Median Technologies Submits 510(k) Application for eyonis® LCS Lung Cancer Screening SaMD

Analysis reveals significant industry trends and economic implications

Release Date

2025-05-14

Category

Drug Approval Event

Reference

Source

Breakthrough Clinical Results

Median Technologies announced the submission of a 510(k) application to the FDA for eyonis® LCS, an AI-powered software as a medical device (SaMD) for computer-aided detection and diagnosis (CADe/CADx) in lung cancer screening. The submission is based on positive data from two pivotal studies, REALITY and RELIVE, which met their primary endpoints, demonstrating robust diagnostic performance and improved radiologist accuracy. The FDA clearance is expected in Q3 2025, and eyonis® LCS targets a significant market opportunity in the US and globally, addressing the high costs associated with advanced-stage lung cancer treatment. The device aims to improve early detection and characterization of lung nodules, leading to better patient outcomes.

Key Highlights

  • FDA 510(k) application submitted for eyonis® LCS.
  • Positive data from REALITY and RELIVE studies supporting the application.
  • Expected FDA clearance in Q3 2025.
  • Significant market opportunity in lung cancer screening.

Incidence and Prevalence

Lung Cancer Incidence and Prevalence: Latest Global Estimates

The most recent data from GLOBOCAN 2022 provides the latest estimates on the global incidence and mortality of lung cancer. GLOBOCAN 2022 is considered the most comprehensive resource for global cancer statistics. Here's a summary of the key findings:

Incidence:

  • In 2022, approximately 2.48 million new cases of lung cancer were diagnosed globally.
  • This makes lung cancer the most frequently diagnosed cancer worldwide.
  • The age-standardized incidence rate (ASIR) was 23.6 per 100,000 population.
  • There were significant differences in incidence rates between sexes, with higher rates observed in males (1.57 million new cases) compared to females (0.91 million new cases).
  • Incidence rates also varied considerably across different regions of the world, reflecting varying patterns of tobacco smoking, exposure to environmental risk factors, and genetics.

Mortality:

  • In 2022, lung cancer was responsible for an estimated 1.8 million deaths worldwide.
  • This makes lung cancer the leading cause of cancer-related death globally.
  • The age-standardized mortality rate (ASMR) was 16.8 per 100,000 population.
  • Similar to incidence, mortality rates were higher in males (1.23 million deaths) than in females (0.67 million deaths).
  • Mortality rates also showed substantial geographic variation.

Prevalence:

While GLOBOCAN 2022 provides incidence and mortality data, it doesn't directly report on prevalence. Prevalence refers to the number of people living with lung cancer at a given point in time. Prevalence is influenced by both incidence and survival rates. Given the relatively poor survival rates for lung cancer, prevalence is generally lower than incidence. Several studies have attempted to model lung cancer prevalence, but these estimates vary depending on the methodology and data sources used. For example, one study estimated the global 5-year prevalence of all cancers combined to be 28.8 million in 2008, with a substantial portion concentrated in high-HDI countries. However, this figure includes all cancer types, not just lung cancer.

Projections:

  • Projections from GLOBOCAN 2020 suggest that if incidence and mortality rates remain stable, the burden of lung cancer will increase to 4.62 million new cases and 3.55 million deaths by 2050.
  • Other studies have also projected future lung cancer burden, with varying estimates depending on the methodology and assumptions used.

Key Factors:

  • Tobacco smoking is the leading risk factor for lung cancer, and lung cancer incidence largely reflects trends in smoking patterns.
  • Environmental and occupational risk factors, such as exposure to unprocessed biomass fuels, asbestos, arsenic, and radon, also contribute to lung cancer incidence in certain parts of the world.
  • Low-dose CT screening has been shown to reduce lung cancer mortality by enabling earlier diagnosis and treatment.

It's important to note that these are global estimates, and the actual burden of lung cancer can vary significantly between countries and regions. Further research and data collection are needed to improve the accuracy and precision of these estimates, particularly in low- and middle-income countries where data are often limited.

Economic Burden

Lung Cancer's Economic Toll: USA and Europe

United States

  • 2019: A study projected the national patient economic burden associated with cancer care, including lung cancer, to be $21.1 billion. This figure encompasses out-of-pocket costs and time costs. Another study, using nationwide data from 2010-2017, found that lung cancer patients had the highest expenditures among the four most common cancers (lung, breast, colorectal, and prostate). A 2016 study reported that COPD, often associated with lung cancer, was estimated to cost $31.3 billion in 2019, with projections to increase to $60.5 billion in 2029. While not solely focused on lung cancer, this highlights the substantial respiratory disease burden.

