Hospital Labs Have New Options for Molecular Dx

Combination of growing physician demand and new molecular technologies open door for labs

CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier for even smaller community hospital laboratories to establish and perform molecular tests that are both clinically useful and financially sustainable.

Strong physician demand for molecular tests makes this a hot growth area for hospitals and independent laboratories,” stated Gregory J. Tsongalis, Ph.D., Director, Molecular Pathology, at the Dartmouth-Hitchcock Medical Center, in Lebanon, New Hampshire.

“Pathologists are wise to add molecular components to their lab’s menus because these tests are changing the way medicine is practiced,” explained Tsongalis during a conference call sponsored by THE DARK REPORT on September 23, “How Hospital And Health System Labs Can Profit From New Must-Have Molecular Tests.”

However, along with his enthusiasm for the opportunities in molecular testing, Tsongalis provided a caveat. “Molecular testing is a new and developing area of clinical testing —but it offers more pitfalls than other types of testing in the clinical lab because many things can go wrong!

“One simple example illustrates this point,” added Tsongalis. “In a chemistry lab, I could take a pipette of 10 milliliters of plasma and spin it in the air across the lab and it is improbable that any patient’s results would be affected. This is not the case in the molecular lab! A worker could contaminate the entire lab with as little as 50 microliters of specimen depending on the instrument systems being used. That is why, when adding new molecular tests in your lab, you must proceed with care and precision.”

Smart Business Decision

Notwithstanding this complexity, Tsongalis believes that adding molecular tests represents a smart business decision for labs because of the sustained growth in physician demand for these tests. “Labs that do molecular testing see strong growth in four particular areas: oncology, hematopathology, infectious diseases, and personalized medicine,” he explained.

“Of these, oncology is the single biggest growth area in molecular diagnostics, with assays emerging for diagnostic, prognostic, and predictive applications,” Tsongalis continued. “We used to say that, using traditional methods and depending on experience, a pathologist could diagnose correctly about 96% to 98% of the specific tumor types. But new knowledge of the underlying mechanisms of these tumors and the new classification of tumors will make it difficult for pathologists to do testing with traditional tools only. Therefore, forward-looking labs should be supporting these new molecular applications for diagnostics.

Rising Therapeutic Demand

“Further, therapeutic applications are stimulating the demand for molecular testing,” he added. “Look at how molecular testing is involved in decisions to treat a patient with Gleevac or Herceptin. We are now at the point where we can identify patients who need specific therapies. That is a new capability linked to genetic knowledge.

“Steady advances in these technologies are allowing researchers and labs to revisit old questions about genes and the way we have classified different types of cancers,” he said. “This research helps us better understand how certain genetic abnormalities, oncogenes, and tumor suppressor genes affect the diagnosis and prognosis of individual patients. This information is having an effect on therapy and is driving this field forward in a big way.

“For example, in colon cancer, physicians are now looking at the K-ras oncogene as they make therapeutic decisions and evaluate how patients respond to treatment,” Tsongalis explained. “New molecular tests like these give the laboratory a role in changing the way patients are diagnosed and managed. This is a big growth area for our laboratory here.”

Hematopathology And WHO

Similar advances are under way in the field of hematopathology. “We also have an active service in hematopathology at Dartmouth Hitchcock,” he continued. “This area is important because later this year, the World Health Organization (WHO) will publish new classifications regarding leukemia and lymphoma testing.

“These new classifications will be based on very specific molecular targets for these diseases,” he noted, “and they will affect diagnostic and therapeutic decision making. I expect that testing for these diseases will follow the path that we have seen for Gleevac and Herceptin.

“But even without the forthcoming new classifications, there are ongoing discoveries of new gene mutations involved in different types of cancers,” Tsongalis said. “In turn, this creates a clinical need for molecular tests that support diagnosis—and fast turn-around times for these tests because physicians want to treat these patients in a timely fashion. Pathologists will need to be prepared to identify the targets and to do these tests quantitatively so that physicians can monitor therapies.”

