Diagnostic and Theranostic Markers


Immunohistochemistry (IHC) has evolved and expanded its use in pathology from diagnosis and classification, to predictive and prognostic utility. Our laboratory provides a wide range of these markers.We have two state of the art latest fully-automated IHC platforms,VentanaBenchMarkXT (http://www.adriamed.mk/en/tissue-diagnostics-ventana-benchmark-xt/),VentanaBenchMark Ultra (https://diagnostics.roche.com/global/en/products/instruments/benchmark-ultra.html) and Leica Bond III systems.

Theranostic and Prognostic Biomarkers

Discipline of immunohistochemistry for the surgical pathologist has been evolving rapidly, and it also has theranostic and genomic applications. IHC has been adapted to the identification and demonstration of both prognostic and predictive markers.

The term “theranostics” is used to describe the proposed process of diagnostic therapy for individual patients and to tailor a treatment for them based on a test result.

Hormonal Receptors [Estrogen Receptor (ER),Progesterone Receptor (PR)]

Breast Carcinomas– Hormone receptors {Estrogen receptor (ER) and Progesterone receptor (PR)} and HER2 testing is recommended to be done on all primary invasive breast carcinomas and on recurrent or metastatic tumors, and reported as per guidelines published by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP).

Hormone receptor (HR) expression in invasive breast carcinoma has both prognostic and predictive significance; the use of endocrine therapy in HR-positive breast carcinomas has been shown to reduce the rates of recurrence and mortality.

The recommended pre-analytic and analytic variables required for tests, like cold ischemia time, are strictly maintained.

Endometrial Carcinomas – Hormone receptor (ER and PR) expression is also assessed on primary invasive endometrial endometrioid adenocarcinomas to predict response to endocrine therapy.

Human epidermal growth factor receptor 2 (HER2) Receptor testing

Breast Carcinoma- HER2 status is primarily evaluated to determine patient eligibility for anti-HER2 therapy in breast carcinomas. Reflex FISH (fluorescence in situ hybridization) test is performed in equivocal cases to confirm the amplification status.

 Female genital tract – HER2 Testing is done on high grade endometrioid and serous endometrial carcinomas as a prognostic marker.

Gastric carcinoma – Assessment for tumor HER2 overexpression using IHC is done to determine patient eligibility for anti-HER2 therapy.

Salivary gland tumors- HER2 expression is done using IHC as a diagnostic marker for the aggressive salivary duct carcinomas.


BRAF V600E is done as a surrogate marker for BRAF gene mutations (with predominant mutation seen at V600E). It has a role in thyroid papillary carcinoma, colon adenocarcinoma, and melanoma, with therapeutic implications.

Human papillomavirus (HPV)

P16 immunohistochemistry is used as a surrogate marker of active HPV in head and neck oropharyngeal squamous cell carcinomas (OPSCC), and cervical carcinomas.

Epstein-Barr virus (EBV) detection using in situ hybridization (ISH) for EBV-encoded small RNAs (EBER) in nasopharyngeal carcinomas, lymphoepithelial carcinomas, and also for several types of hematopoietic malignancies.

NUT (nuclear protein in testis) : NUT is used as a diagnostic marker for NUT midline carcinoma which is a rare, aggressive, squamous cell carcinoma variant uniquely defined by NUT gene translocations.

Succinate Dehydrogenase (SDH)

SDH-B is performed to identify cases with germline/sporadic mutation in the enzyme succinate dehydrogenase, seen in gastrointestinal tumors (GISTs), extra adrenal paragangliomas, pheochromocytomas and some renal tumors (SDH-B deficient RCC).

PD-L1 (programmed death ligand-1)

RGCIRC was the first centre in North India to introduce PD-L1 immunoexpression testing by IHC as a predictive marker of immunotherapy in various solid organ tumors. PD-L1 scoring is done by Roches’s Ventana SP263 clone, on Ventana  Benchmark XT autostainer. The SP263 assay is CE (European conformity) labeled to inform treatment decisions in lung cancer patients being considered for Keytruda (Pembrolizumab) immunotherapy as a first line of treatment.

PDL-1 scoring for by monoclonal antibody SP142 is done on benchmark ultra Ventana autostainer, which is FDA approved assay for metastatic triple negative breast cancer (TNBC), Non-small cell lung carcinoma (NSCLC) and urothelial carcinoma for patient selection, to be treated with Tecentriq (atezolizumab).

Mismatch Repair (MMR) Immunohistochemistry Testing

IHC testing for DNA MMR protein expression (MLH1, MSH2, MSH6, and PMS2 expression) is performed to detect germline mutations in these MMR genes, and identify Lynch syndrome (hereditary nonpolyposis colorectal cancer syndrome [HNPCC]) which is associated with risk of cancers of colorectal, endometrial, gastric, upper urinary tract origin. HNPCC is an autosomal dominant inherited cancer syndrome with mutation in DNA mismatch repair genes. Loss of one or more proteins by IHC is suggestive of defective DNA mismatch repair within the tumor.

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Rajiv Gandhi Cancer Institute and Research Centre is today counted amongst Asia’s premier exclusive cancer centres that offer unique advantage of cutting edge technology, put to use by renowned super specialists. This potent combination of man and machine ensures world-class cancer care to not only patients from India, but also from the neighboring SAARC countries and others.

Sir Chotu Ram Marg, Sector - 5, Rohini Industrial Area, Rohini, New Delhi - 110085, India | +91-11-47022222
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Squadron Leader Mahendra Kumar Jain Marg, Block K, Niti Bagh, New Delhi - 110049 | +91-11-45822222
OPD Timings: 09:00 am to 05:00 pm (All Weekdays except Sunday and Holiday)
Emergency Services: 24x7 All Weekdays

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