Choosing the right partner: Special sample needs for in vitro diagnostics

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:

For your test to be valid, you need the right patient population. Does your biomaterials supplier have access to that population? How? 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 use,—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.

Collecting samples can be time-consuming—but any delay can extend your trial timeline. Does your biomaterials supplier have a robust enough pipeline? Are their relationships up to date? One advantage of having a partner manage your sample collection is knowing that you don’t need to develop a host of relationships with hospitals and other sample collection sites. Yet not all potential partners have an active relationship with a sufficiently robust group of sites. Ask to see a list of sites they work with regularly—and how recently they have worked with them.

The FDA will want to see a specific sample size, depending on the type of IVD you are developing. Does your biomaterials supplier have the on-staff expertise to advise you accurately? Some tests require 500 samples; some tests require 1,000. If you don’t collect and test enough samples, you risk the FDA rejecting your study—meaning you have to withdraw your application and start again from the beginning. If you err on the side of too many samples, you may be safe from the FDA standpoint, but you will have wasted both time and money on a trial that was double the necessary size. Look for an experienced partner with in-house experts who can guide you appropriately.  

Just because your trial is successful, it doesn’t mean you qualify for reimbursement. Does your biomaterials supplier have on-staff expertise in market access? 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.

About The Author

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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.

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