Report_25010008735_YAM KUMARI SIGDEL
Report_25010008735_YAM KUMARI SIGDEL
Report_25010008735_YAM KUMARI SIGDEL
TEST NAME
HER2
SPECIMEN INFORMATION
Labelled as 2097/24
CLINICAL HISTORY
Invasive carcinoma.
METHODOLOGY
Fluorescence In Situ Hybridization
DIAGNOSIS
FISH MARKER Result
Probe used: HEALTHCARE HER2/CEP17 dual color probe. HER2: Orange, CEP17: Green
CLINICAL INTERPRETATION
1. As the Her2/neu IHC is 2+ the sample is Negative for HER2/neu amplification as per ASCO 2018 guideline
2. Her2:CEP17 ratio is <2 and Average Her2 signals 4-6 (Group 4).
COMMENTS
1. Evaluation of this specimen shows a normal hybridization pattern. These findings are indicative that the patient is not
eligible for anti HER2 therapy (Trastuzumab).
2. Her2 gene amplification is seen 18 to 20% of invasive breast cancers. These tumours show increased over all survival rate
with Her2 targeted therapy such as Trastuzumab.
3. It has been recognised as a poor prognosis indicator in early breast cancer.
4. In cases where tumor heterogeneity is present, analysis of HER2 FISH on additional blocks is recommended for conclusive
result.
REFERENCES
1.Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer American Society of Clinical Oncology/College of
American Pathologists clinical Practice Guideline Focused Update
2. Antonio C. Wolff, M. Elizabeth Hale Hammond, Kimberly H. Allison, Brittany E. Harvey, Pamela B. Mangu, John M.S. Bartlett,
Michael Bilous, Ian O. Ellis, Patrick Fitzgibbons, Wedad Hanna, Robert B. Jenkins, Michael F. Press, Patricia A. Spears, Gail H.
Vance, Giuseppe Viale, Lisa M. McShane, and Mitchell Dowsett Journal of Clinical Oncology 2018 36:20, 2105-2122
Disclaimer:
• Testing only validated for FFPE specimens; specimens fixed in other than 10% neutral buffered formalin have not been validated using this method. Fixation time
should not be less than 6 hours and not more than 72 hours for FISH testing.
• Specimens placed in decalcifying solution may have a false-negative result.
• This test is not FDA approved / cleared for specific uses.
• Repeat testing is recommended for discordant results.
If you have any ques ons about this report or would like to have a conversa on about the test results,
please feel free to reach out to us at
CONDITIONS OF REPORTING
1. The tests are carried out in the lab with the presump on that the specimen belongs to the pa ent named or
iden fied in the bill/test request form.
2. The test results relate specifically to the sample received in the lab and are presumed to have been
generated and transported per specific instruc ons given by the physicians/laboratory.
3. The reported results are for informa on and are subject to confirma on and interpreta on by the referring
doctor.
4. Some tests are referred to other laboratories to provide a wider test menu to the customer.
5. CORE Diagnos cs Pvt. Ltd. shall in no event be liable for accidental damage, loss, or destruc on of specimen,
which is not a ributable to any direct and mala fide act or omission of CORE Diagnos cs Pvt. Ltd. or its
employees. Liability of CORE Diagnos cs Pvt. Ltd. for deficiency of services, or other errors and omissions
shall be limited to fee paid by the pa ent for the relevant laboratory services.
This report is the property of CORE Diagnos cs. The informa on contained in this report is strictly confiden al and is only for
the use of those authorized. If you have received this report by mistake, please contact CORE Diagnos cs
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