Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
The Abolish OIVD Act of 2011
A torches-and-pitchforks approach to LDT regulations
Tuesday, October 18, 2011
A torches-and-pitchforks approach to LDT regulations
Tuesday, October 18, 2011
The Invisible Hand Pushes Back
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 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
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
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Rant Utility Obvious
Because "only" is such a difficult word to interpret
Thursday, December 23, 2010
Because "only" is such a difficult word to interpret
Thursday, December 23, 2010
DTCG Shenanigans
What happens when we turn scientific inquiry into a carnival attraction
Tuesday, December 21, 2010
What happens when we turn scientific inquiry into a carnival attraction
Tuesday, December 21, 2010
We'll Drink to That
Enforcement discretion is ending. So let’s start with accepting the new reality, then get to work shaping it.
Friday, December 03, 2010
Enforcement discretion is ending. So let’s start with accepting the new reality, then get to work shaping it.
Friday, December 03, 2010
LDTs: Where's the Fire?
The news is not new about LDTs and their impending regulatory oversight.
Wednesday, December 01, 2010
The news is not new about LDTs and their impending regulatory oversight.
Wednesday, December 01, 2010
Putting the "Lab" Back in LDTs
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
I See Dead Business Models
DTCG companies are like ghosts in The Sixth Sense: dead and deeply confused
Wednesday, July 28, 2010
DTCG companies are like ghosts in The Sixth Sense: dead and deeply confused
Wednesday, July 28, 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
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
These aren't new rules. You don't get to keep doing what you're doing.
Monday, July 19, 2010
Keep Calm and Carry On
Whoever says these words to me after Monday's LDT mtg. gets their first drink on me.
Friday, July 16, 2010
Whoever says these words to me after Monday's LDT mtg. gets their first drink on me.
Friday, July 16, 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
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
LDTs Losing Enforcement Discretion?
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 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
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
The Incredible Shrinking LDT
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
"Square One" for IVDMIA?
FDA is probably executing a strategic retreat, not signaling their surrender.
Friday, August 14, 2009
FDA is probably executing a strategic retreat, not signaling their surrender.
Friday, August 14, 2009
The Last Gasp?
It's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Monday, August 03, 2009
It's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Monday, August 03, 2009
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
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
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
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
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
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Rumors
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration.
Sunday, January 18, 2009
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration.
Sunday, January 18, 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
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008