The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.

Various government agencies are proposing greater government oversight of genetic testing, with the most controversial recommendation asking the FDA to regulate "home brews," the tests that clinical labs develop in-house for clinical purposes. As implementation plans are hashed out slowly, IVD kit makers and clinical labs see both opportunities and hurdles. Hospital labs are concerned about being overburdened by the new rules, while iVD makers worry that reform would give labs an unfair advantage.

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