.

LPL – MEDITRON LAB

Asramom S.O, MC VI/177/544, VIJAYGIRI TO
WERS, NEAR NAIRS HOSPITAL JN, ASHRAMAN P

Name : SUSEELAN K
Collected : 23/03/2022 17:03:00
Received : 23/03/2022 18:03:46
Lab No. : 322079909 Age: 53 Years Gender: Male
Reported : 25/03/2022 21:41:03
Report Status : Final
A/c Status : P Ref by : Dr. RAJIV KUMAR

TEST CONDUCTED BCR-ABL QUANTITATIVE, MRD MONITOR

INDICATION &
Known case of CML
SAMPLE INFORMATION

METHOD Real Time PCR

Type of Transcript Copy Number

P210 (e13a2, e14a2, Major) BCR-ABL rearranged copy number 332
P190 (e1a2, minor) BCR ABL rearranged copy number 0
ABL copy number 47110

RESULT DETECTED (Major)

PERCENTAGE RATIO 0.704 % (as per Limit of detection)

BCR-ABL International Scale

0.441 % (as per Limit of detection)
Normalized copy number

Page 1 of 5
.

LPL – MEDITRON LAB

Asramom S.O, MC VI/177/544, VIJAYGIRI TO
WERS, NEAR NAIRS HOSPITAL JN, ASHRAMAN P

Name : SUSEELAN K
Collected : 23/03/2022 17:03:00
Received : 23/03/2022 18:03:46
Lab No. : 322079909 Age: 53 Years Gender: Male
Reported : 25/03/2022 21:41:03
Report Status : Final
A/c Status : P Ref by : Dr. RAJIV KUMAR

HISTORICAL DATA
Date Percentage Log Log Reduction from International
Ratio Value Baseline Scale
0.704 % Base line value not 0.441 %
25-03-2022 -0.152
(as per Limit of detection) provided (as per Limit of detection)

(as per Limit of detection)

ABBREVIATION FULL FORM INFERENCE

CHR Complete Hematological Response Blood counts returning to normal values
MCyR Major Cytogenetic Response Ph Chromosome 1-35% on FISH
CCyR Complete Cytogenetic Response Ph Chromosome 0% on FISH
MMR Major Molecular Response BCR-ABLIS <0.1
MR4 Molecular Response Molecular response with 4 Log reduction
MR4.5 Molecular Response Molecular response with 4.5 Log reduction
(Deep MR)
MR5 Molecular Response Molecular response with 5 Log reduction

Page 2 of 5
.

LPL – MEDITRON LAB

Asramom S.O, MC VI/177/544, VIJAYGIRI TO
WERS, NEAR NAIRS HOSPITAL JN, ASHRAMAN P

Name : SUSEELAN K
Collected : 23/03/2022 17:03:00
Received : 23/03/2022 18:03:46
Lab No. : 322079909 Age: 53 Years Gender: Male
Reported : 25/03/2022 21:41:03
Report Status : Final
A/c Status : P Ref by : Dr. RAJIV KUMAR

EARLY TREATMENT RESPONSE MILESTONES

(adapted from NCCN guidelines Version 3.2021 CML)

BCR-ABL1 (IS) 3 months 6 months 12 months

>10% Yellow Red
>1%-10% Green Yellow
>0.1-1% Green Light Green
≤0.1% Green

Color Concern Clinical considerations Recommendations

Evaluate patient Compliance and drug
TKI- resistant interactions Switch to alternate TKI and evaluate
RED
disease for allogenic HCT
Consider mutational analysis
Evaluate patient compliance and drug
interactions Switch to alternate TKI or Continue
Consider Mutational analysis same TKI (other than Imatinib) or
Increase Imatinib dose to Max of
Consider bone marrow cytogenetic 800 mg and Consider evaluation for
Possible TKI analysis to assess for MCyR at 3 mo or
Yellow allogenic HCT.
resistance CCyR at 12 mo
Note: Careful consideration is required
Note: Achievement of response
as patient with slightly >10% IS may
milestones must be interpreted
achieve <10% at 6 months and have
within the clinical context.
greatly favorable outcome.
If treatment goal is long-term survival:
If optimal: continue same TKI
Light TKI-Sensitive >0.1%-1% optimal
Green Disease If treatment goal is treatment-free If not optimal: Shared decision-
remission: ≤0.1% optimal making with patient
Continue same TKI
TKI-Sensitive Note: Discontinuation of TKI with
Green Monitor response and side effects
Disease careful monitoring is feasible in
selected patients.

