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The regulators have different criteria and decisions The potential regulatory risks for diagnostic players developing CDx was well illustrated by the experience of Myriad Genetics . Myriad developed a CDx for Tesaro ’ s Zejula only to find that the FDA ultimately approved the drug for use in patients beyond the scope of CDx and thus diagnostics would not be required for its use . Equally , the market opportunity for CDx can be limited by competition from copy-cat laboratory diagnostic tests . The lack of incentives for diagnostics companies to risk capital and human resources on innovation calls for regulatory change . The EMA and FDA have different criteria for accelerated and conditional approval respectively . This has led to discrepancies between approvals for tests in the two regions as shown in ( Table 13 ).
CDx has a difficult regulatory space with few approvals in recent years
Table 13 : Selected regulatory decisions pre-2020 |
Approval type |
FDA regular approval |
FDA Accelerated approval |
No FDA accelerated approval
Total
EMA Regular Approval - 7 ( 33 %) - 7 ( 33 %) EMA Cma 5 ( 24 %) 4 ( 19 %) 1 ( 5 %) 10 ( 48 %) No EMA Approval - 4 ( 19 %) - 4 ( 19 %) Total 5 ( 24 %) 15 ( 71 %) 1 ( 5 %) 21 ( 100 %)
Source : Adapted from ( Salcher-Konrad , Naci , & Davis , 2020 )
Future outlook and progress
CDx are designed to identify patients likely to be responsive to a specific drug . The case for complementary diagnostics is less clear cut ( Figure 20 ). A positive test indicates that a patient is more likely to respond , while a negative result does not necessarily rule out a potential response to treatment .
Figure 20 : Companion vs . complementary diagnostics
Source : goetzpartners Research , Jørgensen , 2016
Smaller companies often develop tests with a view to be acquired by dominant market players
Development path and status There continues to be a plethora of deals between large pharma and diagnostics companies and laboratories to develop CDx . While most of these deals are focussed on the discovery phase ( Table 14 ) with limited information released into the public domain , there has been a marked shift away from diagnostics based on tissue biopsies to the analysis of liquid biopsies as following the general diagnostic trend . Fundraising for pre-clinical companies is commonplace to keep up with newer therapies being developed ( Figure 21 ). The lag time between therapies and CDx being approved is reducing .
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