The patient journey is long, complex, and contains many important events that can be often overlooked, especially for precision medicine therapies. Using our extensive precision medicine expertise and real-world experience, Diaceutics have identified 6 key barriers to seamless testing on this intricate and difficult path.
At Diaceutics, we believe that every patient deserves the right test and the right treatment to positively benefit their disease outcome. we asked our precision medicine expert Dr. Helen Sadik to answer 12 commonly asked questions on these key barriers that hinder seamless integration into the treatment pathway for a precision medicine therapy.
Read on to discover some of the critical aspects you need to consider in your precision medicine strategy to drive success and maximum patient identification.
Barrier 1: Clinical utility
Q: How does awareness of the clinical utility of a biomarker impact its adoption in precision medicine?
If the clinical utility of a biomarker and its association with a precision medicine is not widely known, it may not be integrated into the patient's clinical journey. As a result healthcare providers (HCPs) might not order the test, deprioritize it, or not know how to act on the results, ultimately leading to a missed opportunity to identify eligible patients and provide them with the most appropriate therapy.
This missed opportunity can lead to slow adoption of recommended treatments and potential revenue loss due to patient leakage. Labs may also hesitate to include the biomarker in testing panels, particularly for newly established biomarkers, rare diseases, or cases where biomarker testing is not standard practice.
Q: What factors contribute to establishing clinical utility?
Some of the main factors contributing to establishing clinical utility include the biomarker being included in clinical guidelines and endorsed by Key Opinion Leaders (KOLs). Strong clinical validity and efficacy data, along with publications linking the biomarker/assay to improved benefit or survival on precision medicine therapy will provide crucial support in establishing clinical utility and enhancing awareness.
This comprehensive validation process ensures that the biomarker's relevance and effectiveness are recognized, contributing to its successful integration into clinical practice.
Barrier 2: Sample availability
Q: Why is sample availability a significant barrier, and how does it affect specific indications like NSCLC?
Sample availability is a significant barrier to biomarker testing. When samples are not available due to factors like infeasible biopsies or uncommon diagnostic practices (as seen in cases like Renal Cell Carcinoma), biomarker testing cannot proceed. Using the wrong biopsy type, such as archival vs. fresh or tissue vs. liquid (as observed in breast cancer), can lead to false results.
In the context of Non-Small Cell Lung Cancer (NSCLC), where biopsies are typically small and hard to obtain, the challenge intensifies. The concern lies in compromised accuracy and potential deprioritization of biomarkers, especially novel ones. NSCLC involves at least 10 established biomarkers that should be tested, making sample availability crucial.
These challenges contribute to reduced testing rates and delayed patient identification for specific treatments.
Q: Which tissue sparing methodologies can help in addressing sample availability concerns?
In addition to promoting best practices in biopsy handling and utilization, the choice of testing methodology plays a crucial role in overcoming the challenges associated with sample availability.
Next-generation sequencing (NGS) is a more cost-effective and efficient option, particularly when multiple biomarkers need testing to support comprehensive treatment decision-making. It allows for simultaneous testing, sparing tissue and reducing wastage. This approach ensures materials remain available for future testing needs.
Liquid Biopsy (LBx) is a less invasive alternative with minimal pain and risk. It enables tumor molecular profiling, therapy response monitoring, and the detection of acquired resistance. LBx becomes particularly essential when tissue biopsies are not feasible or when the tissue is limited.
By adopting these tissue-sparing methodologies, you not only address sample availability concerns but also enhance overall efficiency and effectiveness of biomarker testing processes.
Barrier 3: Testing availability
Q: How does the availability of testing impact adoption?
The availability of testing significantly impacts its adoption, and there are several factors that contribute to this:
The seamless availability of a test within clinical labs is crucial for testing rates and turnaround time, directly affecting Rx uptake. Tests must be accessible in labs preferred by (HCPs to ensure quick adoption and optimal Rx uptake.
The methodology and approach used for testing are equally vital. Tests should be offered in an adequate and validated approach to cover the alteration(s) of interest. For instance, a PCR assay designed for EGFR may only detect up to 70% of all exon 20 insertions, leading to potential false negatives and patient misidentification.
Equally important is understanding how a test is advertised within test menus and requisition forms, including indications and biomarkers covered within panels, and what details are provided within reports. For example, does a neuromuscular panel include all relevant and emerging biomarkers to support the differential diagnosis of a rare disease?
Unclear or complicated test request/reporting can impact accurate test ordering, interpretation of results, and eventually therapeutic decisions or clinical trial enrolment. Clarity and simplicity in these aspects are essential for facilitating accurate adoption and usage of the testing methodologies.
Q: Why is understanding the preferred methodologies/platforms, assay regulatory status and sample type crucial for pharma?
This will support pharma to implement the most effective diagnostic strategy by identifying high-priority labs, understanding key stakeholders, and making informed companion diagnostics (CDx) partnership decisions. It will also inform lab segmentation, engagement and support strategies to reduce patient leakage if suboptimal testing behavior in key labs is identified.
Barrier 4: Test quality
Q: How do false negatives and positives impact patient outcomes, and what factors should be considered to ensure test accuracy and reliability?
False negatives and positives in testing can significantly impact patient outcomes. Ensuring test accuracy and reliability is crucial for the success of a precision medicine. Low-quality testing leads to missed, incorrect, or sub-optimal treatment decisions, potentially causing adverse effects. Moreover, such incidents can erode confidence in the utility of precision medicine and prescription practices.
