Laboratory Professionals Member Community

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)? 

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)? 

Please do not use acronyms type out what you mean.  Do not use acronyms or abbreviations you lose your audience.

------------------------------
David Lusk
Knoxville TN
(865)335-6159

Original Message:
Sent: 01-26-2024 11:58
From: Leon Razai
Subject: Joint Statement Released by FDA and CMS

Original Message:
Sent: 1/20/2024 12:37:00 PM
From: Michelle Campbell
Subject: Joint Statement Released by FDA and CMS

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)? 

------------------------------
Michelle R. Campbell
MS, MLS, MB, SC
Senior Developer
Mayo Clinic
Rochester, MN
------------------------------

@David Lusk, I think in this case we're good. LDT is commonly known for Lab Developed Test and IVD for in vitro diagnostics.

@Michelle Campbell, I think webinars or virtual workshops, and possibly in person options for laboratories in collaboration with their reference labs, would be very valuable. As regular implementers of LDTs, your insight into what goes into that validation and implementation process, how you manage it on a routine basis, and what it means going forward, could really help labs understand the resources and involvement required, and better inform the standard that needs to be met and defined in policy and practice.

I think we also need clarity.  What does it mean for the FDA taking additional oversight?  Does it mean that, in addition to following the CMS/CLIA regulations, you have to submit your studies to the FDA like a manufacturer/vendor and wait for their approval?  Or does it mean the FDA inspects your lab in this arena in addition to your CLIA accrediting body?  And do they (FDA/CMS) really know?

I appreciate you keeping us updated on this.  I see it potentially an innovation killer with the additional alphabet people involved. I understand their concern with LDT because you don't want just anyone putting unproven tests out there and marketing it.  However, it could slow the ability for us to bring novel advances (as it already does) to our patients. When you look at Europe, they are typically utilizing testing methodologies for years before the US can access them in the market. 

One more question: do you know if this impacts Emergence Use Authorization testing designation at all?

Thank you!

------------------------------
Jonathan Perry, MLS(ASCP)
President
ASCP West Virginia Chapter

Original Message:
Sent: 01-27-2024 00:23
From: David Lusk
Subject: Joint Statement Released by FDA and CMS

Please do not use acronyms type out what you mean.  Do not use acronyms or abbreviations you lose your audience.

------------------------------
David Lusk
Knoxville TN
(865)335-6159

Original Message:
Sent: 01-26-2024 11:58
From: Leon Razai
Subject: Joint Statement Released by FDA and CMS

Original Message:
Sent: 1/20/2024 12:37:00 PM
From: Michelle Campbell
Subject: Joint Statement Released by FDA and CMS

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)? 

------------------------------
Michelle R. Campbell
MS, MLS, MB, SC
Senior Developer
Mayo Clinic
Rochester, MN
------------------------------

@David Lusk, I think in this case we're good. LDT is commonly known for Lab Developed Test and IVD for in vitro diagnostics.

@Michelle Campbell, I think webinars or virtual workshops, and possibly in person options for laboratories in collaboration with their reference labs, would be very valuable. As regular implementers of LDTs, your insight into what goes into that validation and implementation process, how you manage it on a routine basis, and what it means going forward, could really help labs understand the resources and involvement required, and better inform the standard that needs to be met and defined in policy and practice.

I think we also need clarity.  What does it mean for the FDA taking additional oversight?  Does it mean that, in addition to following the CMS/CLIA regulations, you have to submit your studies to the FDA like a manufacturer/vendor and wait for their approval?  Or does it mean the FDA inspects your lab in this arena in addition to your CLIA accrediting body?  And do they (FDA/CMS) really know?

I appreciate you keeping us updated on this.  I see it potentially an innovation killer with the additional alphabet people involved. I understand their concern with LDT because you don't want just anyone putting unproven tests out there and marketing it.  However, it could slow the ability for us to bring novel advances (as it already does) to our patients. When you look at Europe, they are typically utilizing testing methodologies for years before the US can access them in the market. 

One more question: do you know if this impacts Emergence Use Authorization testing designation at all?

Thank you!

------------------------------
Jonathan Perry, MLS(ASCP)
President
ASCP West Virginia Chapter

Original Message:
Sent: 01-27-2024 00:23
From: David Lusk
Subject: Joint Statement Released by FDA and CMS

Please do not use acronyms type out what you mean.  Do not use acronyms or abbreviations you lose your audience.

------------------------------
David Lusk
Knoxville TN
(865)335-6159

Original Message:
Sent: 01-26-2024 11:58
From: Leon Razai
Subject: Joint Statement Released by FDA and CMS

Original Message:
Sent: 1/20/2024 12:37:00 PM
From: Michelle Campbell
Subject: Joint Statement Released by FDA and CMS

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)? 

------------------------------
Michelle R. Campbell
MS, MLS, MB, SC
Senior Developer
Mayo Clinic
Rochester, MN
------------------------------

Please do not use acronyms type out what you mean.  Do not use acronyms or abbreviations you lose your audience.

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)? 

Please do not use acronyms type out what you mean.  Do not use acronyms or abbreviations you lose your audience.

On Thursday, January 18th the FDA and CMS released a joint statement of mutual support of FDA oversight of laboratory-developed tests (LDTs), specifically stating that they do not believe an expansion of CLIA is the appropriate action to ensure accurate and reliable LDTs are being offered to patients. This is another interesting development in the series of events unfolding since the FDA released the proposed rule on the oversight of LDTs in late September of last year.

If there is indeed increased oversight and regulation of LDTs by the FDA, what resources (aside from more staff and more money, we would all love both :) ) would be valuable to laboratories to help understand and incorporate changes in their validation studies? This could be for full-scale validations of LDTs developed "from scratch" or simpler modifications of FDA-cleared/approved tests. Are educational resources needed (if so, what kind- workshops, webinars, etc.)?