Congress has the chance to consider the VALID ACT, which would extend FDA regulation to many lab-developed tests. There hasn't been much known about how much this would cost on per-lab basis.
An international team - with experts from MGH to Melbourne and Antwerp, along with Friends of Cancer Research - tackles the problem. Huang et al. report that VALID could cost an active molecular pathology lab from $638,000 to $1.2M (potentially raising US health costs by as much as $1B over a 3-year period). This modeled the added expense for the U.S. count of 886 cancer treatment centers.
Here are some links:
- See an MGH press release here.
- See the original article released ahead-of-print at Journal of Clinical Oncology Practice.
- Link here.
I had the chance to be author 4 of 8. The article points out that VALID doesn't lead directly to cost projections; you have to interpose a series of assumptions, and the FDA could have wide latitude to produce a less expensive or more expensive regulatory program.