) -- in Q3 2026.
• Added evidence. Clinical utility readouts – the DECIDE physician survey and the Kaiser Permanente retrospective study – are expected to reinforce the file during review, with real-world data from the ASSURE registry to follow.
• Decision. MolDX evaluates the dossier, publishes a draft coverage policy for public comment, and issues a final determination defining which patients are covered.

A positive determination is the point where clinical value translates directly into revenue. The PancreaSure launch then enters the revenue-growth phase. Further, the path to private-payer coverage opens, since private insurers typically want to see Medicare coverage before covering the test themselves.