Infectious Disease Testing

Infectious disease testing was the first fast-growth area in molecular diagnostics. It continues to be a dynamic and changing field. “In the area of infectious diseases, we already have assays for different pathogens that run the gamut of qualitative, quantitative, and genotyping,” he noted. “Just as in oncology and hematopathology, there is a strong clinical demand for these tests, and, again, one important clinical need is for speedy turnaround times.

“For instance, labs batching clinical tests for infectious disease testing two days a week may not be providing the best service,” Tsongalis cautioned. “Labs should expect to see physicians want faster and faster access to test results for infectious diseases. New automated solutions in molecular testing will help the lab meet this demand.”

When discussing the last of the four areas—molecular testing in personalized medicine—Tsongalis described progress in this field as somewhat disappointing. “Personalized medicine is a growth area. But labs should be deliberate in their approach to adopting personalized medicine,” he explained. “For example, last year, targeted therapy programs for patients taking warfarin were instituted. These projects were called the first broad use of personalized medicine, in which a person’s genetic makeup was used to identify the best medicine or dose for each patient. But the programs did not produce the results expected by researchers. With hindsight, warfarin was not the best choice of a therapeutic to serve as a model for these programs.

“It is in the field of oncology where there is an active demand for targeted therapeutics,” added Tsongalis. “Our molecular laboratory at Dartmouth Hitchcock is focusing on therapeutics in personalized medicine, particularly in oncology. Knowing in advance whether an individual patient will or will not respond in a positive fashion makes a difference in their management.

“Keep in mind that, at the moment, development of these tests is challenging, since there are not many FDA-approved assays for the different conditions,” he said. “The other challenge is for a laboratory to determine the cost-benefit ratio of any new test for personalized medicine.”

Not only is Tsongalis bullish on the future of molecular testing in labs, but he believes new molecular tests coming to market will make it easier for even smaller community hospitals to establish a clinically useful and financially viable molecular testing menu.

Consider Overall Cost of Healthcare Encounter When Evaluating Possible New Molecular Tests

MOLECULAR TESTS GENERALLY COST MORE than most traditional laboratory tests. “But that’s not the whole story,” observed Gregory J. Tsongalis, Ph.D., Director, Molecular Pathology, at the Dartmouth-Hitchcock Medical Center. “Pathologists concerned about the cost of these new tests should consider how the results from molecular testing can help control other health system costs and save a lot of money!

“In a recent review of our contracts with reference labs, we noted that the cost of the molecular tests ranged from $2,500 to $10,000,” Tsongalis said. “That’s a lot of money and shows why many clinicians believe molecular testing is expensive. But often an expensive lab test brings about the least-cost outcome.

“Let me explain. At a recent tumor board meeting, the discussion was about a transplant patient who had a particular virus. One oncologist asked about the cost of a PCR assay for a virus. I hesitated, but as an educational opportunity I reported that it would cost the hospital about $7,500 to run this test. The consensus was, despite this high cost, that’s what should be done for the best management of the patient. Actually, the test under discussion only cost $150, illustrating the perception physicians have that new molecular tests are expensive.

“Additionally, despite the increased cost of some of the more elaborate and complex molecular assays, they can have a benefical effect for the overall finances of our institution. That is something that lab directors and pathologists must consider,” he added. “For example, if the lab performs a particular molecular test, what does that mean for patient management? Will that test result help identify a targeted therapy that allows the patient to go home sooner? If so, then the institution will save the cost of several days in-hospital care for that patient, generating savings that may far exceed the initial cost of the molecular test.

“For too long, the laboratory has failed to consider its total role in the continuum of clinical care,” observed Tsongalis. “As laboratory professionals, we have been isolated for too long. In today’s medicine, we should recognize that what we do has an effect on overall costs and on patient management. In other words, we need to get out of our labs and be contributing at every appropriate step in patient care.”

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