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Immunohistochemistry Prostate Benign vs Malignant Panel Test

DNA Labs India | ISO 9001:2015 Certified

Immunohistochemistry Prostate Benign vs Malignant Panel Test

Short Name: IHC Prostate B vs M Panel

Also known as: IHC Prostate Panel, Prostate Benign vs Malignant IHC Panel, AMACR p63 CK5/6 Prostate Panel, Prostate Carcinoma Immunohistochemistry Panel

Immunohistochemistry Prostate Benign vs Malignant Panel Test test available at DNA Labs India for ₹5,000. Uses Immunohistochemistry (IHC) on Tumor tissue in 10% Formal-saline or Formalin fixed paraffin embedded (FFPE) block samples. Results in Daily sample acceptance by 6 PM. Report delivery: Tissue biopsy — 5 working days; Tissue large complex — 7 working days.. Free home collection in 300+ cities across India.

ImmunohistochemistryMaleAdults (40+)🏠 Home Collection

🩺 Medically Reviewed By

Overview

The purpose of this test is to immunohistochemically characterize prostate biopsy tissue to determine whether atypical glandular foci represent benign conditions or prostatic adenocarcinoma. By evaluating the expression pattern of AMACR (positive in carcinoma), p63 (positive in basal cells, negative in carcinoma), and CK5/6 (positive in basal cells, negative in carcinoma), this panel helps pathologists reach a definitive diagnosis in equivocal cases. It is especially valuable for confirming malignancy in small biopsy cores and for differentiating carcinoma from mimickers such as high-grade PIN with glandular outpouchings.

Test Code
1033
CPT Code
88342
ICD Code
C61
Price
₹5,000
Sample Type
Tumor tissue in 10% Formal-saline or Formalin fixed paraffin embedded (FFPE) block
Result Time
Daily sample acceptance by 6 PM. Report delivery: Tissue biopsy — 5 working days; Tissue large complex — 7 working days.
Fasting Required
No
Method
Immunohistochemistry (IHC)
Step 1

Sample Collection

Provide a copy of the histopathology report, site of biopsy, and relevant clinical history. No special preparation is required from the patient as this test is performed on an already obtained biopsy specimen.

Method: Tissue biopsy (prostate)

Step 2

Laboratory Analysis

The biopsy tissue is submitted in 10% Formal-saline or as a formalin-fixed paraffin-embedded (FFPE) block. The specimen is shipped at room temperature.

Step 3

Report Delivery

After sample receipt at the laboratory, tissue sections are prepared and stained with the three immunomarkers (AMACR, p63, CK5/6). The stained slides are evaluated by a qualified pathologist and a detailed report is generated.

Timeline: Daily sample acceptance by 6 PM. Report delivery: Tissue biopsy — 5 working days; Tissue large complex — 7 working days.

Patient Instructions

1
Before the Test:No patient preparation is required as this test is performed on an already collected biopsy tissue specimen. A copy of the histopathology report, site of biopsy, and clinical history must accompany the specimen.
2
During the Test:The tissue is processed, sectioned, and stained with antibodies against AMACR, p63, and CK5/6 using standardized immunohistochemistry protocols. The stained slides are then examined under a microscope by a pathologist.
3
After the Test:A detailed immunohistochemistry report is generated with the staining results for each marker and an interpretive conclusion. The report is shared with the referring physician for clinical decision-making.

About This Test

Who Should Get This Test

The purpose of this test is to immunohistochemically characterize prostate biopsy tissue to determine whether atypical glandular foci represent benign conditions or prostatic adenocarcinoma. By evaluating the expression pattern of AMACR (positive in carcinoma), p63 (positive in basal cells, negative in carcinoma), and CK5/6 (positive in basal cells, negative in carcinoma), this panel helps pathologists reach a definitive diagnosis in equivocal cases. It is especially valuable for confirming malignancy in small biopsy cores and for differentiating carcinoma from mimickers such as high-grade PIN with glandular outpouchings.

