What is Test Adoption? | Diaceutics

What is Test Adoption?


This case study provides an overview of the core concepts of diagnostic adoption and its main drivers. It will also give you an understanding of how publications, guidelines and hands-on studies can impact on adoption and how diagnostics often undergo successive generations of improvement after their first launch. It will help you understand:
  • The core concepts of Dx adoption and its main drivers
  • The impact of publications, guidelines and hands-on studies on Dx adoption
  • How diagnostics often undergo successive generations of improvement after their first launch
Download this case study to learn more.

1: Case Summary

This case will help you understand:

The core concepts of diagnostic adoption and its main drivers.

The impact of publications, guidelines and hands-on studies on diagnostic adoption.

How diagnostics often undergo successive generations of improvement after their first launch.
Key messages:

Traditional test adoption is slow and evolves over three stages.

Adoption of individual markers can differ significantly.

Addressing six adoption drivers can speed adoption.

Each of the six drivers has a set of associated workstreams that need to be addressed.
Key actions:

Know the six adoption drivers and how to impact them.

Plan for lifecycle management - diagnostic tests undergo successive generations of improvement.

Communicate with physicians and labs effectively.

Driving diagnostic adoption takes time - make sure you start early.

2: Traditional Test Adoption can be Described as Evolving Over Three Stages

Display_966a7f36463d4a05a8192040dbb703b0();
  •  
    Innovative Phase
  •  
    Imitative Phase
  •  
    Marketing Push Phase
So What?

Test adoption is defined as the consistent use of a test or testing approach by physicians as part of routine clinical practice.

Commentary
In the normal market evolution the three stages are called innovative, imitative and the marketing push.

3: Adoption of Molecular Diagnostics is Generally Promising Among American and European Physicians

Display_tdslidefshjsdh62378js();
Display_tdslidefshjsdh75672js();

Question: For which of the following applications, if any, have you ordered or recommended molecular diagnostics in the past 12 months?

4: Adoption of Individual Markers has Historically Taken up to Several Decades

  •  
    Innovative Phase
  •  
    Imitative Phase
  •  
    Marketing Push Phase
Display_divSlide285_4178js();

 

  • 1981 - "Dr. John Mendelsohn, University of California, San Diego, focusing since 1981 on a receptor called EGFR which is host to a protein called epidermal growth factor (EGF)."
  • 2002 - "Racing to be the first EGFR drug on the U.S. market are London-based AstraZeneca and New York City-based ImClone. If all goes well, these drugs could get FDA approval and be on the market sometime in 2002."
  • 2003 - "Tarceva, plus standard chemotherapy in metastatic non-small-cell lung cancer, didn't meet the primary endpoint of improving overall survival."
  • 2003 - "Although EGFR is commonly expressed in NSCLC and other tumours, its role as a prognostic factor is not well defined and conflicting results have been reported (Nicholson et al, 2001). This may, in part, be due to the lack of a standard validated method for assessing EGFR expression, which makes it difficult to compare results from different studies (Arteaga, 2002). It is not known whether the level of EGFR expression is predictive of response to EGFR-targeted therapy."
  • 2004 - "ImClone Systems Incorporated (Nasdaq:IMCL) and Bristol-Myers Squibb Company (NYSE;BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved ERBITUX(TM) (Cetuximab) Injection for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer."

5: Six Main Drivers will Accelerate Adoption of a Test, if Addressed Effectively

6: Test Technology is an Important Consideration

Example: HER2 testing and Herceptin

CriterionCISHFISHIHC
Signal stabilityArchivableFades over timeArchivable
MicroscopeBright-FieldFluorescenceBright-Field
Magnification40x60-100x20-40x
Protocol lengthOvernight + 3hr, 55minOvernight + 3hr, 12min3hr, 2min
MorphologyGoodLimitedGood
Amount of training requiredMediumHighLow
Internal controlYesYesNo
InterpretationObjective/QuantitativeObjective/QuantitativeSubjective/Qualitative
Overall costMediumHighLow
Market adoption by oncologists in 20081-2%20-40%100%

 

So What?

The best test is not always the most successful test.

Commentary

When planning for CDx development, ensure the test chosen is the optimal solution in clinical and laboratory routine, not just the scientifically or technologically most advanced option.

7: Labs Will Consider Many Supposedly Minor Aspects Before Offering Novel Dx

Example: Labceutics Delphi study with leading EU Mol Dx labs

What aspects would make you consider changing your method or technology for a particular test? Sort the list below giving a number from 1 to 10 (being 1 the least important one and 10 the most important)

 
 
Display_divSlide285_4181js();
So What?

