Has the ISI been changed on CoaguChek strips? Seems that it was going to change from 2 to 1 sometime this year.
ISI on CoaguChek strips?
- Thread starter catwoman
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Ross
Well-known member
Marty might know for sure, but I think they are scheduled to roll the product out in September.
G
Guest
I think that the FDA has approved them but Roche wants to make "extra sure" before they bring them out.
Marty
Well-known member
Coaguchek ISI?
Coaguchek ISI?
Coaguchek ISI?
I received a very official appearing envelope from Roche a couple of days ago and I thought this it. Notification of new ISI. Nope, theysimply stated my price for 12 strips was going up from $72 to $80!allodwick said:
S
spillo
I doubt if any company that gets FDA approval will wait to put that product on the shelves. I think CLIA has taken over the medical device certification from the FDA. This just happened recently. It seems to jump back and forth every few years. No one wants the hassle !
12 strips for $80 is getting close to medical lab prices. We charge $12.00 for a pt/inr, including phlebotomy.
Roche is owned by LabCorp, the second largest lab in our galaxy. No matter what they charge, they can't lose. If the strips get too high they will send you a map to their nearest draw station. It's a racket.
Spillo
12 strips for $80 is getting close to medical lab prices. We charge $12.00 for a pt/inr, including phlebotomy.
Roche is owned by LabCorp, the second largest lab in our galaxy. No matter what they charge, they can't lose. If the strips get too high they will send you a map to their nearest draw station. It's a racket.
Spillo
G
Guest
I have to disagree with everything Spillo wrote.
1. Many pharmaceutical companies do not put something on the market as soon as it gets approved. They have to make enough product to be sure that they can supply everyone. This often takes months.
2. CLIA (Clinical Laboratory Improvement Act) is a law not a government agency they way the FDA is.
3. Roche is owned by Roche Holdings of Switzerland. They may own LabCorp too but not the other way around.
$80.00/$12.00 = $6.66 or roughly half the charge for a phlebotomy. But then you have the lab test charge and the pathologist's charge. In our area this adds up to about $45.00 by the time you are done.
1. Many pharmaceutical companies do not put something on the market as soon as it gets approved. They have to make enough product to be sure that they can supply everyone. This often takes months.
2. CLIA (Clinical Laboratory Improvement Act) is a law not a government agency they way the FDA is.
3. Roche is owned by Roche Holdings of Switzerland. They may own LabCorp too but not the other way around.
$80.00/$12.00 = $6.66 or roughly half the charge for a phlebotomy. But then you have the lab test charge and the pathologist's charge. In our area this adds up to about $45.00 by the time you are done.
S
spillo
Hello everyone,
I guess I need to straighten a few statements I made that Al responded to.
1. To be fair, Al said that Roche wanted to be "extra-sure" before bringing them (new coag strips) "out", or to the pharmacy shelves. That is not the same as saying they are waiting to make more so that everyone will have them. In any event I respectfully disagree with both statements. I think when a company comes out with something they rush it to the shelves, period.
2. While you are correct in saying CLIA is not a goverment agency, it is the set of regulations that allow medical devices like Coaguchek to be certified, in this case as a waived device, allowing people like Marty to use it at home.
By the way I meant to say CDC, not CLIA, sorry about that. We just had our CLIA inspection and CLIA has been on my mind. Since 1/2000 the FDA has regulated medical devices ( before that it was the CDC ), now I think I read the CDC got that headache back.
3. Al is right, Roche Diagnostic Corp. is a division of Hoffman-LaRoche in Switzerland but it no longer owns LabCorp. They sold it the lab back when it was called Roche Labs just after they got fined around $300,000,000 for Medicare fraud. LabCorp may still have some holdings in Roche Diagnostics however.
Our lab only charges $12 for a PT/INR. This includes phlebotomy, testing, hard copy of results. In Ohio, where we are at, and about 30 other states you can get whatever lab test you want drawn on yourself without a doctors prescription. This is called "direct lab access". You can't use insurance to pay for it of course. We keep the price down because it is cash payment.
