This article has been updated with information about a Citizen Petition filed against FDA regulation of LDTs by the American Clinical Laboratory Association, and with quotes from Sherri Bale. Originally published June 4.
Originally published Oct. 1.
A new bill strongly supported within the diagnostics industry could put pressure on the Centers for Medicare & Medicaid Services to alter its procedures for setting reimbursement rates for molecular diagnostics.
Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.