"Perhaps Vitamin D is unique in that it has ALL of the above kinds of problems, but the problems themselves have existed in the past with other analytes and the basic solutions to the various problem types have been known for many years...."

I'm the one who posted about having experience w/ a major player in the Vit-D wars. The above quote is all true, but having had hands-on-experience w/ this analyte, I can assure you that it will not be too soon that a near perfect and simple bio-assay gets to the market anytime soon. Off the top of my head I can think of several absolute specifications that are all essential requirements for this assay and all will be very difficult to get in one single method.

1. Exceptional sensitivity /avidity of Ab.
Values in the very low ng/ml and eventually the pg/ml range
will be required for clinical studies. The avidity of the Ab is especially important as the Vit-D binding proteins hold the D3 form very strongly, even as displacing reagents are used. Compounding the problem is that D2 is less tightly bound, creating a double equilibrium issue within the displacing and assay equilibrium if a competitive system is used.

2. Equal molar recognition
This is very difficult to attain in a single Ab w/o creating XR issues w/ other analogs. Also the Ab will have to have the extreme sensitivity at the same time.

3. Vit-D is very labile
Many preservatives/ anti-oxidents are needed to stabilize the analyte and they often interfere w/ particular platform chemistries, or make CV's worse.

4. Assay format
Because several steps are needed to stabilize Vit-D and to displace Vit-D from the binding protiens, several incubations and rinses may be necessary, creating issues for individual platform limitations and maintaining reasonable results turnaround time.

I could go on for many more issues, but you get the point by now I'm sure.......this is not your everyday assay and will be problematic for companies to develope a "perfect" assay for many more years to come.

The problems with developing a Vitamin D assay may be great, but most of the are not novel by themselves. Thirty years or so ago, one had to boil samples with a solution to assay Vitamin B12 and, in some cases, folate. There were also issues with contamination of the binding protein (intrinsic factor contamination with 'R-protein') which acts much like antibodies do in other immunoassays. Cholesterol is an example of another analyte in which simply knowing the total is not as valuable as knowing the HDL and LDL (or Apo A1 and Apo B) values. Many of the 'sex hormone' tests (testosterone and estriol, estradiol, etc) suffered from problems with analytes binding to the surface of the test container (cuvette, test tube, etc.). PSA went through a significant period of debate and discussion relating to the best clinical utility for various assay forms as well.

Perhaps Vitamin D is unique in that it has ALL of the above kinds of problems, but the problems themselves have existed in the past with other analytes and the basic solutions to the various problem types have been known for many years. Nonetheless, accomplishing the development and commericallization of a Vitamin D test is a noteworthy achievement. My guess is that, as the years go by, most of the so-called deficiencies with existing tests will be solved and many of the people who have posted on this thread will have to find another assay to discuss, promote, and attack. So be happy about the contraversy that exists now. It gives you a few things to keep your blood flowing !

The problem is that the CES1 unit that is routinely used is not up to standard laid out in the SETI protocols, thus causing cross reactivity with the Abbott test kits. This will all come out in the investigations.

Diasorin has been getting pretty aggressive with their pricing. This might be a good time to speak with your rep and see what they have to offer.
We have a Centaur and there's no way I would consider adding vitamin D.
I'm currently looking at moving Free t4 and PSA off the Centaur and on to our chemistry analyzer. The precision on the Centaur is disturbingly bad and they don't seem to have much to offer by the way of advice.

".....It's just an evolutionary thing and right now, Vitamin D is in the early stages...."

This is true in a general way, but I'm very sure that Vit-D will not follow this path in an even manner. This simply is not your typical assay/ analyte, as all of the difficulties normally encountered in developing an assay are greatly magnified with Vit-D......binding proteins, interfering factors, sensitivity requirements, temp/light degradation, dual equal molar recognition requiements, displacing agent needs, etc., etc. This is probably the most difficult assay normally requested by Dr.'s for diagnostics firms to develope. I know, I was involved in this assay development and it is not an easy nut to crack, hence the limited acceptable assays out there. While Diasorin is the best bioassay, it DOES NOT read equal molar in terms of Vit-D2/ D3; one is only about 65% vs the other (I can't recall which was which). The only true test referance is mass spec but the cost is prohibitive, so it will only be used as a reference method to compare against bioassays for the near future. There is work on reducing the price and increasing tru put on a mass spec system, but this, if possible, is years away from the market.

