From the editor:

Two weeks ago, the FDA released a new draft guidance that should be of interest to anyone working in the digital pathology field to or anyone interested in companion diagnostics. It could be even more important to those not interested in companion diagnostics if they are into drug development. I’ll briefly summarize some main points but the draft clearly deserves detailed reading.

First, the FDA provides important clarifications: “An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product” because its use “allows the therapeutic product’s benefits to exceed its risks”.

In such cases the therapeutic product is considered to depend on the use of the respective diagnostic test. The FDA emphasizes that such dependencies have become more common and encourages the pharmaceutical industry to actively embrace and advance this development. They suggest contemporaneous development of therapeutic product and companion diagnostic and “expect that the therapeutic sponsor will address the need for an approved or cleared IVD companion diagnostic device in its therapeutic product development plan.” FDA intends to review “diagnostic device submission within the context of, or in conjunction with, its corresponding therapeutic product” and “intends to issue approvals or approval and clearance for both products at the same time”.

Very important is the following statement: “…FDA does not believe it may approve a novel therapeutic product or new therapeutic product indication for use with an IVD companion diagnostic device if the IVD companion diagnostic device is not approved or cleared for that indication.” Possible exceptions to this general rule are discussed but even for these “FDA expects that an IVD companion diagnostic device that is intended for use with the therapeutic will be subsequently approved or cleared through an appropriate IVD device submission.”

Wow. Steve Potts, CEO of Flagship Biosciences, summarizes his conclusion on the matter succinctly:

“Failure/lack of test approval = no therapeutic product approval”

He provides a dramatic estimation of how high the stakes may be. His numbers have 9 digits. Pharmaceutical executives may want to think harder about their companion diagnostics programs before losing billions.

There’s clearly interesting times ahead for anyone into companion diagnostics.