Increased soluble ST2 predicts long-term mortality in patients with stable coronary artery disease: results from the Ludwigshafen risk and cardiovascular health study.
Soluble suppression of tumorigenicity ST2 has emerged as a strong prognostic biomarker in patients with heart failure and myocardial infarction. The aim of this study was to evaluate the long-term prognostic value of sST2 in patients with stable coronary artery disease CAD
sST2 plasma concentrations were measured in 1345 patients with stable CAD referred for coronary angiography at a single tertiary care center. The primary endpoint was all-cause mortality.
During a median follow-up time of 9.8 years, 477 36% patients died. The median sST2 plasma concentration at baseline was significantly higher among decedents than survivors In multivariate Cox proportional hazards regression analysis, sST2 was an independent predictor of all-cause mortality risk ratio 1.16 per 1-SD increase in log-transformed values; 95% CI 1.05-1.29; P = 0.004 In the same multivariate analysis, amino-terminal pro-B-type natriuretic peptide NT-proBNP and high-sensitivity cardiac troponin T hs-cTnTwere also independent predictors, whereas galectin-3 was not. Patients with sST2 in the highest quartile ( 24.6 ng/mL) displayed a 2-fold increased risk of death in univariate analysis, which was attenuated but remained significant in a fully adjusted model risk ratio 1.39; 95% CI 1.10-1.76; P = 0.006. Further analysis showed that the prognostic impact of sST2 was additive to NT-proBNP and hs-cTnT. Using a multibiomarker approach combining these 3 complementary makers, we demonstrated that patients with all 3 biomarkers in the highest quartiles had the poorest outcome.
In this cohort of patients with stable CAD, increased sST2 was an independent predictor of long-term all-cause mortality and provided complementary prognostic information to hs-cTnT and NT-proBNP.
Head-to-head comparison of 2 myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 versus galectin-3.
ST2 and galectin-3 (Gal-3) were compared head-to-head for long-term risk stratification in an ambulatory heart failure (HF) population on top of other risk factors including N-terminal pro-B-type natriuretic peptide.
ST2 and Gal-3 are promising biomarkers of myocardial fibrosis and remodeling in HF.
This cohort study included 876 patients (median age: 70 years, median left ventricular ejection fraction: 34%). The 2 biomarkers were evaluated relative to conventional assessment (11 risk factors) plus N-terminal pro-B-type natriuretic peptide in terms of discrimination, calibration, and reclassification analysis. Endpoints were 5-year all-cause and cardiovascular mortality, and the combined all-cause death/HF hospitalization.
During a median follow-up of 4.2 years (5.9 for alive patients), 392 patients died. In bivariate analysis, Gal-3 and ST2 were independent variables for all endpoints. In multivariate analysis, only ST2 remained independently associated with cardiovascular mortality Incorporation of ST2 into a full-adjusted model for all-cause mortality (including clinical variables and N-terminal pro-B-type natriuretic peptide) improved discrimination and calibration, and reclassified significantly better (integrated discrimination improvement: net reclassification index: Incorporation of Gal-3 showed no significant increase in discrimination or reclassification and worse calibration metrics. On direct model comparison, ST2 was superior to Gal-3.
Head-to-head comparison of fibrosis biomarkers ST2 and Gal-3 in chronic HF revealed superiority of ST2 over Gal-3 in risk stratification. The incremental predictive contribution of Gal-3 to existing clinical risk factors was trivial.
Enrique, go to pub med and you'll see as of late ST2 is kicking Gals 3's butt, in one test head to head the abstract calls Gal 3 results trivial, I know that they both take different paths, but ST2 seems to be getting all the positive press lately.
Jess, You'll know what's going on by just watching the share price, If this sets a new low of under .36 IMO there's very little hope, seems the shareholders here have their heads buried in the sand, They only want to hear good news and refuse to take any bad post as bashing, there are some good points to BGMD , But as of late the bad points seem to outweigh the good, Case in point, ST2 seems to be overtaken Gal3 as the BioMarker of the future in heart attack consideration in emergency rooms
IMO They have basically pre warned that earnings would not be good because of the 300k cask outlay due to the layoff of 10 employees 're 8k "As a result of the Restructuring, the Company expects to record one-time charges with respect to severance payments and benefits continuation, which are estimated to be approximately $0.3 million and are expected to be recorded in the third quarter of 2014. As a result of the Restructuring, the Company estimates it will generate annualized expense savings of approximately $1.9 million primarily from savings in employee salaries and benefits. "
That along with decreased earnings the last 2 quarters dose not bode well for Q3,
It's a very long shot they have a good Q3
I agree with you, I'm taking about what happened in the 2012 submission, the fda gave them till Feb 2013 to answer the question they wanted answered, if the company pulls the submission it doesn't change the fact that the fda gave them till Feb 2013. It stays active. I'm finished for the night
King you're hard to talk to, I was talking about the submission in 2012 WHICH WAS PULLED IN JUNE , I DIDNT SAY THIS Submission, Because it is still on the fda website means it is still active, THE PULLED SUBMISSION IN 2012 WAS ALSO STILL ACTIVE AFTER IT WAS PULLED, And it stayed active till Feb 2013 the time the FDA gave the company to reply, The same COULD be happening right now for all we know.
The one thing I'll agree with you on is this will fly if Cleared, and I've said it many times.
