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Studies Shore up BG Medicine's Push for Galectin-3 Test in Hospital Readmission Risk Assessment


BG medicine is hopeful that data from two studies published earlier this year will help shore up the scientific foundation for the company's new strategy of marketing its galectin-3 test to hospitals as a tool for reducing unplanned readmissions.

The company announced the strategy shift in its third-quarter earnings call last year — a move to capitalize on the Centers for Medicare and Medicaid Services' new guidelines and penalties aimed at reducing hospital readmission rates (ProteoMonitor 11/16/2012)

The newly published studies involved more than 3,300 subjects between them and showed that serial evaluation of galectin-3 levels can help clinicians identify those at greater risk of cardiovascular morbidity and mortality as well as associated unplanned hospital admissions.

"We believe these findings validate our commercial focus on the use of galectin-3 testing to combat unplanned hospital readmissions, and will help us drive further clinical adoption of galectin-3 testing as a routine part of heart failure management," Eric Bouvier, the company's president and CEO, said in a statement at the end of last month.

Speaking with ProteoMonitor last week, BG Medicine's chief scientific officer Aram Adourian discussed the two studies in more detail.

"To the best of our knowledge these are the first two publications — spanning three separate studies — to investigate whether repeat galectin-3 testing has utility in terms of stratifying patients by their risk profiles."

"The reason why we are excited [about the results] is that they show that galectin-3 levels do change over time in a proportion of patients and that change does appear to reflect disease progression in terms of the underlying pathophysiology," he said. "The data showed that if galectin-3 is increasing over several months that patient has a much higher risk profile in terms of hospitalization than one whose level stays stable or even decreases over time."

While Adourian said that "physicians and hospitals will have to see how to fold this [information] into their own readmission reduction programs," the studies have demonstrated how this sort of serial measurement could be used to ascertain a patient's real risk profile for the type of disease progression that leads to an unplanned trip back to the hospital.

The first study, published online in Circulation Heart Failure looked at almost 2,000 patients enrolled in two larger clinical studies, CORONA, and COACH. Researchers from Norway and the Netherlands used BG Medicine's galectin-3 test to assess patients at baseline and then after either three or six months. Looking at patients' percentage change in galectin-3 levels, the group found that those whose levels increased over time by 15 percent or more had significantly more subsequent hospitalizations and higher mortality compared to those who's levels were stable, or decreased over time.

This increased risk was independent of other risk heart failure risk factors, including cardiac function, renal function, age, and levels of NT-proBNP, according to the study authors.

In the second study, published online in the European Journal of Heart Failure, a team from the University of Minneapolis and the Minneapolis VA Medical Center measured galectin-3 levels in about 1,000 patients from the Valsartan heart failure trial at three month intervals. The authors demonstrated that patients who experienced increases in galectin-3 were at significantly increased risk of subsequent unplanned hospital admissions for heart failure. The researchers reported that this increased risk, as in the first study, was independent of all other baseline heart failure risk factors the group considered.

Previously, BG Medicine has marketed its galectin-3 test as a more general monitoring tool for heart failure patients: to track the progression of heart failure and assess and predict outcome. The move to place the testing more squarely within the assessment of patients' risk for unplanned readmission to the hospital still fits within this indication.

BG Medicine has also said it is investigating whether the test can be used to predict the risk of developing heart failure, not just project outcomes for those who already have the disease.

The company received a CE Mark to offer the test for this expanded indication last May, filing a 510(k) application for the new use of the test with the US Food and Drug Administration at the same time. According to Bouvier, this additional use would significantly expand the market for the test from around 20 million to roughly 200 million patients in the US and Europe.

However, independent research has since called galectin-3's predictive potential into question. Researchers from the Framingham Heart study last year published results from the 3,353-patient effort that showed that though elevated galectin-3 levels were linked to an increased risk of heart failure, adding the marker to existing risk models did little to improve predictions of heart failure or mortality (PM 9/7/2012).

Despite the mixed message of that large study, BG Medicine maintained at the time that galectin-3 could be useful as a predictive, and not only prognostic tool. The FHS researchers are pursuing a follow-up investigation looking at galectin-3 levels measured serially — as in BG Medicine's two recently-published studies.