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Path report & staining method...
I had my path report out looking for my ki-67 today. I never noticed it till today but in super small print that you can't read with the naked eye it says:
Note: These staining procedures were developed by Ventana Corp. & their performance characteristices verified in the Histology Laboratory of (my hospital name). The results above may include stains for ER (clone 6F11), PR (clone 1A6), HER-2/neu (anti-c-erbB-2 (ASR) clone #4B5) and/or pankeratin (AE1, AE3, and PCK26). These reagents have not been cleared or approved by the U.S. Food and Drug Administration. Controled stains were run concurrently and show appropriate staining.
I was a little concerned to read the part I highlighted in RED. These aren't ok'd or cleared by the FDA? I wonder if I can fully trust my path report. Would this bother any of you if you saw it on your report? Maybe I should have my Er & Pr checked again? It was weakly postive on both.
Chelee
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DX: 12-20-05 - Stage IIIA, Her2/Neu, 3+++,Er & Pr weakly positive, 5 of 16 pos nodes.
Rt. MRM on 1-3-06 -- No Rads due to compromised lungs.
Chemo started 2-7-06 -- TCH - - Finished 6-12-06
Finished yr of wkly herceptin 3-19-07
3-15-07 Lt side prophylactic simple mastectomy. -- Ooph 4-05-07
9-21-09 PET/CT "Recurrence" to Rt. axllia, Rt. femur, ilium. Possible Sacrum & liver? Now stage IV.
9-28-09 Loading dose of Herceptin & started Zometa
9-29-09 Power Port Placement
10-24-09 Mass 6.4 x 4.7 cm on Rt. femur head.
11-19-09 RT. Femur surgery - Rod placed
12-7-09 Navelbine added to Herceptin/Zometa.
3-23-10 Ten days of rads to RT femur. Completed.
4-05-10 Quit Navelbine--Herceptin/Zometa alone.
5-4-10 Appt. with Dr. Slamon to see what is next? Waiting on FISH results from femur biopsy.
Results to FISH was unsuccessful--this happens less then 2% of the time.
7-7-10 Recurrence to RT axilla again. Back to UCLA for options.
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