King, in the end they did NOT GET CLEARED, your thinking of the 2010 Gal 3 test that was cleared, In the case of the 2012 submission, The company pulled that submission but didn't tell the shareholders for 5 Months , thats the problem I have with this company, when they pulled it the price was $7.00 , when they told the shareholders , the price was $1.43
King, I hope you make a fortune here, I TRULY do, if this gets cleared I'll get a taste myself, But what this company did to the shareholders in 2012 by not informing them of that news for 5 months was unconscionable to say the least, In July of 2012 the stock was selling for $7.00 in November 2012 it was selling for $1.43, you get where I'm going. I not only post what you think is bad news, I post good news also, I don't bury my head in the sand, I'll post the good bad and the ugly, good luck
King, How do you address the issue of this company not informing the Shareholders when they knew that the FDA has asked additional information in their 2012 510k submission for Automated Gal 3 test in July and didn't inform the Shareholders till the 10Q filing in Nov 2012, How do you know they're not going to do the same this time too.
1 , They announce that ABBOTT Submission is still active.
2 , They announce that ABBOTT Submission is still active but the FDA has requested more information, Or worse, The FDA has requested more trials and Abbott and BGMD are in the process of starting those trials.
3, They announce that ABBOTT Submission is still active but the FDA has requested more trials and Abbott pulls their support.
They announce that ABBOTT Submission has been Cleared.
They announce that ABBOTT Submission has been rejected and Abbott pulls out.
Or more true from BG Medicine, THEY DON'T SAY A GOD/DARN THING.
Heart failure (HF) results from the impaired ability of heart to fill or pump out blood. HF is a common health problem with a multitude of causes and affects ~30 million people worldwide. Since ageing is a major risk factor for HF and as several treatment options are currently available to prolong the patients' survival, the number of affected patients is expected to grow. Even though traditional methods of assessment have been in use for managing HF, these are limited by time consuming and costly subjective interpretation and also by their invasive nature. Comparatively, biomarkers offer an objective and biologically relevant information that in conjunction with the patients' clinical findings provides optimal picture regarding the status of the HF patient and thus helps in diagnosis and prognosis. The current gold standard biomarkers for the diagnosis and prognosis of HF are B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP). Additional novel biomarkers (e.g., mid-regional pro atrial natriuretic peptide (MR-proANP), mid-regional pro adrenomedullin (MR-proADM), troponins, soluble ST2 (sST2), growth differentiation factor (GDF)-15 and galectin-3) can potentially identify different pathophysiological processes such as myocardial insult, inflammation and remodeling as the causes for the development and progression of HF. Different biomarkers of HF not only reflect the underlying mechanisms/pathways of HF and also its progression and also point specific therapy options. A multi-biomarker approach for personalized medical care is not too far fetched and such approach can greatly enhance diagnosis, prognostication, and therapy guidance for HF. In this review we describe the current status of HF biomarkers in clinical use and in laboratory research and the efforts aimed at the identification of novel biomarkers for HF.
Jess, I'll disagree with you on one point, if Cleared this will hit $3.00 within a week.
J, I agree with you on your post, Although IMHO this may last till January, hope I'm wrong
That's his job, It really doesn't matter what he does to manipulate the stock. Everything depends on the 510k, if it doesn't clear it's just about over, if it clears your golden, As for the MM ,, That's how he makes his living.
You guys got to get over your paranoia about the MM
on the other hand = we believe that automated instrument versions of our test will be required for us to achieve broad customer acceptance and clinical adoption. We have entered into worldwide development and commercialization agreements with Abbott Laboratories, for the inclusion of our galectin-3 test on a variety of automated laboratory instruments, We believe that, subject to completion of development of the galectin-3 test on these instruments, one or more of these laboratory instrument manufacturers will be in a position to submit a 510(k) premarket notification to the FDA no later than the fourth quarter of 2011 in order to obtain regulatory clearance to market automated instrument versions of our galectin-3 test in the United States. Subject to clearance from the FDA, we expect an automated instrument version of this test to be available for commercial use through one or more of these instrument manufacturers in the first half of 2012. We believe that it will take considerably less time for laboratory instrument manufacturers to develop and obtain FDA regulatory clearance for an automated version of our galectin-3 test than it took for us to develop and receive FDA regulatory clearance for the manual version of the test, since only the method for performing the test will change. The automated version of the test will be designed in the same way and be indicated for the same use as the manual test, and the manual test will serve as the predicate device under the FDA’s 510(k) clearance requirements. As a result, we expect that the FDA will be able to rely on much of the data and information reviewed, and knowledge gained, during the clearance process for the manual version of our test, thereby reducing the time necessary to receive clearance for the automated version of the test. Notwithstanding these factors, the FDA may not clear the automated version of this test as and when we expect.
see if this helps = In March 2009, we submitted a 510(k) premarket notification to the FDA in order to obtain the regulatory clearance to market this test in the United States. Upon review of our 510(k) application, the FDA indicated that additional clinical and other data was required in support of our filing and therefore denied clearance. We re-submitted a 510(k) application in December 2009 with additional data that we believe is responsive to the FDA’s comments. Subject to clearance from the FDA, we expect to begin marketing the test in the United States in the second half of 2010.
November 23, 2010—(BUSINESS WIRE) BG Medicine, Inc., a U.S.-based life sciences company, announced today that the U.S. Food and Drug Administration has cleared the company’s Galectin-3 test for use in conjunction with clinical evaluation as an aid to assess the prognosis of patients diagnosed with chronic heart failure. This marks the first time the FDA has cleared a test to measure galectin-3 blood levels, and is the first novel cardiac test cleared by the FDA in five years.