BG Medicine this week said that data from a clinical validation study of its CardioScore cardiac risk test indicates the test identifies patients at risk of suffering near-term major cardiovascular events with more than double the sensitivity of conventional methods.
The data is from the 6,600-patient BioImage Study – an effort undertaken as part of the High-Risk Plaque Initiative founded in 2007 by BG Medicine, Merck, AstraZeneca, Philips, Takeda, and Abbott to study heart attack and stroke. When combined with the Framingham Risk Score – the current standard for predicting cardiovascular risk – CardioScore identified at baseline 54 percent of patients who would experience a major cardiovascular event within two years, BG said.
Alone, the FRS – which combines risk factors like cholesterol, blood pressure, smoking status, obesity, diabetes status, and age – identified at baseline only 26 percent of patients who experienced a major event in the next two years.
The results of the study are the core of a 510(k) submission for CardioScore that BG Medicine filed with the US Food and Drug Administration in December. The test consists of measurements of seven plasma proteins, which are then combined into a single risk score presented on a scale of zero to ten, with ten being highest risk.
"The intent is that it will provide an assessment of near-term risk for major cardiovascular events … looking at men 55 years and older and women 60 years and older," BG Medicine chief commercial officer Stephen Miller told ProteoMonitor. "We know that the Framingham Risk Score is not perfect. Some people are low risk or moderate risk on the Framingham Risk Score, but they have an event."
By adding CardioScore to the assessment process, "you are more than doubling the number of patients you are identifying that will have a major event."
In an investor presentation this week, company officials also suggested the test might be useful as an alternative to conventional coronary calcification testing, which has also been shown to improve risk prediction when combined with FRS.
Currently, such testing relies on CT scans, which, according to data presented by the company, cost on average between $200 and $400 and expose patients to radiation levels equivalent to 33 chest X-rays. CardioScore could offer a less expensive, radiation-free alternative, the company said.
"One of our design objectives was to create a test that performed at the level of coronary calcium score … and in our performance comparison, CardioScore performs at the level of coronary calcium score testing." said chief medical officer Pieter Muntendam.
In his interview with ProteoMonitor Miller said that the company had decided not to release specificity data from the BioImage study, noting that it plans to discuss this figure "in the near future." During the investor presentation, though, Muntendam said CardioScore demonstrated specificity in the mid-60 percent range when combined with the FRS assessment, compared to specificity in the mid-80 percent range for the FRS alone.
Low specificity has caused difficulties for other protein-based diagnostics – perhaps most prominently Vermillion's OVA1 ovarian cancer test (PM 5/13/2011). However, Miller suggested, specificity might not be as important for a test like CardioScore where a positive outcome would likely lead to steps like increased physician monitoring as opposed to a more invasive procedure like a biopsy.
"If the outcome [of a positive CardioScore result] is that you're going to be monitoring the patient because they're now at risk of an event and so you're increasing the number of times you see them, that's not a negative outcome, necessarily," he said.
Miller said that the company has yet to disclose its business plan with regard to CardioScore, but noted that if it is implemented as a screening test similar to the FRS, it will make sense from a marketing perspective to target physicians "that have patients that are [at points] earlier in the [diagnosis and treatment] process."
The company also hopes to expand use of the test to younger populations, Muntendam said during the investor presentation, noting that it is "aggressively planning to measure CardioScore on other available sample assets [from] other major cohort studies, and we hope with that data that we can convince FDA to allow us to go to a younger population."
BG Medicine also announced this week that it has entered into a secure loan facility for up to $15 million with GE Capital's Healthcare Financial Services and Comerica Bank. An initial $10 million was funded to the company on Feb. 10, and subject to certain revenue milestones and other conditions being met, it may draw an additional $5 million term loan on or before Feb. 10, 2013.
According to Michael Rogers, the company's chief financial officer, the funds will go toward the launch of CardioScore and the continued development of its galectin-3 protein assay for predicting the prognosis of patients diagnosed with chronic heart failure.
A manual version of that test was cleared by FDA in November 2010, and is currently marketed by Laboratory Corporation of America, Health Diagnostics Laboratory, and the Cleveland Heart Lab. In November, the company received a CPT code for the test from the American Medical Association.
Key to the company's strategy for the galectin-3 test is securing approval for an automated version of it, which, Miller said, should spur wider adoption.
"With the automated test, you have immediate access to the test," he said. "So if a hospital is running the test, they can get the results back quickly and make [patient treatment] decisions based on those results."
Getting results with the current manual version of the test can take as long as three days, Miller noted, while an automated version performed on-site in a hospital lab could return results in under an hour. "So designing a treatment plan can occur now versus three days from now," he said.
The company has partnered with four firms – Siemens, Abbott, Alere, and BioMérieux – in this effort and expects to have automated tests on two of these platforms available in Europe sometime this year, Miller said. He added that a US launch of the automated test is likely in 2013.
The company is also looking to expand the use of galectin-3 to heart failure risk assessment, prognosis of acute heart failure patients, measuring treatment response, preeclampsia screening, and renal disease risk assessment.
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