Companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. Companion diagnostics can also decrease costs by identifying the patient population that will most likely benefit from the therapy, and ruling out therapies that are not likely to be effective. This is especially critical given the cost of many new cancer therapies. Companion diagnostics also improve patient outcomes by selectively determining which patients will respond to therapy.
The emergence of new technology has opened doors for companion diagnostic research, discovery, development and commercialization. This has resulted in a huge increase in exploratory studies, diagnostic developments, and clinical usefulness in the pursuit of personalized medicine.
The growing interest in companion diagnostics is fueling many novel partnerships between big pharma and diagnostic companies. In the past, each individual company would develop its own product, many times at great risk and expense. In many cases, it was viewed by industry participants as too risky to devote resources towards the development of a test that may never be used. This has opened the door for co-development and partnership deals to take center stage. In 2010 there were approximately 25 big pharma and diagnostic companies’ deals, up from 19 in 2009 and only 7 in 2008. That number has increased to over 50 since 2011 with oncology as the primary area of companion diagnostic licensing/partnership deals in recent years.
Following is a list of recent companion deal etched in the first half of the year.

Produced from information included in Kalorama Information’s study Companion Diagnostic Markets

Companion DX Partnerships, First Half 2014
Diagnostic Company Pharmaceutical Company CDx Area Date Roche/Ventana Merck Cancer July 2014 Roche/Ventana Ferring Infertility June 2014 Qiagen Eli Lilly Undisclosed June 2014 Sysmex Inostics Merck Colon cancer June 2014 Roche/Ventana MedImmune NSCLC June 2014 Nanostring Celgene Lymphoma June 2014 Qiagen Eli Lilly Cancer June 2014 Dako Merck Cancer May 2014 Foundation Medical Clovis Cancer May 2014 Abbott Diagnostics Iderra B-cell Lymphoma May 2014 Roche/Ventana Genmab Cancer April 2014 20/20 Gene Systems NIH Kidney cancer February 2014 Dako Amgen Cancer February 2014 Theradig Splicos HIV/obesity January 2014 Illumina Amgen Colon cancer January 2014 Dako Merck Cancer January 2014 Lab Corp Arca biopharma Atrial Fibrillation January 2014 Leica Arno Cancer January 2014

The majority of partnerships have been with established diagnostic players such as Roche and Abbott but there seems to be a shift recently moving toward specialized diagnostic companies as seen in the Eli Lilly and PrimeraDx partnership. Most of the partnerships have been exclusive for a limited time period.
There are at least four current business models for the development of companion diagnostics.
The first of these models is in-house development. This usually is seen in large pharmaceutical companies with many divisions. The company uses internal expertise to develop a companion diagnostic usually for its own research and development projects in clinical trials.
A second model is the partnership/licensing approach. This seems to be the most popular approach and one that is the most cost effective for the pharmaceutical company and the diagnostic company alike.
The third approach is the acquisition model where the pharmaceutical company acquires the companion diagnostic company to provide in house development. Eli Lilly’s acquisition of Avid Radiopharmaceuticals to
develop a diagnostic for Alzheimer’s disease and advance diagnostics development platform is just one of many examples of this approach.
A fourth model is the hybrid approach where pharmaceutical company collaborate with companion diagnostic companies to develop products, while also developing internal capabilities as well. Novartis established an internal molecular diagnostics unit but it also collaborates with other companies for companion diagnostic development.
Cancer is the driver of companion diagnostic products. With the advent of gene sequencing, treatment for cancer began to move to a more personalized approach. . There are more than 41 oncology-focused biomarker/companion diagnostic products.
The majority of competitive participation for companion diagnostics is in the United States and Europe. However, competition is steadily escalating in the United States and Europe, which is encouraging more participation in other areas such as Asia and Latin America. There are numerous companies in the market which include large multiproduct companies such as Roche and Abbott and small niche developers such as 20/20 GeneSystems. Other companies include:
 20/20 GeneSystems
 Affymetrix
 Agendia
 Alere
 Beckman Coulter
 Becton Dickinson
 Biocartis SA
 Biodesix
 bioMerieux
 BioReference Laboratory
 bioTheranostics
 CardioDX
 Celera Alameda
 Clarient
 deCODE Genetics
 DiaGenic
 Genomic Health
 Genoptix Medical Laboratory
 Illumina
 Johnson & Johnson
 Life Techologies
 Memory Dx
 Myriad Genetics
 Nanostring Technologies
 OPKO Health
 Provista Dx
 Qiagen
 Seimens Healthcare
 Singulex
 Thermo Fisher Scientific

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