The recall is for diluent packs to auto-dilute high samples. Their recommendation is to dilute high samples offline.

This still doesn't explain the poor precision and poor correlation with established methods.

Only 442 kits involved its nothing, a load of them were probably still on the shelves at Siemens or a few customers. EVERY vendor has a bad lot slip through now and then, it may not have even been in reagent production maybe it was stored wrong.. who knows.

You sound a little on the desperate side, but I guess you hit all of the talking points.

Only 442 kits involved its nothing, a load of them were probably still on the shelves at Siemens or a few customers. EVERY vendor has a bad lot slip through now and then, it may not have even been in reagent production maybe it was stored wrong.. who knows.

On march 21 there has been a recall of a diluent of the Siemens kit, you may see in the fda database the details. My questions to those who are more technically proficient is: how serious is this problem, this recall? To a non technical person like me this sounds like one of those routine issues, unfortunate but not deadly.
I will be grateful for any comment. Thanks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=107628

What's amazing is that the FDA actually approved the Centaur test. The test has poor precisiion and poor specificity.

Siemens Vitamin D is horrible.
It doesn't correlate with anything, yet they tell you that it's OK ?
In their eyes, it's a unique assay and can't be compared with other methods ? (At least that's what they tried to tell us).
They are out of their minds !

I agree that comparing Diasorin to Abt is wrong, so I looked this morning on Bloomberg at smaller companies, and this is what I get (Current P/E):

BioMerieux 14.8
Meridian 25.8
Bio-Rad 17.0
Qiagen 32.4
Gen-Probe 37.7
Alere neg
Diasorin 11.1

All companies need to evolve. Gees what a consultative genius.

"But other companies are getting ready to launch their versions as well. For labs like mine, competition helps weed out inferior products."

I agree that inferior products will be weeded out. Companies like Siemens will eventually do whatever it takes to fix their problems. Maybe not on Centaur, but whatever system they come up with next will run a decent Vitamin D. VISTA may as well, although VISTA still has too many problems to have many systems in the field and it is not clear how much more time and money Siemens will put into it.

Historically, it seems that when new tests come out there is a big rush to find the best. For a while, the best holds a large market share. Eventually, everyone catches up more or less and things like cost/test and ability to consolidate testing onto as few systems as possible takes over. In many cases, cost and convenience will outweigh superior performance. One example of that is digoxin. The initial RIA methods were quite good and low end sensitivity was not a big problem. But when homogeneous, automated methods like EMIT and Abbott's TDX came out, they took over the market very rapidly even though they were basically at the low end of their relative technology when it comes to detection level and were not nearly as precise at the low end. It's just an evolutionary thing and right now, Vitamin D is in the early stages.

What this means for companies like Diasorin is that they will need to keep coming up with the new assays, and maintain a stable of relatively unique, and probably low volume assays like some of Diasorin's current menu. If this is their strategy, they will likely succeed. If it isn't and they now consider it after reading this post, they can be thankful for a free consultation.

:-)

I wouldn't worry about Diasorin losing too much of its Vit.D business in the near future. Siemens Centaur Vit.D is a horrible kit and customers like my lab are already dumping it from their in-house menu. The only current competition for Diasorin would be Roche. Siemens is already downplaying their version and accepting the loss. They are hoping the VISTA version does better. Apparently the DX branch has been a major revenue loss for Siemens.
But other companies are getting ready to launch their versions as well. For labs like mine, competition helps weed out inferior products.

That being said, when a small company like Diasorin loses a great deal of their sales it is not good. They have nothing new to fill in that hole.

