NEW YORK (GenomeWeb News) – The Center for Medical Technology Policy is funding a project that will develop guidance on evidence standards needed to evaluate next-generation sequencing-based tests for cancer diagnosis and treatment.
The CMTP-funded Green Park Collaborative is leading the effort via its Oncology Consortium.
The initiative aims to produce an Effectiveness Guidance Document that will inform decision making on coverage and reimbursement for NGS-based tests, CMTP said. Elisabeth Houtsmuller, senior program director for GPC, will direct the project, which will be led by a technical working group comprising representatives from health plans, the US Food and Drug Administration, the Centers for Medicare & Medicaid Services, NGS test developers, patient groups, oncology guideline organizations, clinical oncologists, drug/biologic companies, and other stakeholders.
CMTP said that the guidance document will focus on NGS-based tests used to manage patients with a known diagnosis of cancer, rather than risk prediction testing, and will be informed by its recent work on "evidentiary standards for studies of the clinical validity and clinical utility of molecular diagnostics in oncology."
CMTP said that the GPC's Oncology Consortium is also developing a guidance document on the best ways to use sequencing for research on cancer care treatments. This work is led by Donna Messner, research director at CMTP, and Anne Schott, a medical oncologist at the University of Michigan.
A CMTP official said the guidance documents should be available in the fourth quarter.