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The blind men and the elephant
SEATTLE—Despite the proven value of diagnostic (Dx) testing (see sidebar, "The IVD hall of fame"), Dx testing is under-rewarded for its relative impact and value, says Epigenomics Inc. CEO Noel Doheny.
For example, only 4 percent of the $2.7 trillion spent on healthcare is on Dx—despite the fact that it's responsible for 72 percent of diagnostic decisions, according to Doheny. In the United States, diagnostic labs bill about $60 billion per year, and products sold to them account for about $18 billion, against the $2.7-trillion total healthcare spend.
Epigenomics, along with its Berlin, Germany-based parent company Epigenomics AG, is a company focused on developing molecular diagnostic tests for the early detection, prognosis, monitoring and personalized medicine in the field of cancer.
To date, cancer diagnostics are not even recognized as a category in Scientia's recent analysis of the global in- vitro diagnostics (IVD) market, Doheny notes.
"Cancer will emerge," he predicts. "We'll see it more and more. Today, oncology is a $250-billion-per-year healthcare crisis, and fewer than 25 percent of patients are cured by their chemotherapy. "
In particular, according to Doheny, the oft-sought goal of personalized medicine (PM) is more akin to something he calls "personalized alignment," where PM is viewed by the various participants in a way that emulates the old adage about the blind men and the elephant. Pharma sees a likelihood of smaller markets since their drugs won't be administered on a trial-and-error basis. Payers worry about additional costs if more PM assays are approved for payment. Physicians may see it as a tradeoff between the loss of individual choice and better control of the disease process. Regulators, as is their tendency, worry about consequences they can't foresee. And to the patient, of course, it's a matter of survival.
But Doheny is convinced the time is right to make progress at a faster clip.
"Why now?" he asks rhetorically.
Because technology has moved beyond macro level testing that differentiated disease from non-disease and characterized cancer, for example, by location and size. Today, molecular-level testing predicts outcomes of specific therapeutics, screens for adverse events and stratifies and monitors disease progression. Specifically, Doheny notes, leukemia has progressed from being categorized as acute and chronic types and lymphoma from indolent and aggressive, to the present state of 38 identified leukemias and 51 lymphomas.
Doheny estimates that 70 percent of all new Dx technology comes from the United States, creating an approximate $15 billion-per-year trade surplus. Among the "wins" lauded in the Dx "hall of fame," he points to HIV, myocardial infarction/heart attack, influenza and group-B strep.
How does a company prepare for the personalized environment? Doheny breaks it down into a 2D, 3R or 4P process: 2D, which is disease (treatable with a specific therapy) and demographic (patients and payment); 3R, which is references (peer-reviewed publications), reimbursement (third-party payment codes) and regulation (FDA and CMS); and 4P, which is payer (understood and accepted medical economics), provider (documented improved outcomes), patient (results that can be relied on) and pharma (behavior change).
In turn, the industry needs funding support from public and private sources, including venture capital, the reduction of over-regulation and a workforce of qualified technologists.
"We've got a long way to go," Doheny concludes, "but there's a lot of opportunity."
The IVD hall of fame
Recently, Mya Thomae, founder and CEO of MYRAQA, a regulatory consulting firm for the IVD space that Noel Doheny describes as "the best regulatory group in the world," dubbed May 2013 "Diagnostics Appreciation Month." To mark the occasion, she and her colleagues developed a blog describing a "diagnostics hall of fame." Here is a greatly abbreviated selection of six assays. The complete stories can be found at http://myraqa.com/blog/.
HIV: Viral load was defined as the more accurate predictor of clinical outcome. The disease, though not cured, was at least under control. Long-term survival became available for thousands of HIV-positive patients.
Hepatitis B & C: The yearly incidence of HCV infection averaged more than 200,000 cases per year in the 1980s, but by 2001, had declined to around 25,000 cases per year. As a result of hepatitis blood screening assays, the risk of acquiring the disease through a blood transfusions or organ transplant has been largely eliminated.
Lipid profiling: Monitoring of lipid panel results has allowed patients to recognize and reduce their overall risk for cardiac disease. Statin drugs, the first of which was approved in the United States in 1987, are a good example of therapies developed to address control of lipid levels.
HER2/neu assay: Dako received FDA approval in 1988 for the Hercep-Test, an assay used to identify patients with HER2-positive metastatic breast cancer. These HER2-positive patients were subsequently eligible for treatment with Genentech's Herceptin. The first FDA-approved HER2/Neu test was Ventana Medical Systems' oncor inform her-2/neu gene detection system, which was approved in 1997. This assay is also run to select breast cancer patients for treatment with Herceptin, as well as determining the prognosis for patients.
Myocardial infarction (MI) panels: MI panels test for elevated levels of enzymes or proteins that are linked with injury of the heart muscle. Before MI panels were available, physicians ordered each individual assay separately. As a result of MI panels, physicians are able to obtain relevant information with one test to aid in the diagnosis of myocardial infarction.
Prenatal group B strep tests: Prior to the introduction of group B Streptococcus bacteria tests, there were higher rates of early onset group-B strep in infants with an infant mortality rate of 55 percent for newborns. Infection was largely due to transmission from mother to newborn at birth. The introduction of group-B strep tests made it possible to identify pregnant women who carry group B-strep and administer antibiotics during labor, thereby greatly reducing the risk of transmission to the infant.