Two columns for the price of one

Jan. 21, 2016
I received a press release from New York-based GBI Research, a good source for information on trends in the laboratory business, which focused on the somewhat controversial topic of biobanking. According to GBI, there are two reasons the topic is a touchy one: concerns about cost among potential investors, and ethical concerns among potential donors.

Biobanks, which are organizations that collect human biospecimens and related data, are valuable resources for clinical research. They can be used to leverage samples and genetic data to accelerate the development of companion diagnostics, help to reduce development times and costs for new therapeutic drugs, and support cross-disciplinary scientific discovery. The main aim of clinical trial-related biobanking is to identify and provide disease or trial-associated biomarkers. The potential impact of biobanking will only increase as Big Data techniques are applied.

Still, the high cost of the enterprise is an obstacle; potential investors are being asked to make long-term commitments in a new business whose model is still a hazy one. According to Rodrigo Gutierrez Gamboa, Managing Analyst for GBI Research, “Most biobanks are reportedly employing relatively vague cost models, suggesting a lack of financial strategy. Failure to accurately capture costs may lead to the early termination of projects, and may prove to be the downfall of various biobanks.”

The other challenge, public skepticism, may be even more difficult to overcome. Gutierrez Gamboa explains: “The public’s attitude towards biobanking is mixed, with some people having concerns over disclosing personal and medical information. Public support also depends to a large extent on what the samples are used for, as the treatment of disease is generally valued highly, while other interventions [e.g., the development of cosmetics] are seen as less acceptable.” To overcome these concerns, he says, biobanks must reassure the public that information is safely stored and encourage them to donate samples.

GBI Research concludes that despite the useful applications of biobanking, the creation and endurance of biobanks depends on people’s willingness to donate and have their samples stored. In this way, community engagement is a central component of biobanking management. The participation and support of the public is important for the success of any biobank.

The full GBI Research report is called “Biobanking: Developing Smart, Sustainable and Ethically Compliant Biorepositories for the Future.”

In this issue’s “Special Feature” article, “A20 modulation: a potential biological threat that can be mitigated by immunohistochemistry” (pp.16-17), Maj. Michael A. Washington, PhD, M(ASCP), Chief of Microbiology Research in the Department of Clinical Investigation at Tripler Army Medical Center in Honolulu, HI, makes a chilling observation: he suggests that we are now in “an environment in which it is possible to engineer a new biological threat agent in a matter of days, while the characterization of the threat and the development of countermeasures can take months to years.” The nightmare scenario of international terrorism unleashing a bio-threat that will be difficult to counter promptly is no longer just a staple of “techno-thriller” paperbacks; it is real. Maj. Washington goes on to describe efforts by researchers to combat that threat, particularly through the techniques of immunohistochemistry.

The author concludes that “the clinical laboratory staff is on the frontlines of biodefense and will undoubtedly play an important role in the detection and response to future biological threats, whether natural or manmade. In order to be prepared for novel threats, it is essential that laboratory staff have a thorough understanding of what is possible and are provided with the tools to respond to unusual and novel situations.”

No lab director would prefer to use the specter of a cataclysmic bioterror event as a way to induce hospital management to loosen the budgetary purse strings. But legitimate threats are legitimate threats, and decision-makers should be aware of them and of the role labs can play in averting or responding to them. Can institutions afford not to invest appropriately in their labs?