2 studies have recently come out on Serial Gal-3 testing. One which shows that it helps in 1st indication and this recent one which supports 2nd indication ( general population). Go figure why SP is 0.19
Incredible that SP is where it is as new studies even support 2nd indication. This is a Major Study yet company has yet to deliver.
Serial galectin-3 and future cardiovascular disease in the general population
A Rogier van der Velde1, Wouter C Meijers1, Jennifer E Ho2, Frank P Brouwers1, Michiel Rienstra1, Stephan J L Bakker3, Anneke C Muller Kobold4, Dirk J van Veldhuisen1, Wiek H van Gilst1, Pim van der Harst1, Rudolf A de Boer1
Published Online First 15 April 2016
Background Lifetime risk for cardiovascular (CV) disease is high but predicting incident events on an individual level remains difficult. Single measurements of galectin-3, a marker of tissue fibrosis, predict mortality and new-onset heart failure (HF). Persistently elevated levels may indicate a clinically silent disease process.
Objectives Our aim was to establish the value of serial galectin-3 measurements to predict CV outcomes in the general population.
Methods Plasma galectin-3 was measured in the Prevention of REnal and Vascular ENd-stage Disease (PREVEND) study at baseline and after ∼4 years. Changes in serial galectin-3 were expressed as categorical changes or absolute change from baseline and were related to subsequent outcome.
Results Serial galectin-3 was measured in 5958 subjects (mean age 49±12 years; 49% female). The median duration of follow-up was 8.3 years. Persistently elevated galectin-3 (defined as highest quartile at baseline and highest quartile during visit 2, n=757 subjects) was associated with a higher risk for new-onset HF, CV mortality, all-cause mortality, new-onset atrial fibrillation and CV events, compared with subjects with non-persistently elevated galectin-3. After multivariable adjustments for baseline characteristics, serial galectin-3 remained an independent predictor of new-onset HF (HR 1.85 (1.10–3.13); p=0.02) but not for other outcomes. Serial measurements provided more accurate prognostic value to predict new-onset HF, compared with a single baseline measurement (Harrell's C: 0.72 (0.68–0.75) vs 0.68 (0.65–0.72); p=0.002, respectively) with significant net reclassification.
Conclusions Persistently elevated galectin-3 predicts new-onset HF after adjustment for covariates, and serial measurements provide more accurate prognostic information compared with single determination of galectin-3. This may help to identify individuals who are at risk for incident HF and might provide a measure to monitor interventions.
You can expect more of this or next to no volume as a result of deregistration.
This is what management is getting paid for?
Stock is dark and off the grid as far as the market is concerned.
Management should be horsewhipped.
Potential for nothing. This is a zero growth stock now off the radar as deregistered.
Any revenue will be just enough to pay for their high salaries,
Agree on all points. Makes it a good short for someone over the next couple of months with not a lot of risk. There is potential...just not sure how we will hear about it.
for quite some time until perhaps some revenue from Abbott.
And we can expect no information from management at all
(even less than the pitiful communication from them before deregistration).
If they want to save money why are they not reducing their
salaries which they get paid for doing nothing.
No one is going to invest in this company now.
Management's ineptitude has eliminated any real possibility of growth.
Yes both Abbott and Biomeriuex sold the automated version in EU. During the Q&A session of the 2013 Q4 earnings, I think, someone asked about EU sales. What Paul Sohmer said was "The EU sales were insignificant. The reason for that according to him was Galectin-3 was not in EU guidelines and also the other reason the test was not reimbursed. Paul also said that they are working on getting Gal3 into at least one EU country's guidelines by end of 2015.
related disorders was the subject of 10 papers that were published in peer-reviewed medical and scientific journals during the third quarter, and eight presentations made at the American Heart Association's scientific session's annual meeting in early November."
( from Nov 2015 10-q edited transcript)
Please note that for the first time, we have broken out product fees in our financial statement. These revenues reflect product fees payable to BG Medicine by both Abbott and bioMerieux for automated galectin-3 tests that these automated partners have sold. To date, the revenues recognized for product fees reflect sales of automated tests for galectin-3 outside the US.
They reported 334k for the 3rd quarter. They broke it down 274k Product Revenue
60k Product Fee
If I read this right, BOTH have sold the test OUTSIDE the US. Therefore, not sure what guidelines you are referring to. The 60k is from outside of the US. This contradicts what you said.
In the 2015 10-K filed just recently the product fee they show is 140k for the year. We know 60k of that came in the 3rd quarter not sure how the rest breaks down. Once can break it down to 60k for 3rd quarter and 80k for 4th? Not sure out of the 140k Product Fees reported in 2015 10k how much is domestic and foreign?
