AACC: New diagnostics help labs avoid the commodity trap

2019 08 05 17 59 6641 Aacc 2019 400

ANAHEIM, CA - With laboratory medicine at risk of becoming a commodity, professionals will need to get better at showing the system-wide value of tests and communicating with colleagues in other specialties, experts advised at a session on August 6 at the American Association for Clinical Chemistry (AACC) conference.

If all labs are viewed as being alike, the focus moves to cost and volume of testing, as opposed to recognition of the value of testing, said Robert Christenson, PhD, medical director of core laboratories and point-of-care services at the University of Maryland Medical Center. Christenson distinguished lab medicine as a service rather than a product, or commodity, during a session titled "The Value Proposition: Actionable Strategies for Enhancing the Value of Laboratory Medicine."

The value proposition for lab services includes the utility of tests, the quality of evidence supporting testing, benefits of care to a range of stakeholders (including patients, providers, and payors), and a plan for assessing metrics. Communication with colleagues will be key.

"We can't just take a lab test and put it into a system and think it will have an impact on a health-related outcome," Christenson said.

Different stakeholders, different value stories

Developing the value proposition entails an analysis of the primary customers for tests and creating a narrative relevant to their particular interests. Sometimes adding value may mean an investment in new technologies that will reduce costs in other areas of a healthcare system.

As an example, Christenson noted that a whole new generation of high-sensitivity tests for measuring cardiac troponin are now available. Cardiologists and emergency room departments are in the process of learning how to use these tests most efficiently to differentiate myocardial infarction from other kinds of cardiac injury.

New cardiac troponin tests offer excellent precision with high positive predictive value and sex-specific cutoffs for use in assessing heart disease, the leading cause of death, Christenson said. There is a role for lab professionals in helping cardiologists interpret results and triage patients.

"How often do we get an opportunity to improve a critical analyte?" Christenson asked. "We have the biggest killer in the Western world. We have new technology [and] a lot of evidence showing that it actually allows folks to get out of the hospitals more quickly."

"The patients like that. Providers like that. Payors like that. It's a winner," he added. "I would say this is something we should all give very serious consideration to in laboratory medicine."

Putting EGFR tests to use

Panelist Dr. Michael Oellerich, a professor of clinical chemistry at the University of Göttingen in Germany, also highlighted the deployment of new tests in building the value proposition for lab medicine. Companion diagnostics have been developed to guide the response to treatment of non-small cell lung cancer (NSCLC). Patients with EGFR mutations should be directed to targeted drug treatment with tyrosine kinase inhibitors such as erlotinib (Tarceva, Astellas/Roche) and gefitinib (Iressa, AstraZeneca).

However, even though EGFR testing is the standard of care, the reality is that it is underused. For example, a study of about 1,200 NSCLC patients seen in the U.S. community oncology setting showed that only 54% had EGFR testing and 22% had testing for EGFR and three other mutations that could be targeted with pharmaceuticals (Journal of Clinical Oncology meeting abstracts, May 20, 2019, Vol. 37:15_suppl, p. 1585). Treatment resistance is also an issue for EGFR inhibitors, and newer drugs such as osimertinib (Tagrisso, AstraZeneca) are effective for patients with T790 mutations.

"If we use these new drugs, we have to identify patients that would have a benefit," Oellerich said.

Tissue and plasma circulating tumor DNA (ctDNA) tests are available for assessing EGFR mutation status, and both add value for patient management, he noted.

Oellerich also sees a role for lab medicine in addressing unmet need in the field of immunotherapy. Programmed cell death 1 (PD-1) inhibitors are life-saving for a large subset of patients with NSCLC, but the biomarkers used to date -- expression of programmed cell death ligand 1 (PD-L1) and tumor mutational burden -- are not good enough to be used reliably in predicting treatment response, and the drugs are expensive. New biomarkers are in development; Oellerich and colleagues published promising early results with a copy number instability score in cell-free DNA (cfDNA) for helping to predict response to chemotherapy and immunotherapy (Therapeutic Drug Monitoring, April 2019, Vol. 41:2, pp.115-120)

Getting involved in tracking results

To add value, laboratory medicine professionals need to become more than "partialists" -- that is, specialists -- in their field, said panelist Dr. Michael Kanter, a board-certified pathologist and regional medical director of quality and clinical analysis for the Southern California Permanente Medical Group.

Physicians are prone to focusing on their core duties and have become separated from their colleagues in other specialties, he suggested. For pathologists, the focus is on reporting what they see on a slide and reporting out lab results that someone else interprets.

In diagnostics, there is a need to identify areas for improvement, find solutions, and track outcomes. Diagnostic errors are common, accounting for about 10% of deaths in hospitals, he noted.

There are many steps and physicians involved in the process of making a diagnosis and following it up. After a lab reports a result, the ordering physician needs to read and register it and follow up with the patient. Patients may be difficult to contact or they may fail to come back for additional tests. This can result in patients slipping through the cracks and delayed diagnoses.

Approximately 13 billion tests are ordered every year in the U.S., and abnormal results are missed 8% to 10% of the time, he said.

"This is an epidemic, and I am not using this term loosely," Kanter said.

He gave an example of a patient who had an incidental finding on a creatinine test. It was reported by the lab but not followed up by the ordering clinician, resulting in a delayed diagnosis of kidney failure four years later. Failure to follow-up can be costly, resulting in malpractice suits.

Kanter also shared experience from Kaiser Permanente Southern California (KPSC) in Pasadena and the implementation of a safety net system to identify lapses in care, using electronic health records and a small centralized team that intervenes before a patient is harmed. The system focused on 35 tests, including prostate-specific antigen (PSA), hepatitis C, and kidney function. In July, researchers at KPSC reported their results with estimated glomerular filtration rate tests, noting that 58% of patients did not get a needed repeat creatinine test within 90 days.

At Kaiser, prior to the implementation of an electronic system for tracking results, there were about three malpractice cases per year related to missed diagnoses of prostate cancer following an abnormal PSA test result.

When they looked into the situation, they found that it wasn't just subtle or marginally high scores that were being overlooked -- rather, obviously abnormal test results had been ignored, Kanter said.

"It's hard to justify that in a courtroom," he said.

The Kaiser system analyzed past PSA test results over three years, brought men in for follow-up and biopsy when necessary, and wound up finding 745 prostate cancers, Kanter noted. The safety net system has brought an end to malpractice cases related to PSA tests in the health system, he added.

Breaking the news to patients

Kanter acknowledged challenges with the system at Kaiser. Some patients can understandably get angry when they are informed of a delayed diagnosis -- for example, due to failure to follow-up with a confirmatory test after a positive hepatitis C result.

"Those patients were quite upset, and it took some skill to do this, but I think transparency is key," Kanter said.

And in the beginning, doctors were often annoyed at being second-guessed. It's important to recognize legitimate reasons for deciding against a follow-up test and minimize inappropriate electronic notifications to referring doctors, he said.

However, implementing the system has created a culture of safety and transparency, and the process for monitoring additional tests is now streamlined.

"We can launch one of these things in about three or four months from start to finish," Kanter said.

What's needed to implement something similar?

"In theory, as long as you can track lab results, you should be able to do this," he advised the AACC audience.

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