How to Prepare

  • Submit tumor tissue in 10% Formal-saline or as a Formalin Fixed Paraffin Embedded (FFPE) block
  • Ship the specimen at room temperature
  • Provide a copy of the histopathology report along with the sample
  • Include the site of biopsy and relevant clinical history with the referral form
  • Ensure the sample is properly labeled with patient details and specimen source

Doctor's Notes

Reviewed by — MBBS, MD (Pathology) · Reg. No. 21521

"The IHC Prostate Benign vs Malignant Panel is a critical adjunct to routine H&E-stained biopsy evaluation. In cases where a small focus of atypical glands is identified, the combined assessment of AMACR positivity with absence of basal cell markers (p63 and CK5/6) provides strong evidence supporting a diagnosis of prostatic adenocarcinoma. This panel is particularly valuable when differentiating a small carcinoma focus adjacent to high-grade prostatic intraepithelial neoplasia (PIN) from glandular outpouchings of a PIN lesion. Early and accurate diagnosis through this panel enables timely clinical decision-making and appropriate treatment planning."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeTumor tissue in 10% Formal-saline or Formalin fixed paraffin embedded (FFPE) block
Sample VolumeAs per tissue biopsy specimen
Container10% Formal-saline container or FFPE block
Collection MethodTissue biopsy (prostate)

Sample Stability

FFPE blocks: Stable at room temperature indefinitely when stored properly
Tissue in 10% Formal-saline: Stable at room temperature for up to 48 hours before processing
Stained slides: Stable for review and archival as per laboratory retention policy
Sample Rejection Criteria:
  • Specimen received without adequate clinical information or histopathology report
  • Tissue that is excessively necrotic, autolysed, or inadequately fixed
  • Specimen container without proper patient identification or labeling
  • Unlabeled or incorrectly labeled FFPE blocks
  • Specimen received in fixatives other than 10% neutral buffered formalin without prior arrangement

Understanding Your Results

The interpretation of the IHC Prostate Benign vs Malignant Panel is based on the combined staining pattern of three markers: AMACR, p63, and CK5/6. The presence or absence of each marker helps determine whether the atypical glandular focus is benign or malignant.
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Supports a diagnosis of prostatic adenocarcinoma. The absence of basal cell markers (p63, CK5/6) with positive AMACR labeling in atypical glands is consistent with malignancy.

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Supports a benign diagnosis. The presence of an intact basal cell layer with negative AMACR is consistent with benign prostate glands.

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Basal cells are present with AMACR expression. This pattern may be seen in high-grade PIN or other benign mimickers. Clinical correlation and further evaluation may be needed.

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Loss of basal cells without AMACR expression. This pattern is atypical and requires correlation with H&E morphology. Further workup may be necessary.

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When staining results are equivocal or patchy, correlation with H&E morphology, clinical history, and additional immunomarkers as recommended by the pathologist is advised.

⚠️ When to Consult a Doctor:

Consult your oncologist, urologist, or treating physician if the biopsy report shows atypical or suspicious glands, if your PSA levels are elevated, or if the IHC panel results indicate malignancy. Timely consultation is essential for appropriate treatment planning and management of prostate cancer.

Limitations

  • This panel provides immunohistochemical support and must be interpreted in conjunction with H&E morphology and clinical context
  • Rare variants of prostate cancer may show atypical staining patterns for AMACR, p63, or CK5/6
  • AMACR is not entirely specific to prostate cancer and can be positive in some benign mimickers
  • Results are qualitative and do not provide quantitative data on tumor burden or grade
  • Small or fragmented tissue samples may not yield sufficient material for all three markers

Risks & Considerations

  • This test is performed on an already obtained biopsy specimen; no additional invasive procedure is required
  • There is no direct risk to the patient from the IHC staining process itself
  • A small possibility of inconclusive results may require repeat biopsy or additional testing

