Cancer diagnostics are entering a pivotal era, with advances in genomics, AI, and non-invasive testing reshaping how and when we detect disease. From liquid biopsies to multi-cancer early detection assays, new technologies are pushing the boundaries of what’s possible in early diagnosis and personalized care. But scientific breakthroughs alone aren’t enough. To successfully bring a novel oncology diagnostic to market, sponsors must navigate a complex web of regulatory pathways, clinical trial design, and a specialized go-to-market strategy.

The Rise of Early Detection: What Market Leaders Get Right

The diagnostic landscape is evolving toward more accessible and patient-friendly approaches, with companies like Exact Sciences leading the way through at-home, stool-based screening that has significantly expanded access to colorectal cancer detection. Meanwhile, companies like GRAIL are advancing blood-based multi-cancer early detection through clinical laboratory testing, demonstrating how different focused approaches can expand screening reach.

Exact Sciences has set a high bar in the field with Cologuard, its FDA-approved, at-home stool DNA test for colorectal cancer screening, demonstrating 92% sensitivity for colorectal cancer and 87% specificity in a large, prospective trial. Similarly, clinical studies on GRAIL's Galleri test have shown a 99.5 % specificity (with 0.5 % false-positive rate) and around 51.5 % overall sensitivity, with much higher detection rates for certain cancer types, including colorectal, pancreatic, ovarian, esophageal, liver, and head & neck cancers

These complementary approaches underscore key advantages of next-generation cancer diagnostics: improved diagnostic accuracy through novel biomarker strategies, enhanced clinical decision-making driven by more precise performance metrics, and the potential for cost-effective implementation across diverse healthcare settings. While large-scale health economic studies are still limited, the non-invasive nature and scalability of technologies like liquid biopsy suggest opportunities for broader access and efficiency in cancer screening programs.

Targeting the Right Patient Population

Your choice of target population can make or break your diagnostic's commercial success. The most successful approaches focus on well-defined, high-risk cohorts where clinical utility can be clearly demonstrated. For trials involving widely screened cancers like colorectal, breast, prostate, or lung cancer, researchers have access to established screening pathways and larger potential participant pools. These studies often benefit from decentralized or hybrid approaches.

High-risk population targeting should prioritize patients with strong family histories of specific cancers, known genetic predispositions, occupational exposures, or previous cancer diagnoses requiring surveillance. GRAIL is currently investigating this in the INFORM study, a prospective trial evaluating the Galleri test specifically in hereditary high-risk populations, such as individuals with pathogenic germline mutations, with the aim of identifying which cancers and how frequently they’re detected in this group.

Demographics and disparities matter. Patient groups facing higher cancer burden—such as individuals with obesity, Black or Hispanic communities, or underserved rural populations- represent both a clinical need and an opportunity for innovation. Carefully selecting these cohorts can also strengthen future reimbursement arguments by demonstrating utility in populations with significant unmet need.

Ultimately, strategic population selection supports the broader go-to-market strategy—helping sponsors position their test not just for approval but also for uptake by clinicians, guideline committees, and payers.

Mastering Recruitment and Retention in Long-Duration Studies

Cancer diagnostic trials often require large patient cohorts and long-term follow-up to capture meaningful outcomes, making recruitment a significant operational hurdle. Traditional site-based models alone are rarely sufficient at this scale. To meet these demands, trial teams must go beyond traditional site-based recruitment. Decentralized strategies and direct-to-patient outreach are increasingly essential. This includes digital advertising, patient registry partnerships, social media campaigns, and collaborations with advocacy groups to expand reach, especially to high-risk or underrepresented populations.

Retention starts with relationship-building. Multi-channel communication (phone, text, email, mail) tailored to individual preferences helps keep participants engaged. Flexibility in scheduling, such as offering weekend or evening appointments, and tiered compensation models tied to participation duration further support long-term involvement.

Managing follow-up at scale requires infrastructure. This includes centralized tracking systems, well-trained staff skilled in participant relationship management, and integration with electronic health record (EHR) systems where appropriate. The goal is to maintain contact without overburdening participants or compromising privacy.

Ultimately, trials that prioritize trust, accessibility, and open communication are far more likely to sustain long-term participant engagement and produce reliable, high-quality data.

Build Trust Through Informed Consent

Cancer diagnostic studies require particularly thorough informed consent processes that clearly communicate test performance limitations and potential consequences.