I don't think it is reasonable to compare the profitability of a small niche company like Diasorin to large conglomerates like Siemens, Danaher, Roche, or Abbott. These latter companies are engaged in many different businesses and diagnostics represents only a small fraction of their revenues and profits, and, thus, have a much smaller impact on P/E ratios, stock prices, etc. The only real comparisons should be among the various diagnostics product lines and/or individual tests. It is very possible for a small company to have a superior individual product, but not achieve large market share simply due to a lack of a complete product line.

As an analogy, I would have never compared Ben and Jerry's Ice Cream (before it was sold) to a company like Kraft Foods or a company like Maserati to GM or Honda.

I would be afraid that 1/3 of their sales is Vit D as that number is dropping like stone off of a bridge as we speak

I am the small shareholder, very happy to see all this debate, as it helps me understand the situation.
Competing with large companies like Abbott and Siemens must be hard, but Diasorin is a niche company, with a fraction of their sales. Not so for profits, which are pretty good, current p/e is fairly low at 11.5, all comparables have much higher/worse numbers. And VitD is only one third of their sales.
I am sticking to this stock!

It seems that the Diasorin system does have a wide menu and quite a number of esoteric tests. It does not appear to have a full complement of hormone assays or drug assays. As such, it would not be competitive with systems from competitors that offer a wider menu. This suggests that Diasorin occupies a niche market and I was wondering if anyone here has any data on market share or countries in which Diasorin is a significant player. Their Vitamin D assays may be as good as others or not, but if they don't have a large number of systems in the field, the significance of their assay is minimal.

...says the Diasorin rep.

Some of the comments on here are bizarre. The Diasorin platform has over 100 immunoassays. Sure it is not a chemistry analyser as well, but for those still wanting an accurate immunoassay method and the ability consolidate other Immunoassays, their is choice. Just because you sell the test, doesnt mean you do it any good. The Roche method is Protein Binding (and is a 27 minute assays that cruels throughput for other assays). Nichols failed with that years ago (ps the first automated, not Diasorin) as it just doesnt have the range and has major interference issues and poor precision. Siemens is a basket case assay that most people accept is a dog and the Abbott has good CVs on poor accuracy and sensitivity. Labs are set up to deliver correct results to physicians. Thats what patients need. Workflow and costs are understandable, but a one-trick pony is not our experience. Living in the past by the looks of it. We use a Liaison XL for Serology, Vit D, some specialist endocrinology and tumour markers.

O_CD are showing a Total 25-OH Vitamin D assay as under development for the 3600/5600 platforms. Presumably this will measure both the D2 and D3 forms of 25-OH Vitamin D. No launch date yet - could be years away given their recent product development record.

"BCI may be entering the VitD market at the end of this year or early next, with a CE approval later this year."

Guess again dude!
They have to get troponin fixed first and get through their temperature issues that they tell customers everyone else has too.
Not!

"However, since Diasorin, and others like it, cannot provide a complete menu of tests on their systems (both immunochemistry and routine chemistry) "
No one has Vit D on their chemistry analyzer. That won't happen. Diasorin does not have the R & D to put the other popular immuno methods so they will result in a somewhat stat manner.

Companies like Diasorin will continue to develop new tests. However, since Diasorin, and others like it, cannot provide a complete menu of tests on their systems (both immunochemistry and routine chemistry) it is unlikely they will ever get to play with the big boys. It simply can't be worth it for them to develop their own glucose, cholesterol, etc. Their business is primarily novel or niche analytes. My guess is that Diasorin will eventually sell or license their good assays, such as Vitamin D as a more profitably way to benefit from their good science.

In terms of efficiency, it only makes sense to implement the test on an existing automated immunoassay instrument. If not, there is an opportunity to expand your in-house test menu offering if the new instrument is able to perform other tests that could be performed on it.

Since we are finally seeing more automated systems out there able to perform VitD, such as Architect or Centaur, the added competition will certainly bring down the overall pricing for the test. BCI may be entering the VitD market at the end of this year or early next, with a CE approval later this year.

