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Pink Sheet – US FDA Oncology, Device Centers Developing Public Diagnostic Standards

Pink Sheet – US FDA Oncology, Device Centers Developing Public Diagnostic Standards

The US Food and Drug Administration’s oncology and device groups are working together to set minimum standards for cancer diagnostics that all sponsors can use.

Oncology Center of Excellence Director Richard Pazdur said the pilot program in the works with the Center for Devices and Radiological Health would add criteria for tests to clinical trials. When validated, the standards will be made publicly available, he said.

“Rather than having a specific test, having minimal performance criteria of that test embedded into the clinical trial and then have those patients selected based on tests that meet that minimal performance criteria,” Pazdur said of the program during a session at the Friends of Cancer Research Annual Meeting last month.

“Having this concept of a minimal performance criteria where they’re published, you can use any test that meets that, would be something,” Pazdur added. “That doesn’t preclude people from companies developing and commercializing a test that’s for sure that meets this minimal performance status, but it really broadens the perspective out.”

Pazdur said the pilot will help get around the practice of developing individual tests for each treatment, which does not serve patients well because many different tests are used in the real world. In addition, intellectual property issues can force companies to duplicate the work.

“It’s wasteful in a sense,” he said.

FDA Commissioner Robert Califf, who interviewed Pazdur as part of the meeting session, supported the idea.

“We have vastly underestimated the consequences of errors made in testing and diagnosis,” he said. “I hope that we come up with more capability of ensuring that the laboratory community is delivering reliable tests.”

The diagnostic landscape could undergo dramatic changes if Congress grants the FDA oversight of lab-developed tests. The provision and other FDA reforms are under consideration for the appropriations or other legislation to be passed during the lame-duck session.

Many riders, including diagnostic reform, were part of the FDA user fee reauthorization bill, but removed before enactment.  (Also see “After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?” – Pink Sheet, 28 Sep, 2022.)

Could Pilot Affect Combination Product Policy?

Questions continue to be asked about drug-device combination regulation. Usually, the FDA’s Office of Combination Products determines the primary mode of action and assigns a lead agency.  (Also see “US FDA Preparing For New ‘Combination Product Agreement Meetings’” – Pink Sheet, 22 Oct, 2018.)

The prescription drug user fee reauthorization also included requirements to publish guidance on software for use with prescription drugs, which could provide some answers.  (Also see “PDUFA VII: Human Factors Review, Finance Flexibility, REMS, And Manufacturing Get Attention” – Pink Sheet, 10 Nov, 2020.)

But products as complex as gene therapies soon could have substantial device components, which could raise questions about the appropriate regulatory pathway. CDRH Director Jeffrey Shuren already has said that the Center for Biologics Evaluation and Research should continue regulating cell and gene therapies. (Also see “Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?” – Pink Sheet, 25 Nov, 2022.)

NCI Study Of Cancer Detection Tests Upcoming

In addition, the National Cancer Institute is launching a vanguard study of multi-cancer early detection (MCED) assays that will look at the ability of the tests to reduce mortality.

The study will include 24,000 patients. NCI Director Monica Bertagnolli said during the meeting that a larger definitive study will follow based on the results, which could include 250,000 patients.

After describing the study, Bertagnolli anticipated a question from session moderator and FOCR Chair and Founder Ellen Sigal.

“What’s going to make it go fast? Getting the studies streamlined, fit for purpose in the community, accrued to as rapidly as possible,” Bertagnolli said.

“The faster we can move these studies through to complete accrual the faster we can get answers,” she added. “You can’t compromise on the time to the endpoints. But what we can do faster is make sure they’re designed so we can accrue them very rapidly and we have an adequate community buy-in of this, for these studies so that they get very, very rapid accrual.”

The NCI also soon will open the grant application process to establish the NCI Cancer Screening Research Network, which “will provide infrastructure to efficiently conduct cancer screening clinical trials to assess the clinical utility of innovative cancer screening modalities and strategies,” according to the notice outlining the upcoming grant solicitations.

A statistics and data management center, and coordinating and communications center, as well as accrual, enrollment and screening site hubs, will be funded. The first application deadline is expected to be 6 February 2023. The earliest award and start date is 1 December 2023.