In cancer diagnostic studies, participants are often blinded to the results of the investigational test, particularly when the test is not yet clinically validated. However, investigational diagnostics may sometimes detect cancers that standard-of-care (SOC) testing misses. This creates ethical and operational challenges for study teams. Sponsors and investigators must develop a clear plan for handling unexpected cancer signal detections, especially in cases where SOC would not typically prompt further evaluation.

Incidental findings management requires established protocols addressing which findings will be reported, how results will be communicated, available support resources, and patients' rights to refuse information. Clear policies must be developed before study initiation, ideally with expert committee evaluation of clinical significance and actionability.

Regulatory Strategy: Early Detection Diagnostics vs Companion Diagnostics

Early cancer detection diagnostics face a distinct and complex regulatory pathway. Unlike companion diagnostics (CDx), which are developed in tandem with a specific cancer therapy and are intended to identify patients who are most likely to benefit from or be harmed by that treatment, early detection diagnostics aim to identify cancer in asymptomatic individuals, often without an immediate therapeutic follow-up. This fundamental difference significantly shapes how regulators assess each type of test.

Companion diagnostics are typically classified as high-risk (Class III) devices and generally require premarket approval (PMA) due to their direct impact on treatment decisions. The FDA evaluates CDx based on how accurately they measure a biomarker linked to drug response, and their ability to stratify patients for a known clinical intervention. In contrast, early detection tests must address broader population-level concerns, including:

Choosing the Right Regulatory Pathway

The FDA offers several pathways for in vitro diagnostics (IVDs), depending on the test’s risk level and novelty:

• 510(k): For moderate-risk devices with a valid predicate (rare for novel cancer detection diagnostics).
• De Novo: For novel, low-to-moderate risk devices without a predicate.
• PMA: For high-risk or breakthrough diagnostics, often the default for early detection products due to their significant impact on clinical decision-making.

What Regulators Want to See

To succeed, sponsors must generate robust evidence across several domains:

• Analytical validation: Accuracy, precision, reproducibility, and limit of detection across specimen types (often blood, plasma, or other biospecimens).
• Clinical validation: Demonstrated sensitivity (especially for early-stage cancers) and specificity (to minimize false positives), ideally using case-control or prospective cohort designs.
• Clinical utility: Evidence that test results lead to actionable clinical decisions or improved outcomes—this is often the hardest bar to clear in early detection.

The Reimbursement Challenge: Why Early Payer Engagement Matters

For next-generation cancer diagnostics, especially those targeting early detection or using novel technologies like liquid biopsy or AI, securing reimbursement remains one of the most formidable barriers to market access. Recent cases like Interpace Diagnostics discontinuing their DNA-based diagnostic molecular test for pancreatic cyst progression to cancer, due to Medicare reimbursement loss illustrate the stakes: without payer buy-in, even clinically validated tests can fail commercially.

Payers expect more than strong sensitivity and specificity. They require robust clinical utility data, proof that using your test improves patient outcomes or reduces downstream costs. Health economic models must show how your diagnostic compares to existing standards of care. And increasingly, real-world performance data is valued over tightly controlled trial results, especially for tests used in broad screening populations.

Engaging payers early is critical. Conversations during the development phase can help clarify evidence expectations, reduce uncertainty, and shape your trial endpoints. Formal interactions, like pre-submission meetings or advisory boards, should follow, culminating in a carefully crafted coverage dossier aligned with payer priorities.

Reimbursement strategies should also consider:

• Whether to pursue national or regional coverage
• Starting with tiered or population-specific coverage for high-risk groups
• Exploring value-based arrangements that tie reimbursement to real-world test performance

Conclusion: From Innovation to Impact

Successfully launching a cancer diagnostic isn’t just about developing breakthrough science. It’s about building a strategy that connects scientific innovation with clinical adoption and real-world impact. The most effective companies understand that regulatory, clinical, and commercial strategies can’t operate in silos. Instead, they must be tightly integrated from the earliest stages of development.

This means designing studies that not only demonstrate analytical and clinical validity but also anticipate what regulators, payers, and providers will need to see to support approval, reimbursement, and adoption. It means choosing patient populations that represent real unmet need, not just for trial feasibility, but for long-term clinical relevance and health equity. And it also means investing in the kinds of evidence, such as real-world performance, health economic modeling, and usability, that will resonate with stakeholders beyond the FDA.

The future of diagnostics is fast, precise, and patient-focused. At Lindus Health, we partner with you throughout your oncology diagnostics journey from start to finish. Ready to accelerate your innovation to market? Get started with our team today.