FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, 2019, the US Food and Drug Administration (FDA) issued final guidance setting out a streamlined process that allows companies to apply to have the IVD test involved in a cancer drug trial reviewed simultaneously with the drug itself.

The New Streamlined Cancer Drug Process

The new streamlined process is optional but the FDA “encourages sponsors to use it . . . when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory approval.”  the agency said in its final guidance. Sponsors submit to the Center for Devices and Radiological Health (CDER) or Center for Biologics Evaluation and Research (CBER) all information about the oncology codevelopment program (including information about the investigational IVD) in the trial protocol for the investigational new drug application (IND).

One sponsor should take the lead in communicating with FDA about the IND. To indicate its intent to use the streamlined process, the sponsor should include the text “Streamlined IVD SRD” in either:

  • In Section 11 (under “Other”) of the Form FDA 1571, Investigational New Drug Application; or
  • The cover letter it submits with the IND (along with a reference to which section(s) of the electronic common technical document contains relevant information).

The final guidance also lists the additional information about the IVD and how it will be used in the trial that the sponsor should list in the protocol it submits for the IND, including:

  • A description of the device;
  • How the results from the investigational IVD will be applied in the clinical trial;
  • A description of the population and information regarding what is known about the prevalence of the biomarker (evaluated by the investigational IVD) in the patient population;
  • The specimen type that will be collected for investigational IVD testing (including the anatomical site) and whether any biopsy conducted exclusively for investigational IVD testing could present a potential for serious risk to the health, safety, or welfare of the subject.

By signing Form FDA 1571 (section 17) sponsors provide assurance of an institutional review board review of the complete clinical trial protocol and activities for the investigational IVD and the investigational drug, the final guidance specifies.

The CBER or CDER will then use the information to determine as part of the IND review and within the 30-day review period whether use of the IVD is significant risk (SR), nonsignificant risk (NSR) or exempt from investigational device exemption (IDE) requirements.

Determination Consequence
NSR CBER or CDER confirms determination in appendix to Study May Proceed Letter + reminds sponsor to follow NSR procedures in obtaining biopsies for testing + submit unanticipated adverse device effect reports to IND
SR CBER or CDER confirms determination in appendix to Study May Proceed Letter + asks sponsor to submit IDE application to CBER or Center for Devices and Radiological Health (CDRH) + not start trial until after IDE is approved
Exempt CBER or CDER confirms determination in appendix to Study May Proceed Letter



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