Biology Reference
In-Depth Information
Essentially, if the device is being utilized in the manner defined above as a companion diag-
nostic, then the history, or previous use and development of that device is irrelevant and the
device would be subject to the same regulatory oversight as any other device. As the guid-
ance states:
'An IVD companion diagnostic device that supports the safe and effective use of a particular therapeutic
may be a novel IVD device (i.e., a new test for a new analyte), a new version of an existing device developed
by a different manufacturer, or an existing device that has already been approved or cleared for another
purpose
[1]
.'
7.3 A MINI REVIEW OF FDA GUIDANCE ON APPROVAL
OF THE COMPANION DIAGNOSTIC
The guidance document breaks down the approval process of the companion diagnostic
into two major classifications - novel therapeutics and approval of a therapeutic product
without an approved IVD device. For novel therapeutic products, the intention is for the
companion diagnostic to be developed and approved in conjunction with the novel thera-
peutic. This intention is evident based on the previous description of an IVD companion
diagnostic. As the companion diagnostic is required for safe and effective therapeutic use,
the approval of the companion diagnostic would be therefore required for the therapeutic
approval. The second classification provides more complicated scenarios. In these cases, a
therapeutic product may have been previously approved or the FDA has determined that it
is appropriate to approve the therapeutic without the benefit of the companion diagnostic
device. While the definition of an IVD companion diagnostic indicates that the device is
required for approval, the guidance clarifies the scenarios in which a therapeutic could be
approved without prior or concurrent approval of the diagnostic device. The two scenarios
in which this may apply are if the therapeutic is a novel approach for the treatment of a
serious or life-threatening condition, or if the therapeutic is already approved. In the first
case, the benefits of the potential treatment must outweigh the potential implications of not
having the approved device available. In the second case, the FDA will not generally revise
a label without the companion diagnostic approval, but in cases where serious safety issues
are at play. An example of this case would be the revision of the labels of the epidermal
growth factor receptor (EGFR) inhibitor cetuximab to include testing for KRAS mutation
in codons 12 and 13 despite there being no approved diagnostic device, based on strong
clinical data
[4]
. Despite these two scenarios, it is generally assumed that approval of the
diagnostic device will be required for approval of the therapeutic, and therefore the spon-
sor will appropriately plan for the device approval in the course of their clinical design. In
addition to this general policy, the FDA has laid out a number of additional general poli-
cies. These policies include a risk-based approach to assignment of a regulatory pathway;
the approval of a therapeutic and its companion diagnostic are intended to be reviewed
and approved in concert. Should a pre-approved device be utilized for a novel therapeutic
device, it will be reassessed under a new premarket approval (PMA) filing, and a new IVD
companion diagnostic for a previously approved use will also be reviewed under a sepa-
rate submission.
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