Companion diagnostics

Tools

Companion diagnostics follow on logically from predictive biomarkers, but instead of speeding drug development these are tailored for use by physicians to help select the right drugs for the right patients.

Companion diagnostics serve a vital role in Big Pharma outfits' big plans to sell expensive new drugs for specialty markets. Reimbursement is key, of course. And payers have a huge influence on adoption of the tests in pharma, pressuring drugmakers to include companion diagnostics to confirm that a pricy new med has a better shot at working for a patient. Payers cut spending on ineffective treatments and reduce the costs of supporting patients through unpleasant or disabling side effects.

Pharma companies have responded in a variety of ways. Roche ($RHHBY) is investing heavily in this area, with around 60% of its pipeline drugs expected to come paired with companion diagnostics, Roche CEO Severin Schwan said in September, as quoted by Reuters. Bayer, Bristol-Myers Squibb ($BMY) and GlaxoSmithKline ($GSK) are also creating or expanding alliances. Bayer has signed an agreement with Qiagen ($QGEN) for companion diagnostics to use with Bayer's solid tumor treatments, and Bristol-Myers  has set up a partnership with California's Life Technologies ($LIFE), initially in cancer and then branching out into other therapeutic areas. GSK already has an agreement with Response Genetics but has expanded its interest in the company, acquiring 5 million newly issued shares.

From 2008 to 2010, pharma partnerships with in vitro diagnostics players soared, according to a PricewaterhouseCoopers from December 2011. The report saw such deals jump from 7 in 2008 to 19 in 2009 to 25 in 2010. And the firm saw the FDA's draft guidance on companion diagnostics in July 2011 as an indicator of increased investment in the field.  

Patients can win too. Companion diagnostics ensure that they get the most effective treatment for their specific type of disease, and reduce the number of ineffective or potentially harmful treatments they may receive. For doctors they make it easier to match patient and treatment, especially as the drug choice in certain diseases such as cancer become dizzyingly complex.