The Burrill Report


The U.S. Food and Drug Administration says that in most cases, companion diagnostics—tests used to determine whether a drug is appropriate to treat an individual patient—should be approved or cleared at the same time that the agency approves the drug with which the diagnostic is to be used. The direction is part of a newly issued draft guidance aimed at facilitating the development of personalized medicines and diagnostics.

When finalized, the document is intended to provide companies with the agency’s current thinking about companion diagnostics. The agency is seeking public comments through beginning of September.

“Because an IVD companion diagnostic device with inadequate ‘performance characteristics’ or other issues related to safety and effectiveness could expose a patient to preventable treatment risks, FDA will assess the safety and effectiveness of the IVD companion diagnostic device as used with the therapeutic when a therapeutic product depends on the IVD companion diagnostic device for its safe and effective use,” the draft guidance said.

The guidance does contemplate circumstances where the agency may choose to approve a therapeutic product even if a companion diagnostic for which it is labeled is not being approved at the same time. Such instances could include new therapies to treat serious or life-threatening conditions or cases where an already approved therapy needs safety changes to its label.

“These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability,” says Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. “It is the agency's goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients.”





July 15, 2011
http://www.burrillreport.com/article-fda_wants_companion_diagnostics_approved_with_paired_drugs.html