Highlights from FDA Industry IVD Roundtable

The fall FDA‐Industry IVD Roundtable Meeting hosted by the Office of In Vitro Diagnostics and Radiological Health (OIR) of the FDA’s Center for Devices and Radiological Health took place in Silver Spring, MD on December 2nd.  Here are a few of the day’s highlights.

Post-Election, OIR Halts LDT Oversight Policy

In his opening remarks OIR Director Alberto Gutierrez, Ph.D., noted that while there may be a lot of change with a new incoming White House administration, OIR’s 2017 priorities are:

  • Quality Management
  • CLIA Waiver
  • EAP
  • Patient outreach

Gutierrez went on to give an update on the agency’s work on developing a new oversight policy for Laboratory Developed Tests (LDTs). On November 18 the agency released this statement:

“The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions – inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”

Gutierrez explained that FDA still believes that regulating LDTs is important, but it will wait until the new White House administration is in place before updating the LDT framework.

Also of note, OIR has introduced payer participation in pre-submissions. Even if sponsors aren’t eligible or don’t want to participate in the Parallel Review Program with CMS, they can still request CMS or private payer feedback in their pre-submission meetings if it is requested first.

Roche: FDA Collaboration Cheaper than Repeat Studies

Reena Philip, Ph.D., director of the Division of Molecular Genetics and Pathology, reviewed the first “liquid biopsy test” to be approved for non-small cell lung cancers (NSCLCs): the cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.). The Roche test was one of three to date to be granted EAP status. It is a true unmet need because Stage III/IV lung cancer patients are too sick to give a biopsy.

Roche Director of Regulatory Affairs Lesley Farrington recalled that they had been at FDA 10 times over 18 months during the submission process, and commented that it costs less to talk to FDA frequently than to repeat studies. This is why Beaufort pushes clients to do pre-submissions—FDA collaboration is vital to success!

One of the interesting parts of the process was how FDA worked with Roche on labeling. This is the first instance we have seen a “reflex” companion diagnostic; the intended use states “Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.”

AdvaMed POC Highlights Innovator Issues

Leanne Kiviharju, with the AdvaMed POC Diagnostics Subteam, presented some interesting points to consider regarding Point of Care (POC) Diagnostics.

She pointed out that “FDA has no definition for POC” and posed the following questions:

  • How does FDA educate reviewers and other groups that POC and CLIA waived tests are not the same?
  • Why does FDA identify differences in POC tests compared to mainframe tests that are also moderate complexity?
  • When a POC predicate is traceable to a standard, such as NIST, what is the scientific reason for requesting a method comparison of the new POC device with a clinical laboratory device in addition to the traceable POC device?

At the conclusion of the presentation OIR Director Gutierrez remarked that POC means near patient testing, and that the questions posed during the presentation were too narrow to be answered in a general sense and can be answered only in reference to specific projects.

The IVD Roundtable agenda and presentations can be found here.


Lucy Gibney, MD, is Medical Director at Beaufort where she provides clients with a breadth of experience in medical, scientific and clinical leadership. Lucy advises operations staff in all aspects of medical management of clinical trials, while serving as a medical expert during the project delivery lifecycle.

Date posted: December 20, 2016

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