Questions

The questions a hematologist asks.

Straight answers, grounded in the WHO 2022 and ICC 2022 criteria and in what Axiisium actually ships today. Where something is roadmap, we say so.

The five signals
Do you really need all five signals to diagnose AML?
For a yes/no diagnosis, often not: morphology plus flow can get you there — roughly 20% blasts that are MPO-positive is AML. But a bare "AML" label is a dead end under modern care. Treatment is genetics-gated, and ELN risk class and targeted therapy require the molecular and cytogenetic context. Axiisium solves for the treatment decision, not just the baseline call.
Aren't cytogenetics and molecular just "genetics"? Why count them separately?
They are different laboratory workflows on different instruments and timelines. Cytogenetics reads whole chromosomes by karyotype and FISH, in days. Molecular NGS sequences specific genes, in weeks. Fusing them means temporally reconciling two different data structures that arrive at different times — which is exactly the friction the product is built for.
Is clinical history really a signal, or just context?
Under WHO 2022 it is diagnostic. "Therapy-related myeloid neoplasm" and "AML with myelodysplasia-related changes" are distinct entities defined in part by clinical history: prior cytotoxic chemotherapy or a prior MDS fundamentally changes the biology and risk of the current leukemia. So it is a genuine feature. Today Axiisium treats clinical history as context the clinician weighs; full clinical fusion is on the roadmap.
Architecture · pending signals
How do you produce a result before the molecular and cytogenetic results are back?
It defers, it does not infer. From the fast-available signals, Axiisium produces a provisional, signed call with every assumption flagged in plain language — for example, "lineage not confirmed by flow; myeloid assumed" — and re-derives it to final when the slow signals arrive, but only while a pending signal could still change the answer. Each state, provisional and final, is its own signed record chained to the last, so how the call evolved is itself auditable. It never fabricates a pending result to force a definitive answer.
Does the morphology model diagnose the genetics?
No, by design. The morphology model can predict NPM1 status from the smear, but that prediction is used only to rank who to sequence first, never to make the genetics call. The signed WHO 2022 / ICC 2022 diagnosis uses the actual molecular assay result, and a confirmatory assay gates any real decision. The ranking cannot itself drive an unconfirmed clinical action.
Validation · the numbers
How accurate is the NPM1-from-morphology model?
0.894 ±0.066 AUROC, patient-level with leakage-free cross-validation, on patient-grouped public data. That is at literature level: the published benchmark (Eckardt et al., Leukemia, 2021) reports roughly 0.92 AUROC for the same task. Reported as validation, not a marketing claim.
Why does the same case get two calls, WHO and ICC?
Because the two consensus systems genuinely disagree on the blast threshold when a defining lesion is present. Under WHO 2022, an NPM1 mutation waives the 20% blast requirement entirely. ICC 2022 holds a 10% threshold, and 10 to 19% becomes MDS/AML. Axiisium returns the call under both and shows exactly where they diverge, so the molecular result, not a hard-coded number, decides.
Safety
Is Axiisium a diagnostic device?
No. Research use only, decision support: a qualified clinician makes the diagnosis. The value is a signed, independently verifiable record of exactly how each call was made, and a confirmatory assay upstream of any real decision, not autonomy.
What can I verify myself?
Every call, and every change to it, is bound to a tamper-evident record — the input digest, the model id and version, the output, the attributed clinician, and a cryptographic signature — each linked to the record before it. The ledger runs in production, and its head is anchored to a public, append-only transparency log with a checkpoint signed by a key that never leaves hardware. You can confirm, independently and with no access to us, that a specific model version on specific inputs produced a given call and that nothing was altered. The production ledger is anchored publicly right now: public log index 2051205018 →. Audit-grade, powered by Project AIR.