Problem: With the promise of personalized medicine, the drug and diagnostic industries are booming, as are academic medical research programs. Never before have we seen such a proliferation of research questions, magnifying the need for human biospecimens on which to conduct the research. But finding qualified human biospecimens has long been a problem, with researchers often unable to find enough, or the right type, or the right quality to meet their needs. Many scientists find themselves trying to cobble together collections, approaching different labs or biobanks that they know may have samples, but quality and quantity issues still abound and the procurement process can be tedious and long. Further, as research becomes more advanced, scientists need rich data along with their biospecimens, to understand the patient context within which the specimen originated. Six years ago, one study reported a striking 81 percent of researchers limit their work due to a shortage of both the quantity and quality of human biospecimens.1 Fast forward to today, a year in which President Obama has committed $215M for personalized medicine research in next year’s budget, and it is clear that this shortage must be remedied.
Solution: Every year, millions of human biospecimens in hospitals and labs are destroyed when clinical testing is complete—but they could be put to good use to fuel the aforementioned research. Actually, moving remnant biospecimens into research is a practice that has long been happening anyway, with researchers requesting samples on a piecemeal basis. Although this does happen, it is often done with little compliance oversight and requires researchers to reach out to a vast but fragmented network of labs and biobanks to manually fill their needs, further compounding their specimen collection issues. iSpecimen saw an opportunity to create a new type of consolidated marketplace whereby technology could be used to “watch” the flow of remnant biospecimens across a broad network of hospitals and labs and pull them before being discarded when they meet researcher needs. And this is what iSpecimen did.
Now in place at dozens of hospital and lab sites throughout the country, the iSpecimen cloud-based technology enables a virtual “one-stop shop”, providing researchers with access to a ready supply of high-quality human biospecimens. By aggregating supply sites, the breadth of patient cohorts and quantity of specimens available to scientists multiplies, and by seamlessly interfacing with hospital and lab medical record systems, researchers gain access to valuable patient and specimen data. All of this is done with full regulatory oversight, including adherence to HIPAA [Health Insurance Portability and Accountability Act ] privacy rules, ensuring compliance to a process that often lacks such rigor.
Through this virtual procurement marketplace, researchers can submit extraordinarily specific requests that span patient demographics, diagnoses, medications, and procedures. And because of the volume and diversity that aggregation brings, specimens such as blood, plasma, serum, urine, cerebrospinal fluid, stool, solid tissues, and more, are available across a broad range of patient cohorts and medical tests and corresponding results.
Benefits of the process are plentiful on the laboratory side, research side, and even for patients. Research shows that patients are largely in support of contributing their de-identified remnant specimens to help advance care.2
Hospitals and labs gain the opportunity to contribute to medical research as well as to their bottom line with a previously untapped source of new revenue. Researchers finally get access to the high quality, data-rich specimens they need from the patients they want, saving precious time and money required by older more laborious approaches. Patients experience a new way to meaningfully contribute to research. And finally, potentially life-changing discoveries are accelerated, advancing diagnostics and treatments for all.
For more information, visit www.ispecimen.com
1. “The Cancer Human Biobank (caHUB): Advancing the Vision of Personalized Medicine”, by Carolyn C. Compton, M.D., Ph.D., Director, Office of Biorepositories and Biospecimen Research, National Cancer Institute, presented at 2nd Annual Biospecimen Research Symposium, March 17, 2009.
2. “Report of the Public Responsibility in Medicine and Research (PRIMR) Human Tissue/Specimen Banking Working Group”, Part II, Tool F, March 2007.