LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common

One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]


FDA Warns About Biotin Interference With Lab Tests

In late November the U.S. Food and Drug Administration issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with laboratory testing results. The warning comes … [Read more...]


CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]


Kellison Award goes to FDA’s Dr. Alberto Gutierrez

Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after more than 25 years of public service from his post as … [Read more...]


Forget 2014: New Discussion Paper Outlines FDA’s Current Thinking on LDT Regulation

In December, the U.S. Food and Drug Administration ended two years of anticipation or dread, depending on your point of view, by announcing that it would not finalize the guidance on agency oversight … [Read more...]


FDA Puts Final LDT Guidance on Ice—Agency Decides to Wait for Trump Administration

Whether you dreaded it or craved it, you will not be getting it—at least not any time soon. In the wake of the election, the U.S. Food and Drug Administration (FDA) let it be known that it will not … [Read more...]


Liquid Biopsies Get FDA Attention

In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of liquid biopsies? So-called "liquid … [Read more...]


Congressional Leaders Query FDA and CMS about Theranos

Earlier this summer, ranking members of U.S. House of Representatives Committee on Energy and Commerce requested a briefing from Theranos to inform the committee about Theranos' efforts to comply with … [Read more...]


FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight

Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents in early July, addressing oversight of next generation sequencing-based tests and … [Read more...]


AACC Adds to List of Alternative LDT Oversight Proposals

Another industry trade group has chimed in on the issue of the U.S. Food and Drug Administration (FDA) regarding its intent to regulate laboratory developed tests (LDTs). The American Association of … [Read more...]