AACC
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.
Diagnostic Companies Aim to Bring Routine Testing to Point of Care, but Face Significant Hurdles
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The Theranos scandal still hangs over the space, but several firms are working to move miniaturized clinical analyzers into settings like doctors' offices.
Large national labs and applications like oncology, genetics, and infectious disease dominate the database, which comprises more than 10,000 LDTs.
Top Five Articles on 360Dx Last Week: ADLM Taking on LDTs; Juno Dx Shuts Down; and More
Last week, readers were most interested in a story about the Association for Diagnostics & Laboratory Medicine's challenge to FDA's plans to regulate LDTs.
Though many laboratories have stepped up automation to alleviate staffing concerns, stakeholders emphasize that automation is not a cure-all.