HER2 Support Group Forums - HER2 Serum Test

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- - HER2 Serum Test - Approved in Canada (https://her2support.org/vbulletin/showthread.php?t=35196)

HER2 Serum Test - Approved in Canada

I'm pleased to announce that the
HER-2/neu ELISA
was approved by Health Canada today (see attached).
This approval will greatly reduce the burden on our customers
who previously could only purchase the kit through Special Access.
I'd like to thank Don Tenney for all of his support.
With his help we produced a high-quality submission
that only raised a few minor questions during review.

The following parts may now be sold in Canada (with the Special Access restrictions removed):

Part

Part Number
HER-2/neu ELISA
06489876

HER-2/neu ELISA Controls
06489884

Matt Gee
Regulatory Affairs Associate
Siemens Medical Solutions Diagnostics, Inc.
1200 Courtney Park Drive East(new address)
Mississauga, ON L5T 1P2
Tel: 905-795-4539 (new number)
Fax: 905-795-4410 (new number)
Email: matthew.gee@siemens.com

Joe,

I am happy to hear this for all the women in Canada who are HER2. I had another test ran in July and my level is 9.

Amelia

That is good for Canadians indeed.

does anyone as an idea of the cost of the her2 serum?
and how it compares to CA15-3 even perhaps?

Thanks Joe for letting us know. I will ask my onc. about this at my next appointment.

all the best
caya (in Toronto, Canada)

Cost of HER 2 Test

I talked to my oncologist yesterday and got him to find out how much my test cost.

In Georgia, the cost is around $300.00 dollars. If your insurance has a plan with the lab it will be less than this.

He was amazed at the cost of the test. He thought it would be much higher.

Amelia

Hi caya.... is the test available here?
LILI7

Now we just need to get it down here...........