Those involved with the medical diagnostics sector like to refer to how diagnostics – despite accounting for under 5% of hospital costs and less than 2% of total healthcare expenditures – are responsible for between 60% and 70% of healthcare decisions. Ken Buechler, president and chief scientific officer of Biosite (San Diego), expressed the diagnostics development proposition succinctly: “Improving diagnostics will improve healthcare outcomes and save lives.”

Discussing Biosite’s line of cardiac testing products during the JPMorgan Healthcare Conference, Buechler cited in particular the growing use of the firm’s Triage test panel, which he characterized as addressing “a huge market” of diagnosing acute myocardial infarction.

Noting that some 6 million persons present in emergency departments (EDs) annually with chest pain, he said cardiac assessment “is relatively poorly served by Troponin I.” Thus, the Triage Cardiac Panel has carved out an 18% share of the ED chest pain assessment market.

Use of the Triage BNP test in cardiovascular profiling is another area of large market potential for Biosite, and the test also is widely used in hospitals for acute monitoring on an off-label basis, Buechler said.

He cited several additional areas of interest to the company for its protein- and antibody-based technologies, including applications for stroke, sepsis and abdominal pain which, taken together, represent some $1 billion in market potential.

“Stroke is a massive medical problem,” Buechler said. “Early diagnosis can lead to greatly improved outcomes.”

He said the market for the stroke product would include some 2.4 million tests annually in EDs, 800,000 additional tests in other U.S. care settings, and 2.1 million tests outside the U.S.

Biosite has its Triage Stroke Panel at the FDA for review, but the application is on hold pending submission of additional data by the company in the present quarter.

The stroke panel is in use in some 50 centers in Europe, where Buechler said it “has shown comparable accuracy to that of an assessment by an expert stroke professional.”

Of the company’s sepsis program, he said 750,000 patients in the U.S. develop sepsis each year, and about 215,000 of them die.

“The condition is very complex, symptoms vague,” he said, and the current testing regimen, blood culture tests, “low.” Biosite has identified about 80 potential markers for analysis, and a prospective study involving about 1,000 patients is under way.

Abdominal pain is another potentially large market for the company, according to Buechler. “Abdominal pain is the leading cause for patients coming to the emergency department, some 8 million patients.”

He noted the complexity of this diagnosis, primarily via ultrasound, so there obviously is room for a test panel such as that under study by Biosite.

— Jim Stommen, Executive Editor