When planning for CDx development, ensure a thorough understanding of all relevant stakeholders’ needs and expectations from the test – avoid slow adoption due to 'secondary issues'.

8: For a CDx, Pharma Needs to Invest in a Mix of Critical Activities that Address the Six Main Drivers

Six main test adoption driversCritical pharma activities
Reduce perceptions of complexityEducation of physicians to order tests; direct stakeholder promotion 
GuidelinesMinimum weight of publications in the clinical domain
Lab–physician interfaceTimely inclusion of test in treatment- and/or test-specific policy frameworks
Stakeholder reimbursementEffective test reimbursement which ensures profitability for service providers 
Direct educationHands-on trial to enable familiarity with testing and support education 
Hands-on useFacilitation of office laboratory / test provider set-up

9: Inclusion in Guidelines Remains the Most Important Endorsement for the Use of Molecular Diagnostics Across EU Physicians...

Display_divSlide285_4183js();

10: … While Overly Complex Testing Algorithms Lead to Slow Dx Adoption

Example: HER2 testing and Herceptin

 

So What?

When launching a CDx program into the marketplace, ensure the test allows for easy, straightforward integration into clinical routine and is positioned as such in relevant guidelines and policies.

11: A Substantial Number of Physicians Don’t Know Which Laboratory to Send Samples to

Example: Survey of US Oncologists

 

So What?

Specific workstreams with the lab or pathologist are required to optimize sample and report logistics.

12: Diagnostics Often Undergo Generations of Improvement so Proactive Management of the Lifecycle is Important

13: The Journey Towards Improving the Quality of Novel Tests must be Communicated to Physicians and Laboratories

14: Critical Initiatives to Drive Adoption Need to Start Early

DriverTiming ConsiderationsTiming
Incorporation into GuidelinesInitial work with relevant KOLs can occur by including it in clinical studies and early hands-on work
Guideline work with diagnostic and relevant professional organizations within TA can be initiated when clear clinical utility for the test is established in the literature
At least 2-3 years before test launch depending on cycle of major guidelines
Stakeholder Education and Direct Detailing to LabsStakeholder education to establish clinical utility of novel biomarker prior to test launch

Laboratory Dx sales effort starts at launch
Approx 1-2 years pre-launch to 18-months post-launch in each market
Hands-on StudiesIdeally, hands-on studies can begin before full commercial launch - definitely want to have these in place at launchApprox 1 years pre-launch
Reimbursement / Test Cost SubsidyAny necessary HE studies should be part of pre-launch planning and execution
Ensure pragmatic, barrier-free funding solution is in place
Up to 2 years pre-launch
PublicationsDx publication strategy should be part of pre-launch planning and execution, as well as ongoing, to accommodate Dx lifecycle plansUp to 2 years pre-launch through lifecycle of test
Set-up of Testing at Target LabsLong term plan to minimize technical sales support costs in balance with need to have instrumentation in placeAt launch through completion of lab footprint

15: Key Messages

Key messages:

Traditional test adoption evolves through three stages.

Adoption of individual markers can differ significantly.

Traditional diagnostic adoption is slow.

Addressing six adoption drivers can speed adoption.

Each of the six drivers has a set of associated activities that need to be addressed.
Key actions:

Understand diagnostic adoption.

Know the six adoption drivers and how you can impact them.

Diagnostic tests undergo successive generations of improvement so plan for lifecycle management.

Communicate with the physicians and labs effectively.

Driving diagnostic adoption takes time - make sure you start early.

Expert Insights

View all expert insights

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017
View all reports

Publications

June 25th, 2019
FLT3 testing in relapsed Acute Myeloid Leukemia setting is becoming increasingly common, but laboratory turnaround times (TAT) may be a barrier to treatment with second generation FLT3 inhibitors
The treatment landscape in AML has developed at an astonishing pace in the last 3 years, with 5 therapies being approved by the FDA. FLT3 inhibitors gilteritinib (Gil) and quizartinib (Quiz) present an unprecedented opportunity for improved surviv...
May 23rd, 2019
Diaceutics reviews the ongoing debate on diagnostics reform legislation
Thought leaders at Diaceutics recently authored a peer-reviewed article that covers the ongoing national debate over diagnostics reform legislation in the United States. The article is now available online ahead of print in the Journal of Molecula...
View all publications