These days Precision Medicine is characterized by miraculous discovery and progress in terms of biomarkers and targeted treatment. But the practical application of these advances into the lives of patients continues to be thwarted by a broken diagnostic testing ecosystem unequipped to optimally accommodate such progress. From Day 1 of drug launch, the commercial readiness of the diagnostic testing market is invariably absent. In fact, it usually takes about 36 months after a drug is launched for enough supportive lab coverage to exist.1 Consequently, patients are missing treatment opportunities every day as they leak out of the system due to diagnostic testing inefficiencies. And challenges remain—even in those labs that have already adopted relevant tests. In fact, Diaceutics recently discovered that patient leakage adds up to as many as 156,000 missed patients each year in the United States and Europe because of reimbursement, quality, or sample management issues.2
The testing ecosystem will respond with adequate pre-launch planning and investment
In spite of multiple hurdles, the testing ecosystem will respond “when adequate pre-launch planning and investment are proactively pursued,” according to Peter Keeling, CEO of Diaceutics, in the recently published Pharma Precision Medicine Readiness Report 2019.1 Such strategic preparation, writes Keeling, “will help to ensure not only that early prescribers know how and where to request testing, and understand how to interpret the results, but also that their trusted pathology or hematology lab has had at least 6 months prior experience running and optimizing the test on one or more lab platforms in an efficient, cost-sparing manner. Investing in adequate pre-planning and providing hands-on assistance to laboratories at the frontline of clinical demand in a commercial system of interventions can help ensure no patient is left behind because of suboptimal testing.”1
So, what is the problem exactly?
Although broken, the diagnostic testing ecosystem is clearly fixable. So, what’s the problem? Well, Pharma companies are generally looking in the wrong direction for solutions, Keeling reveals.1 Specifically, Pharma has historically looked to the diagnostic technology supply industry to fix the “imperfect testing ecosystem” based on the following assumptions1:
- It makes sense to use the right test in the clinical trial setting, and
- The Diagnostic company that developed the companion diagnostic (CDx), which follows the targeted therapy all the way through the regulatory process to market, stands to theoretically benefit from the demand for that test being linked to a new treatment.
Monopolization of the diagnostic supply chain
The regulators, particularly the FDA, in turn, feed into this process by encouraging pre-launch diagnostic/therapy company collaborations to ensure that at least one approved test is available to support clinical and laboratory testing. But so much reliance on the diagnostic supply industry has turned out to be a flawed strategy and, instead, has hindered the progress by encouraging the monopolization of the diagnostic supply chain and further fragmenting the Pharma-Laboratory relationship. As of 2019, this has resulted in the current testing ecosystem in which only 6 Diagnostic companies manage the oncology revenues of 54 therapies—“with just over half of those therapies depending on a single Pharma competitor, Roche, and its family of diagnostic enterprises,” writes Keeling.1
Labs are beset by multiple hurdles
On the other side of the coin is the Laboratory industry, which plays a critical role in serving better testing for patients. But in this testing ecosystem monopolized by a few diagnostic suppliers, Labs are beset by multiple hurdles—economic, technological, and regulatory, among others—that make it impossible for them to run the tests that are approved alongside newly approved targeted therapies, ultimately inhibiting test diffusion and broad availability. For example, Labs often simply can’t afford to and/or are not equipped with the right technology or their pathologists have not been trained to run or interpret the tests. Instead, many labs develop their own versions of CDx tests, known as “laboratory-developed tests” (LDTs). The use of LDTs is common in oncology. For example, almost 75% of all (oncology) testing in the US (and more in the rest of the world) is provided via LDTs in lieu of commercially developed, FDA-approved in vitro diagnostic (IVD) test kits.3 This statistic is especially impressive when one considers that, according to the Diaceutics Global Diagnostics Index database, approximately 2850 labs in the top 20 pharma markets are conducting 60% of patient testing in cancer alone.3 Indeed, Labs play a critical role in serving better testing for patients. So, with this Lab network/infrastructure in place to streamline diagnostic testing, why does the ecosystem remain broken?
Pharma’s confusion over where and with whom to partner for diagnostic development
The ongoing regulatory debate over LDTs, in the US at least, and their suitability to support test-dependent treatments,4 have “clearly colored” the “partnering of Pharma companies, whose regulatory departments seek to reduce any delay in therapy approval by the FDA and whose compliance departments remain uncertain how to manage the risk of recommending a non–previously FDA-approved test kit,” Keeling reveals.1 This situation leaves Pharma confused about which partners to select and how that process should ideally work. As Keeling explains, “Understandably, it is perceived within Pharma as difficult to partner with a fragmented distributor base for which the preferred test is one that is technically ‘off-label’ and, conversely, easier to partner with a small core of technology suppliers who are funded to support an approved kit. We accept and support that this preference for seeming convenience among Pharma demands an evidence-based policy discussion with regulators—and have advocated for global harmonization.”1 (Thought leaders at Diaceutics put this advocacy in action earlier in 2019 by authoring an article entitled “Diagnostics Reform and Harmonization of Clinical Laboratory Testing,”5 which was published in the Journal of Molecular Diagnostics.)
Keeling suggests that the bigger question goes beyond that of partnering models and, instead, asks “What is the right long-term commercialization model for Precision Medicine and the patients it seeks to transform by ensuring they are tested with the right test at the right time?”1 The centralized lab model, in which all samples are sent to one regulated lab, is not the answer. Although this strategy would avoid the need to collaborate with a fragmented lab industry and could start early patient testing in the US, it “has failed to work outside the US. And it is not the right model to democratize precision testing in the future,” writes Keeling.1
Keeling points out that a “tsunami” of Precision Medicine clinical trials is currently underway, underpinned by multiple assets in late-stage development.1 Looking to the diagnostic technology supply industry to ensure the optimal diagnostic diffusion of tests post-launch has proven futile. Instead, Keeling advises that better solutions are needed “if we are to meet the demand for better testing that will follow the 40 to 50 new drug/test launches expected annually during the next 5 years (based on our analysis of clinical trials completing in 2019 to 2025).”1 Read the Diaceutics’ Pharma Precision Medicine Readiness Report 2019 today to find out what these solutions are.
Click here to learn more about Diaceutics’ insights and solutions regarding the broken diagnostic testing ecosystem.
- Pharma Precision Medicine Readiness Report 2019. Diaceutics website. https://www.diaceutics.com/pmreport19/. Published October 2019. Accessed December 12, 2019.
- Diaceutics finds 156K cancer patients could miss out on life-saving drugs every year in US and Europe. Diaceutics website. https://www.diaceutics.com/diaceutics-finds-156k-cancer-patients-could-miss-out-on-life-saving-drugs-every-year-in-us-and-europe/. Published May 18, 2017. Accessed December 12, 2019.
- Diaceutics Data on File: Diaceutics Global Diagnostics Index, unpublished data, 2019.
- Genzen JR. Regulation of laboratory-developed tests. Am J Clin Pathol. 2019;152(2):122-131. https://doi.org/10.1093/ajcp/aqz096.
- Schreier J, Feeney R, Keeling P. Diagnostics reform and harmonization of clinical laboratory testing. J Mol Diagn. 2019 May 8. Sep;21(5):737-745. doi: 1016/j.jmoldx.2019.04.002.