As one who has known SG from the Dade days, be careful of every word he says.

From BEC 2007 Q2 conference call

SCOTT GARRETT: Well we believe we have got the gold standard Troponin in the industry. And in fact we have recently compiled a brochure that includes a lot of clinical papers detailing just how excellent our Troponin assay is. We have got as many or more claims than any other Troponin in the industry. So this is clearly an opportunity for us to differentiate our entire cardiac panel and win new immunoassay business. But as you know there is a lot more to winning the entire immunoassay panel hospital lab then just Troponin or even just cardiac. So it is creating an advantage for us. It is not necessarily a lay down that turns the business over.

http://www.accessmylibrary.com/coms2/summary_0286-32586311_ITM

"Check out the Centaur with the FDA recall about temperature bias too."

which did not affect the Centaur TnI assays, so, of course, has no relevance to this thread - other than to try and divert attention from BC. Way to address an issue guys!

Check out the Centaur with the FDA recall about temperature bias too.

"algorithms being developed to bias from ambient temperature"
so slapping a software patch over a chemistry problem
was that supposed to be faster than really fixing it cuz first post is from 2010

So is it
A. After getting rid of "deadwood" the repurposed bottle washers that are left can't fix it.
B. DBS and 6 sigma just aren't good for complex problems that just might need knowledge experience and other pensiony things.
C. R and D folks think that once it's fixed they get an escort to the parking lot.
D. Be sure and add SDS to the antibody prior to conjugation -- that'll solve all your problems.
E. Varible sonication is another great trick which combines well with variable conjugation from D above.
F. All of the above.
Maybe y'all should hire back some consultants. Triple your previous rate is pretty standard guys

The FDA allowed only current Access/Access2 users to continue running the test. However, they cannot sell new Access2's for those labs who have not run it historically. It was removed on the DXI's by software to prevent DXI users who also had Access2's to continue running on the DXI.

There are two FDA 510K submissions to approve the assay on the Access (new sales) and the DXI. From what I heard, there were delays in the submission due to the algorithms being developed to bias from ambient temperature.

The quick answer to your question is that it is not available, has not been for about a year and no one knows when it will be available.

"So....it's still years away?!?!"

just like DxN
its pcr guys
it old tech and it aint that hard

So is it
A. After getting rid of "deadwood" the repurposed bottle washers that are left can't fix it.
B. DBS and 6 sigma just aren't good for complex problems that just might need knowledge experience and other pensiony things.
C. R and D folks think that once it's fixed they get an escort to the parking lot.
D. All of the above.
Maybe y'all should hire back some consultants. Triple your previous rate is pretty standard guys.

So....it's still years away?!?!

Of course the FDA is going to look into Carlsbad at changes made to the reagents. They will scrutinize everything about this assay. If you thought any different then you are just as ignorant as the old management that was here.

FDA are looking into the changes made in Carlsbad to the reagents, does not look good.

"So, what is latest? Beckman keeps telling us 'soon'.
Signed, Tired of Waiting."

now its up to the FDA on how long you will need to wait...

Tired of waiting when you finally will be able to purchase Troponin you will have an assay that has been scrutinized and investigated by the US FDA like no other assay.

Dear 'Tired of Waiting':

Your wait, although over two years already, has just begun. I don't see it coming back till 2015 or after.

So, what is latest? Beckman keeps telling us 'soon'.
Signed, Tired of Waiting.

Now it is spam for a peanut machine? geez, I thought looking at the same DNA sequences each day was a bore, at least I do not have to suffer through a job posting pnt machine links.

Beckman rep didn't tell me he couldn't sell Troponin till I asked.

*****
Even if he could sell it, would you trust it? Would you put your reputation, your lab reputation or even patient safety on the line? I doubt it.

Beckman rep didn't tell me he couldn't sell Troponin till I asked. Thank you poster. I wonder what other skeletons are in the Beckman chemistry analyzer closet.

[Danaher Corp. (DHR), which is buying Beckman for $5.87 billion, has said that Beckman's heart-test issues were a key area of focus.]

Were a key area of focus? Seems like it still is a key area of focus. Might be a little blurry though - maybe Danaher can sharpen that up. RC won't be able to sell snake oil to Danaher - or will he?

====
[But citing progress in an ongoing clinical trial...]

Progress? What progress? If they were making progress the timeline would not have slipped and they would be getting ready to submit the 510(k)'s.

Beckman, do yourself a favor and send RC, the rest of SG's buddies and the inept ex-Sanofi clique in Chaska someplace far, far away where they can do no more damage.

Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q

By Jon Kamp, Of DOW JONES NEWSWIRES

Beckman Coulter Inc. (BEC) has pushed back the timeline for two important U.S. regulatory filings, which the company needs to clear a test for heart problems it recalled last year, to the third quarter.

The company had long maintained that it expected to file Food and Drug Administration applications for the so-called troponin test in the first half this year. But citing progress in an ongoing clinical trial, talks with the FDA plus internal compliance and quality efforts, the company disclosed a delay to that timeline in a filing with the Securities and Exchange Commission Monday.

Beckman is filing two applications two cover the test's use with different systems.

The Orange County, Calif., company recalled the test in question, which measures a protein that signals heart problems, due to faulty results. Beckman last year also came under fire from the FDA, which believed the company marketed that test without the needed agency clearance.

Danaher Corp. (DHR), which is buying Beckman for $5.87 billion, has said that Beckman's heart-test issues were a key area of focus. Danaher Chief Executive H. Lawrence Culp Jr. said in February that the test could get back on the market by year-end, although he also said Danaher has "allowed ourselves a little bit of wiggle room."

A Danaher spokesman could not be reached for immediate comment Monday. The company in late March said it was extending its tender offer to acquire all outstanding Beckman shares to April 27.

Beckman shares recently traded down 18 cents to $82.97, near the planned take- over price of $83.50 per share. Danaher shares were recently down 2.6% to $ 51.35.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201104181139d...

Chaska better figure out how to make it "right" with ex-employees before anymore skeletons come out of the closet. If not, there won't be much left on the bone for Danaher to acquire.

Guess RC & MR thought they could slide that pile of excrement past the FDA's nose without them actually smelling it.

"Based on the progress of the company’s clinical trial, its ongoing compliance and quality system improvement initiative, and its discussions with the FDA, the company expects to delay its submission..."

Guess what... troponin didn't work well before and it still doesn't. Throw all the compliance, quality initiatives, lean and six sigma at it that you want but if you put lipstick on a pig you still have a pig.

Now is it time for RC to go?

Hospitals got along just fine before TnI and seem to be getting along just fine during this period without it. They have CK-MB and yes folks some physicians actually have brains and diagnostic skills.

News Breaks
08:13 EDT BEC theflyonthewall.com: Beckman Coulter to delay submission of two 510(k) notices to FDA until Q3
As Beckman Coulter has previously disclosed, the company is currently conducting a prospective clinical trial to establish the diagnostic performance of its troponin test on its DxI instruments and Access instruments using patient samples from the intended use population. Based on the progress of the company’s clinical trial, its ongoing compliance and quality system improvement initiative, and its discussions with the FDA, the company expects to delay its submission of two separate 510(k) notices to FDA for the troponin test until Q3, one for Access instruments and another for DxI instruments. However, there can be no assurances that such 510(k) notices will be submitted in such time frame or that, upon submission, the updated 510(k) clearances will be received in a timely manner from FDA, if at all.

"Having said that, Beckman does not make mistakes. :-) (Just ask RC.)"

RC's position is that RC doesn't make mistakes, but everyone else does (whether Beckman or not).

"Especially bad when you consider that the Beckman rep is the one who set up the standing order. So if he/she made some mistakes, it cost the customer $150 each time they adjust it."

Reps set up standing orders based on historical customer usage and data provided by the customer.

Having said that, Beckman does not make mistakes. :-) (Just ask RC.)

I'm sure if the Rep made an error that he would arrange to waive the fee(s). If not, then you really would have a gripe.

Especially bad when you consider that the beckman rep is the one who set up the standing order.
So if he/she made some mistakes, it cost the customer $150 each time they adjust it. $150 for typing a new number into the computer.
Quite a profit margin,eh?

[Beckman started charging for $150 for each standing order change, and another $150 for order "expediting" expense...]

Starting to sound like the airlines. They cannot make a buck providing their core business so they resort to fees and misc. charges.

"Oh yes, Beckman is on the top of my list. (guess which list)."

If you are that unhappy (and you certainly have a right to be) you should have dumped Beckman from your laboratory long ago.

So, let me get this straight...Glucose, TSH, Na, K, CL, CO2, Troponin, instrument cuvette flooding, and now T4. And, Beckman started charging for $150 for each standing order change, and another $150 for order "expediting" expense, on top of freight charges. Oh yes, Beckman is on the top of my list. (guess which list).

"And just how will a company whose busienss is selling Craftsman Tools (made in China) deal with this major FDA IDx [DxI?] issue?"