Diasorin is the most prevalent system our there now but it will definitely start shrinking as those contracts start to expire. They had their opportunities for sucking in tons of profit with high test costs. I remembered a few years ago their proposed cost per test was around $13-16. If you include the cost to perform calibtrations and quality control the cost per reported test ends up very close to $18-20 per test. Their assay is well characterized and their specificity towards D2 and D3 are pretty good; however, their precision used to be pretty bad...I think the new forumalated assay has improved precision.

What do you recommend? You obviously don't follow the market.

I would sell that 'small share' of Diasorin you have.
They were the first to bring out Vit D in an instrument
that was somewhat automated. As noted here, it is a one trick pony.
It is also way more hands on than the other manufacturers noted.
Now that it is out on truly automated platforms Diasorin's market share is going to plunge, along with your investment.Sell immediately, but don't buy siemens or abbott. You'll lose with both of those also.

"Does anyone here have any data of the current size of the Vitamin D market in the US and worldwide? ..."

Diasorin claims to have 55% market share, market is worth approx $350m w/w (€ 270m)

I am a small shareholder of Diasorin, and cannot understand if the products is as bad as some of you guys say, then why has it got such a nice market share? Maybe there are Diasorin sales reps here, but me thinks competition also...
--------------------------------------------------------------

The assay performs well but it is very labor intensive and you can't run other tests on the analyzer like you can with Siemens and Abbott. The more automated systems by Siemens and Abbott allow you to do much much more with less manpower and equipment. That's why nobody is giving Diasorin any love on here.

It is probably true that Diasorin has 55% of the market share...because, they were the only non-mass spec method that is somewhat automated. However, I think the market share will drop as laboratories continue to implement the Abbott Architect and Siemens methods. I am sure there will be other automated IA systems in the near future to further impact Diasorin's market share.

Let's face it, Diasorin's pretty much a one-trick pony, so you'd hope that it performs its one trick reasonably well. That's why the vitamin D assay is reasonably good.

"Does anyone here have any data of the current size of the Vitamin D market in the US and worldwide? ..."

Diasorin claims to have 55% market share, market is worth approx $350m w/w (€ 270m)

I am a small shareholder of Diasorin, and cannot understand if the products is as bad as some of you guys say, then why has it got such a nice market share? Maybe there are Diasorin sales reps here, but me thinks competition also...

In what vacuum are you living? Isn't it obvious to you by now that Siemens decided to cancel Immulite a long time ago and that the decision was final and irreversible. It no longer matters whether this was the right decision or not; what matters is that it was and is reality. It is completely puzzling to me that some people are still not able to accept the reality of Immulite's demise. What is the point of continuing to 'shoulda, coulda, woulda' over Immulite?

Siemens should have developed the Vit D onto the Immulite as it was designed to be by LA and would probably work. Instead (due to a certain groups political agenda) they bodged it onto the Centaur to try to keep the tired old dog breathing. Putting diesel in a gasoline car is never going to give great outcome.

Does anyone here have any data of the current size of the Vitamin D market in the US and worldwide? How many tests does the average lab do in a day or a week? Also, as I understand it, there are some debates about the form(s) of Vitamin D to measure, and if so, what are the basic issues there (not who is right, just the issues themselves). I'm just trying to put all of these posts in perspective.

It is incredible that the FDA approved the Siemens Centaur assay. I think their CV's are the worst in the industry. This is comparing the IDS, Diasorin, Abbott Architect assay.

I sure hope Siemens is working on their Vitamin D II assay with improved performance.

Siemens Centaur Vitamin D really is a disaster.
CV's are horrible and we couldn't get any kind of correlation with any of the three reference labs we use.
We were hoping to add it to our menu, but there's no way I'd even consider it at this point.

Pretty sure the Dia method has close to 100% recovery of D2 and D3. Comparison to a well standardised LCMS will show that. Check the IFU if you are unsure. I think the Abbott method under-recovers on D2 and has a high bias, but you can check this yourself with some simple evaluations. Depends if sensitivity is important to you or not as well. Always best to go with the evidence. Agree with Centaur comments, a terrible assay in general, you would have to be desperate to go with that.

