More multiplex and multi-analyte testing lies ahead for clinical pathology laboratories.
Several experts predict that clinical pathology laboratories will see the use of multiplex assays and multi-analyte diagnoses increase significantly in the near future. As this happens, both the science and the operations of clinical laboratories and pathology practices will grow in sophistication and complexity.
This week at the Executive War College on Laboratory and Pathology Management in New Orleans, Louisiana, almost 600 pathology and laboratory leaders gathered from 12 nations across the globe. During Wednesday’s general session, Thomas M. Grogan, M.D., Founder and Chief Scientific Advisor of Roche Ventana Medical Systems laid out his vision of how surgical pathology will evolve in the future.
Grogan organized his predictions around six key areas of science which are experiencing rapid refinement and will contribute to new capabilities within anatomic pathology. He characterized each as a forward move “beyond” the current status quo:
- First, beyond diagnosis to therapeutics. Grogan noted that new lab testing technologies give pathologists more precise understanding about the disease being studied. In turn, that additional knowledge makes it possible to pathologists to identify which therapies will be most appropriate for the patient.
- Second, beyond single-analyte diagnosis to widespread use of multiplexing. This is appropriate because both clinicians and patients want more sophisticated knowledge about the tissue, the disease, and the most appropriate therapies.
- Third, Beyond protein to “gene + protein” assays. Grogan provided several cases to illustrate how the standard of practice for selected types of cancers now requires more than just protein analysis. To provide a more sophisticated understanding of the patient’s disease, pathologists will evaluate the specimen using both protein and genetic assays.
- Fourth, Beyond qualitative to quantitative assays. This is a steady shift away from “yes or no” assays in favor of lab tests which provide more detailed information about the cancer being diagnosed. It is this richer set of data which the clinician can use to identify therapies likely to be effective, to monitor the patient, and to predict recurrence of the disease.
- Fifth, Beyond informatics to cellular informatics. This relates to the detailed understanding of cells, including individually and collectively, along with their functional and spatial relationships within the tissue. He emphasized the importance of morphological context.
- Sixth, Beyond written reports to electronic patient-centric reports. On this point, Grogan emphasized the need for pathologists to be more consultative and to contribute to the creation of an integrated report which incorporates all the relevant clinical data for the physician and the patient.
To illustrate these six key areas of evolving science, Grogan showed several cases of cancer and discussed how new technologies are providing pathologists with increasingly sophisticated ways to tease more detailed information from the analysis of tissue. These examples included testing approaches for HER2, EGFR, and KRAS.
Finally, Dr. Grogan stated that pathologists should be the “deliverer of the integrated results” and the “provider of the patient-centric report.” This allows pathologists to contribute their expertise, experience, and acumen, to the benefit of the referring physician and patient.
On one point, Grogan was most emphatic and caught the attention of his Executive War College audience. He stressed the importance of the pathology profession developing an integrated report format that presents all the relevant information, including pathology, imaging, and other modalities, in a unified manner that is easy for the patient to read and understand. But it was his additional advice that was notable. He went further to recommend that the patient’s report include all the medical analysis of the case. For example, in the case of a cancer patient, this should include the same survival rate chart used by the physicians when they evaluate the likely course of the patient’s disease, including mortality.
In Dr. Grogan’s view, today’s patient is entitled to know all the information about his or her medical condition that is being used by the clinicians. He did observe that, to his knowledge, there is no healthcare provider that currently does present such an integrated report—which includes things like the same survivability tables used by clinicians.
This year’s Executive War College was a high energy event. In coming weeks, both The Dark Report and Dark Daily will provide additional intelligence briefings on the sessions and the most notable developments in clinical laboratory management and anatomic pathology.
Your Dark Daily Editor,
Robert L. Michel
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