Page 3 of 5
.

LPL – MEDITRON LAB

Asramom S.O, MC VI/177/544, VIJAYGIRI TO
WERS, NEAR NAIRS HOSPITAL JN, ASHRAMAN P

Name : SUSEELAN K
Collected : 23/03/2022 17:03:00
Received : 23/03/2022 18:03:46
Lab No. : 322079909 Age: 53 Years Gender: Male
Reported : 25/03/2022 21:41:03
Report Status : Final
A/c Status : P Ref by : Dr. RAJIV KUMAR

1. Sensitivity of the assay is 0.01% when copies of ABL detected is 100,000.

Sensitivity is 0.001% when ABL copies detected is 10,00,000 copies/PCR

2. Limit of detection is 10 copies of BCR-ABL fusion gene transcripts per PCR

3. This is an in-house developed assay designed as per EAC (Europe Against Cancer)
protocol

4. This test detects Major (M) gene rearrangements namely- e13a2 & e14a2 or p210
NOTE and Minor (m) gene arrangement e1a2 or p190. This test does not detect micro gene
rearrangement e19a2 or p230.

5. Test conducted on Whole blood / Bone Marrow.

6. This test gives percentage of BCR-ABL fusion gene detected with respect to the
ABL transcript present as well as the International scale value to harmonize the
result.

Chronic Myeloid Leukemia (CML) is the commonest Myeloproliferative neoplasm and

possibly the commonest adult leukemia in India. This clonal stem cell disorder is
characterized by a proliferation of myeloid cells at all stages of differentiation and the
t(9:22) (q34:q11) leading to formation of BCR-ABL fusion gene. Cytogenetic and
COMMENTS molecular studies are vital for the diagnosis of CML by using detection procedures for
Philadelphia chromosome. The abnormality is present in over 95% patients of CML while
remainder 5% have complex or variant translocations involving additional chromosomes.
Major gene rearrangements are detected in CML while minor gene arrangement may be
detected in ALL.

 To monitor therapy in CML patients. A 3 log reduction in BCR-ABL gene

rearrangement is associated with good prognosis.

 Monitoring of Minimal Residual Disease (MRD).

USES
 As a prognostic marker in ALL patients. Presence of BCR-ABL gene
rearrangement is associated with poor prognosis.

Page 4 of 5
.

LPL – MEDITRON LAB

Asramom S.O, MC VI/177/544, VIJAYGIRI TO
WERS, NEAR NAIRS HOSPITAL JN, ASHRAMAN P

Name : SUSEELAN K
Collected : 23/03/2022 17:03:00
Received : 23/03/2022 18:03:46
Lab No. : 322079909 Age: 53 Years Gender: Male
Reported : 25/03/2022 21:41:03
Report Status : Final
A/c Status : P Ref by : Dr. RAJIV KUMAR

Dr Atul Thatai Dr Lopamudra Deka

PhD, Biotechnology DCP; DNB (Pathology)
Technical Director - Molecular Diagnostics Dy. HOD - Histopath & Cytopath - NRL
and R&D NRL - Dr Lal PathLabs Ltd

%
IMPORTANT INSTRUCTIONS

·Test results released pertain to the specimen submitted. ·All test results are dependent on the quality of the sample received by the
Laboratory. ·Laboratory investigations are only a tool to facilitate in arriving at a diagnosis and should be clinically correlated by the Referring
Physician. ·Sample repeats are accepted on request of Referring Physician within 7 days post reporting. ·Report delivery may be delayed due
to unforeseen circumstances. Inconvenience is regretted. ·Certain tests may require further testing at additional cost for derivation of exact
value. Kindly submit request within 72 hours post reporting. ·Test results may show interlaboratory variations. ·The Courts/Forum at Delhi shall
have exclusive jurisdiction in all disputes/claims concerning the test(s) & or results of test(s). ·Test results are not valid for medico legal
purposes. *Contact customer care Tel No. +91-11-39885050 for all queries related to test results.
(#) Sample drawn from outside source. (*) Not in NABL scope.

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