Sunday, February 1, 2015

Proposed FDA Regulations of 'Lab Developed Tests': A Potential Problem

I need your help.

There are newly proposed FDA regulations requiring approval for "lab developed tests", (LDTs).   Although these regulations will apply to all LDTs,  I'm particularly concerned because these regulations could have significant consequences for cancer patients.  Approval of LDTs can take years. I fear that those of us with advanced cancer will die waiting for the approval of tests that have already been validated; proven to be accurate, sensitive and specific. These regulations will put the brakes on breakthrough testing which leads to new treatments and potential cures.  I am alive only because of new science and the testing and treatments that have followed.  These regulations would be a huge step BACKWARDS. 

I know, one day, my medication will stop working and I will need testing 
to guide my doctors in a new treatment direction.  I will need this testing  quickly and, potentially, would not be able to get it if the test is new and not yet approved by this FDA regulatory body. 

Please read the information provided in the link below.  Please sign the petition.

If you have it in you, let your Congressional Representative and your Senators know that these proposed regulatory measures should not be passed. (You can email them.)

Find your Sentors: 

Find your Representative:

You can even email President Obama/the White House:

Any help is greatly appreciated by me, everyone with cancer, and those that love us.  


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Jeff Etten said...

Signed the petition, contacted my Senator, House Representative and the White House!