Biomarkers and Precision Medicine Community (BPMC)

Recently, we had a short survey on the BPMC discussion board asking about how companies handle the classification of Biomarker assays, specifically how they differentiate or define what constitutes qualified versus validated. It has generated some discussion and I wanted to open it up to the wider community to get your feedback.

Please share with us (anonymously if you prefer) what constitutes a validated biomarker assay at your organization (we are specifically meaning analytical validation). Does it require more runs and experiments than qualified? Does it simply mean that it has been deemed fit-for-purpose based on the context of use? Does the involvement or non-involvement of QA determine classification?

I would also be interested in knowing / understanding if the Global CRO Consortium (GCC) has had any discussions or offered any consensus on this topic.

Thanks!

Use of the term qualification for biomarker assays is an artifact of the bioanalytical community and has never been part of the biomarker world where the term qualification is solely used in the clinical sense - qualified biomarkers have demonstrated clinical utility.

It is important for us to remember that the definition of the term 'method validation' indicates that "the method has been demonstrated to be fit for its intended purpose".  Simplified version being: validation = demonstrated fit-for-purpose.

For biomarker assays, the purpose is the context of use.  So validation = fit-for-context of use (COU).  Therefore, every biomarker assay needs to be validated for its COU.  Either the assay is valid for the COU, or it is not.  There is no middle ground.  This has been difficult for the bioanalytical community to accept because there is some notion of validations being a predefined set of assessments.  This may be true for PK assays, but that is because they have a singular COU.   

For biomarker assay validations, the types and extent of assessments performed are dictated by COU and there can be no one-size-fits-all. If the context changes, you may need to do additional/different assessments to demonstrate validation (or you may need an entirely different assay).  If you are asked to deliver an assay without knowing COU, then you can analytically characterize the assay, but not claim validation.

Our organization has always operated on these principles.  We never have, and never will, use the term qualification in association with biomarker assays.  We analytically characterize our assays and validate them to COU.  This approach is scientifically driven and has been universally successful for all assays that we have validated in support of a diverse portfolio of drug programs, delivering data that reliably support internal decision-making as well as regulatory approvals

Recently, we had a short survey on the BPMC discussion board asking about how companies handle the classification of Biomarker assays, specifically how they differentiate or define what constitutes qualified versus validated. It has generated some discussion and I wanted to open it up to the wider community to get your feedback.

Please share with us (anonymously if you prefer) what constitutes a validated biomarker assay at your organization (we are specifically meaning analytical validation). Does it require more runs and experiments than qualified? Does it simply mean that it has been deemed fit-for-purpose based on the context of use? Does the involvement or non-involvement of QA determine classification?

I would also be interested in knowing / understanding if the Global CRO Consortium (GCC) has had any discussions or offered any consensus on this topic.

Thanks!

Use of the term qualification for biomarker assays is an artifact of the bioanalytical community and has never been part of the biomarker world where the term qualification is solely used in the clinical sense - qualified biomarkers have demonstrated clinical utility.

It is important for us to remember that the definition of the term 'method validation' indicates that "the method has been demonstrated to be fit for its intended purpose".  Simplified version being: validation = demonstrated fit-for-purpose.

For biomarker assays, the purpose is the context of use.  So validation = fit-for-context of use (COU).  Therefore, every biomarker assay needs to be validated for its COU.  Either the assay is valid for the COU, or it is not.  There is no middle ground.  This has been difficult for the bioanalytical community to accept because there is some notion of validations being a predefined set of assessments.  This may be true for PK assays, but that is because they have a singular COU.   

For biomarker assay validations, the types and extent of assessments performed are dictated by COU and there can be no one-size-fits-all. If the context changes, you may need to do additional/different assessments to demonstrate validation (or you may need an entirely different assay).  If you are asked to deliver an assay without knowing COU, then you can analytically characterize the assay, but not claim validation.

Our organization has always operated on these principles.  We never have, and never will, use the term qualification in association with biomarker assays.  We analytically characterize our assays and validate them to COU.  This approach is scientifically driven and has been universally successful for all assays that we have validated in support of a diverse portfolio of drug programs, delivering data that reliably support internal decision-making as well as regulatory approvals

------------------------------
Lauren Stevenson Ph.D.
Chief Scientific Officer
Immunologix Laboratories
Tampa FL
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 06-12-2025 15:23
From: Jennifer Vance
Subject: Qualification vs Validation for Biomarker Assays

Recently, we had a short survey on the BPMC discussion board asking about how companies handle the classification of Biomarker assays, specifically how they differentiate or define what constitutes qualified versus validated. It has generated some discussion and I wanted to open it up to the wider community to get your feedback.

Please share with us (anonymously if you prefer) what constitutes a validated biomarker assay at your organization (we are specifically meaning analytical validation). Does it require more runs and experiments than qualified? Does it simply mean that it has been deemed fit-for-purpose based on the context of use? Does the involvement or non-involvement of QA determine classification?

