Bespoke Biospecimen Collection as a Driver for Precision Medicine
Rolls Royce Boat Tail Photo Credit Wikimedia Commons
Medical experts from around the world have become increasingly aware of the opportunities that come from “decoding the human genome” to offer personalized treatment; this is the core of precision medicine. Technological advancements in gene sequencing and multi-omics have brought the dream of precision medicine closer home. Currently, scientists have been able to identify hordes of biomarkers that are linked to various diseases such as diabetes and cancers. A few have been successfully incorporated into clinical practice.
According to recent research, the number of drugs with biomarkers in their labeling have increased three-fold in the last two decades. [1]This trend is more pronounced in cancer therapies and it demonstrates a progressive shift from a “one size fits all” approach to medicine towards personalized medicine which looks at the unique traits that an individual brings to the treatment equation.
Biospecimen Centrality to Precision Medicine
The Precision Medicine Initiative (PMI) which was launched in 2015 aims at tailoring the delivery of preventive and curative healthcare services to accommodate individual characteristics such as environment, lifestyle, and genetics. The short term goal of the initiative is focused on using precision medicine to enhance cancer treatment while the long term goal hopes to incorporate other conditions as well.
Precision medicine relies heavily on the availability of large and varied biosamples as well as annotated clinical and pathological data which is stored by biobanks. Researchers can use the samples to identify biomarkers of certain diseases and use them for early disease diagnosis, prognosis, and treatment. Hence, biobanks play a key role in enabling the realization of the goals of precision medicine. [2]
Medical researchers can always rely on biobanks for easy access to biospecimens, assuming that the available specimens match their desired characteristics. Unfortunately, this is hardly ever the case.
The Cancer Genome Atlas (TCGA) project found that 99% of the tumor samples collected did not meet the histological quality control threshold and therefore had to be discarded. Dr Carolyn Compton who coordinated the collection of biosamples for the project had the following to say:
“You might have thought that doing the science would be the biggest challenge of a massive undertaking like the Cancer Genome Atlas … But acquiring the biospecimens turned out to be the hardest part, bar none. It’s the Wild West out there.”
Challenges in Accessing Biospecimens for Precision Medicine
When it comes to medical research that's geared towards bringing new drugs or medical devices into the market, every second counts. However, the biospecimen collection is usually encumbered in a myriad of challenges that stalls the research process. After months of behind-the-scenes designing of research projects, researchers often find themselves at crossroads when they realize that the available biospecimens from biobanks do not meet specific requirements for their project. This often implies going back to the drawing board to redesign the project, a process that results in loss of both time and money.
Although biobanks may possess a massive inventory of human biospecimens, they may not be in the quantities or specifications that a researcher needs. The biosamples may be too old, of a different quality, or even from the wrong patients.
Samples such as urine and stool are not stored for extended durations by biobanks because their analytes and biomarkers easily disintegrate. In addition, fecal samples take up a lot of storage space and this can be expensive in the long run. There’s also the issue of deep, rich, and annotated data that may be difficult to come by. Take for example a researcher working on a liquid biopsy project. The researcher makes a request for 15mls of plasma from hundreds of donors. Most biobanks may not be able to meet this order as most don’t hold such amounts of plasma from one patient. This would need a special or bespoke request which should have been made in the early stages of designing the study. Another significant challenge that researchers often run into is in finding biospecimens that portray racial, ethnic, and geographical diversity.
What are Bespoke Specimens?
Bespoke biospecimens are collections of biospecimens that have been customized to meet customer specifications. Advances in precision based medicine spanning a range of “omics” and cancer immunotherapies have increased the demand for highly characterized samples that were previously unavailable. This includes parameters such as warm/cold ischaemic times in addition to specific patient parameters such as treatment histories and response to certain drugs.
Biobanks conduct prospective biospecimen collection to meet customer specifications that may include the following:
Inclusion and exclusion criteria
Biospecimen collection protocol ( such as type of collection tubes)
Shipment conditions (such as temperature during transportation)
Laboratory processing protocol
Type and volume of aliquots
Storage conditions
Volume and contents of biosample-associated information
Additional laboratory tests
Documents associated with biosamples
Prospective specimen collection is usually a long process that requires a lot of authorizations. Hence, there's a need to plan ahead to prevent delays. Ultimately, the benefits of a highly-customized specimen collection is usually worth the wait.
Matched Biospecimen
This refers to different specimens that are obtained from the same individual/ donor. The biospecimens may vary in terms of type; time of collection; or storage conditions. There has been an increased demand for matched biospecimens in precision driven medical research. This is an indication of the level of sophistication in biomedical research and signals an unwavering demand for customized biological samples.
Forging Partnerships to Support Customized Biospecimen for Precision Medicine
Bespoke biospecimen collection is a key driver for precision medicine. Hence, research teams seeking to get ahead of the game must be willing to build networks that provide them direct access to bespoke biospecimens whenever needed.
At Garner Biosolutions, we are constantly expanding our geographical presence especially in regions that are underrepresented in clinical research. We go an extra mile to ensure that our specimens meet the “fit-for-purpose” criteria for biospecimen. We work closely with our customers to understand their unique research needs and combine this with current trends to ensure that we offer a flexible and customized biospecimen collection.
Our end goal is to provide the highest quality of biospecimens and the related data that researchers need for precision-driven diagnostics and treatments. Time is always of the essence; don't hesitate to get in touch with our team and learn how we can help gain access to bespoke biospecimens, right on time.
References
Kim, J. A., Ceccarelli, R., & Lu, C. Y. (2021). Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000-2020). Journal of personalized medicine, 11(3), 179. https://doi.org/10.3390/jpm11030179
Liu, A., & Pollard, K. (2015). Biobanking for Personalized Medicine. Advances in experimental medicine and biology, 864, 55–68. https://doi.org/10.1007/978-3-319-20579-3_5
