“Are you sure your sample is well-characterized?” and other questions

4 considerations to guide your vendor selection

If you are developing in vitro diagnostics (IVDs) you probably rely heavily on a steady supply of patient samples, both with and without the target disease. By now, you are also well aware that neither all samples nor all suppliers are equal. To help ensure you get the consistent quality you need, we offer 4 points you should consider when selecting a sample vendor.



  1. Are you really sure your sample is well characterized?


Sample characterization is, perhaps, the most important concern IVD companies have in sourcing samples. Because many dealers are not forthcoming about details, companies may waste a lot of time verifying that materials are active for a specific disease, that the purported titer is accurate, and that no HIPPA regulations or other ethical standards were violated when sourcing the sample. Depending on the test, they may also need to verify that samples represent a certain gender, age, or set of comorbidities—or that they span a full demographic range.


How can you have confidence in your sample? How can you be certain?


The answer is actually pretty simple: Every sample should be accompanied by information detailing specific data you need about that sample.



  1. Do you care about matched plasma and PBMC samples?


Just as IVD companies are honing diagnostics, pharmaceutical companies are researching treatments targeting the same diseases—and to do that, they need peripheral blood mononuclear cells (PBMCs). By using plasma collected in tandem with the PBMCs, IVD companies can have far greater insight into the patient, and therefore into the efficacy of their test. Matched samples are particularly useful in developing companion diagnostics, when the FDA requires testing before and after treatment.


Of course, plasma collected as a by-product of PBMC collection has an additional benefit. Generally, there is lots of it.



  1. Can your vendor supply sufficient samples?


Throughout the product development life cycle, you may need to run multiple tests on a single sample or access multiple samples over time from a single patient. That means you go through a lot of sample material. Not every vendor can supply sufficient volume, and many researchers find themselves going to multiple groups to access the material they need. At best that is a nuisance; at worst it puts the product development lifecycle and studies dependent on that sample at risk.


Choose a vendor that has large volumes of biomaterial on hand, and can offer both prospective and retrospective sampling.



  1. Would you like some expertise with those samples?


Should your trial include 100 samples or 500 samples to satisfy FDA requirements? Too few and your trial will be rejected; too many and you have wasted valuable time and money. Seasoned vendors with biometrics and market access experts on staff can help you select the right number of samples, the right sites, and the right time from patient to lab to processing to give your trial the greatest chance of success.

About The Author


Karen Richards

Leader and innovator in the GMP/ISO/FDA/EU-regulated in vitro diagnostic (IVD) industry. Spearheads regulatory approvals worldwide for both novel and traditional IVD assays and products, as well as laboratory developed tests in the United States. Builds ground-up quality systems, meeting the requirements of US FDA, ISO 13485, CLIA, and CAP.