Personalis and the Future of MRD Testing in Early-Stage Lung Cancer

The rise of molecular residual disease (MRD) testing in oncology represents a paradigm shift in cancer care, offering clinicians a tool to detect microscopic traces of disease long before traditional imaging can. For investors, the intersection of clinical innovation and commercial scalability in this space is particularly compelling. Personalis, a leader in tumor-informed liquid biopsy technologies, is emerging as a key player in this transformation, particularly in early-stage lung cancer. By analyzing the company’s recent clinical milestones, strategic partnerships, and the evolving reimbursement landscape, it becomes clear that Personalis is well-positioned to capitalize on the growing demand for precision oncology solutions.

Clinical Catalysts: NeoADAURA and Tumor-Informed MRD Testing

Personalis’ NeXT Personal® test has demonstrated groundbreaking performance in a phase 3 trial, NeoADAURA, conducted in collaboration with AstraZeneca. The trial focused on patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer (NSCLC) receiving neoadjuvant therapy. According to data published in September 2025, the test achieved a sensitivity of 95% in detecting circulating tumor DNA (ctDNA), outperforming existing methods [1]. This level of precision is critical for identifying patients at high risk of recurrence, enabling earlier intervention and potentially improving survival rates.

The trial also revealed that pre-surgical MRD negativity and clearance were strongly correlated with major pathological response (MPR), a key indicator of treatment efficacy [1]. These findings underscore the test’s dual utility: not only as a prognostic tool but also as a dynamic monitor of therapeutic response. For investors, the clinical validation of MRD testing in lung cancer—a disease responsible for over 1.8 million deaths annually—represents a significant unmet need and a vast market opportunity.

Strategic Expansion: Tempus AI and Multi-Cancer Access

Personalis’ collaboration with Tempus AI, extended through 2029, further amplifies its commercial potential. By expanding MRD testing to four major cancer types—breast, lung, colorectal, and solid tumor immunotherapy monitoring—the partnership leverages Tempus’ extensive data infrastructure to accelerate patient access [3]. This multi-cancer approach aligns with the broader industry trend of diversifying MRD applications beyond hematological malignancies, where the technology has already gained traction.

The inclusion of colorectal cancer (CRC) is particularly noteworthy. CRC is the third most common cancer globally, and early recurrence detection remains a challenge. By integrating tumor-informed MRD testing into CRC care, Personalis can tap into a market segment with high unmet demand while reinforcing its position as a leader in solid tumor diagnostics.

Commercial Catalysts: Market Growth and Reimbursement Progress

The MRD testing market is poised for explosive growth, driven by advancements in next-generation sequencing (NGS) and the increasing adoption of liquid biopsy technologies. According to a report by Grand View Research, the global MRD testing market is projected to expand from $2.5 billion in 2025 to $5.64 billion by 2032, with a compound annual growth rate (CAGR) of 11.8% [2]. The U.S. market alone is expected to grow at a CAGR of 9.38%, reaching $986.54 million by 2033 [5].

Reimbursement remains a critical enabler for widespread adoption. In 2025, Medicare expanded coverage to include Natera’s Signatera test, a tumor-informed MRD assay, under LCD L38779 [5]. This precedent has emboldened Personalis to pursue Medicare reimbursement for its NeXT Personal test in breast and lung cancer. The company submitted data from a breast cancer study with the Royal Marsden Hospital in 2025, positioning itself to secure coverage for its flagship product [4]. If successful, reimbursement would remove a major barrier to adoption, particularly in the U.S., where out-of-pocket costs for advanced diagnostics can deter patient uptake.

Navigating the Reimbursement Maze

Despite progress, reimbursement for MRD testing in solid tumors remains complex. The Centers for Medicare & Medicaid Services (CMS) imposes strict guidelines, including a limit of one test per cancer diagnosis unless genetic changes are detected [1]. Labs must also navigate prior authorization requirements and inconsistent payor policies, which can delay patient access. For Personalis, the challenge lies in demonstrating the clinical necessity of serial testing to monitor disease progression—a hurdle that requires robust real-world evidence and strategic payor negotiations [2].

Long-Term Value: Precision Oncology’s Next Frontier

Personalis’ “Win in MRD” strategy—targeting reimbursement for at least two indications in 2025—highlights its focus on sustainable growth [4]. The company’s clinical data, strategic partnerships, and proactive engagement with payors collectively position it to capture a significant share of the MRD testing market. For investors, the key metrics to watch include the pace of reimbursement approvals, adoption rates in key cancer types, and the ability to scale operations without compromising margins.

The broader implications for precision oncology are equally profound. As MRD testing becomes a standard of care, it will drive demand for personalized treatment pathways, fueling innovation in targeted therapies and immunotherapies. Personalis’ role in this ecosystem extends beyond diagnostics; it is a catalyst for redefining how cancer is managed, from early detection to recurrence monitoring.

Conclusion

Personalis stands at the intersection of clinical innovation and commercial scalability in the MRD testing space. With a robust pipeline of clinical data, strategic collaborations, and a clear path to reimbursement, the company is well-positioned to capitalize on the $5.64 billion market opportunity by 2032. For investors, the long-term value lies not only in the company’s ability to monetize its technology but also in its potential to transform cancer care through precision medicine.

**Source:[1] Personalis Announces New Data from a Landmark Neoadjuvant Lung Cancer Trial Showing Superiority of Ultra-Sensitive Tumor-Informed MRD Testing [https://www.businesswire.com/news/home/20250903630415/en/Personalis-Announces-New-Data-from-a-Landmark-Neoadjuvant-Lung-Cancer-Trial-Showing-Superiority-of-Ultra-Sensitive-Tumor-Informed-MRD-Testing][2] Minimal Residual Disease Testing Market Size Report, 2030 [https://www.grandviewresearch.com/industry-analysis/minimal-residual-disease-testing-market-report][3] Personalis Expands Tempus Strategic Collaboration to Bring Ultra-Sensitive MRD Testing to Four Major Cancer Types [https://investors.personalis.com/news-releases/news-release-details/personalis-expands-tempus-strategic-collaboration-bring-ultra][4] Personalis Q1 Revenues up 6 Percent as Firm Anticipates First MRD Reimbursement [https://www.genomeweb.com/molecular-diagnostics/personalis-q1-revenues-6-percent-firm-anticipates-first-mrd-reimbursement][5] U.S. Minimal Residual Disease Testing Market Report, 2033 [https://www.grandviewresearch.com/industry-analysis/us-minimal-residual-disease-testing-market-report]