Member
Posted 25 December 2017 - 09:41 PM
Has anyone heard about this new test for CML? MRDx BCR-ABL I've tried to read about it and it's just a level past my understanding. Is it to be used as an additional test when one's PCR is very low? Would love help understanding this one.
http://markets.busin...igna-1011846112
DX 09-2011 PCR 8.08 not IS WBC 17 , Began Tasigna 600mg
in 2012 Tasigna 450mg/day ,in 2013-2017 Tasigna 300mg/day
DATE/PCR
09-11/ 8.08 not IS
03-12/ 0.054 not IS
06-12/ 0.035 not IS
09-12/ PCRU, 01-13/ PCRU
4-13/ 0.042 IS
7-13/ 0.014 IS
11-13/ PCRU, 04-14/ PCRU
8-14/ 0.006 IS
PCRU: 12-14/ 05-15/ 10-15/ 02-16/
09-16/ 02-17/ 09-17/
10-17 tapered off
11-3-17 Stopped Tasigna
1-15-18 still PCRU
Advanced Member
Posted 26 December 2017 - 10:13 AM
This MRDx BCR-ABL PCR test has been around since 2013 so it is not new, and it is just a regular PCR test. The "new" part is that the FDA has begun approving PCR tests for use in monitoring minimum residual disease (MRD) levels in CML patients, something they had never done oddly enough. With the advent of TKI cessation they figured they should start approving PCRs for monitoring cessation patients. The FDA now requires PCRs to reach at least -4.5 log reduction (.003% IS) before they will approve their use for monitoring cessation patients. That is no better than most PCRs have been capable of for quite a while.
I know of two PCRs which the FDA has approved for MRD TKI cessation monitoring, this MRDx BCR-ABL Test and Asuragen's QuantideX. I am sure the other PCR manufacturers will seek FDA approval as well.
Advanced Member
Posted 26 December 2017 - 12:26 PM
Trey, I wish I didn't know you or have any desire to check this web-site three times per day but I do. I was diagnosed a year ago and I have peace of mind that something else will probably kill me but not CML. What I want to say is THANK YOU!!!!!
While I have a great Doctor, I only get so much "face time" with him. The big issues have been dosing and coping with adverse events for which this site has been invaluable. I am looking forward to my daughter's wedding in Sweden in June, enjoying my two grandchildren and enjoying my wife. Trey, the amount of time that you donate to us is truly appreciated. I used to visit San Antonio twice a year assisting the "kids" at BAMC that were severely injured in Iraq and Afghanistan. These guys and gals would come back missing a leg or two or perhaps with severe burns and tell us that they would go back and do it again. My complaints about TKI side effects are fairly petty. But I wouldn't be able to handle any of it without this group and especially with the sound knowledge that you obviously possess. May your New Year be Happy and Healthy!
Member
Posted 26 December 2017 - 01:21 PM
Trey, first ditto to what Jan said! You are treasured here!
One followup: does this mean I need to ask my doctor if the lab uses one of these FDA approved tests for it to be covered by insurance while I'm in cessation?
DX 09-2011 PCR 8.08 not IS WBC 17 , Began Tasigna 600mg
in 2012 Tasigna 450mg/day ,in 2013-2017 Tasigna 300mg/day
DATE/PCR
09-11/ 8.08 not IS
03-12/ 0.054 not IS
06-12/ 0.035 not IS
09-12/ PCRU, 01-13/ PCRU
4-13/ 0.042 IS
7-13/ 0.014 IS
11-13/ PCRU, 04-14/ PCRU
8-14/ 0.006 IS
PCRU: 12-14/ 05-15/ 10-15/ 02-16/
09-16/ 02-17/ 09-17/
10-17 tapered off
11-3-17 Stopped Tasigna
1-15-18 still PCRU
Advanced Member
Posted 28 December 2017 - 09:35 AM
Insurance has never cared about the FDA approval issue as far as I know. PCRs had never been FDA approved for monitoring CML yet insurance has covered the tests all these years. FDA approves all drugs, but often does not approve testing devices and procedures.
For CML not even FISH is FDA approved, but insurance covers it. The current FDA approved medical devices for CML only has the Asuragen QuantideX PCR but not yet the MRDx BCR-ABL since that just happened this month:
https://www.fda.gov/...s/ucm330711.htm
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