The diagnostic testing ecosystem is broken

“It typically takes 36 months after launch for supportive efficient lab coverage . . . to be achieved, taking on average up to 4.5 years for a diagnostic to be available to test the biomarker-positive patient population it was designed to help.”Diaceutics’ Pharma Precision Medicine Readiness Report 2019

4.5 years—that is the average amount of time patients may have to wait to access the appropriate Precision Medicine treatment after it is launched. Even when the targeted therapy is approved, on the market, available, ready to be prescribed—access to the right test designed to find the right patient population for that treatment is delayed for up to 4.5 years. While discoveries and advancements in Precision Medicine continue to usher new targeted treatments onto the market more quickly than ever, the pace of patient access to these treatments remains unacceptably slow and inefficient.

Why? Because the diagnostic testing ecosystem is broken. Complications, inefficiencies, and impediments are hard coded into the framework of diagnostic commercialization, stifling test adoption and stealing time from patients by delaying or preventing access to treatment. Diaceutics’ recently published Pharma Precision Medicine Readiness Report 2019  identifies the multiple hurdles impeding diagnostic commercialization today, describing the diagnostic clinical ecosystem as “ill-prepared” to provide patients with access to better treatments. As the Report explains: “The pernicious systemic issues we repeatedly observe include slow laboratory test adoption, lack of effective test reimbursement, inadequate physician biomarker education, and lengthy lag times between the publication of guidelines recommending a new therapy and guidelines recommending the associated diagnostic test.”

The inertia within the diagnostic marketplace is actively maintained by stakeholder refusal to engage in synergistic partnerships. Instead these stakeholders engage in “siloed” thinking, operating in isolation, leaving the responsibility of repairing this broken ecosystem to others. As a result, the diagnostic supply chain is left manacled by monopolization that perpetuates patient leakage.

In the meantime, the key player in making this ecosystem run smoothly is ignored and repeatedly challenged: diagnostic testing laboratories. The simple fact is many labs cannot afford to run certain tests, are not equipped with compatible platforms to run tests, and/or haven’t been trained or informed about new tests.

As Peter Keeling, CEO of Diaceutics, states in the Report, “the march towards diagnostic dependency” continues to unfold, but the currently “imperfect testing ecosystem” within which this is happening is “far from the ideal setting that maximum patient reach” requires. But what the stakeholders seem to be forgetting is it is only when maximum patient reach is achieved that maximum return on investment (ROI) can also be achieved. Indeed, the logic within those words is hard to deny—particularly when it is backed by Diaceutics’ data analyses. As Keeling states, “Our data clearly illustrate the lag in clinical uptake between therapy and associated test and, consequently, the depressed ROI created by poor pre- and post-launch market development of diagnostic-dependent treatments.”

The current testing ecosystem is ill-equipped to support the progress of Precision Medicine. Click here to learn more about Diaceutics’ insights and solutions regarding the broken diagnostic testing ecosystem. Read Diaceutics’ Pharma Precision Medicine Readiness Report 2019.

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