NEW YORK (GenomeWeb) – The Association for Molecular Pathology today published its recommendations on establishing the clinical utility (CU) of molecular diagnostics.
As the group noted in a report in the September issue of the Journal of Molecular Diagnostics, "many stakeholders have adopted narrow definitions for the clinical utility of molecular testing as applied to targeted pharmacotherapy in oncology, regardless of the population tested or the purpose of the testing. This definition does not address all of the important applications of molecular diagnostic testing."
AMP added that a model for determining the clinical validity of molecular diagnostics with a variety of testing purposes must include measures of analytic validity, clinical validity, clinical utility, and ethical, legal, and social implications, and further recommended that patient-centered definitions of clinical utility be taken into account.
The group also addressed the practical challenges inherent in demonstrating clinical utility for molecular pathology tests, stemming mostly from the tests' unique features "that hinder collecting evidence at the same level" as other medical tests such as imaging or clinical chemistry.
Given those challenges and keeping its model in mind, AMP wrote, clinical utility for molecular diagnostics should not be limited to diagnosis of a disease, but should be defined as "the ability of a test result to provide information to the patient, physician, and payer related to the care of the patient and his/her family members to diagnose, monitor, prognosticate, or predict disease progression, and to inform treatment and reproductive decisions."
The group also said that a new approach is needed for defining clinical utility. The term is often limited to whether a molecular diagnostic with established clinical validity can also mandate or inform therapy selection with an expected improvement in health outcome. But this narrow definition "attempts to force all molecular diagnostics into a companion diagnostics model for CU evaluations," excluding a wide range of purposes for these tests, AMP wrote.
"The existence of evidence for CU that is outside of the norm of traditional models is different from evidence against CU," AMP wrote. "In summary, we recommend the following: promotion of patient-centered definitions of CU; utilization of a modified model incorporating aspects of CU beyond drug selection; support for multiple modalities of CU evidence generation; development of professional organization-driven practice guidelines; and recognition of the critical role of the molecular professional in patient care."