Companion Diagnostics drive better outcomes
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Companion Diagnostics drive better outcomes
Molecular diagnostics are playing an increasingly important role in the personalisation of cancer therapy . There are currently over 45 companion diagnostics (“ CDx ”) linked to the use of specifically targeted cancer therapies , with biomarkers used in 39 % of oncology trials in 2018 , up from 25 % in 2010 ( IQVIA ). A growing repertoire of additional genetic markers are increasingly used to guide treatment and determine individual prognosis . Such tests can help ensure patients receive the most effective treatments for their specific cancer and avoid the discomfort and expense of unnecessary or ineffective interventions . Increasingly CDx are using non-invasive liquid biopsies to personalise and monitor treatment for increasingly specialised drug targets . This type of companion complementary testing will , we believe , increasingly become a continuum from early diagnosis guiding treatment from an early stage . The development of these tests will continue to be the domain of the larger incumbent diagnostic players .
Foundation medicine and Dako are set up for success
CDx ensure the right patients get effective and safe treatment
Multi testing capacity a necessity for success As the numbers of CDx increase and become more heterogenous it is difficult to predict who will be successful in the market . We believe that due to cost and time savings companies that can offer multiple CDx within one test / sample will be likely more successful . This will allow personalised treatment from one sample for a patient and allow clinicians to decide on a treatment for late-stage cancer where time is crucial . Companies such as Foundation Medicine and Dako ( Agilent ) are starting to offer this and likely to continue their market dominance .
CDx can increase patient pool size for big pharma Although the development of CDx has largely been performed through collaboration between large pharma and the larger diagnostic players , there are increasing numbers of smaller service-based companies that provide a range of proprietary and / or widely available tumour profiling and prognostic tests . The shift towards liquid biopsies should also allow more repeated longitudinal testing , opening opportunities for point-of-care platforms developed by smaller innovators . If simpler tests confirm the suitability of a patient for a particular big pharma treatment this increases the number of patients receiving that drug and therefore the revenue . This has led to acquisitions of CDx tests from large pharma companies . Overall , we would expect increasing opportunities in liquid-based companion and disease / treatment monitoring diagnostics .
Current status of CDx
According to the FDA , a CDx is defined as a diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product . CDx have been a focus in oncology since the development of tamoxifen in the mid-1970s to the approval of the Tecentriq in 2016 ( Figure 16 )
CDx can detect driver mutations that can be targeted with specific drugs Many CDx are based on biomarkers that link a drug to a specific genotypic marker that defines the sensitivity or otherwise of the cancer cell to a particular drug . Sequencing efforts have identified about 140 genes known to be drivers of the oncogenic phenotype . These are closely linked to disease mechanisms that support oncogenesis and determine cell fate and survival , and genome maintenance . These driver genes frequently encode the receptors and / or intracellular enzymes that form part of a growth cascade that ultimately leads to cancer cell proliferation or survival . It is frequent mutations in these pathways that lead to the uncontrolled growth that promotes cancer . The prevalence of driver mutations varies widely from patient to patient , with the result that many targeted drugs are only effective in a small proportion ( 5 % - 15 %) of patients which can make clinical trials difficult . The use of the CDx allows these small numbers of responding patients to be picked out for treatment with a highly targeted therapy .
Companion and complementary diagnostic tools are important These diagnostic tests can be complementary or companion . A CDx device is an essential part of a therapy being safe and effective . Whereas a complementary diagnostic test is designed to aid in treatment decision making . The FDA first approved complementary diagnostics for Tecentriq
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