Interfering Factors

  • Inadequate fixation of tissue specimen may affect antigen preservation and staining quality
  • Excessive decalcification can degrade antigens and produce false-negative results
  • Crush artifact or necrotic tissue may yield unreliable staining patterns
  • Delay in fixation beyond recommended time may compromise immunoreactivity
  • Prior treatment such as radiation or hormonal therapy may alter marker expression

Compare With Similar Tests

TestImmunohistochemistry Prostate Benign vs Malignant Panel TestPSA Blood TestProstate Biopsy with H&E StainingProstate MRI
ComparisonImmunohistochemistry Prostate Benign vs Malignant Panel TestPSA is a screening blood test that detects elevated prostate-specific antigen levels. It indicates the need for further evaluation but cannot distinguish between benign and malignant conditions. The IHC panel provides tissue-level confirmation of malignancy.Routine H&E staining is the standard first-line evaluation of prostate biopsy tissue. The IHC panel serves as a complementary test when H&E findings are equivocal or when a small focus of atypical glands requires confirmation.MRI is an imaging modality used to identify suspicious areas in the prostate for targeted biopsy. It does not provide histological diagnosis. The IHC panel confirms the histological nature of the lesion at the protein expression level.

Frequently Asked Questions

What is the Immunohistochemistry Prostate Benign vs Malignant Panel Test?
This is a diagnostic test that uses immunohistochemical staining with antibodies targeting AMACR, p63, and CK5/6 proteins in prostate tissue. It helps distinguish between benign and malignant prostate tumors by evaluating the expression pattern of these markers on biopsy specimens.
Why is this test recommended?
This test is recommended when a prostate biopsy shows small foci of atypical glands where routine H&E-stained slides alone are insufficient to confirm whether the tissue is benign or malignant. It provides immunohistochemical evidence to support a definitive diagnosis.
What do AMACR, p63, and CK5/6 indicate?
AMACR is a marker that is typically positive in prostatic adenocarcinoma. p63 and CK5/6 are basal cell markers that are present in benign prostate glands and absent in carcinoma. The combination of AMACR positivity with p63 and CK5/6 negativity supports a diagnosis of malignancy.
What sample is required for this test?
The test requires a prostate biopsy tissue specimen submitted in 10% Formal-saline or as a formalin-fixed paraffin-embedded (FFPE) block. A copy of the histopathology report, site of biopsy, and clinical history must also be provided.
Is fasting required before this test?
No, fasting is not required. This test is performed on a tissue biopsy specimen that has already been collected. No additional patient preparation is needed.
What is the cost of this test at DNA Labs India?
The Immunohistochemistry Prostate Benign vs Malignant Panel Test costs INR 5000 at DNA Labs India. This is a special discounted price available across India.
How long does it take to get the results?
Results are typically available within 5 working days for standard tissue biopsy samples. For large or complex tissue specimens, the turnaround time may extend to 7 working days.
Is home sample collection available for this test?
Yes, DNA Labs India offers free home sample collection for online bookings. However, since this test requires a biopsy tissue specimen, the sample is typically collected at the hospital or clinic where the biopsy was performed and shipped to the laboratory.
Can this test confirm prostate cancer?
This test provides strong immunohistochemical evidence to support a diagnosis of prostatic adenocarcinoma when the staining pattern shows AMACR positivity with absence of basal cell markers (p63 and CK5/6). However, the final diagnosis is made by the pathologist based on combined H&E morphology and IHC results along with clinical context.
What happens if the results are equivocal?
If the IHC staining results are equivocal or do not fit a clear benign or malignant pattern, the pathologist may recommend additional immunomarkers, repeat biopsy, or clinical correlation. Your treating physician will guide you on the next steps.
Is this test the same as a PSA test?
No. A PSA (Prostate-Specific Antigen) test is a blood test used for prostate cancer screening. The IHC Prostate Panel is a tissue-based test that examines protein expression in biopsy tissue to determine if the tissue is benign or malignant.
Who should I consult after receiving the test results?
You should consult your referring oncologist, urologist, or treating physician to discuss the results. They will interpret the findings in the context of your overall clinical situation and recommend appropriate treatment or further evaluation.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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