.

LPL - LPL-ROHINI (NATIONAL REFERENCE LAB)

SECTOR - 18, BLOCK -E ROHINIDELHI 110085

Name DUMMY N072 Collected 29/7/2020 1:25:00PM

Received 29/7/2020 3:45:34PM

Lab No. 153672477 Age: 54 Years Gender: Female Reported 31/7/2020 2:07:20PM

A/c Status P Ref By: UNKNOWN Report Status Final

TEST CONDUCTED EGFR MUTATIONAL ANALYSIS

(PCR, Sequencing, Fragment analysis)

RESULTS

EGFR Exon 18 Mutation EGFR Exon 19 Mutation EGFR Exon 20 Mutation EGFR Exon 21 Mutation

Not Detected Not Detected Not Detected Not Detected

Note
1. This is an in-house developed test useful for the detection of point mutations and insertions/deletions in
Exons 18 - 21.
2. Sanger Sequencing detects Point mutations in exons 18, 20 and 21 (LOD 10%) while Fragment
analysis detects insertions/deletions in exons 19 and 20 (LOD 1%)
3. The tissue should contain at-least 10% of tumor cells.
4. This assay does not detect mutations located in regions of the genes that are not analyzed and gross
genetic alterations including most large deletions, duplications, and inversions.

Comment
The identification of EGFR as an oncogene has led to the development of anticancer therapeutics directed
against EGFR (called "EGFR inhibitors"), including Gefitinib and Erlotinib for lung cancer, and Cetuximab for
colon cancer. Patients positive for EGFR mutations benefit from Tyrosine kinase inhibitors like Gefitinib. About
20% of Non Small Cell Lung Cancer (NSCLC) carry the EGFR mutation and 85% of these patients benefit
from therapy with Erlotinib and Gefitinib.

Mutations detected by the assay

--------------------------------------------------------------------------------
| EGFR EXON | EGFR CODON | MUTATION |NUCLEOTIDE |APPROXIMATE % OF |
| | | (AMINO ACID)|SUBSTITUTION |ALL EGFR MUTATIONS |
| | | | |(LINDEMAN ET.AL 2013)|
|-----------|-----------------|-------------|--------------|---------------------|
| | | E709K |c.2125G>A | |
| | |-------------|--------------| |
| | | E709A |c.2126A>C | |
| | |-------------|--------------| |
| | | E709G |c.2126A>G | |
| | |-------------|--------------| |
| | E709 | E709V |c.2126A>T | 1 |
| | |-------------|--------------| |
| 18 | | E709D |c.2127A>C, | |
| | | |c.2127A>T | |
| | |-------------|--------------| |
| | | E709Q |c.2125G>C | |
| |-----------------|-------------|--------------|---------------------|
| | | G719S |c.2155G>A | |
| | |-------------|--------------| |
PatientReportSCSuperPanel.FLOWCYTO_DYNAMIC_SC (Version: 6)

*153672477*
Page 1 of 3
.

LPL - LPL-ROHINI (NATIONAL REFERENCE LAB)

SECTOR - 18, BLOCK -E ROHINIDELHI 110085

Name DUMMY N072 Collected 29/7/2020 1:25:00PM

Received 29/7/2020 3:45:34PM

Lab No. 153672477 Age: 54 Years Gender: Female Reported 31/7/2020 2:07:20PM

A/c Status P Ref By: UNKNOWN Report Status Final

| | G719 | G719A |c.2156G>C | 2-5 |

| | |-------------|--------------| |
| | | G719C |c.2155G>T | |
| | |-------------|--------------| |
| | | G719D |c.2156G>A | |
|-----------|-----------------|-------------|--------------|---------------------|
| |K739, I740, P741,| Insertions | | |
| |V742, A743, I744 | 18-bp ins | | 1 |
| |-----------------|-------------|--------------|---------------------|
| | | Deletions | | |
| 19 |E746, L747, R748,| 15-bp del | | |
| |E749, A750, T751,| 18-bp del | | 45 |
| | S752, P753 | 9-bp del | | |
| | | 24-bp del | | |
| | | 12-bp del | | |
|-----------|-----------------|-------------|--------------|---------------------|
| | | Insertions | | |
| |S768, V769, D770,| 3-bp ins | | |
| 20 |N771, P772, H773,| 6-bp ins | | 5-10 |
| | V774 | 9-bp ins | | |
| | | 12-bp ins | | |
| | S768 | S768I |c.2303G>T | 1-2 |
| |-----------------|-------------|--------------|---------------------|
| | T790 | T790M |c.2369C>T |2(Associated with |
| | | | |resistance) |
|-----------|-----------------|-------------|--------------|---------------------|
| | L858 | L858R |c.2573T>G | |
| | |-------------|--------------| 40 |
| | | L858M |c.2572C>A rare| |
| 21 |-----------------|-------------|--------------|---------------------|
| | L861 | L861Q |c.2582T>A | |
| | |-------------|--------------| 2-5 |
| | | L861R |c.2582T>G | |
--------------------------------------------------------------------------------

Dr Anand Chandrasekaran Annan Dr Atul Thatai

MD (American Board of Pathology) PhD, Biotechnology
PhD (Molecular & Cellular Pathology) HOD Molecular Diagnostics
HOD - Oncopathology NRL - Dr Lal PathLabs Ltd

-------------------------------End of report --------------------------------

PatientReportSCSuperPanel.FLOWCYTO_DYNAMIC_SC (Version: 6)

*153672477*
Page 2 of 3
.

