If you’re developing an in vitro diagnostic device (IVD) you are going to need samples. A lot of samples. Unlike pharmaceutical companies who may need to track a single patient over time, you need hundreds of samples from your target population to ensure that you get consistent test results—and hundreds of samples from a control population, as well. But the target population may be difficult to find, or the test parameters may require a specific type of sample handling, or you may even need two types of samples from the same donor.
You may already be planning to partner with a firm to supply those samples, saving yourself the need to manage the multiple collection sites (and their IRBs) required to supply sufficient samples. Yet quantity is not the only metric for success, and the right partner can make a tremendous difference in the speed, cost, and validity of your trial.
Here are some questions that can help in your selection of sample supplier:
Maybe you are developing a diagnostic test for aiding the diagnosis of a cardiac condition. To make sure your test detects the biomarker needed for the test, you need 300 samples from patients presenting to the Emergency Room with the type of cardiac condition meeting your proposed intended us—and another 300 samples from a control “healthy normal” group of subjects who don’t have the cardiac condition. Don’t run the risk of not getting the right samples. Ask potential suppliers if they have the samples you need in their data bank already, and if not, how they will facilitate collection.
Your trial may be an unqualified success, and the FDA approves your device immediately. Yet payers and regulators look for different metrics—and if your trial doesn’t have the correct percentages of confounding samples, for instance, you run the danger of your marketed test being non-reimbursable. A partner that has biostatisticians and market access specialists on staff can help you design your trial correctly from the start, so you can avoid any potential pitfalls at the end.
Some people may think that a sample is a sample.
If that were so, it wouldn’t matter so much where it came from. In truth, regardless of which biomaterial your device tests—serum, plasma, urine, saliva, DNA—sample sources matter very much.
Explore Precision for Medicine’s extensive biospecimens collection >
Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
