Ovarian Cancer Support Group

Hi Orrange,

I hope you will look at my discussion on a screening test available that is 100% accurate in detecting ovarian cancer in clinical trials. This test has been available since 2002. It's called proteomics and I have been waiting since then because I am so high risk for ovarian cancer. Why is it not available? I did some research and the FDA is holding it up. They approve drugs that cause damage to the liver and death but this non-invasive test that only requires a drop of blood is being held up. There has been conflicts of interest at the NIH and the FDA and you guessed it it's all about the money. Check on the web. Use these key words. Correlogic, conflict of interest, NIH and FDA and you will read plenty. This technology can diagnose all kinds of cancer in it's early stage but think of all the money that would be lost by companies in the business of curing advanced cancer.

Hey SharonHanson
I am not nearly as cynical as you about this.
Everyone in medicine is incredibly excited about the field of proteomics (the study of proteins..to be distinguished from genomics which is the study of genes) and tons and tons of money is being poured in to basic research using proteomics for detection/treatment/predicting prognosis of ALL cancers (colon, ovarian, etc)
Remember a lab test does NOT require FDA approval and even on Correlogics own website they report they are still waiting to publish results from any long term prospective studies on ovacheck (the test you are talking about.)
It will be very very expensive for patients and I think we ALL want to make sure it works..the 100% accuracy you quote has not been tested in large trials (they tell you this on their own website) but wont that be great if that proves to be true....
Dr O.

Hello Dr. Orrange,

I don't believe I am cynical just honest. I have to respectfully disagree with you as I have reviewed their website and read numerous articles regarding this. You have to understand I have been waiting five years for this test to become commercially available and you can say all you want but five years for whatever reason is a long time to wait for a non-invasive test that only requires a drop of blood.
The FDA in a departure from previous practice decided to exercise regulatory authority in this area. It could be offered as a laboratory developed test, regulated under the Clinical Laboratory Improvement Act however because they decided to exercise regulatory authority over In Vitro Diagnostic Multivariate Index Assays it will require large-scale prospective clinical trials and many months of additional sample/data collection. I still ask why? A drop of blood is pretty non-invasive and I want to know why and I think others should also ask why and call their representatives to find out why the FDA has decided to do this. Lives could be saved.