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The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.
Q3 medtech financing doubled in dollar volume to $3 billion, with debt offerings again representing the majority of the aggregate; acquisitions totaled $5.3 billion, mainly due to Johnson & Johnson’s $4.3 billion buy of Abbott Medical Optics. Diagnostics financings, which brought in $85 million, continued to decline, but at $5 billion, acquisitions showed a slight increase over the previous quarter, with Danaher’s takeover of Cepheid accounting for most of the M&A volume.
Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.
A House Subcommittee plans to take up draft legislation at a hearing next month that brings together test kits and lab-developed tests into a new regulatory category. The proposal offers many ways for tests to avoid a “high-risk” classification. “The Gray Sheet” compares the provisions to recent proposals vetted in the Senate.
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