A case study in finding cost effective FFPE blocks
March 11, 2022
Some of the best values are hidden in plain sight, like Toyotas, index funds and refurbished electronics.
The same is true in the biospecimen world. Let us walk you through it.
We’re known by many clients for giving researchers access to millions of banked and clinical remnant samples through our online platform, the iSpecimen Marketplace, as well as arranging for the custom collection of highly specific human biospecimens from consenting patients. Research often demands access to large sample volumes and broad diversity – demanding challenges that we relish.
Often overlooked, however, are our archived formalin-fixed paraffin-embedded (FFPE) tissue blocks. Hospitals and clinics originally collect these tissue samples in surgery or for diagnostic testing, and they are immediately preserved in wax by pathologists. Their main purpose is to serve patients in treatment – as a medical record of sorts. Because these specimens are collected for clinical use, research consent is typically not obtained at the time of collection.
Eventually there comes a time to discard them, not because they’ve lost their scientific value but because they are no longer deemed important to a patient’s case. These archived samples can offer great value in research, however, reflecting a wide range of diseases that researchers are studying as well as normal tissue. Archived FFPE blocks can be valuable in oncology, hematology and immunology – notably for replication, validation and immunohistochemistry (IHC) testing – whether in academic research, drug discovery or diagnostic development.
The good news? They’re affordable, plentiful and easy to procure.
Reclaiming valuable, well-preserved biospecimens that typically go to waste
In the United States, clinics must store their patients’ FFPE blocks for 10 years after collection. Then they can be made available for research. These archived samples are exactly what many research organizations need for their work, and researchers are increasingly discovering and demanding them.
Although consent for use in research is not obtained by patients at the time of collection, institutional review boards (IRBs) in the United States grant full approval to use such specimens for research by waiver of consent per federal regulations as long as the FFPE block has met the 10-year storage requirement. As with any specimen we distribute, patient privacy remains fully enforced, and any specimen-level data remains de-identified.
The advantages of using archived tissue blocks
Archived FFPE blocks can alleviate significant procurement challenges in that they are typically:
More affordable, usually costing up to 70 percent less than prospectively collected samples. That means a research organization can get more than three times as many samples for the same budget.
More plentiful, since they have been collected for years. This is especially important for researchers needing rare disease samples in larger quantities.
Quicker to arrive. These samples are already fixed and ready to ship.
Scientifically viable and reliable: Tissue is fixed immediately upon removal and, thus, well-preserved despite the number of years in storage. They are highly reliable samples that perform very well in research.
In some cases, uniquely valuable: FFPE blocks in general are more likely than newer specimens to reflect later stages of certain diseases that in the past decade have been diagnosed and treated earlier.
Sourcing outside of the United States quickens access
It is important for researchers to know they can source archived FFPE blocks outside of the United States, where mandatory storage periods can be considerably shorter than in the U.S. – typically two or three years after collection. Since these samples are relatively simple to ship, out-of-country logistics pose no barriers to procurement. The extensive iSpecimen partner network opens access to thousands of these “shorter-term” archived blocks.
What do you really need? Better understanding acceptable levels of patient consent
Despite their value, many research organizations don’t think to purchase archived FFPE blocks. Rather, these organizations as a rule restrict themselves to using only tissue collected or stored for research use, with affirmative patient consent. For many types of research, such as replication, validation and IHC testing, however, the procurement process for fresh and banked, consented specimens may be unnecessarily difficult and expensive – especially given that archived blocks may be a superior fit for certain types of research.
(We are sensitive to the fact that many of our specimen providers are vigilant about informing and asking their patients for use of de-identified clinical discards even though the law does not require it. Thus, we have always offered consent programs for our partner sites who choose to meet them.)
An unsurpassed selection of archived FFPE blocks
Archived FFPE blocks are often requested by smaller and mid-sized organizations performing necessary but comparatively routine research, often validating previous findings that don’t involve rigorous regulatory approval. These are high-performing scientific organizations nonetheless.
Many FFPE block archives are enormous with inventories in the millions, and a lot of them are now made available to researchers worldwide – thanks to our extensive provider network – giving us one of the largest such inventories anywhere. Some of our archived FFPE blocks may not yet be visible on the iSpecimen Marketplace, but they are available nonetheless. Log in to the Marketplace (or quickly signup with your email and self-selected password) to initiate your search. If you are not able to find what you’re searching for, you can simply request a quote through the Marketplace or contact sales for more information at [email protected].