They will get one of those great big, Chinese-made Danaher monkey wrenches and throw that at it.

[And now you can't run Total T4 on pregnant patients on the Access and have to review your previous 9 months of testing for potential misdiagnosis.]

Won't that be fun.

Folks, it's long past time to realize that Access/Access 2 hardware and software technology is from the mid-90's and actually was developed by Sanofi not Beckman. Access/Access 2 is certainly not up to par with more current instrumentation. Beckman dumped the employees that knew the technology (SG's brainfart called R4G) so customers will be drifting in the wind until Beckman either figures it out, finds people who can figure it out or develops something better - none of which are likely to occur anytime soon.

And now you can't run Total T4 on pregnant patients on the Access and have to review your previous 9 months of testing for potential misdiagnosis.

"And just how will a company whose busienss is selling Craftsman Tools (made in China) deal with this major FDA IDx issue?"

----
I trust you meant DxI issue.

Do you mean deal with or solve? They have been dealing with this issue unsuccessfully for some time. Solving it is another matter. They do have some secret weapons - lean, six sigma and RC - none of which have worked so far.

"And just how will a company whose business is selling Craftsman Tools (made in China) deal with this major FDA IDx issue?"

By having BH do a Quality dance across the screen every time you open a browser window. Every BCI employee will take the Quality training. That will do it. See FDA, we are all about Quality! We didn't care before, but now we do!

And just how will a company whose busienss is selling Craftsman Tools (made in China) deal with this major FDA IDx issue?

"...most customers seem to be doing a wait & see approach."

It's a royal pain to do all the work required to establish new instruments/assays in a lab. Beckman knows this. In addition, customers are human - it's human nature not to want to do extra work unless it is absolutely needed.

Undoubtedly many customers just grew tired of the Beckman lies, poor quality, etc. and just moved on to new instruments. However those who chose to ride it out certainly do not have any light at the end of the tunnel.

It is suprising that labs would allow a critical, stat assay like troponin to be run on alternative instrumentation for any great length of time.

Beckman did a good job of managing the storm. Most of their customers bought the "pay no attention to the man behind the curtain" story. They're reimbursing labs for alernative means to run troponin, so, most customers seem to be doing a wait & see approach. Don't know how Beckman kept some of their current business, must have been some smooth talkin' sales pitches.

So, I'm assuming labs that have Beckman equipment have made alternative arrangements to test Troponin.

I suspect the FDA will cut deeper, as they learn more of the Beckman ways...

In the Beckman FDA warning letter, it cites the Access too. There must have been a deal cut with the FDA to allow existing Access placements to continue running Troponin, but no new Access can have Troponin on it. This does sound like a strange ruling by the FDA.

The reason Tn-I is available on the Access and not the DxI is because they perform the testing differently. The Access was designed on a 42 second cycle. The DxI was designed with 4 pipetting units but only 1 wash and read unit. This meant that the DxI had to wash 4 samples in the same time the Access only washed 1. Without sufficient washing, the DxI was experiencing difficulties at the low end. They resolved this by adding a wash cycle. While the extra wash improved performance, it also may have altered the characteristics of the assay and should have been submitted to the FDA. This is why the FDA only has an issue with the DxI.

Doesn't make sense. If BCI changed their Troponin formula without notifying the FDA, hence making it a new device, then why is it still on the market for a couple of analyzers, and taken off the market for all other analyzers. Seems the FDA should do an all or nothing call here. Wonder what FDA logic algorithm was used on that decision.

What did Beckman say about troponin when you called them?

Just as we suspected, a Beckman troll.

"Sounds like you're close to this. If Beckman did not confirm, did they deny?"

Why don't you call them and find out? 800-854-3633 Please let us know.

Sounds like you're close to this. If Beckman did not confirm, did they deny?

"So, what's the truth? Did Beckman actually make formula changes, the FDA caught them, and the Troponin is still on the market for some of their systems? Really ?"

Are we trolling a bit?

FDA alleges that Beckman did make formula changes. BEC has not confirmed this. Troponin is available (in the US) for customers currently having an Access/Access 2 instrument but not for DxI. DxI instruments were loaded with a software lock to prevent running Troponin.

There are a number of resources available on both the FDA and SEC Web sites outlining the BEC Troponin fiasco. Since FDA sent a warning letter to BEC they have also sent the following letter to manufacturers offering a Troponin test:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDi...

So, what's the truth? Did Beckman actually make formula changes, the FDA caught them, and the Troponin is still on the market for some of their systems? Really ?