ARC Regulatory set to attend the 3rd Annual Companion Diagnostics Forum on September 12-14, 2018, at the historic Bell Works building in Holmdel, NJ. This targeted forum of over 120 attendees focuses on key issues related to the growth of Companion Diagnostics.

Precision Diagnostics have played a critical role in the introduction of precision medicine in the clinic. Whereas first generation companion diagnostics have largely been single-analyte tests, researchers are now engaged in converting even more complex biology into novel drug therapies and next generation assays to treat a broader array of diseases. At the same time, biopharma companies are communicating with FDA and the Centers for Medicare & Medicaid Services to facilitate parallel approval and coverage determinations of these novel drugs and assays. A notable next generation example is CMS proposed coverage of the multi-gene F1CDx assay; this test is the second IVD to be approved and covered by the FDA and CMS under the Parallel Review Program. At this Forum, talks and topics will focus on the value of new and existing precision diagnostics from the development stage to reimbursement coverage as well as factors influencing the uptake of these technologies in healthcare.

Topics expected to be covered include:

  • Role of Precision Diagnostics in Precision Medicine
  • Tools for educating Physicians on Companion Diagnostics, Precision Medicine, and related products
  • Updates on FDA Regulatory topics and related issues
  • Experiences and expectations of Payers, Patients, and Patient Advocates on Reimbursement
  • Approaches to incentivize Adoption and Uptake of Companion Diagnostics and Precision Medicine by Physicians.
  • Representative from Patient Advocacy Groups on educational channels for patients to community Physicians and Clinics
  • Experiences of Patients who have used Companion Diagnostics
  • FDA path vs. LDT/CLIA: related issues, pros/cons, trade-offs
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