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Failure to Test Before Prescribing Precision Medicine Indicates Lack of Awareness of Biomarkers

3 December, 2020

Precision Medicine is a customized approach to medical care guided by genetic or molecular profiling tests with the goal of optimizing patient outcomes. So, the whole premise of Precision Medicine is based on accurate, timely testing—using the right tests at the right time to identify the right patient populations for appropriately individualized treatments. In order to deliver improved health outcomes, stakeholders involved along the patient diagnostic pathway must be aware of the precision tests these optimal outcomes are dependent upon.

However, many stakeholders—physicians, labs, and payers, in particular—may lack awareness of the biomarkers associated with Precision Medicine treatments. This is clearly demonstrated in multiple real-world studies showing how patients with non‒small cell lung cancer (NSCLC) continue to be prescribed Precision Medicine treatments without first or ever undergoing a relevant test.1-3 For example, as shown in the Figure below, of the approximately 8800 oncologists in the United States (US) comprising the main segment of health care professionals treating patients with NSCLC characterized by PD-L1 testing, 50% or more of those in oncology/hematology, medical oncology, and internal medicine tested at least one of their patients for PD-L1 expression.1 Similarly, one study revealed that only 11.3% of patients with metastatic NSCLC were tested for PD-L1 expression prior to receiving nivolumab or pembrolizumab.3,4

Figure.  Specialists treating patients with non‒small cell lung cancer characterized by PD-L1 testing.5*

*Based on claims data; tests were not necessarily ordered by the treating physician.

In addition to prescribing treatment before receiving test results, some oncologists prescribe treatment regardless of test results. One international survey of oncologists in North America treating patients with NSCLC (published in 2015) revealed that 60% did not base treatment decisions on patients’ genetic mutation profile, with 21% of those oncologists determining their patients’ treatment regimen before receiving test results.2,4 In the same survey, 23% of oncologists did not base treatment decisions on EGFR mutation subtypes.2,4 Another real-world analysis of EGFR testing and treatment patterns found that, of patients with stage IV NSCLC, less than 25% received EGFR testing, while less than 50% who were EGFR-positive received targeted treatment.4,6

This failure to test appropriately is happening because many physicians simply are not aware of what tests are available. And those physicians who are aware of tests available face the additional challenge of determining the appropriate test from multiple molecular diagnostic testing options offered by hospital and commercial labs.7 Still others are unsure what tests will provide the “accurate and actionable information” they are seeking for their patients.7

As a result, many patients currently are not receiving the right therapies, even though their test results indicate they are eligible for life-saving Precision Medicine therapies.1 The consequences of this lack of awareness are clearly evident in the aforementioned leakage of more than 50% of patients—which means multiple missed opportunities for treatments that could have saved lives.5

As with physicians, other stakeholders, including labs and payers, struggle to keep up with the pace of innovation in precision testing. As it is, when a new Precision Medicine treatment is launched, it typically takes 4.5 years for enough physicians, labs, payers, and other stakeholders to be aware of the associated biomarker test for it to achieve 80% clinical uptake.1 Protocols that can keep up with the current level and pace of innovation are urgently required to ensure that specific test variations and combinations are embraced quickly enough by physicians, regulators, labs, ad companies designing new clinical trials. (Click here to download the Pharma Precision Medicine Readiness Report 2020: NSCLC—An Axis for Change to learn more about lack of biomarker awareness and other testing hurdles impeding the progress of Precision Medicine.)

In order to increase awareness of these vital biomarker tests among physicians, improved communication avenues must be built to introduce new biomarker tests to physicians—as well as labs and payers with whom their actions within the clinical diagnostic testing ecosystem are intertwined. A collaborative platform network could connect these stakeholders and coordinate the timely flow of information and education. Such a network could realign the precision testing process to ensure the right timing of testing and accurate identification of patients for testing, and, ultimately, improve patient outcomes.

That network is finally here. It is DXRX - The Diagnostic Network®, the world’s first diagnostic network for Precision Medicine, enabling every patient to get the treatment they deserve by:

  • Enabling a vibrant marketplace where all stakeholders in Precision Medicine come to find trusted partners and collaborations in a secure, standardized way, and

  • Providing access to a pipeline of global diagnostic testing data on one secure platform.

With collaboration at its core, DXRX - The Diagnostic Network® is a multi-sided platform built to drive the essential “Network Effect” that brings stakeholders together at critical stages throughout a patient’s testing journey to diffuse testing hurdles that are today substantially hindering NSCLC outcomes. An end-to-end solution for the development and commercialization of precision medicine diagnostics, DXRX - The Diagnostic Network®: 

  • Integrates a global flow of diagnostic testing data into one secure platform, thereby unlocking a network of industry leading partners to get every patient the treatment they deserve;

  • Informs better business decisions and value-driven outcomes, enabling better outcomes for patients through the integration of diagnostic testing data at critical stages of the development and commercialization journey; and

  • Provides access to transparent, real-time tracking of diagnostic market performance of brands at local level to maintain and enhance test uptake across the portfolio.

One of the many benefits of being part of the collaborative, data-rich DXRX - The Diagnostic Network® is visibility of companion diagnostic (CDx), or biomarker test, development programs to enable necessary preparation—prior to biomarker launches—in the form of access to training services and emerging technologies. In this way, the DXRX - The Diagnostic Network® provides essential information access to help reduce delays in the adoption of new tests.

To learn more about DXRX - The Diagnostic Network® visit


  1. Diaceutics Data on File. Diaceutics’ Data Repository unpublished data, 2020.

  2. Mason C, Ellis PG, Lokay K, et al. Patterns of biomarker testing rates and appropriate use of targeted therapy in the first-line, metastatic non-small cell lung cancer treatment setting. J Clin Pathw. 2018;4(1):49-54. doi: 10.25270/jcp.2018.02.00001. Accessed December 2, 2020.

  3. Enewold L, Thomas A. Real-world patterns of EGFR testing and treatment with erlotinib for non-small cell lung cancer in the United States. PLoS One. 2016;11(6):e0156728. doi: 10.1371/journal.pone.0156728. Accessed December 2, 2020.

  4. Hardtstock F, Myers D, Li T, et al. Real-world treatment and survival of patients with advanced non-small cell lung cancer: a German retrospective data analysis. BMC Cancer. 2020;20:260. doi: 10.1186/s12885-020-06738-z. Accessed December 2, 2020.

  5. Spicer J, Tischer B, Peters M. EGFR mutation testing and oncologist treatment choice in advanced NSCLC: global trends and differences. Ann Oncol. 2015;26(Suppl 1):i57–i61. doi: 10.1093/annonc/mdv128.04. Accessed December 2, 2020.

  6. Khozin S, Abernethy A, Nussbaum N, et al. Rates of PD-L1 expression testing in U.S. community-based oncology practices (USCPs) for patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab (N) or pembrolizumab (P). J Clin Oncol. 2017;35(suppl 15):11596. doi: 10.1200/JCO.2017.35.15_suppl.11596. Accessed December 2, 2020.

  7. Levit LA, Kim ES, McAneny BL, et al. Implementing Precision Medicine in community-based oncology programs: three models. J Oncol Pract. 2019;15:6,325-329. doi: 10.1200/JOP.18.00661. Accessed September 17, 2020.

About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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