Skip to main content
Premium Trial:

Request an Annual Quote

CMTP Publishes Guidance for Assessing Utility and Validity of Cancer Molecular Dx

NEW YORK (GenomeWeb News) – Seeking to set a standard for how molecular diagnostic cancer tests are evaluated, the Center for Medical Technology Policy has issued a set of recommendations covering how to best assess the clinical validity and utility of these tests.

While molecular diagnostic tests offer great promise for oncology, evidence supporting the use and safety of these tests is lacking, and there is "considerable debate" about how much evidence is required and how it should be acquired, CMTP said yesterday.

Although several molecular diagnostic tests for cancer do have strong data that they improve patient outcomes, a "large and growing" group of tests are lacking in evidence, particularly regarding their clinical utility, the nonprofit center said.

The effectiveness guidance document, or EGD, that CMTP published yesterday — which the group likened to a Food and Drug Administration Guidance document — was developed through a multi-year process with major stakeholders and was created to improve the quality, relevance, and efficiency of studies of the utility and validity of such oncology tests for adults.

"Determining what constitutes a reasonable level of evidence of clinical utility for molecular diagnostics could significantly accelerate access to useful tests, while preventing widespread adoption of tests that don't improve patient outcomes," CMTP President and CEO Sean Tunis said in a statement. "This guidance provides test developers and those designing clinical studies with concrete recommendations on what types of studies are needed."

The goal was to create a framework of recommendations that test developers and researchers could use to plan studies that anticipate the evidence that will be required for the tests to be reimbursed. Additionally, payers and technology assessors would use the same standards to assess study results.

"The purpose of this initiative was to close the gap between the presumed benefits of tests undergoing technology assessments and the information needs of payers, clinicians and patients," added Pat Deverka, a senior research director at CMTP and the EGD's lead author. "Our overarching goal is to bring greater clarity and predictability regarding the evidence requirements of all interested stakeholders."

The project was funded by a number of life sciences industry and healthcare firms and foundations, including Becton Dickinson; Cepheid; Myriad Genetics; Genomic Health; Amgen; Daiichi Sankyo; AstraZeneca; Sanofi- Aventis; and others.

The document includes recommendations for reporting analytic validity; selecting patient populations for assessing validity; the metrics required for clinical validation; anticipating clinical pathways; measuring outcomes for clinical utility; and using randomized controlled trials for clinical utility, prospective-retrospective clinical trials, single-arm studies, longitudinal observational studies, and decision-making techniques.

Filed under

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.