Historic Consensus Reached on Biospecimen Standards: Carolyn Compton, NBDA


Guest:

Carolyn Compton, Professor of Pathology, ASU Bio and Contact Info

Listen (4:54) A historic new consensus

Listen (6:33) CAP committed to enforcement

Listen (2:50) Five core variables

Listen (5:16) Non-governmental leadership

Listen (4:20) Problem unique to biomedicine

Listen (3:25) Ramifications for our audience

Listen (4:48) Does this mean more work and higher prices?

A unique event happened at ASU last week that has the potential to positively impact all of biomedical research and therefore patients.

Carolyn Compton has been a tireless crusader for higher standards in biospecimen collection, handling, and storage. (See our interview earlier this year with Carolyn here where she argues that uneven sample quality is a major reason that biomedical research has such poor reproducibility rates.) Beginning as a pathologist herself, Carolyn has served at various organizations, including a stint at the National Cancer Insitute, which have prepared her for a special leadership role on the topic of biosamples. Last week she saw her long time dream come true.

“I’m delighted to report that we did in fact come to consensus after four days of discussion on what standards would be needed to raise the quality of ALL biospecimens from ALL patients to a standard that would be acceptable—perhaps not optimized—transparent and of known quality level for all patient samples. This is huge!” Carolyn exclaims in today’s show.

What does Carolyn mean by consensus? As we’ve been uncovering in our recent series on the topic, there have been no uniform standards in the collection, handling, and storage of biospecimens. It’s all been done with “poetic license” Caroly says. Until now. Last week Carolyn and a very special organization at ASU known as the National Biomarker Development Alliance put on two “convergence conferences” back-to-back that brought the major stakeholders—pathologists, physicians, patients, tool makers, and regulators—together AND found broad agreement on five basic standards to improve biospecimen handling.

This is indeed huge. Because the President and President Elect of the College of American Pathologists attended the conferences and committed to enforce these five basic standards in all of the labs which they accredit.

In her ebullience, Carolyn is careful to say that this is just the beginning, that the standards must now be written out and optimized. But it’s a very strong beginning which will have ramifications throughout the industry.

Who will be most affected? Patients, Carolyn says. Because tests, such as the popular HER2 assay for breast cancer, will be more accurate.

This story is not only unique in how it will change the course of the industry, but a powerful example of how non-governmental leadership can effect much needed change.

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