I would also be interested in knowing / understanding if the Global CRO Consortium (GCC) has had any discussions or offered any consensus on this topic.

Thanks!

------------------------------
Jennifer Vance Ph.D.
Dir. of Bioanalytical and Biomarker Development
Recursion Pharmaceuticals
Salt Lake City UT
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Use of the term qualification for biomarker assays is an artifact of the bioanalytical community and has never been part of the biomarker world where the term qualification is solely used in the clinical sense - qualified biomarkers have demonstrated clinical utility.

It is important for us to remember that the definition of the term 'method validation' indicates that "the method has been demonstrated to be fit for its intended purpose".  Simplified version being: validation = demonstrated fit-for-purpose.

For biomarker assays, the purpose is the context of use.  So validation = fit-for-context of use (COU).  Therefore, every biomarker assay needs to be validated for its COU.  Either the assay is valid for the COU, or it is not.  There is no middle ground.  This has been difficult for the bioanalytical community to accept because there is some notion of validations being a predefined set of assessments.  This may be true for PK assays, but that is because they have a singular COU.   

For biomarker assay validations, the types and extent of assessments performed are dictated by COU and there can be no one-size-fits-all. If the context changes, you may need to do additional/different assessments to demonstrate validation (or you may need an entirely different assay).  If you are asked to deliver an assay without knowing COU, then you can analytically characterize the assay, but not claim validation.

Our organization has always operated on these principles.  We never have, and never will, use the term qualification in association with biomarker assays.  We analytically characterize our assays and validate them to COU.  This approach is scientifically driven and has been universally successful for all assays that we have validated in support of a diverse portfolio of drug programs, delivering data that reliably support internal decision-making as well as regulatory approvals

Recently, we had a short survey on the BPMC discussion board asking about how companies handle the classification of Biomarker assays, specifically how they differentiate or define what constitutes qualified versus validated. It has generated some discussion and I wanted to open it up to the wider community to get your feedback.

Please share with us (anonymously if you prefer) what constitutes a validated biomarker assay at your organization (we are specifically meaning analytical validation). Does it require more runs and experiments than qualified? Does it simply mean that it has been deemed fit-for-purpose based on the context of use? Does the involvement or non-involvement of QA determine classification?

I would also be interested in knowing / understanding if the Global CRO Consortium (GCC) has had any discussions or offered any consensus on this topic.

Thanks!

Lauren,

How do you handle biomarker assays for which the context-of-use is "To explore the correlation of XX to drug response" or other such exploratory purposes? Do you still refer to those as validated? And what is the level of QA involvement in biomarker validations, particularly these very exploratory ones?

Jennifer

Use of the term qualification for biomarker assays is an artifact of the bioanalytical community and has never been part of the biomarker world where the term qualification is solely used in the clinical sense - qualified biomarkers have demonstrated clinical utility.

It is important for us to remember that the definition of the term 'method validation' indicates that "the method has been demonstrated to be fit for its intended purpose".  Simplified version being: validation = demonstrated fit-for-purpose.

For biomarker assays, the purpose is the context of use.  So validation = fit-for-context of use (COU).  Therefore, every biomarker assay needs to be validated for its COU.  Either the assay is valid for the COU, or it is not.  There is no middle ground.  This has been difficult for the bioanalytical community to accept because there is some notion of validations being a predefined set of assessments.  This may be true for PK assays, but that is because they have a singular COU.   

For biomarker assay validations, the types and extent of assessments performed are dictated by COU and there can be no one-size-fits-all. If the context changes, you may need to do additional/different assessments to demonstrate validation (or you may need an entirely different assay).  If you are asked to deliver an assay without knowing COU, then you can analytically characterize the assay, but not claim validation.

Our organization has always operated on these principles.  We never have, and never will, use the term qualification in association with biomarker assays.  We analytically characterize our assays and validate them to COU.  This approach is scientifically driven and has been universally successful for all assays that we have validated in support of a diverse portfolio of drug programs, delivering data that reliably support internal decision-making as well as regulatory approvals

Recently, we had a short survey on the BPMC discussion board asking about how companies handle the classification of Biomarker assays, specifically how they differentiate or define what constitutes qualified versus validated. It has generated some discussion and I wanted to open it up to the wider community to get your feedback.

Please share with us (anonymously if you prefer) what constitutes a validated biomarker assay at your organization (we are specifically meaning analytical validation). Does it require more runs and experiments than qualified? Does it simply mean that it has been deemed fit-for-purpose based on the context of use? Does the involvement or non-involvement of QA determine classification?

I would also be interested in knowing / understanding if the Global CRO Consortium (GCC) has had any discussions or offered any consensus on this topic.

Thanks!