By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
A virtually unlimited number of genes tied to hereditary cancer risk can be simultaneously assessed in commercially available tests given both advances in technology and the Supreme Court’s two-year old ruling overturning gene patents. By screening multiple genes in parallel, research has shown that diagnostic yields are on the rise and time to results are down, with the added benefit of not adding much incremental cost for delivery of additional information. Clinical adoption of multigene panels faces some hurdles, however, including questions about clinical utility and reimbursement.
While the industry is well aware of the need to generate evidence of clinical utility, there remains scant evidence as to the cost effectiveness of panel-based testing. Yet, industry watchers are hopeful that momentum is gaining for reimbursing these multigene panels. In mid-August a multi-stakeholder group convened by the Center for Medical Technology Policy (CMTP, Baltimore, Md.) recommended coverage for sequencing panels of 5-50 genomes if they include a subset of constituent genes that are considered to be standard-of-care and medically necessary for the patient. Additionally, the group’s recommendations call for proposals to incentivize laboratory and clinician sharing of data, to promote patient participation in clinical trials and registries.
For in-depth coverage of this topic, see the next issue of Diagnostic Testing & Emerging Technologies.