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ARUP Laboratories

www.aruplab.com

Latest From ARUP Laboratories

Lab Professionals Oppose Draft Dx Reform Bill; Lab, IVD Industry Ready To Work With Congress

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.

Regulation Legislation

Device/Diagnostics Quarterly Deal Statistics, Q3 2016

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.

Market Intelligence Deals

Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

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.

In Vitro Diagnostics Policy & Regulation

House Diagnostics Reg Reform Draft Proposes Pathways For Relaxed Scrutiny

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.

Medical Device Legislation
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Company Information

  • Industry
  • Laboratory Testing Services
    • Esoteric Laboratories
  • Services
  • Therapeutic Areas
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • ARUP Laboratories
  • Senior Management
  • Edward R Ashwood, MD, Pres. & CEO
    Jerry W Hussong, MD, CMO & Dir., Labs
  • Contact Info
  • ARUP Laboratories
    Phone: (801) 583-2787
    500 Chipeta Way
    Salt Lake City, UT 84108
    USA
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