A multidisciplinary, international panel that includes AACC board of directors member Andrea Rita Horvath released a 14-item checklist to ensure more efficient biomarker development and translation into practice. The group published its report in the September 2016 issue of Clinica Chimica Acta.

The Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine conducted its work in response to calls for increased value and reduced waste in the healthcare system coupled with the growing number of available in-vitro diagnostic (IVD) tests for biomarkers. Such tests, the panel noted, are increasingly introduced before the clinical utility of the biomarker is clear. Conversely, the clinical utility of a biomarker may be apparent, yet there may be long delays in defining its ideal use.

One reason for the disconnect is that biomarkers are typically not identified in response to an unmet clinical need, but as the byproduct of technological advances. As the panel wrote: “This technology ‘push’ and other non-clinical factors, including financial pressure or reward, can drive technology innovations beyond healthcare needs if inadequate efforts are made to align biomarker development to the ‘pull’ of clinical needs.”

Thus, the panel developed a four-step process for researchers, clinical scientists, and industry to identify unmet needs and improve the development of IVD biomarker tests and, as a result, clinical outcomes.

The first step is to identify the unmet clinical need for a biomarker by asking:

  • What is the clinical management problem and desired outcomes?
  • What is the patient target group and clinical setting?
  • What is current practice and what are the limitations?
  • What are the desired outcomes of the development of this test?

Step two involves verifying the unmet need for the biomarker. Can an existing solution be optimized? Are such solutions medically appropriate and cost-effective? Are there barriers to their use? If an existing solution meets these criteria, then research should stop.

In the third step, the panel wrote, researchers should validate the intended use of the biomarker, asking, “would the biomarker contribute to the solution (of the unmet need)?” This includes altering and improving current clinical practice; determining if the risk/benefit ratio warrants continuing with development; and identifying the minimal clinical performance characteristics required for the test to be favored over any existing solution.

Finally, in step four, the panel recommends that researchers assess the feasibility of the new test from a commercial, economic, technical, and organizational perspective. They should also identify any other barriers to its clinical integration.

The laboratory medicine profession plays an important role in identifying unmet clinical needs through audit or active post-market surveillance of the clinical performance and effectiveness of existing tests, the panel wrote.

“By identifying poorly performing medical tests, laboratory professionals may assist in both removing biomarkers from the test repertoire and replacing them with better performing tests, or exploring novel test purposes where appropriate.”

The next step, the panel wrote, is for stakeholders to field-test and validate the four-step process, with clinical laboratory professionals serving at the interface between the clinical, academic, and industry settings.