Fullerton-based Beckman Coulter Inc. is looking to capitalize on an industry push to bolster the accuracy of heart testing with one of its newer diagnostic procedures.
The test, called Access AccuTnI, measures levels of cardiac troponin I, a protein that’s released into the blood after a heart attack. Access AccuTnI is designed for use in emergency rooms. It received regulatory clearance last summer.
Beckman was showcasing the new test, known as an assay, at the American Heart Association’s Scientific Sessions 2001 conference last week in Anaheim.
Several professional groups, including the American College of Cardiologists and the National Association of Clinical Biochemistry, asked heart doctors and hospitals to adopt new testing standards for test-gear makers to incorporate into their products. Beckman officials say their new test is the only one now on the market that meets the new standards.
The overall cardiac testing market is estimated at $300 million and is expected to grow about 10% a year. Other makers of troponin I tests include Abbott Laboratories Inc. of suburban Chicago, Germany’s Bayer AG, Dade Behring Inc. of Deerfield, Ill., and New Brunswick, N.J.-based Johnson & Johnson and Ortho-Clinical Diagnostics, a J & J; unit.
Access AccuTnI is considered more accurate and sensitive than existing troponin tests. Its accuracy, and what it could mean for Beckman, was mentioned in an August research note by Theodore Huber, an analyst with Banc of America Securities.
“Given the superior sensitivity of the AccuTnI, (Beckman) believes this test could support incremental sales of the Access platform,” Huber said in his note.
In October, Huber wrote that Beckman’s overall immunoassay business posted its strongest results since Beckman Instruments Inc. and Coulter Corp. merged in 1998. The analyst mentioned that Access system placements were up 60%, and reagent sales were up 20%, “led by the company’s new troponin assay.”
On the hospital level, improving the accuracy of cardiac testing may help the average midsize to large acute-care hospital decrease annual emergency department costs by nearly $1 million, according to Bob Parsons, a Beckman senior staff biostatistician. Parsons’ numbers were based on industry guidelines for managing patients with chronic stable angina.
“Distinguishing, treating and educating these patients early in their disease can help prevent a catastrophic future event, an obvious benefit from both a medical and cost standpoint,” Parsons said.
Increasing testing accuracy also could save hospitals in other ways, according to Parsons.
Incorrect diagnoses of heart attack patients “are the leading cause of malpractice,” he said. “Diagnostic misadventures average $150,000.”
He also noted that the average damage award on failure-to-diagnose cases was around $250,000.
St. Jude Medical Center in Fullerton was one of the first U.S. hospitals to receive Access AccuTnI. St. Jude is on schedule to hit the $1 million savings mark, according to Ard Roshan, the hospital’s laboratory administrative director.
The test’s accuracy, Roshan said, has cut the need for costly hospital stays for chest-pain patients.
St. Jude, which is owned by Orange-based St. Joseph Health System, was one of three U.S. beta test sites for the cardiac test. Access AccuTnI is a refinement of a troponin detection test originally introduced by Beckman in late 1996.
“Troponin is not new,” said Linda Rogers, Beckman’s principal technical marketing consultant. But she said that the new test has improvements, including agents that reduce the likelihood of false positive results.
There still may be some resistance, though, to adopting the new cardiac testing standards. Parsons suggested that those who are reluctant to do so might be influenced by managed care-related cost constraints and treatment protocols.
Since the Food and Drug Administration cleared Access AccuTnI in June, between 700 and 800 Beckman Access cardiac testing customers have switched to the new system, said Jim Rigo, the company’s market manager for immunoassays.
But Beckman isn’t only counting on trade shows to increase awareness of the new heart attack test, Rigo said. He said he’s hired three former medical laboratory directors as educators to do seminars for cardiologists and lab directors.
“The problem is that this is viewed as a commodity,(people) believe that it’s all the same,” Rigo said. “We want to help educate physicians and laboratory managers,” he said. n
