Following are three lists depicting recent activity in the development of companion diagnostics: a rundown of all 15 FDA-approved companion diagnostics, as listed on the “Companion Diagnostics” page of the agency’s website, last updated April 17 and accessed May 3; a pair of submissions submitted in recent months for FDA review; and 35 of the most recent announcements of companion diagnostic collaborations between developers of diagnostics and drugs. The announcements appear on the companies’ websites, and/or were reported by GEN and other news outlets between August 2011 and this month. Not included were announcements of diagnostics agreements that merely specified they would be used in “research,” without a mention of current or future drugs they would accompany.
In many cases, the announcements do not specify a specific drug for the diagnostic, but state that the diagnostic is intended for use with several drugs. Some announcements did not cite the specific technology being applied in the trumpeted companion diagnostic. And nearly all announcements omitted financial terms, though there were a few exceptions.
Not surprisingly, diagnostics developers have been active in signing agreements with several drug companies for companion assays; Qiagen has said publicly it has 15 such projects in the works. The August 2011 cutoff omits details of numerous earlier deals by other diagnostics providers with drug companies; in addition to the deals listed below, for example, Agilent Technologies (which acquired Danish-owned Dako last year) has earlier collaboration agreements with AstraZeneca, Quintiles, and Roche. On the diagnostics side, Roche inked earlier deals with Merck, Clovis Oncology, and Transgene.
Approved companion diagnostics are listed by name, sponsor-developer, and a summary of the official intended use/indications for use (IU/IFU) as listed by FDA. Companion diagnostics submitted recently for review or in the works are listed by sponsor-developer, date of submission or announcement, summary of what the diagnostic is supposed to do, and financial details, if disclosed.