biospecimen quality


I Won’t Rest Until We Have Quality Standards in Place for Biospecimens: Carolyn Compton, ASU

She’s a force of nature, and she’s back on Mendelspod. A decade ago, Carolyn Compton was hired by the NCI to solve a problem that has plagued the world of not just cancer research, but all of biomedical research. To this day, there are no standards in place for the acquisition, collection, storage, and delivery of human biological samples used for research. The leader of the NIH has acknowledged that this is a major part of biology’s non-reproducibility problem.

Yet Carolyn couldn’t solve it at the NCI. It took going to Arizona state where as part of the National Biomarker Development Alliance, she brought all of the stakeholders, government institutions, patients, private companies, and perhaps most importantly, the professional organizations such as CAP or the College of American Pathologists together, to put what in today’s program she calls “a basic floor” in place.

It was like the story of the blind men and the elephant.

"Despite the backgrounds of this broad swath of stakeholders who came to the conference—patients and regulators and scientists and physicians—they all had a certain knowledge of what was important. They all had knowledge of a certain part of the elephant, but they didn’t see the big picture until we came together. And what we came up with was astoundingly cohesive,” she says.

What has happened since? What changes has Carolyn seen toward the adoption of better standards and improving this immense problem that she simply calls, “garbage in, garbage out.”

We come in at around 25 min today.

You can find Carolyn’s referenced (free) article for Pathologist Magazine here.

Are We Ready to Trust Liquid Biopsies? with Milena Cankovic, Henry Ford Hospital

If you followed the news from the recent show of the American Association for Cancer Research (AACR), no doubt you heard about the exciting potential of liquid biopsies. These new blood-based tests, made possible by better tools and analysis techniques, offer a non-invasive way of understanding various cancers. Traditionally, with non-hematological cancers, solid tumor biopsies are obtained through surgical recession or an invasive needle.

It’s been known for some years that there are biomarkers in the blood -- circulating tumor cells (CTCs), for example -- which would give us information about a diagnosed -- or undiagnosed — cancer, but it is just recently that scientists and pathologists have tools with high enough resolution and specificity to detect them. With these new tools, the potential to change cancer treatment and detection has those in the field almost giddy in anticipation. Not only would a non-invasive method replace existing tests, but earlier detection and diagnoses would be possible.

“It has been shown that people were able to detect cancer metastases [with liquid biopsies] about six months earlier than with imaging,” says today’s guest, Milena Cankovic, the Director of Molecular Pathology and Genomic Medicine at Henry Ford Hospital in Detroit. She’s the co-author of a recent paper offering a snapshot of just where the field is at today, "Do Circulating Tumor Cells, Exosomes, and Circulating Tumor Nucleic Acids Have Clinical Utility?”

Milena says her lab is currently doing studies of liquid biopsies alongside their traditional solid tumor work. She says the lab plans to offer their first blood-based cancer tests later this year. What tests might those be, and what is involved in ensuring they are ready for prime time? Find out in today's show.

It’s Pretty Bad: Andy Brooks of RUCDR on Sample Quality

The future of diagnostics is in the hands of those taking care of the biospecimen samples says, Andy Brooks our final guest in the series, Improving Biospecimen Standards. Andy is the Chief Operating Officer at Rutgers University Cell and DNA Repository, or RUCDR.

While acknowledging that the current state of tissue sample collection, handling and storage is “pretty bad,”  Andy points to areas where progress has been made. And he would know. RUCDR serves as the biorepository for 4 NIH institutes. A biobank such as RUCDR is a unique place where various segments of biomedical research—academia, industry, regulation-- come together.

Andy was at the convergence summit put together last December by Carolyn Compton and the National Biomarker Development Alliance (see our interview with Carolyn here) to develop some standards in this area. While he’s excited to see Carolyn rally the community and bring CAP and the FDA on board, he sounds a warning.

“There’s only so much you can do to standardize samples at the time of collection and control for variables, some of which are uncontrollable," he says.

So what can be done?

Andy and his colleagues at RUCDR have made important strides toward developing what one of our former guests called a "tissue quality index,” a score that will tell you whether a sample in storage is what you think it is. While they don’t have an overall score yet, Andy and his team have worked with companies like Fluidigm and Wafergen to develop a panel that measures the quality of some analytes and can predict the performance of a sample.

We end the interview with Andy’s thoughts on the future of genomic consent.

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