Blog Posts with Tag: LDTs

The Staple That Changed an Industry
LDT regulation and the perils of challenging Eminem to a rap battle
Tuesday, August 05, 2014
FDA Releases the Kraken
Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Thursday, July 31, 2014
No Substitute for Planning
Expecting a miracle isn't the best strategy
Monday, December 23, 2013
RUO + NGS = FDA FTW
MolDx and the prisoner's dilemma
Friday, December 06, 2013
Final RUO Guidance: First Impressions
FDA appears ready to get serious about RUO
Friday, November 22, 2013
The Hero We All Needed
Lessons from boy that wanted to be Batman
Tuesday, November 19, 2013
The CMS Take on LDTs, CLIA and FDA
Not a rose by any other name
Friday, October 25, 2013
How Much Are Lab Tests Really Worth?
Charting a re-direction from a vicious to a virtuous cycle in test development
Wednesday, September 18, 2013
Laboratory Developed Tests
Is something brewing in the world of home brews?
Thursday, July 11, 2013
Too Early For LDT Skepticism?
More evidence that LDTs will be regulated?
Wednesday, June 26, 2013
Looking Back on the IVD Hall of Fame
Even if it's not your list, here's no denying their impact on the practice of medicine
Friday, May 31, 2013
Waiting for LDT Guidance
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
Taming the Elephant in the Room
Another small step forward in the regulation of molecular diagnostics
Tuesday, April 16, 2013
Life on the A-List
FDA seems to be sending mixed messages on LDTs and CoDx
Friday, March 22, 2013
Not Just Another Biomarker Meeting?
The IOM takes on co-development
Friday, March 01, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
Change is Coming to CE-IVDD
The EU embraces its inner FDA
Tuesday, December 04, 2012
OIG Signals Interest in LDTs
We are not taking any bets this time around
Wednesday, November 28, 2012
Reframing the Discussion
Should market size dictate regulatory enforcement?
Monday, November 19, 2012
Return of the Crystal Ball
What does an Obama re-election portend for the next four years?
Wednesday, November 07, 2012
LDT Guidance Documents... Where are They?
For better or worse, shouldn't we at least see them?
Friday, June 15, 2012
Waiting for Guidance
When will it be time for a final decision on LDTs?
Monday, June 11, 2012
Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
The Invisible Hand Pushes Back
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
Policy Change We Can Believe In
Our RUO Guidance Comments
Tuesday, August 30, 2011
FDA + NGS = BFFs
We may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing
Friday, June 24, 2011
RU O Kidding? OMG!
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Putting the "Lab" Back in LDTs
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
FDA's LDT Meeting Slides
Serrano, Harper & Mansfield
Tuesday, July 27, 2010
It's My Genome and I'll Do What I Wanna
Mr. Biggers deserves a clear, direct answer to his LDT meeting questions
Thursday, July 22, 2010
A Hearing... but not a Listening
These aren't new rules. You don't get to keep doing what you're doing.
Monday, July 19, 2010
The Wrong Raptor
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
Unicorns, Santa Claus and Instrument-Only Clearances
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
A Statement of (Unreviewed) Beliefs
Sure, I got my information from a television commercial, but if you can’t believe television, what can you believe?
Wednesday, May 27, 2009
The Right Balance
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 2009
IVD's and LDT's - What's the difference?
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Genentech Citizen's Petition
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008

Recent Blogs

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!