The Power of Molecular MRD Monitoring NOW in India

HemaTrack ALL ^TM- Accurate, Reliable, Economical

In Acute Lymphoblastic Leukemia (ALL), Measurable Residual Disease (MRD) is the best predictor of outcome and is used to direct risk-stratified therapy. HemaTrack^TM ALL is a robust, highly accurate, and economical MRD assay based on next generation sequencing (NGS) technology.

In the framework of a multi-center clinical study, DKMS Life Science Lab is bringing a molecular, DNA-based MRD diagnostic method for ALL patients with a maximum level of sensitivity to cancer hospitals in India. The study aims at demonstrating compatibility in TAT (turn-around time) and costs in comparison to flow-based MRD.

Advantages

Highly sensitive and highly specific test for determining MRD
Robust and objective results; operator-independent analysis
Clonotype detection and quantification based on DNA

Ensuring Precision

Overall optimization of ALL treatment
Optimization/reduction of drug administration and chemotherapy intensity
Treatment suggestions based on the findings by experienced oncologists
Contamination monitoring using Unique Molecular Identifiers (UMIs)

Dilution experiment demonstrates the sensitivity of HemaTrack^TM ALL

In this experiment, DNA extracted from the cell line 'REH' with known clonotype identities was diluted with DNA extracted from a healthy donor (NC - negative control) to investigate the alignment of HemaTrack^TM ALL to the ground truth in an artificial setting with known clonotype frequencies. In this dilution series, the clonotype frequencies measured by HemaTrack^TM correlate impressively with the ground truth (expected clonotype frequency). HemaTrack^TM ALL accurately quantifies clonotype frequencies up to a dilution of 8*10^-5.

Indication

B- and T-cell acute lymphoblastic leukemia (ALL)
Research in the field of hematology and immune repertoire analysis

Purpose

Supporting diagnostic with an influence on the treatment protocol

Profile

IgH, IgK, TRG, TRD and TRB

Sensitivity

At least 10^-4(1 cancer cell in 10,000 healthy cells)

Material

Bone marrow

HemaTrack^TM is currently applied

In clinical studies in India

Retrospective study (completed)

Cohort: 62 paediatric ALL patients
With 154 End of induction and End of consolidation samples
At TMC, Kolkata
HemaTrack ALL achieved high sensitivity and specificity, comparable to the gold standard method of molecular MRD, RQ-PCR.

Prospective studies (ongoing)