AACC

The rule could force labs to shed tests deemed nonessential to their institutions' missions as well as influence decisions around instrumentation and vendor choices.

At the ADLM annual meeting, firms said they see game-changing opportunities for platforms that provide the right combination of clinical utility and convenience.

The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.