To enhance accuracy and reliability it's essential to consider various factors:
- Lab Accreditation: Consider accredited labs adhering to standards.
- External Quality Assurance (EQA): Active lab participation in EQA programs matters.
- CDx vs. LDTs: Distinguish between these for reliable testing.
These considerations collectively contribute to the accurate identification of patients, minimizing the risk of false results and optimizing patient outcomes within the realm of precision medicine.
Q: Why is EQA participation especially important for labs using LDTs?
Participation in EQA is crucial for labs utilizing LDTs, and several considerations highlight its importance:
The choice between CDx and LDTs holds significance. CDx offers validated results with manufacturer assurance, ensuring quality-assured results with appropriate control materials and guidelines for interpretation. In contrast, LDTs although potentially cheaper and more flexible, are subject to less regulation. Labs using LDTs need to conduct internal validation, leading to increased variability in quality between labs.
To mitigate this variability and furnish objective evidence of testing quality, labs should actively participate in external quality assessments for each clinically relevant biomarker or methodology. EQA participation is instrumental in monitoring the accuracy of reporting, providing a standardized benchmark for comparison.
The importance of EQA participation becomes especially pronounced when labs are testing with LDTs for biomarkers or alterations that are challenging to sequence, or when employing new technologies. This ensures that the quality of testing remains consistent and up to the mark, contributing to reliable and accurate outcomes in the realm of laboratory developed tests.
Barrier 5: Test turnaround time
Q: Why is the time it takes for a test to be completed and reported crucial in precision medicine?
The time it takes for a test to be completed and reported is crucial in precision medicine. Delays in receiving results, beyond the optimal treatment decision-making window, can have significant consequences. Such delays may discourage HCPs from requesting testing, or even push them towards non-personalized treatment options. This, in turn, hinders the uptake of precision medicine therapies in situations where it could be of clear benefit.
This challenge is particularly notable in certain types of testing, such as NGS testing, diagnostic testing in rare or inherited diseases, or prognostic testing in some cancers. For instance, NGS often has a longer Turnaround Time (TAT) compared to other methods like Immunohistochemistry (IHC). In situations where HCPs receive IHC results before NGS results, there might be a tendency to act on the available information, potentially leading to poorly informed therapy decisions that lack the insights provided by complete molecular testing. Timely completion and reporting of tests are, therefore, crucial for ensuring that precision medicine decisions are based on comprehensive and accurate information, optimizing patient outcomes.
Q: what are common factors causing delays and long lab TAT?
Multiple factors can impact laboratory TAT end hence test adoption, including: sample logistics and handling, methodology (e.g NGS vs PCR vs IHC, somatic vs germline, tissue vs liquid), sample batching, location of testing (in-house vs send-out) and availability of expertise
For example, suboptimal analyte quality, repeat testing, or new sample requests can result from shipping and/or storage delays, which lead to extended TAT.
Barrier 6: Test Reimbursement
Q: How does reimbursement influence test adoption, and what challenges arise when reimbursement is sub-optimal?
Reimbursement significantly influences the adoption of tests, and when reimbursement falls short, several challenges emerge. High test costs coupled with insufficient reimbursement are widely recognized as formidable barriers to testing across various markets, with these financial considerations not only impacting testing behavior but also influencing lab availability and test adoption.
In the face of sub-optimal reimbursement, labs may make strategic choices, such as opting not to offer certain tests or employing cost-saving practices. This could involve using less expensive LDTs instead of validated but more costly CDx kits. Labs may also stop offering fully comprehensive tests or batching samples to reduce costs, potentially extending TAT and negatively impacting treatment decisions.
Physicians, too, respond to insufficient reimbursement by selectively prescribing tests based on cost-effectiveness or necessity. This selective approach can result in sub-optimal testing practices, diminishing the overall effectiveness of patient identification.
Addressing these challenges and ensuring more equitable reimbursement practices is crucial for fostering a testing environment that is both accessible and effective.
Q: How do reimbursement systems varying between markets contribute to healthcare disparities?
Differences in sufficient reimbursement to cover test costs are striking. Some markets require substantial patient co-payments, while others rely on sponsorships to drive test adoption, particularly when testing is constrained by the limited annual budget of hospitals or labs.
In markets or regions with advanced In-Vitro Diagnostic reimbursement systems, labs are more likely to swiftly and comprehensively adopt testing for novel biomarkers or technologies, such as NGS. HCPs in these regions tend to order testing for all their patients, fostering a more inclusive approach to healthcare.
Conversely, in markets or regions with suboptimal reimbursement, accessibility and availability of testing are reduced. This leads to a scenario where only patients who can afford the test have access to it, resulting in an increase in socio-economic healthcare disparities. The disparities in reimbursement systems contribute significantly to uneven healthcare access and outcomes, emphasizing the need for a more equitable approach to testing accessibility.
The integration of precision medicine faces multifaceted challenges. Overcoming these barriers requires collaboration among physicians, labs, and pharma, along with a deep understanding of the specific nuances within each barrier.
Diaceutics Market Landscape provides a qualitative diagnostic market analysis of the current testing landscape for a specific disease, providing insights and recommendations to overcome these challenges and optimize the commercialization strategy for your precision medicine therapy.
Our team of precision medicine experts have enabled our customers across leading pharma and biotech organizations to overcome barriers to patient identification in over 160 successful Landscapes globally, positioning us as the ideal partner for your team.
Discover more about Diaceutics Market Landscape here: https://lp.diaceutics.com/market-landscape