We need to see product fees grow exponentially. Interesting how we are seeing the medical community increasingly in agreement over galectin-3 efficacy as a biomarker but until it translates into real sales, perilous track to be on. This is the crazy part, science today is more supportive than just a few months back when they said this:
We believe that our efforts will continue to benefit from ongoing interest in galectin-3, as reflected in the frequency of presentations and publications in which its measurement is included. The role of galectin-3 testing in cardiovascular disease and
It sure would be nice if you could just post link: Do a search it was on medscape at the bottom it mentions BGMD and most of the test partners we have been talking about.
CHICAGO, IL — Patients experiencing a first type 2 MI (T2MI), related to supply-demand inequity, rather than classical plaque rupture, have similar or worse prognosis than those with incident type 1 MI (T1MI), new research suggests.
The Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study prospectively enrolled 1251 patients undergoing coronary or peripheral angiography. Over a median 3.4 years of follow-up, it found that T2MI patients had a higher rate of subsequent major adverse cardiovascular events (MACE) than those without T2MI (100 vs 17.6 events per 100 person-years; P
I suspect that BioMerieux and ABT are waiting for guidelines in EU to fully market it there. It is available by both companies and probably minimally used somewhat, but definitely not full scale until guidelines.it would be a waiste of time and money for them to market a test which is not validated by the EU guidelines, thus no incentives for Drs to prescribe it in EU. My guess is that BioMerieux and Seimens are waiting for EU guidelines in order to file with the FDA. At that point in time, they would market the test both in EU and US at the same time. IMHO ABT is by far the leader, and the US market is always first and fastest to gain traction. Let's hope they deliver
Does that mean Biomerieux and Siemens face the same obstacle in marketing the test in the EU as Abbott - also waiting for "Healthcare guidelines"? Biomerieux website is marketing the test. Just not sure when they started. Or is this a case of an American company trying to market in the EU and face stiffer guidelines? Currently all bets are on Abbott to deliver. Biomerieux and Siemens remain dark horses.
Gal-3 is CE approved in EU. It isn't being marketed yet by ABT in EU( confirmed by ABT Global Cardiac Product Manager) as its not yet in the guidelines. It's available, but not yet fully marketed there until it gets onto the Healthcare guidelines. Only in the US are they actively marketing it. I know Sohmer had said about 1 1/2 yrs ago that they expected Gal3 on EU guidelines at the earliest end of 2015. So possibly 2016.
Abbott and Biomeriuex did sell the automated test in EU. They started selling in EU a few years back but the sales were insignificant.
Although the microplate version of the BGM Galectin-3 test is the primary, current focus of our commercialization strategy, we have partnered with four leading diagnostic instrument manufacturers to develop automated versions of our galectin-3 test, which we expect will result in broader customer acceptance and clinical adoption of our galectin-3 test. To execute this element of our commercialization strategy, we have entered into worldwide license, development and commercialization agreements with Abbott Laboratories, or Abbott, Alere Inc., or Alere, bioMérieux SA, or bioMérieux, and Siemens Healthcare Diagnostics Inc., or Siemens, for the development of our galectin-3 test on their automated instruments, including point-of-care instruments, which are utilized within hospitals and other medical organizations. We believe that through these four partners we will have broad access to major segments of the diagnostics market, including hospital laboratories, private laboratories, reference laboratories and physician office laboratories, due to the widespread coverage of our partners’ installed bases. Under the agreements, our partners are responsible for developing and commercializing the tests and we are responsible for furthering clinical awareness and developing the market for galectin-3 testing. (Says Worldwide not sure with which one)
As a result, the majority of revenues currently generated from sales of manual test kits are expected to be diminished over time and we expect that any future revenues will be primarily derived from product fees that are generated from the sale of automated tests by Abbott (and our other automated partners when and if their automated tests become available).
The group of partners beside Abbott are biomerieux, Alere and Siemens.
Abbott having bought Alere leaves only Biomerieux and Siemens.
Off those 2 I only see Biomerieux has the automated test available for sale.
Not sure when they started to sell the automated test?
Seimens continues to show test is underdevelopment and not ready for sale.
Sales ONLY from Abbott have been reported for 2015 of the automated test.
Not sure what we can expect from Biomerieux going forward with the automated test.
That leaves Abbott and I'm curious if Abbott is allowed to market the test in Europe? I know Abbott is global and has a European division. What about India - and beyond - who has license for such markets?