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  • 1.  Joint Statement Released by FDA and CMS

    ASCP Ambassador
    Posted 01-20-2024 12:37

    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.)? 



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    Michelle R. Campbell
    MS, MLS, MB, SC
    Senior Developer
    Mayo Clinic
    Rochester, MN
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  • 2.  RE: Joint Statement Released by FDA and CMS

    Posted 01-26-2024 11:58
    Hello everyone 

    So how does this work for flow cytometry, most of the testing is LDT. There some kits that are IVD, no IVD exits for cytoplasmic staining. Are they going say do not perform these testing in patient care.

    V/R
    Leon





  • 3.  RE: Joint Statement Released by FDA and CMS

    Posted 01-27-2024 00:23

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



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


  • 4.  RE: Joint Statement Released by FDA and CMS

    Posted 01-27-2024 05:50
    Edited by Jonathan Perry 01-27-2024 05:53

    @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!



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    Jonathan Perry, MLS(ASCP)
    President
    ASCP West Virginia Chapter
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    Original Message


  • 5.  RE: Joint Statement Released by FDA and CMS

    Posted 01-27-2024 09:43

    Let us agree to disagree.  I have been in the field for 38 years and did not know what you were talking about.  If some your audience does not understand then have not communicated to your audience.  

    only a suggestion.



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


  • 6.  RE: Joint Statement Released by FDA and CMS

    ASCP Ambassador
    Posted 01-27-2024 14:06

    @Jonathan Perry Thank you for your thoughtful response and brainstorming some great ideas for resources that would be of value for laboratory professionals should there be a day with increased oversight and regulation of LDTs. I appreciate that your ideas are centered around knowledge sharing amongst the laboratory community, as there will certainly be a lot for all of us to learn from one another (especially groups that develop tests with more frequency than others). For the EUA topic, in the proposed rule the FDA references the EUA process and how they have not applied this "enforcement discretion" for LDTs for emergency use in the past. I think we would all have a lot to learn from our colleagues in the world of infectious disease who have had a taste of FDA oversight of LDTs when they have submitted their COVID-19 assays, for example. 



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


  • 7.  RE: Joint Statement Released by FDA and CMS

    Posted 01-29-2024 08:35
    I agree 100%

    Sent from my iPhone


    Original Message


  • 8.  RE: Joint Statement Released by FDA and CMS

    ASCP Ambassador
    Posted 01-30-2024 01:54

    Hello Syed Ziauddin Ahmed Zaidi,

    I completely agree with you 100%. Professionalism in Clinical Laboratory Science is the embodiment of precise, prompt, and dependable reporting of test results. If Laboratory Developed Tests (LDTs) have the potential to cause patients to receive incorrect treatment for heart disease, expose cancer patients to inappropriate therapies or deny them effective ones, and lead to incorrect diagnoses, they should be reassessed and immediate action should be taken. Both the CMS and the FDA share the belief that patients and their doctors must have confidence in the validity of LDTs.

    Yours Sincerely,

    Giorgis Yeabyo (ASCP,HTL,CPHQ,PhD(c))

    ABiTi Consultancy Services (ACS)

    www.abiticonsultancy.com

    Addis Ababa, Ethiopia




    Original Message