The patient diagnostic pathway is the segment of the entire patient journey that sets the course for progress in managing disease. Theoretically, if that leg in the patient journey is handled efficiently, the rest of the journey ideally will follow suit—leading to improved health outcomes. With that said, efficiency will be key to setting the optimal course for each patient.
Unfortunately, multiple hurdles exist within the patient diagnostic pathway. These inefficiencies are clearly evident when you take a real-world look into the non‒small cell lung cancer (NSCLC) testing landscape. The Figure below depicts the typical diagnostic pathway of a patient with NSCLC, as reflected by the experience of 235,000 patients newly diagnosed annually in the United States.1 The patient journey shown starts with the initial visit to the primary care physician (PCP) or emergency department (ED) through various specialists and tests to treatment and monitoring. Each visit and test event holds the potential for significant hurdles to disrupt patients’ progress through their journey within the clinical diagnostic ecosystem.
(Click here to download the Pharma Precision Medicine Readiness Report 2020: NSCLC—An Axis for Change to learn more about the hurdles impeding patients’ progress along the diagnostic pathway.)
Figure. The typical NSCLC patient diagnostic pathway.1
ALK, BRAF, EGFR, NTRK, PD-L1, ROS1, TMB: biomarkers; CNB: core needle biopsy; CT: computerized tomography; EBUS: endobronchial ultrasound; ED: emergency department; H+E: hematoxylin + eosin stain; IHC: immunohistochemistry; NSCLC: non-small cell lung cancer; PCP: primary care practitioner; TBNA: transbronchial needle aspiration.
For example, common disruptions occurring as early as the biopsy stage include1:
- Tissue sampling issues
- Interpretation issues
- Delayed test turnaround times
As a result of these and many other hurdles on the patient diagnostic pathway, approximately 50% of patients with NSCLC miss out on appropriate treatment.1
The failure of the clinical diagnostic testing ecosystem starts before the biopsy stage, reaching back earlier into the patient journey when detection of early-stage NSCLC is repeatedly missed. In fact, the majority (75%) of lung patients are diagnosed in late-stage disease.2 How can this be happening in 2020, when for 20+ years we’ve had access to early diagnostic methods (e.g., lung function testing, X-rays, ultrasound and cytology tests, and, recently, ultra-high sensitive liquid biopsy molecular testing)?
And while Precision Medicine has advanced with effective treatments for early-stage NSCLC, these treatments are typically unable to produce substantial health benefit in patients diagnosed in late-stage disease. This failure of stakeholders within the clinical diagnostic testing ecosystem is clearly seen in the low percentage of patients living long enough to progress to second line (50%) or third line (22%) therapy.3
This failure is largely the result of pharma, and the diagnostic companies they sponsor, which predominantly focus investment dollars on the predictive companion biomarker testing phase of the patient diagnostic pathway—specifically, biopsying for companion diagnostic (CDx) tests to inform therapy. For example, according to a Diaceutics’ analysis, pharma spends 80% of educational investment dollars on this narrow pre-treatment phase of the diagnostic journey.1 This isolated investment in one narrow aspect of the patient pathway is indicative of an epidemic in itself among multiple stakeholders within the patient diagnostic pathway: the tendency of stakeholders to focus on isolated steps along the pathway instead of considering the pathway overall.
Many of the systemic inefficiencies within the patient diagnostic pathway develop because these steps are commercially orphaned (due to lack of economic incentive) or are managed on a siloed basis—even though the objectives of multiple stakeholders are intertwined throughout the entire patient pathway. As a result, hurdles arise to disrupt patient progress. So, when pharma, and the diagnostic companies they sponsor, focus spending on one area of the diagnostic pathway only, this leaves ownership of early-stage NSCLC diagnosis—and multiple other steps—largely ignored. This approach, ultimately, compromises the patient journey by cultivating an imbalanced and vulnerable precision testing ecosystem.
How can the suboptimal testing landscape within NSCLC—and within the oncology space as a whole—be reformed to ensure the achievement of optimal health outcomes among patients? The first step in fixing this suboptimal clinical diagnostic testing ecosystem is to rally stakeholders to assume shared responsibility and actively own the early diagnosis of NSCLC. Diaceutics believes this can be achieved through DXRX - The Diagnostic Network®, an integrated multisided platform network benefiting all stakeholders.
Click here to learn more about DXRX - The Diagnostic Network®, an end-to-end solution for the development and commercialization of Precision Medicine diagnostics, from biomarker discovery to in-market test availability.
Download the Pharma Precision Medicine Readiness Report 2020: NSCLC—An Axis for Change to discover Diaceutics’ solution to the inefficiencies of the patient diagnostic pathway.
- Diaceutics Data on File: Diaceutics’ proprietary Global Diagnostic Index (GDI) unpublished data, 2020.
- Knight SB, Crosbie PA, Balata H, Chudziak J, Hussell T, Dive C. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9):170070. doi: 10.1098/rsob.170070. Accessed September 17, 2020.
- Steffens CC, Elender C, Hutzschenreuter U, et al. Treatment and outcome of 432 patients with extensive-stage small cell lung cancer in first, second and third line - Results from the prospective German TLK cohort study. Lung Cancer. 2019;130:216-225. doi:10.1016/j.lungcan.2019.02.026. Accessed September 17, 2020.