LPL - LPL-ROHINI (NATIONAL REFERENCE LAB)

SECTOR - 18, BLOCK -E ROHINIDELHI 110085

Name DUMMY N072 Collected 29/7/2020 1:25:00PM

Received 29/7/2020 3:45:34PM

Lab No. 153672477 Age: 54 Years Gender: Female Reported 31/7/2020 2:07:20PM

A/c Status P Ref By: UNKNOWN Report Status Final

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.

PatientReportSCSuperPanel.FLOWCYTO_DYNAMIC_SC (Version: 6)

*153672477*
Page 3 of 3
.

LPL – LPL-ROHINI (NATIONAL REFERENCE LAB)

SECTOR - 18, BLOCK -E
ROHINIDELHI 110085

Name : DUMMY XX031 Collected: 29-07-2020 13:24:00

Received: 29-07-2020 15:45:27
Lab No. : 153672479 Age : 40 Years Gender: Male Reported: 04/08/2020 13:59:38

A/c Status : P Ref by : UNKNOWN Report Status: Final

Fluorescence in-situ Hybridization (FISH)

ALK1 Break Apart Rearrangement Assay

Specimen : Formalin fixed paraffin embedded tissue block

Clinical Indication : To rule out ALK1 gene rearrangement

Block No: : B/1010 (60% Tumor)

Result: FISH analysis on a paraffin-embedded tissue is negative for ALK1 gene rearrangement in 50 interphase nuclei
scored.
A specimen is considered positive for an ALK gene rearrangement when >15% of tumor cells show split signals or single 3’
ALK signals with a minimum of 50 cells scored. Therefore, this result is considered negative for an ALK rearrangement.
Structural rearrangements of the ALK gene include paracentric inversions of the short arm of chromosome 2 and
translocations involving various translocation partners with the ALK gene. Also, deletions of the 5’ ALK gene region are a
recurrent abnormality in conjunction with inversions and result in the loss of a single 5’ ALK signal.

Normal nuclei Abnormal nuclei

Interphase nuclei analyzed 2 Yellow Signals 1 Orange 1 Green 1 Yellow Signals

50 50 00

Probe : LSI ALK1 (2p23) Spectrum Orange Spectrum Green probe.

Cut off : Sample is considered negative if <10% cells are positive.
Sample is considered positive if >15% cells are positive.
Sample is considered equivocal if <10 to 15% cells are positive.

Note: This is a Laboratory developed test (LDT), developed at Dr. Lal PathLabs and has not been cleared or
approved for specific uses by FDA.

Page 1 of 2
*153672479*
.

LPL – LPL-ROHINI (NATIONAL REFERENCE LAB)

SECTOR - 18, BLOCK -E
ROHINIDELHI 110085

Name : DUMMY XX031 Collected: 29-07-2020 13:24:00

Received: 29-07-2020 15:45:27
Lab No. : 153672479 Age : 40 Years Gender: Male Reported: 04/08/2020 13:59:38

A/c Status : P Ref by : UNKNOWN Report Status: Final

Comment : Non-small cell lung carcinoma (NSCLC) accounts for 75% to 80% of all lung cancers with an overall 5-year
survival rate of 10% to 15%. Standard chemotherapy regimens have had marginal success in improving clinical outcomes.
Rearrangements of the Anaplastic lymphoma receptor tyrosine kinase (ALK) locus are found in a small subset of lung
carcinomas and the identification of ALK-driven lung cancer guides important therapeutic management of these tumors.
Rearrangement (translocation) of the ALK gene with a fusion partner gene, most commonly echinoderm microtubule-
associated protein-like 4 (EML4), results in a constitutively active fusion gene. Lung cancers harboring ALK rearrangements
are highly sensitive to ALK inhibitor drugs, which work by blocking certain kinases including those produced by the abnormal
ALK fusion gene. The FDA has approved the use of Xalkori (Crizotinib), an ALK inhibitor drug, for NSCLC patients with
tumors exhibiting ALK rearrangements.

Uses : Detection of rearrangements involving the ALK gene region at 2p23 in patients with Non-small cell lung carcinoma
who may benefit from treatment with the ALK inhibitor drugs, like Xalkori (Crizotinib).

Dr Anand Chandrasekaran Annan Dr Saurabh Kumar Bhattacharya

MD (American Board of Pathology) PhD, Cytogenetics
PhD (Molecular & Cellular Pathology) HOD Clinical Cytogenomics
HOD - Oncopathology 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.

Page 2 of 2
*153672479*