On the CLIA website I notice that the coaguchek stated using reagent with an ISI of 1. This is since 2002 I think when it was first categorized by CLIA. I should have written it down but here is the web site so anyone can look into the coagucheck.
www.fda.gov/cdrh/pdf2/k021190.pdf
Good luck to everyone ! Thank you for letting me clear this up.
Spillo
I guess I need to straighten a few statements I made that Al responded to.
1. To be fair, Al said that Roche wanted to be "extra-sure" before bringing them (new coag strips) "out", or to the pharmacy shelves. That is not the same as saying they are waiting to make more so that everyone will have them. In any event I respectfully disagree with both statements. I think when a company comes out with something they rush it to the shelves, period.
2. While you are correct in saying CLIA is not a goverment agency, it is the set of regulations that allow medical devices like Coaguchek to be certified, in this case as a waived device, allowing people like Marty to use it at home.
By the way I meant to say CDC, not CLIA, sorry about that. We just had our CLIA inspection and CLIA has been on my mind. Since 1/2000 the FDA has regulated medical devices ( before that it was the CDC ), now I think I read the CDC got that headache back.
3. Al is right, Roche Diagnostic Corp. is a division of Hoffman-LaRoche in Switzerland but it no longer owns LabCorp. They sold it the lab back when it was called Roche Labs just after they got fined around $300,000,000 for Medicare fraud. LabCorp may still have some holdings in Roche Diagnostics however.
Our lab only charges $12 for a PT/INR. This includes phlebotomy, testing, hard copy of results. In Ohio, where we are at, and about 30 other states you can get whatever lab test you want drawn on yourself without a doctors prescription. This is called "direct lab access". You can't use insurance to pay for it of course. We keep the price down because it is cash payment.
On the CLIA website I notice that the coaguchek stated using reagent with an ISI of 1. This is since 2002 I think when it was first categorized by CLIA. I should have written it down but here is the web site so anyone can look into the coagucheck.
www.fda.gov/cdrh/pdf2/k021190.pdf
Good luck to everyone ! Thank you for letting me clear this up.
Spillo
G
Guest
I don't think that Roche has brought out the ISI of 1 in the US yet.
I'd like to give more information but I have signed a non-disclosure statement because of some consulting that I have done.
I'd like to give more information but I have signed a non-disclosure statement because of some consulting that I have done.
S
spillo
Hello,
The following web site that I posted earlier contains pages from 10/21/02.
On page 3 it compares the coaguchek with a similar device that has thromboplastin rgt. sensitivity of approx. ISI 1.0. That tells me that since then the strips ISI is 1.0. I take it the coaguchek was introduced onto the global market at this time as well.
Did Roche say it will be producing strips with new ISI ? I came in a little late to this thread but if this is so it can only be a change for the worse as 1.0 is as good as it gets.
Spillo
The following web site that I posted earlier contains pages from 10/21/02.
On page 3 it compares the coaguchek with a similar device that has thromboplastin rgt. sensitivity of approx. ISI 1.0. That tells me that since then the strips ISI is 1.0. I take it the coaguchek was introduced onto the global market at this time as well.
Did Roche say it will be producing strips with new ISI ? I came in a little late to this thread but if this is so it can only be a change for the worse as 1.0 is as good as it gets.
Spillo
G
Guest
As far as I know, Roche has never marketed the strips with an ISI of 1.0 in the US. The current strips have an ISI of 2.0. I have asked the Roche rep to find anyone who has personally used more CoaguStrips than I have. He was unable to do so. I have probably done between 20,000 and 25,000 tests with them. The ISI actually makes little difference until you get above an INR of 5.0 or so. Below that there is little risk of bleeding. Above that it is time to do something anyhow. So the ISI is actually no big deal. I have had a statistician analyze large numbers of patient visits for tendency to bleed. I also know that my major bleeding rate is 1 per 33 patient years and the clotting rate is 1 per 100 patient years. Switching to an ISI of 1.0 is unlikely to improve patient outcomes - only lab numbers will be slightly affected.
