biospecimen quality

We ran a series this summer highlighting one of the major issues in biomedical research: that the collection, storage, and procurement of biospecimen samples lacks any across-the-board governing standards. Various institutions adopt their own regulations resulting in a checkerboard of quality assurance, and by extension, an unknown effect on the outcomes of research. Our first guest called it “garbage in, garbage out.” (See links below.) This should send shudders through anyone doing research with any human tissue sample.

We also highlighted some of the proposed solutions, from the accreditation of bio repositories that CAP is offering (the same guest thinks biobanks should come under CLIA as laboratories do) to hearing how they handle the problem in the U.K. with their Human Tissue Authority, a light regulation at the government level.

Today we talk with Matt McLoughlin, the V.P. of Compliance at Scientist.com, the rapidly growing online research marketplace (last month they were listed No. 9 on Inc Magazine’s list of the fastest growing companies in the U.S.). Because of the large amount of human tissue samples acquired through their marketplace, Scientist has the chance to implement a market solution to the sample quality problem that makes a real difference. And they are. Think of the Fair Trade certification in the coffee or clothing industries.

“We’ve been in a unique position to do it because we’re agnostic. We’re not a supplier of human samples, nor are we a research organization using those samples. We can take a step back and act as a third party facilitator,” says Matt.

Just how does this private market system work? And does Matt think such a major problem can be fully tackled without any federal government oversight?

Here are the links to our summer series on the topic:

I Won't Rest Until We Have Quality Standards in Place for Biospecimens, Says Carolyn Compton, ASU, Guest #1

Should Biobanking Come Under CLIA? Asks Shannon McCall, Duke, Guest #2

An International Perspective on How to Improve Biobanking with Kiristin Goldring, Guest #3

For the next episode in our summer series on human tissue sample quality and biobanking, we turn to a veteran biobanker in the U.K. who managed several projects there including the U.K. Parkisons’ Disease Society Brain Bank at Imperial College.

Today we talk to Kirstin Goldring, Principal Scientist at Astra Zeneca where she’s in charge of Human Biological Sample Strategy and Governance. Kirstin is a counselor at the European Society for Biopreservation and Biobanking and also a member of ISBER or the International Society for Biorepositories.

So far, in the U.S. biobanks are not regulated. In the U.K., they have what is called the Human Tissue Authority or HTA. Kirstin explains that the HTA is really some light governance that leaves a lot open to the biobanks as to how they go about maintaining standards. Could the program be a model for us here in the U.S.?

What has been Kirstin's overall take away on the field after managing different projects in various locations? Are we getting any better at sample quality?

When former President Obama’s team released the paperwork for what’s become the All of Us Research Program, in the part about biobanking, the wording specified that the biobanks applying for the grants be “CLIA compliant.”

“They didn’t put quotes around it, but whenever I say it, I put quotes around it. “CLIA compliant”—it's not a thing,” says today’s guest Shannon McCall, one of our country’s leading experts in the field of biobanking and biospecimen science. Shannon leads the Precision Cancer Medicine Initiative with her team at the Biorepository and Precision Pathology Center at Duke University.

What Shannon is getting at is that biobanks are not currently required to be CLIA compliant the way labs are required to be. And they never have. Biobanks are unregulated, and many in the field argue standards, and therefore, biomedical research, is suffering as a result.

This is the second in a series of interviews on the topic of biospecimen quality, and today we focus solely on storage and the biobank.

Shannon is also the Vice Chair of the College of American Pathologists (CAP’s) Biorepository Accreditation Program, the country’s only program of its kind to offer such accreditation. This year CAP is celebrating their 50th anniversary of offering laboratory accreditation. They're widely seen as the leader in lab quality assurance.

Biobanking is a relatively new industry, it's true. Time Magazine made it one of their 10 ideas changing the world in 2009. So is it nigh on time for biobanks to come under one regulatory agency such as CMS and the CLIA program? Some international biobanks, many of which were built in Europe based originally on American models, now serve already as standards of excellence back here across the pond.

Has Shannon heard pushback from the community against coming under CLIA? Why are biobanks going for CAP accreditation in the first place?

What is the biggest issue for storing samples? Why do biobanks struggle with sustainability?

We come in at around 28 minutes.

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.

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.

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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