By Kirell Lakhman
Studying the evolving ways in which disparate US government agencies have recently unveiled plans to rein in and regulate LDTs (and genetic tests in particular) has revealed, perhaps unintentionally, what appears to be a federal-level fetish for databases.
Perhaps it's simply an innocent "government thing:" A database — a registry, depository, repository, even an inventory — is a cheap and easy way to round up and guard under a single roof all common constituent components that require oversight.
By chance, or quite by design, the call for a shiny, new database has appeared each time a federal agency in recent weeks unveiled a new strategy to regulate LDTs and genetic tests, including consumer genetic services.
In fact, I see three distinct database proposals floated by three federal agencies over the past three months, each of which in some ways overlaps with and contradicts the others. I also see a solution to the madness of letting loose what amounts to three masters armed with redundant and conflicting rules and charged with regulating a wide array of lab tests.
The first of these three registries is the voluntary database proposed by the NIH to "enhance transparency" of genetic tests, presumably both homebrews and IVDs, and enable researchers to develop new ones.
According to NIH, the registry, first floated in March, aims to "encourage providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; provide an information resource for the public, including researchers, health care providers, and patients, to locate laboratories that offer particular tests; and facilitate genomic data-sharing for research and new scientific discoveries."
The second registry appears in a potential bill that could soon be submitted to the US Senate. The bill seeks to create an additional bureaucratic buffer in the form of an FDA-based Center for Advanced Diagnostics Evaluation and Research, whose task would be to build a registry for a new category of tests called "advanced personalized diagnostics," which would comprise IVDs and LDTs.
The third database is part of CDRH's unfolding plan to regulate LDTs. When it flips the switch in several months from "enforcement discretion" to "risk-based enforcement," the FDA will have no idea just how many tests it has very suddenly become responsible for regulating.
Because of this, before the switch is flipped, the "likely first step" will be to establish a government registry of homebrews to enable the agency to "get our hands around the universe of LDTs," an agency spokeswoman said recently.
