Guosen Securities released a research report stating that since Q4 2025, the cancer genetic testing sector has witnessed continuous hotspots, frequent major international transactions, and domestic regulatory innovations. Leading US cancer genetic testing companies demonstrated strong stock performance in 2025, with Natera/Exact Sciences/Guardant/Grail achieving annual share price gains of 52%/78%/221%/464% respectively. While conventional businesses of international IVD leaders face growth challenges, the cancer genetic testing industry maintains high growth momentum. As applications for tumor MRD and multi-cancer early screening gradually mature, the addressable market size across various application scenarios is expected to expand several-fold. The firm recommends monitoring technological advancements and leading domestic and international companies in the cancer genetic testing industry.
The cancer genetic testing industry is currently in a rapid development phase, with continuous sector highlights, frequent major international deals, and domestic regulatory updates since Q4 2025. Leading US cancer genetic testing stocks showed strong performance in 2025, with Natera/Exact Sciences/Guardant/Grail posting annual gains of 52%/78%/221%/464% respectively. While traditional IVD leaders experience sluggish conventional business growth, the cancer genetic testing sector maintains robust vitality. Cancer genetic testing is expected to cover the entire precision oncology workflow, including early cancer screening, auxiliary diagnosis, companion diagnostics, efficacy monitoring, and recurrence prediction. With the gradual maturation of tumor MRD and multi-cancer early screening applications, the addressable market size across various scenarios is poised for multi-fold expansion.
Exact Sciences stands as a global leader in cancer screening and diagnostics, with its core business centered on the colorectal cancer screening product Cologuard. The company's 2025 revenue guidance ranges from $3.22 billion to $3.235 billion (representing 16.7-17.2% growth), with medium-term targets (2022-2027) including 15% revenue CAGR and exceeding 20% adjusted EBITDA margin by 2027. The US colorectal cancer screening addressable market corresponds to approximately 120 million average-risk individuals aged 45-85, with currently screened population around 70 million (colonoscopy comprising 77% and Cologuard 13%). Cologuard's future growth drivers can be broken down into: 1) rescreening, 2) Care Gap programs, 3) Cologuard Plus price increases, 4) younger demographic markets, and 5) robust commercial deployment. While the upgraded Plus version shows improved performance across metrics, the competition between stool-based and blood-based colorectal cancer screening tests continues.
Natera emerges as the leader in minimal residual disease (MRD) detection, with applications spanning multiple phases of cancer treatment. The clinical value lies in prognosis assessment and treatment decision guidance, while NGS-based ctDNA mutation detection represents the most common method for solid tumor MRD testing. Natera is a high-growth diagnostics leader centered on cell-free DNA (cfDNA) technology, achieving approximately $2.3 billion revenue in 2025. Its core MRD product Signatera surpassed 200,000 samples in Q3 2025 for the first time in a single quarter, marking 54% year-over-year growth and maintaining over 10% sequential growth. Its advantages include "ultra-low detection limits + unique technical approach + ultra-deep sequencing." Natera generates Category 1A evidence through high-quality large randomized controlled trials to drive guideline updates/inclusion, FDA approvals, and insurance coverage expansion. Signatera ranks among the most rigorously validated MRD detection products, with over 125 peer-reviewed publications covering more than 30 tumor types. Additionally, Natera expands its women's health and organ health businesses while entering the colorectal cancer early screening market.
Investment recommendations focus on monitoring technological progress and leading companies in the cancer genetic testing sector. The industry demonstrates vigorous development with frequent major international transactions and domestic regulatory innovations. Domestically, Amoy Diagnostics (300685.SZ), as a companion diagnostics leader, presented Phase III clinical results for its innovative lung cancer MRD product at 2025 ESMO Asia; BGI Group (300676.SZ) comprehensively deploys across cancer early screening, diagnosis, treatment, and recurrence monitoring scenarios; MIRXES-B (02629), as a leading RNA liquid biopsy company, launched China's first gastric cancer early screening product; Burning Rock's (BNR.US) OverLord achieved excellent results in MRD clinical trials across multiple cancers, while its OverSeek represents a globally leading multi-cancer early detection product; Geneplus's MRD product became the first in China to enter the innovative medical device special review program.
Risk factors include potential setbacks in R&D and clinical trials, product registration delays, underperformance in sales and profitability, volume-based procurement price reductions, regulatory and legal risks, and intensifying competition.
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