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Combidex going away

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Posted 8/13/2009 3:23 AM (GMT 0)
I read on another PCa site that the company (AMAG ?)that makes the Combidex fluid will cease or has ceased to manufacture it. So it looks like the test will not be available in Holland or the US. 

Don 

Posted 8/13/2009 2:11 PM (GMT 0)
Don,
I can't find anything that supports this information. In the latest press releases by Advanced Magnetics Inc. (AMAG) I read where the FDA has approved a fast track for the contrast. If something better is on the horizon for AMAG then I could understand but nothing has been announced. If you can please forward what you saw and I will bring it to my advocacy friends and see what they have heard. The only negative I have heard is that Combidex has led to false positive detections in lymph nodes in up to as much as 25% of cases. But that is not necessarily a bad news item. Once a node is suspected to be positive in the imaging, then biopsy with less invasive needles is possible to verify the imaging.

Tony
Posted 8/13/2009 4:25 PM (GMT 0)
Tony,
The false positives are really not that bad if read by an expert. Each node is graded on a 5 level grade as to suspicion. The grade level along with the location of the node is taken into account in the overall diagnosis. I had one node with a low suspicion level and because all node around it were clear it was determined that it was also clear. PC follows a definate path through the lymphatic system and if only one node at the end of the path shows positive it is highly unlikely that that node would be infected. As in any scan or test it takes interpertation by an expert. You get an overall probability of involvement or non involvement that is pretty accurrate. If a node shows clear there is only a 4% chance that it is positive.
You are correct in that a biopsy can be taken of the suspected nodes which is a less invasive procedure than surgical removal.
JohnT
Posted 8/13/2009 5:11 PM (GMT 0)
Hi Tony,

The posting was from an USToo member out of NJ on prostatepointers.org website. I did a search on the AMAG site and could find no reference to Combidex. I did find some older articles about US trials but nothing else that would confirm the posting. He also mentioned a Dr. Joseph Bender as the source of his information.

There was no information as to why it would be withdrawn. I suspect that without FDA approval it is not economically viable for the producer. All that I have read about it says it is effective. Personally, I was hoping to see it in the US at some point.

Don

Posted 8/13/2009 7:17 PM (GMT 0)
The contrast agent, Sirinum, made in France, is the exact same agent FDA approved for use in detecting liver cancer. The only difference is it is 20 nanos vs the Combidex which is either 2 or 5 nanos.
JohnT
Posted 8/14/2009 2:08 AM (GMT 0)
Don I get the PPML feeds veryday. Up to 50 or 60 sometimes. I have to admit I don't read them all. It's tough enough with my work in different groups to keep up with HealingWell. The beauty of each is that we share what we read. key points still get around. Thank you for the updates. I will keep an eye on the Combidex story. For now, I do know it is on a fast track with the FDA. If it changed then it likely changed for a good reason. Perhaps a better method of imaging. I will contact Mike at the InfoLink. He is the best I know at getting to the bottom of these things. Plus he owes me a dinner...I'll see him in D.C next month...

Tony
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