TAG:
laboratory-developed tests
What if Congress Chooses to Pass an LDT-Specific Law?
CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…
Post-COVID: Repurposing Excess PCR Instruments
CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…
October 26, 2020 Intelligence: Late-Breaking Lab News
In Houston, an 18-year-old high school student started a mobile laboratory company to provide COVID-19 tests to home-bound patients. As the youngest emergency medical technician in Texas, Taft Foley, III, saw the need for this service. Texas Mobile Medical Labs is the name of his company a…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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