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Signature B ALL
Molecular profiling for acute lymphoblastic leukaemia, so treatment intensity and targeted options match the biology rather than morphology alone.
01Acute lymphoblastic leukaemia
Molecular profiling for lymphoblastic leukaemia
Signature B ALL profiles the molecular drivers of acute lymphoblastic leukaemia from blood or bone marrow, so treatment intensity and targeted options can be matched to the biology rather than to morphology alone.
02
What it reports
Driver mutations
The gene changes that define the disease and its subtype.
Fusions and rearrangements
The structural events that drive ALL and guide therapy.
Risk-defining markers
Findings that inform how intensively the leukaemia is treated.
Targetable findings
Alterations with a matched therapy or an accessible trial.
Before launch: Supply the Signature B ALL gene list (SNV and InDel genes, fusion and rearrangement genes, and any copy-number or cytogenetic markers). Add it to _build/genes.py with a count assertion, then render it with genepanel() exactly as the solid-tumour pages do.
03
How it works
- Step 1Sample
Blood or bone marrow, collected by a qualified professional.
- Step 2Sequencing
An accredited laboratory reads the leukaemia’s DNA and fusions.
- Step 3Engine
Annotation, subtype assignment and matching to therapies and trials.
- Step 4KPCIRC sign-out
A tumour board authors and signs the decision.
04
Where it fits
The result feeds Blueprint Care in the same way as a solid-tumour Signature test: a ranked decision, contraindications, matched trials, access mapping and a resistance plan, all signed by KPCIRC.
It also establishes the molecular baseline that Sentinel Blood and Clear Blood track over time.
Being clear about our limits
What we do and do not do
What we DO
- Profile the drivers, fusions and cytogenetic risk markers of the leukaemia
- Support risk stratification alongside morphology and flow cytometry
- Feed a tumour-board-signed Blueprint Care decision
- Establish a baseline that later monitoring can be measured against
What we DON’T do
- Diagnose leukaemia on its own, morphology and flow cytometry remain essential
- Replace your haematologist’s assessment or scheduled testing
- Detect changes in genes outside the panel
- Guarantee a drug, its approval, cover, or that it will work
Plain-language glossary (7 terms)
| Term | What it means |
|---|---|
| Blast | An immature blood cell. Leukaemia is driven by blasts that fail to mature. |
| ALL | Acute lymphoblastic leukaemia, arising from lymphoid precursor cells. |
| AML | Acute myeloid leukaemia, arising from myeloid precursor cells. |
| Karyotype | The chromosome picture of the leukaemia, long used to assign risk. |
| Fusion transcript | Two genes joined abnormally, a common and highly informative driver in leukaemia. |
| MRD | Measurable residual disease, the small amount left after treatment that predicts relapse. |
| Risk stratification | Sorting patients into risk groups so treatment intensity matches need. |
Important information and regulatory status
Signature B ALL is a genomic (DNA-based) test for use by qualified healthcare professionals. It supports clinical judgement, it does not replace it, and it must be read alongside your full clinical history and applicable guidelines.
- A result is not a diagnosis and does not by itself decide treatment.
- A “not detected” result does not rule out cancer or a genetic change.
- Not all cancers release enough DNA into blood to be detected.
- We cannot guarantee that a medicine will be available, approved, covered or effective.
- Collection kits are for qualified phlebotomists. They are not for self-testing.
- Confirmatory testing may be required.
Regulatory status (India). Registration of our genomic tests as in-vitro diagnostic (IVD) medical devices with CDSCO is in progress, with the IVD class pending. Sequencing and variant calling are done by an accredited laboratory partner (CAP-accredited, ISO 15189) following ACMG/AMP/ASCO/CAP guidelines and a CE-IVD certified variant database. The OnKommon interpretation engine is provided for research and decision-support use. Marketing follows the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
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