Profiling the Current Companion Diagnostics Landscape

Profiling the Current Companion Diagnostics Landscape

With the approval of Qiagen’s therascreen KRAS RGQ PCR Kit for use with the Amgen drug Vectibix, the number of applications for non-LDT, marketed companion diagnostics (CDx) products in the United States has reached 20. The companion in vitro diagnostics market is entering a new phase with over half of all FDA approvals in the previous four years and a burgeoning pipeline. Close collaboration has been key to recent simultaneous pharmaceutical-CDx FDA approvals, and partnerships between IVD companies, pharma companies and labs have proliferated as a result.

Pharmacodiagnostics or companion diagnostics are IVD products and other devices or technologies that inform the prescription of pharmaceuticals and subsequent therapy. Companion diagnostics are a major element of personalized medicine, a therapy strategy so far deployed primarily in oncology where individual forms of cancer are characterized to inform targeted treatment. The majority of marketed CDx products are molecular test kits (more sophisticated molecular tests - some using sequencing - are offered as services or laboratory-developed tests [LDTs]). Some immunodiagnostic companion tests have also been developed using analytes identified through sequencing. Additionally, non-IVD CDx products exist: the only FDA-approved CDx product outside of oncology is an MRI imaging technology for patients using the iron chelator, deferasirox.

The companion diagnostics IVD product market has historically been lead by Roche (including its subsidiary Ventana) and Dako (Agilent) with 5 and 6 FDA-approved CDx-drug combinations respectively. QIAGEN has been moving to the top of the pile as well; the company has 3 CDx FDA-approved product applications with a fourth currently under review. Additional market participants include other IVD leaders Abbott Diagnostics and bioMérieux.

Despite a broadening industry landscape for CDx products, Roche will maintain its leadership as it has the greatest stake and position in personalized oncology. The pharmaceuticals-diagnostics giant can more easily achieve synchronicity in drug and CDx development with in-house businesses such as Ventana and Genentech. Roche has also reached development agreements with 6 third party pharmaceutical companies. Abbott is similarly constructed and has experience in joint development and approval from the Xalkori-VYSIS ALK FISH kit with Pfizer and LabCorp. Abbott, QIAGEN and Dako each have three agreements with major third-party pharmaceutical companies.

For more information regarding the development of the global molecular diagnostics market, including companion IVD products, consult Kalorama Information’s latest report.