March 2007
Molecular testing can be a powerful revenue driver for clinical laboratories, but when is the right time to bring it onboard, and how do you choose which tests to offer? And once you’ve "gone molecular," how do you best integrate this type of testing into your laboratory and maximize returns? These were some of the key questions addressed at "Integrating MDx Into Your Lab," Washington G-2 Reports’ 2nd Annual Molecular Diagnostic Conference held in Tampa, Florida, last month.
A highlight of the conference was a session titled "How to Select Test Menus Right for Your Lab and Business Model." Moderated by Ronald McGlennen, M.D., president and medical director of Access Genetics (Eden Prairie, MN), the panel included Cindy Johnson, administrative director of Centracare Laboratories (St. Cloud, MN) and Mark Tulecke, M.D., medical director of Seacoast Pathology (Exeter, NH).
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Ronald McGlennen, M.D.
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Mark Tulecke, M.D.
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The underlying premise of the session was that the old paradigm for the diagnostic laboratory focused almost exclusively on the diagnosis of disease. The new paradigm, as it revolves around molecular diagnostics, is more inclusive of the four aspects of medical diagnostics: evaluating results, identifying risk and symptoms, determining appropriate treatment, as well as diagnosing disease.
McGlennen outlined the talk, and all three participants presented examples from their respective institutions that reinforced the premise of the session. "The selection of technical platforms and testing technologies—which includes an increasing number of instruments and assays, as well as a synthesis of the two," said McGlennen, "becomes a catalogue of extraordinary opportunity, but one that needs to be sorted out intelligently." The panelists outlined the building of a strategic test menu as having four elements: interest and need, IT and infrastructure, testing technology, and assays and tests.
If You Build It, They Will (Not Necessarily) Come
Panelists cautioned against adding a test or assay to the menu as a way to create a need for that test. From a strategic test menu perspective, you determine clinical need—and hence market need—by paying attention to what tests your physicians are requesting. "The agenda is driven by responding to the types of clinical questions that are being asked," said McGlennen.
Johnston agreed. "I can’t stress enough the importance when you are setting up a molecular diagnostic program to listen, listen, listen," she said. "Sometimes we don’t want to listen to our physicians, but we need to. They don’t necessarily understand laboratory testing, but they know what they want in order to make the diagnoses for their patients."
ComplexIT
Molecular diagnostics is an area of testing that requires a fairly strong IT infrastructure to support it; partly because of the complexity of the test results, but also because of the potential for multiplex testing in the molecular diagnostic arena. Many molecular tests already are an adjunct to conventional lab tests, and this drives the need for further analysis, which requires a fairly sophisticated Laboratory Information System (LIS).
"You propose a strategic menu by assessing what is the best combination of IT services and technical platforms that can address the clinical questions," said McGlennen. "There are many examples of one box/one test solutions, but that is not a strategic approach. That’s a very expensive approach. When putting together a strategic approach, you want to find a more multiplex capability."
Follow the Tissue
One of the practical approaches in this area is to follow the tissue types. Molecular diagnostic testing is highly versatile because it can be performed on a variety of tissues, as long as DNA or RNA is present; and due to amplification of DNA and RNA, molecular tests are typically viable on very small sample sizes. This makes it possible for laboratories to offer a variety of tests from a single tissue type.
"We found that by working with small pathology groups, that they often controlled a large proportion of the overall samples selected from patients," said McGlennen. "Do they keep them or send them out? Molecular testing has the ability to use any type of DNA to perform these types of tests. For instance, if you’re using liquid Pap, can you use the DNA from this material to do non-obvious tests as well as obvious tests? The answer is an emphatic ‘yes.’"
Assays vs. Tests
McGlennen was emphatic in distinguishing between a molecular diagnostic test and a molecular diagnostic assay. The tests, by his definition, are broader and include specimen procurement, nucleic acid extraction, gene chemistry, detection analysis, and reporting results. The assays, however, are not as inclusive and involve just the gene chemistry and detection analysis.
"Molecular diagnostics isn’t necessarily a collection of esoteric tests, but rather it is a very practical area," said McGlennen. In discussing HPV testing as an example of strategic test menus, he said, "By bringing those assays in-house, an institution could reduce costs, reduce TAT, and provide an integrated approach to cytology, using molecular techniques. What I’m trying to do here is point out that laboratories embrace this new paradigm of answering more questions for clinicians, of taking on the responsibility of things that have not yet occurred for patients, including diseases for which there are not yet tests."
Molecular Diagnostics in the Marketplace
The conclusion of the panel was that a viable, profitable molecular diagnostics program can be created by developing a strategic test menu built on clinical need, a robust IT infrastructure, and by utilizing technology to provide more thorough and useful test results for physicians, and by utilizing tissue sources for multiple tests. They noted that molecular diagnostics was considered to be worth about $3.71 billion in 2006, with particular growth in infectious disease and cancer diagnosis. Cancer testing, in particular, is smaller in volume, but quite high in relative value. In the next four years they expect 300 newly established laboratories offering molecular diagnostics to be expanding into these market sectors.
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"We believe that the success we’ve had with Seacoast Pathology demonstrates that the private pathology laboratory can deliver cutting-edge molecular technology equivalent to or better than some large private reference labs," said Tulecke. "By performing the molecular tests locally, we can deliver better service through decreased turnaround time and creative molecular reports."
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