EDRN Biomarker Reference Laboratories Subcommittee Meeting

Thursday, November 21, 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, Wendy Wang, Lanbo Xiao, Cecilia Yeung, Hui Zhang

Current Action Items:

1. Lanbo Xiao will send Royce Malnik his SOP for his platform to distribute to the group.
2. DONE: Royce Malnik will send Rob Christenson the tables for him to update and add him to the calendar invites for these calls.
3. 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.
4. The Group will review the SurveySummaryOtherInformation document to make sure the information is correct.
5. ONGOING: 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:

Reviewed 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.

Biomarkers to Validate: The previous version of the table that listed biomarkers to validate across multiple platforms had to be deleted because so many members said that their markers weren’t quite ready to test in multiple labs or platforms. Comments regarding this:

Lanbo Xiao:

• king fisher for extraction
• qPCR is high throughput in 384 wells OpArray platform from Thermo
• Lanbo Xiao said that the standard operating procedure can this be distributed—but he would like to know how we can validate if other labs don’t have this platform. Royce Malnik will distribute to the group for review.

Cecilia Yeung:

• Methylation based digital multiplexed—could be listed as a marker to validate
  • Qiagen system--plug and play
  • BioRad system--was developed
  • SOP is going to be patented
  • pushing this one faster
• Ultrasensitive p53 mutation-could be listed as a biomarker to validate. Doesn’t have to be on the same platform across labs.
  • sequencing platform (NGS)
  • Thermo Fisher error corrected with spike-in controls
  • Will need to check with Thermo
  • Lung with Willey is the first project, but many others
  • What is the biomarker, a specific mutation?
  • A sequencing assay that detects multiple mutations in p53
  • Twin strands comparison would need to be with Rosana Risques
  • Could share what is possible from their platform
  • what biospecimens? fluids (lung washes and nasal washes, blood)
  • Need to build a reference set, we have plenty of blood from leukemia, CLL
  • Do we need to talk with NIST about reference materials
  • And what about cell lines with respect to p53 (they have 1 mutation)
  • Internal spike-in control is key to work for each exon

MSD: Martin Stengelin—might able to validate these markers within 6 months to a year.

Andy Hoofnagle will continue to follow up with those who are not on the call to find out if they have markers they can validate.

Funding Interlab Validation Project: Christos Patriotis said that the Core Funds and set-aside funds have been pretty much committed for this cycle of EDRN, but there might be a small chance to secure funding for an interlab validation project if it is seen as novel and EDRN-goal driven. Andy Hoofnagle said that this was a mandate, but if there is no funding, then it is harder to do. Christos Patriotis said that he would try to find sources of funding.

Continuation of Discussion of Topics from Omaha Steering Committee Meeting:

• Tissue Microarrays: generate materials that can be passed between labs for these experiments.
• Imaging Standardization: Not sure any of our BRLs can do these kinds of projects.

Future Presentations:

• NIST: Christos Patriotis believes that their interagency agreement has not been renewed as of the end of this fiscal year. Any reference materials that were generated by them can be deposited at FNLCR temporarily until it is determined whether EDRN will need them or not, and if not, they will be destroyed. Christos Patriotis will provide a list of materials from NIST. They could talk about their reference methods in a more educational way instead of a collaborative way.
• CMS can discuss reimbursement--for pancreatic and ovarian it’s $1160 per sample for high-risk individuals. This link has more information in ClearNote’s “Recent News” (https://www.clearnotehealth.com/) on their CMS reimbursed Avantect tests, as well as a link to the related San Diego Business Journal’s article (for those that have access): https://www.sdbj.com/life-sciences/biotech-life-sciences/clearnote-cancer-test-scores-cms-code/ Andy Hoofnagle asked Christos Patriotis to provide a question to CMS to start a conversation and provide it to Dr. Hoofnagle in hopes that CMS may present at one of our meetings.
• FDA-talk about regulatory environment and the regulatory changes that are happening at the FDA.

Next Call: December 19th at 12 pm Eastern/11am Central/9am Pacific.