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01-14-2007, 10:07 PM
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#1
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Senior Member
Join Date: Feb 2006
Location: Southern, CA
Posts: 2,511
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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
__________________
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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01-15-2007, 12:30 PM
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#2
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Senior Member
Join Date: Aug 2006
Location: PA
Posts: 188
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Chelee,
That does seem odd. I would definatley ask your onc at the next visit to explain that statment to you. I know I would want to know !
Take Care !!
__________________
Susan V - Pittsburgh PA
DX Age 37 on August 3, 2006
Stage 1 Grade 3
ER/PR + (Highly Positive)
Her 2 +++
1.3 & 1.2 tumors right breast
node negative
lumpectomy 8-15-06
A/C Began 9-5-06 Finished A/C 11/6/06
Port Placement 9-15-06
Negative Test for BRAC1 & BRAC2 10-25-06
Began Tamoxofin November 21, 2006
First Herceptin November 27, 2006 Continues every 3 Weeks
First Radiation Treatment December 11, 2006
35 Rads Completed
Final Herceptin Treatment November 12, 2007
Port Removal November 19, 2007
Living Life to the Fullest !!
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01-15-2007, 02:36 PM
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#3
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Senior Member
Join Date: May 2006
Posts: 93
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Ventana provides test kits. These kits have been FDA approved and contain the antibodies needed to identify the specific items listed in your post, however the kits do not contain some common laboratory items (dewaxing agent, ethanol, sterile water, formalin, some stains, etc.). These items are made by various companies, and are used interchangeably with various tests. Often, these items are not individually FDA approved.
During the FDA approval process, Ventana obviously did not submit every possible combination of stains/reagents/ovens/microscopes, etc. usable with their products. It appears that this is just legalese to protect the company and the lab. The important part is the last sentence - controls were run showed appropriate staining.
__________________
Husband to Jill
Diagnosed 10/05, age 39
R Mast 11/05
Stage II N0
Her2+ er/pr+
Revision Mast due to positive margins 12/05
TCH Chemo started 1/06
Finished TC 4/06
Tamoxifen
Finished H 12/29/06
Currently NED
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01-17-2007, 12:49 AM
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#4
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Senior Member
Join Date: Feb 2006
Location: Southern, CA
Posts: 2,511
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CPA, I was so afraid no one would know anything about this...it isn't the normal question you run into. I see you are very knowledgeable about this subject. I didn't know what to think when I read that on my path report? But I sure feel better about it now.  Thank YOU SO MUCH. I was a bit concerned since staining plays an important part in this.
Again, thank you!
Chelee
__________________
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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01-19-2007, 10:31 PM
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#5
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Webmaster
Join Date: Feb 2005
Location: Home of the "Flying Tomato"
Carlsbad, CA
Posts: 2,036
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Chelee,
The Ventana Test was FDA approved this week. We are in contact with them and will be providing additional information shortly.
Regards
Joe
__________________
A Proud webmaster to the internet's most informed, educated, COMPASSIONATE and caring group of breast cancer survivors.
Illegitimi non carborundum
My Album
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01-20-2007, 11:51 PM
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#6
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Senior Member
Join Date: Feb 2006
Location: Southern, CA
Posts: 2,511
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Thanks Joe, I will look forward to that.
Chelee
__________________
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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