EDRN Biomarker Reference Laboratories (BRL) Meeting

Thursday, December 19, 2024

Present: (In Bold):

Andrew Hoofnagle (Chair), Martin Stengelin (Co-chair), Bill Bulman, Daniel Chan, Rob Christenson, Sidney Fu, Jim Herman, William Hsu, Indu Kohaar, Tao Liu, Royce Malnik, Guillermo Marquez, Anu Mathew, Richard Mazurchuk, Hua-Jun He, Mike Palazzolo, Harvey Pass, Christos Patriotis, Leopoldo Segal, Steve Skates, Lori Sokoll, Stefani Thomas, James Tsay, Wendy Wang, Lanbo Xiao, Cecilia Yeung, Hui Zhang

Current Action Items:

1. Biomarkers to validate: Andy Hoofnagel will follow up with John Semmes about the biomarkers he would like to validate among several labs.
2. Set-aside Funding: EDRN PIs will review their set-asides to see if they have funding for a BRL project.
3. ONGOING: Lanbo Xiao will send Royce Malnik his SOP for his platform to distribute to the group.
4. Andy Hoofnagle will ask an investigator who has validated a marker to see if they are ready for interlab validation and invite them to these calls.
5. The Group will review the SurveySummaryOtherInformation document to make sure the information is correct.
6. Dr. Hoofnagle will follow up with some working group members and ask them about their platforms/assays and their ability to use/test them in other labs.

Discussion:

Survey Summary Technologies.v3 on Public Portal at https://edrn.nci.nih.gov/about-edrn/groups/biomarker-reference-laboratories/survey_summary_technologies/ please let Royce Malnik or Andy Hoofnagle know of any changes. Andy Hoofnagle is still waiting for responses to his questions that he sent to several investigators.

Biomarkers to validate: goal is to optimize clinical assays with the best limit of detection and quantification accuracy. P biomarkers that have biggest bang for buck. Autoantibodies CTAG 1&2 and possibly CA125 and CA19.9. TP53 mutations and p53 expression (look at protein and RNA levels).

• John Semmes sent Andy Hoofnagle some biomarkers that he would like another group develop and wants to collaborate with other investigators who might have other assay modalities that could complement his LCMS assay and come up with other strategies. Dr. Hoofnagle asked other investigators respond to him if they are interested.
• Cecelia Yeung—reviewed list. She is waiting for clinical trial to be activated for the digital PCR assay. For the TP53 her team continues to optimize this. She is waiting for trial to get samples—not sure how these will be collected. She is working with Bill Grady. For TP53 look at protein and RNA levels as measured in different assays. P53 IHC is similar to mutations in terms of prognosis. Could be an BRL project using slightly different assays and compare on a set of patients in terms of early detection and prognostication. Set of patients with plasma, cells, ctDNA and testing it with respective assays and matching it to early detection of cancers. Not sure if these specimens exist—the current EDRN Uterine Lavage study might—it will have blood, cervical swabs and tissue. Specimens from about 200 participants, 30% of which have ovarian cancer.
• MSD: MSD is working with Karen Anderson to develop CTAG1 and 2—they would like to run the assays on multiple platforms including MSD’s, also might run CA125 and CA19.9 with their collaborators in multiple labs and on multiple platforms. Christos Patriotis thought this would be worthwhile.

Set-aside funding for interlab biomarker validation studies: Awards are between July and September—have 90 after that to submit set-aside funds requests. Some that have been submitted are multi-year. This is a potential way for BRLs to fund an inter-lab study. Dr. Hoofnagle asked PIs to check on their set-aside funds to see if they can be used for a BRL project.

Continue Discussion of Topics from In-person Meeting in Omaha

• Imaging standardization: This didn’t get a lot of discussion and Andy Hoofnagle wants to take it off.
• Data mining of available datasets: This didn’t get a lot of discussion and Andy Hoofnagle wants to take it off.

Presenters for future meetings

• NIST (Reference method development)—might present in February.
• CMS (Centers for Medicare and Medicaid Services)—can’t identify anyone from this organization that is willing to talk.
• FDA: can’t find anyone from here—FDA is hosting a lot of webinars, but Mark Lowenthal might present in January.

Next Call: January 16th at 12 pm Eastern/11am Central/9am Pacific.