The Rise of Digestive Disease Diagnostics

The death of actor Chadwick Boseman from colon cancer in 2020 brought widespread attention to the alarming rise of this disease among people under age 50. Digestive health–related conditions now represent one of the fastest-growing chronic health burdens, outpacing many other non-communicable diseases in prevalence. Digestive disorders account for roughly one in every three US medical insurance claims for chronic disease.

Beyond colon cancer, conditions such as GERD (gastroesophageal reflux disease), IBS (irritable bowel syndrome), NAFLD (nonalcoholic fatty liver disease), chronic constipation, and viral hepatitis C have contributed significantly to the overall increase in digestive disorders over the past two decades. Since the COVID-19 pandemic, studies have also reported a rise in GI-related symptoms among survivors, particularly those who experienced severe or long-term illness.

Digestive disease incidence is expected to rise with global public health trends such as the aging population and increased rates of obesity and metabolic health disorders.

In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) are expanding rapidly to support drug-diagnostic model therapies for colorectal cancer, GERD, IBD (inflammatory bowel disease), and other chronic GI conditions. The first wave of digestive-system CDx approvals focused on hereditary and gene-driven diseases. In the past three years, companies such as Agilent, Qiagen, Roche, and Foundation Medicine have received clearances or approvals for tests supporting treatments of gastrointestinal stromal tumors (GIST) and gastric or gastroesophageal junction (GEJ) cancers.

Biomarker Complexity, Screening Simplicity

ClinicalTrials.gov and other registries show a marked increase in interventional studies beyond oncology, addressing GERD, IBD, IBS, and chronic constipation. Over the past five years, next-generation sequencing (NGS) and AI-powered bioinformatics have become prevalent in digestive-disease diagnostics, with PCR and NGS methods now dominating clinical trial protocols.

Among the most promising technologies are EsoCheck and EsoGuard from Lucid Diagnostics—swallowable capsules that screen for Barrett’s Esophagus (BE), a precancerous condition that increases the risk of esophageal cancer. These devices enable detection within minutes in an office setting, without sedation or endoscopy, allowing non-invasive, early identification of one of the fastest growing and most lethal forms of cancers.

Challenges in Research and Regulation

Product development for digestive-disease diagnostics still lags other oncology-related fields. The regulatory environment remains fragmented and complex, particularly where scientific understanding—such as in the gut microbiome—remains limited. The traditional “one-drug/one-test” approval model adds cost and uncertainty, especially when multiple assays target the same biomarker. For instance, current FDA policy requires each drug with a predictive biomarker, such as KRAS, NRAS, or BRAF, in metastatic colorectal cancer (mCRC), to have its own approved CDx test. As a result, the drugs cetuximab (Erbitux) and panitumumab (Vectibix) each require distinct assays, even though both detect the same KRAS exon 2–4 variants.

From a technical perspective, every specimen type used in validation must undergo rigorous studies for accuracy, reproducibility, and stability—an expensive, resource-intensive process. Access to high-quality GI tissue samples is often constrained by challenges in informed consent, biobanking logistics, and sample degradation, which can undermine the statistical power of clinical trials. For example, biobank-dependent colorectal and rectal cancer studies frequently face these hurdles, limiting data quality and reproducibility.

Another barrier is clinician adoption. Even when tests are approved, many gastroenterologists and primary-care providers lack training or decision-support tools to incorporate molecular diagnostics into standard care.

The IVD and Companion Diagnostics market for digestive conditions will continue to grow despite challenges in the regulatory process, research operations, and provider adoption.

Demand Tailwinds and Future Outlook

Despite these obstacles, the GI diagnostics sector is poised for continued growth, driven by population aging, the rising prevalence of digestive disorders, and payer pressure for non-invasive testing solutions like EsoGuard. The success of Cologuard from Exact Sciences demonstrates the potential for durable, large-scale adoption once a diagnostic proves clinical and commercial value.

Developers and clinical research organizations who can navigate regulatory complexity and secure validation advantages stand to build a strong competitive moat in a resilient and expanding segment of the medical-device industry.

Landrich Group has extensive experience developing strategies for designing and conducting clinical trials and preparing regulatory submissions to obtain market authorizations for breakthrough digestive health diagnostic products.  Let’s connect if you seek further discussion in this space.