Cardiac Diagnostics: The Horse is Out of the Barn
This article was originally published in Start Up
The cardiac diagnostic marker field, dormant for years, is changing so rapiidly that studies done five years ago are out of date. Current markers are inreasingly significant in guiding treatment and a lot of promising new markers are in development. As new markers attract the interest of researchers and clinicians, their adoption is likely to be influenced by the history of troponins for detecting MI and the up-and-coming marker for heart failure, BNP. That's the message of E. Magnus Ohman, MD, chief of the division of cardiology at UNC, who spoke at the AACC's annual meeting in July.
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In recent years, some creative diagnostic companies have applied pharmaceutical-like marketing techniques to launches of their flagship products. Five-year-old Ischemia Technologies' launch strategy for its cardiac marker, ischemia-modified albumin (IMA) is based on tenets gleaned from these companies' success stories. It is supporting its marker of cardiac ischemia with strong clinical and market development programs, aimed not just at the laboratory but also at clinicians. But the inherent complexities and nuances of the opportunity it addresses are challenging.
More than 10 years after it was introduced on a broad scale in non-glucose applications, point-of-care testing (POCT) has found a place in carefully selected niches in hospitals. It's still not part of mainstream care, however. Data indicating the importance of getting rapid test results on cardiac markers, notably troponins and BNP, is tempting POCT in vitro diagnostics manufacturers to forge closer relationships with non-lab clinicians, even as they cater to their core, but resistant, laboratory customer base. Manufacturers are going to have to make their devices smaller, easier to use, cheaper, and better connected to data management systems if they want to lower the central labs' resistance to POCT.
Biosite built a business in one area, drugs of abuse (DOA) testing, by producing a rapid result point-of-care (POC) test. This initial success led to the notion of developing other POC tests that would contribute directly to therapies. thereby garnering higher margins. This strategy is currently being tested in cardiology with the company's cardiac marker panel, which has run into marketing problems, in part because it required a very different kind of sales effort. In parallel, Biosite is aiming to come up with high margin proprietary markers: a costly, risky, research-intensive process that most margin-pressured diagnostics companies avoid. To pay for its marker discovery program--enabled by its phage display genomics technology--Biosite has set-up alliances with biopharmaceutical companies, which use the technology to discover and/or validate therapeutic targets, ceding to Biosite POC rights to diagnostic markers discovered along the way.