ER & PR Validation
PhenoPath Laboratories is pleased to offer validation for your estrogen and progesterone (ER/PR) immunohistochemical (IHC) assays as outlined in the recently published ASCO/CAP guidelines. PhenoPath's ER and PR IHC assays have both been clinically validated with outcome data on more than 4,000 patients followed for a median of 12.4 years. Our ER and PR assays have also been validated against biochemical (e.g., DCC) and molecular (RT-PCR) based ER and PR assays.
The ASCO/CAP guidelines recommend testing 40 cases per antibody in parallel with clinically validated assays, with a mix of positive and negative cases. An acceptable validation outcome includes 90% concordance for positives and a 95% concordance for negatives. For further details visit www.cap.org and click on the Reference Resources and Publications link at the top, then on ER/PgR Guideline and Resources.
Getting Started
Order Requisition
Complete the Validation Studies Requisition Form.
- For blocks, include a list of the cases in the shipment (an Excel spreadsheet emailed to lab@phenopath.com is preferred)
- For TMAs, email a blank map of the TMA to lab@phenopath.com for use as a template for scoring (required).
Specimen
Blocks, unstained sections, or tissue microarray (TMA) sections. NOTE: At least four unstained sections or a paraffin block is recommended.
Shipping
Contact Client Services at 888-927-4366 for supplies and shipping instructions.
Service & Report Provided
We will stain and interpret the slides, and record the results
per ASCO/CAP guidelines in a final Excel report, which will include:
- Histologic diagnosis (such as DCIS, infiltrating ductal carcinoma, etc.)
- Percent of invasive carcinoma exhibiting nuclear positivity Staining intensity
- Staining of internal controls
- Final positive or negative result
FAQs
What clones are you using for ER and PR?
PhenoPath has clinically validated assays for ER (clone: SP1) and PR (clone: PgR636)
Do we need to validate with a lab using the same clones as we are using?
No, it is not necessary to match clones. In fact, a comparing your clone against one of our clinically-validated clones is an acceptable method for demonstrating equivalence without performing a complete clinical validation.
What imaging system are you using?
PhenoPath pathologists score ER and PR at the microscope according to ASCO/CAP guidelines. No external imaging system is employed.
Will you accept a PO and invoice our institution?
Yes, we are happy to accept your Purchase Order.
Do you accept credit cards?
Yes, we are happy to accept VISA, Master Card and Discover.
Do you prefer unstained slides or paraffin blocks?
We can work with either. If sending unstained sections, they should be cut at 4μ onto charged (Plus...) slides and submitted for testing within 2 months of sectioning. Please send 4 unstained sections per block.
We utilize microwave-processed breast tissue and need to find a lab that has clinically validated their method on this type of specimen. Have you done so with microwave- processed specimens?
We do not use a tissue microwave processor. We are validating the ER/PR staining, not the processing itself. The microwave-processed tissue needs to be validated against conventionally-processed tissue. Samples could be split between the 2 types of processing, and these split-samples stained for ER/PR, and those results compared. PhenoPath can then validate ER/PR staining on your blocks.
Do you provide stain-only service for ER/PR validation?
No, since our clinically-validated assays include scoring by one of our pathologists, ER/PR validation intrinsically includes scoring.
What is your Turnaround Time (TAT)?
3 weeks from receipt of specimens.
What will the validation report look like?
It will be an Excel format with your case #, a diagnosis, % of tumor staining, intensity of staining (weak, moderate, strong), staining on normal ducts scored as Positive, Negative or Not Present, and a final result of Positive or Negative. This is done for each antibody and each tissue. (see example below)
