I don't think BGM needs to refute ST2 claim. FDA already did a recall of Presage ST2 Assay in July 2012. Read the Enforcement Report for the Week of July 25, 2012 on FDA web site. Search for "Presage ST2 Assay".
Go to fda web site and search for "Presage ST2 Assay". Read the Enforcement Report about the recall of "Presage ST2 Assay" in July 2012. The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits. I wonder why Critical Diagnostics didn't mention the recall in their so called PR?
the article dated sept 30 came out within 30 mins of BGMD's pr on the reimbursement consideration. I find it difficult to believe it was a coincidence. critical diagnostics states the article was published "online" in the JACC. i read the article numerous times and researched the contents. my findings...the article was published by the V P of marketing for critical diagnostics, but it reads like a hit piece from seeking alpha. you will notice that "study investigators" performed the study. study investigators??? not one independent analyst is named. understandably the ceo and president of critical diagnostics tout their product. the article indicates Alan H. B. Wu published a study proving ST2's superiority over G3. turns out Mr. Wu is an editorial editor for critical diagnostics. the article reeks of desperation. I advise BGMD followers to read the article to make their own conclusions. I have been waiting for BGMD to refute the article and still hope they do.
A pr from Critical Diagnostics claimed a head to head comparison showed ST2 superior to G3. So, can a patient be cleared by ST2 testing but with undetected level of galectin be confidently diagnosed as cleared and vice versa? What happens if the patient is mis-diagnosed as cleared and re-admitted with elevated level of galectin? Which should be the first line of testing?
Have they gone through the testing, FDA approval, etc? I don't think so....that one little article is all I have heard or seen and I don't even know how to research this....in the meantime, BG-G3 has already started extensive marketing, all approvals (CE mark in Europe, FDA in USA), partnerships AND sales are already generated, PLUS the new reimbursement increase of 75%....
Seems like it is similar to years past when the NFL was not the least bit worried about much inferior competition such as Arena Football, USFL, etc etc.....BGMD is the NFL, and ST is Arena football at best----
CD is a private company so we have no way to verify their revenue. If their rev. exceeds BGMD, then, that is a indication of higher market share.
They claims ST2 is superior but no other independent studies or articles that I can find to prove this.
Go with a public company where information, research, and data are verifiable
Sentiment: Strong Buy
Both markers are indicative of fibrosis formation and remodeling and are indicators of adverse cardiac events
independent to the natriuretic peptides. Their potential utility has been described in a several applications within heart disease
including diagnosis and risk stratification for acute coronary syndromes, acute decompensated heart failure, and chronic heart
failure. Given the existing prominence of troponin and the natriuretic peptide in the first two of these categories, it is likely that
galectin‐3 and sST2 will be most useful in chronic heart failure disease management. Therefore head‐to‐head comparisons of sST2 and NT‐proBNP for transplant‐free survival of patients with chronic heart failure. Used with permission from Ky et al. Circ
Heart Fail 2011;4:180‐7.
Change in sST2 predicts clinical outcomes. Used with permission from Elsevier Science Boisot et al. J Cardiac Fail 2008;14:732‐8.
between the two tests in this scenario will need to occur in this population now that both tests are cleared by the FDA and CE
Mark. In the end, it is likely that the availability within a clinical laboratory of one marker over the other will be determined by
vendor and instrumentation access and not clinical performance because the two provide equivalent value.
The playfield is huge for both products with heart disease being the most deadly one so the one that executes the marketing plan better will gain more market share.
This head to head competition is like Toyota vs Honda and at end of the day, they both will come out the winners.
Revenue increased from 819k in 2010 to 1.6 mil 2011 to 2.8 mil 2012
Provided no increased rev. in Q4 (1mil estimation), we are looking at 3.8 mil total rev. in 2013.
Rev. for 2014 expects to be 70% higher than 2013 due to increased reimbursement. With a 70% increased yearly rev. and 33% expected cost reduction, I am in for the long run.
Sentiment: Strong Buy
Neither can I, but I can't fix my own car when it breaks down either. I don't think either one of us is an expert here. But there is room for the addition of both assays and probably many, many more. They are both arrows in what will be a well stocked quiver some day. Spending $1000 on a series of assays to establish risk and if necessary initiate preventive therapy of some kind is a hello of a lot cheaper than $1M in radical intervention following an acute cardiac event 5 years later. Obamacare is a watered down version of what a real national health care strategy should be, but this whole debate on it illustrates how impossible it will be to keep the status quo in healthcare. Eventually, half the GDP will be devoted to health care - OK, that's exaggerated, but it is not sustainable. We have to stop people getting catastrophically sick in the first place, or delay it as long as possible. Next generation diagnostics are the key and the market will be huge.
In WWII, before the US entered the war, Britain stood alone against #$%$ Germany. They fought bravely and heroically, but they were outgunned, out manoeuvred, out every-thinged that usually matters in a war; they should have been crushed, and yet they held out. It's a better story to herald the courage of the Brits and the spirit of Churchill, but the real story here was Britain's intelligence and code breaking, which was light years ahead of Germany. In other words, until the US came in to deliver the hammer blow, it was diagnostics that kept Britain from falling.
Critical Diagnostics are private and are not really subject to the same standard of behaviour as a public company on a major exchange. In fact, CD behaves more like a pink sheet in their PRs, huffing and puffing, calling other biomarkers like G-3 useless, etc. In fact, that is not what that study suggested at all, but CD chose to interpret it that way. It's also impossible to find anything letting us know what sales of the now available Presage ST2 assay are.
ST2 do not test galectin level. If a patient is cleared by ST2 with undetected elevated galectin level and is eventually re-admitted, who should bear responsibility?
"Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study" google it and tell me they aren't going for the Galectin-3 jugular. Preliminary decision (positive) by CMS on reimbursement was Sept 30. Stock should have gone up from there but it went down to the 50s. Just so happens the Critical Diagnostics article I just quoted for you was also published same day. Final determination by CMS was Dec 10 which resulted in incredible volume and almost tripling of SP at the top of the range. That was very encouraging but didn't last. That said, the volume of 45M on those days well over $1.20 or so has barely been scratched in the sell off that followed, so that's good. I hope that answers your questions, but if not, feel free to do a little digging.