  • 2020-2050: A study estimated the economic cost of cancers in the US to be $25.2 trillion over this period, with lung cancer accounting for 15.4% of this total. This translates to an annual tax of 0.55% on the global gross domestic product.

  • Undated, but more recent than 2015: A study examining the evolving treatment landscape for advanced NSCLC (since the introduction of immune checkpoint inhibitors) found that the mean total cost across the entire study follow-up was $158,908 ($250,942 per-person-per-year). The total costs were increasing, primarily driven by rising outpatient costs for systemic therapy, likely reflecting the greater use of ICIs.

Europe

  • 2009: A study estimated that lung cancer cost the European Union 18.8 billion (15% of overall cancer costs), followed by breast cancer (12%), colorectal cancer (10%), and prostate cancer (7%).

  • 2012: A study estimated that lung cancer incidence was highest in countries with a very high Human Development Index (HDI) and lowest in countries with a low HDI. Five-year relative survival varied from 2% (Libya) to 30% (Japan), with substantial within-country differences.

  • 2014: A study estimated that malignant blood disorders, sometimes associated with lung cancer, cost 31 European countries 12 billion in 2012. Health care accounted for 62% of total costs, productivity losses 30%, and informal care 8%.

  • 2018: A study estimated the total cost of cancer in Europe (EU-27 plus Iceland, Norway, Switzerland, and the United Kingdom) to be 199 billion, with costs ranging from 160 per capita in Romania to 578 in Switzerland (after adjustment for price differentials). Health expenditure on cancer care was 103 billion, of which 32 billion were spent on cancer drugs.

  • 2022: A study estimated that lung cancer was the most commonly diagnosed cancer worldwide in 2022 (1.57 million new cases) and the most common cause of cancer death in males (1.23 million deaths).

Key Observations:

  • Lung cancer imposes a substantial economic burden in both the US and Europe.
  • Costs vary significantly based on disease stage, treatment, and country.
  • Indirect costs, such as lost productivity, are a significant component of the economic burden.
  • New therapies, while improving outcomes, are driving up treatment costs.
  • Disparities exist in both incidence and mortality based on factors like socioeconomic status and geographic location.

Further research is needed to fully understand the economic impact of lung cancer and to develop cost-effective strategies for prevention, early detection, and treatment.

Eyonis® LCS is a blood test developed by Eyenis, Inc. for the early detection of lung cancer. The provided text does not mention any other indications for which Eyonis® LCS is being trialed, nor does it describe any specific intervention models for such trials. The paragraphs focus on lung cancer screening (LCS) using low-dose computed tomography (LDCT) and other lung cancer treatments, but they do not mention Eyonis® LCS specifically.

Several paragraphs discuss various aspects of lung cancer screening and treatment:

  • Lung Cancer Screening (LCS): Many paragraphs discuss the benefits and drawbacks of LCS using LDCT, including mortality reduction, overdiagnosis, and the importance of shared decision-making. They also discuss eligibility criteria, adherence rates, and disparities in screening uptake. Some paragraphs focus on specific populations, such as smokers, women, and racial/ethnic minorities. Several studies investigate interventions to improve LCS uptake, including patient outreach, shared decision-making interventions, and patient navigation. Other paragraphs discuss the use of risk prediction models to identify individuals at high risk for lung cancer.
  • Lung Cancer Treatment: Several paragraphs discuss various treatment modalities for lung cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy. Some paragraphs focus on specific types of lung cancer, such as non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Others discuss the use of biomarkers to guide treatment decisions and the development of new therapies.
  • Other Cancer Types: Some paragraphs mention other cancer types, such as colorectal cancer, prostate cancer, breast cancer, and melanoma, often in the context of discussing treatments or risk factors that may be relevant to lung cancer.
  • General Cancer Research: Some paragraphs discuss general topics related to cancer research, such as the use of artificial intelligence, clinical trials, and the development of new drugs.

It is important to note that the provided text does not mention Eyonis® LCS or any trials involving this specific blood test for any indication other than lung cancer.