By: Maureen Kingsley

The Association of Medical Diagnostics Manufacturers (AMDM) has created a working group specifically for issues related to the regulation of companion diagnostics. The group's chairman is Eric Lawson, project director for medical devices at Voisin Consulting Inc. (Cambridge, MA) and a member of AMDM. Lawson proposed the formation of the group in April of this year, in response to a request by industry colleagues who had been experiencing difficulty with submissions of companion diagnostics to FDA. Formation of the group was also prompted by acting director of OIVD Don St. Pierre's request for industry input in his drafting of a new FDA guidance on companion diagnostics.

Membership in the Companion Diagnostics Working Group (CDx WG) is varied and “energetic,” says Lawson. It includes such big-time diagnostics players as Abbott and Roche, as well as smaller, younger IVD and biotech firms, such as XDx. Representatives from CDRH round out the group.

CDx WG's primary goal, Lawson says, is to provide some recommendations to CDRH in particular and FDA in general regarding guidance and best practices for managing the regulatory process of a companion diagnostic with a therapeutic. The first phase of this endeavor, Lawson says, is to put together a bulleted list of concerns, experiences, issues, and suggestions for FDA. He expects the group to have this part of its plan complete fairly soon. Phase two is to publish a white paper detailing all of the bullet points in a single, larger document for CDRH, with a wider audience of CDER and CBER as well. Lawson says the white paper will likely “address how the regulatory process should work, how FDA's guidance might want to link up with our suggestions, and how industry—drug/biologic and diagnostics manufacturers—should work together in the advancement of personalized medicine.” Lawson hopes the paper will be completed by the end of this year.

The issues surrounding oversight of companion diagnostics are many. Regulatory agencies are uncertain about the best way to handle the diagnostic and the drug, Lawson says. “The regulations are quite different between drug and diagnostic approvals,” he says. “We're talking about different pathways, different centers within FDA. It is logistically difficult to have the review processes coordinated between the IVD and the drug.”