Roy S. Herbst, MD, PhD

Drs. David Rimm and Roy Herbst identify the top challenges in the area of biomarker testing as well as solutions to these challenges, including availability of sufficient tissue for a large number of biomarker assays, the time some biomarker tests require for completion, the need for a tight association of test results with clinical outcomes, and the development of companion diagnostics for certain immunotherapies.

Drs. David Rimm and Roy Herbst review the problems with the CMS “14-Day Rule” since some of the multigene panel biomarker tests require 21 days or longer to complete.

Drs. David Rimm and Roy Herbst discuss the challenges of reimbursement by payers and the costs to pathology department of molecular biomarker testing, especially immunohistochemistry and DNA testing.

Clearly, immunotherapy has come of age in multiple tumor types, as described in the main article in this publication. The question now is how to develop more personalized immunotherapy and use biomarkers to identify patients most likely to benefit from this therapy.

Drs. Roy Herbst and David Rimm discuss ways in which the time required to complete biomarker testing can be reduced, from obtaining and processing tissues, performing the testing, evaluating results, and reporting results to the cancer care team.

Drs. Roy Herbst and David Rimm review some of the problems associated with obtaining enough tissue to perform biomarker testing, the need to triage tissue to ensure that standard of care tests are completed, and the potential role of liquid biopsies

Drs. Roy Herbst and David Rimm discuss the 50-gene panel that has become an ISLC-mandated standard for all patients with lung cancer; however, the components of cancer biomarker testing panels must be fluid and respond to new developments in the field as reported in the literature and/or at international cancer meetings, with adoption of the test predicated on standardization and the perceived value of the test.

Drs Roy Herbst and David Rimm review how biomarker testing has transformed the way patients with lung cancer are treated, and how both medical oncologists and pathologists contribute to these changes.

Drs Roy Herbst and David Rimm consider novel ways that surgeons, interventional radiologists, pulmonologists, medical oncologists, and pathologists interact at Yale Cancer Center to maximize the use of common molecular biomarkers, as well as NGS and TMB, in providing precision medicine to lung cancer patients.

Biomarkers are critical for the personalization of therapy in oncology. It is quite clear that all therapies, no matter how potent, will require some personalization to reach their maximum effect.