I think Diasorin is working real hard to keep their market share after the release of the Siemens and Abbott methods. Diasorin has always been know to have poor precision; although, their recent reforumulation a couple years ago did improve their low end precision from double digits to a single digit at least. The Diasorin method does not have full 100% recovery or specificity towards D2 and D3. I don't think there is an IA method out there who does. I would be wary of the Siemens method because of >15% CV's at the low end. Abbott seems to have the best precision out there with comparable specificities towards D2 and D3. The immunoassay tests usually cross-react to ViTD metabolites which can yield inconsistent results. Once major metabolite is 24,25-(OH2)-D3. The Abbott method cross reacts with this by 112%; however, the amount in blood is approx 10% of the total ViTD. I am sure the other non-GC/MS-MS methods will have similar issues....so read the package insert carefully.

I am hearing from Siemens users that they are not happy with the imprecision on the Centaur.

The diasorin rep speaks again.
The instrument is way too labor intensive.
There is no menu.
The imprecision you speak of at those levels means little clinically.
The methodology is referenced only because it was the first non LC.

If you want your results to compare to a well run and standardised LCMSMS (or in fact the often cited Diasorin RIA assay), then you need the Diasorin assay. The evidence is clear on that. All the other IA providers will ask you to make compromises on quality and the new instruments get thru 170 per hour with minimal maintenance and instrument downtime. If centralised workflow is more important than clincial results, and you are willing to have an inferior IA at levels below 35, Siemens can give you false highs at the low end, false lows at the high end. Abbott will just give you a strong positive bias, with dubious ability to dilute, and the Roche assay is all over the place (with their record at Vit D, its hard to think anyone can trust their assay).

Who cares if there is a shot taken at Ortho. I'll give another one...their products are inferior...poor hardware and they've seem to have lost the Kodak reputation for reliability and service. I am most unhappy with their field service in terms of response time.

"Vitamin D appears to be absent from the Ortho menu of assays. Wonder if they have one in development. It would need to be a lot better than their Vitamin B12 and Folate immunoassays"

Irrelevant!!! It doesn't sound like B12 or Folate are an issue for the initiator of this thread. Sounds like a cheap shot at Ortho. Someone has come here to ask a simple question and, so far, most of the responses are either irrelevant or are part of a childish war among various marketing departments.

Vitamin D appears to be absent from the Ortho menu of assays. Wonder if they have one in development. It would need to be a lot better than their Vitamin B12 and Folate immunoassays.

I would not recommend that you use this site to get objective information since you have no idea of who is posting it. Much, if not most, will come from marketing and sales people or biased R&D people. My suggestion to you is that you ask your various salemen if they can give you the names of a few labs that you could call who would be willing to discuss their experiences and answer some questions that you might have that are specific to your lab. Expec that the names you get are all happy customers and possibly even consultant, but at least you will be getting information from people who speak your language and won't profit directly from your purchase.

So guys who has the best compromise of assay performance/best throughput/reliability/least maintainence and ease of use out there at the moment?

'Proven and tested'

What are you babbling about this time?

It doesn't matter if it's a waste of money, as long as MDs are ordering it we gotta run it.
This one is from the Dr Oz/Oprah syndrome. Millions of housewives see it and want it run.

Jeez Vit D testing what a waste of money get out in the sun more or take a supplement already

The best answer for the person looking at a few different vendors is that you should try to consolidate your testing on an existing analyzer to minimize cost, training, space, and to maximize a test menu on an existing analyzer.

The only two instrument platforms right now is Abbott and Siemens Centaur. I think the Liaison is going to see their customer base drop because of Abbott and Siemens. The Abbott platform has probably the best precision over Siemens and Diasorin. Beckman is probably 1 year away from releasing it on the DXI. They are focusing so much of their resources on getting Troponin back on their menu right now. So for now, Beckman is not going to be a player yet.