Madison: When sponsors are submitting applications for complementary or companion diagnostic devices, the FDA recommends that sponsors plan ahead to ensure that the timing for the device submission is in line with the therapeutic submission.

We recommend that sponsors take the time to think critically through the entire analytical and clinical validation process prior to submitting their applications to the FDA.

Given that NGS is a complex technology with multiple potential sources of error, the agency advises sponsors to consider the entire assay process when planning their validation strategy. For example, if the assay is intended to be used on samples that require unique pre-processing steps (i.e., bone metastases), it would be helpful for the sponsor’s application to give consideration to the pre-analytical steps. The FDA considers the test system from sample collection all the way through to variant reporting (i.e., results); it would be in the sponsor’s interest to appropriately validate this entire process.

Communication between the FDA and sponsors, as well as between device and drug sponsors, is critical to ensure that timelines for approval are aligned and that all of the pertinent information is relayed to the necessary parties. For those seeking contemporaneous approval of a device and therapeutic, one tip to help facilitate communication would be to invite the drug or device sponsors to their meetings with the FDA in the respective Centers (i.e., CDER or CDRH).

Sponsors would also benefit from reviewing the previously published summary of safety and effectiveness data (SSED) to get an expectation of what the FDA may require for device validation in a marketing application. Reviewing this data can be useful tool for the sponsor when beginning their device development plans.

Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

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