What are Traditional Biomarkers?
Traditional biomarkers are an essential part of clinical practice and research. The FDA-NIH Biomarker Working Group defines them as “characteristics that are measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention including therapeutic interventions. This can include molecular, histological, radiographic, or physiologic characteristics.”
Since the development of modern medicine, traditional biomarkers have been the leading player in assessing patients and evaluating diagnosis, treatments, and prognosis.
Traditional biomarkers are collected through clinical tests or examinations when an individual visits a healthcare provider in-person. Blood pressure readings by a nurse or measuring serum cholesterol or blood sugar at a lab are examples of such biomarkers. However, the integration of smartphones and other digital devices into our daily lives has created a window of opportunity for the emergence of digital biomarkers.
So, What are Digital Biomarkers?
Digital biomarkers refer to “objective, quantifiable, physiological, and behavioral measures that are collected by means of digital devices that are portable, wearable, implantable, or digestible.” A few examples include a smartwatch photoplethysmography sensor that detects irregular pulse rate, accelerometry that measures sleep duration, and wearable digital technologies that track mood.
During the last decade, the number of digital biomarkers has increased rapidly. To better understand them, digital biomarkers, same as traditional biomarkers, can be divided into seven categories based on the clinical goal they serve. These categories are: diagnostic, safety, response, monitoring, prognostic, risk, and predictive.
For example, a diagnostic digital biomarker such as a wearable heart monitor detects heart arrhythmias. Whereas a predictive one such as a wearable sensor assessing gait predicts falls in patients with Parkinson’s disease. Considering that digital biomarkers use a completely different process to produce outcomes, they are different from traditional biomarkers.
How are Digital Biomarkers Different from Traditional Ones?
While traditional biomarkers are well-integrated with the current clinical practice, their limited measurement over time makes their analytical complexity limited, leading to a snapshot view of a condition. In addition, they can be invasive, labor-intensive, and expensive. In contrast, digital biomarkers are less or non-invasive and more cost-effective. More importantly, digital biomarkers continuously measure health data, producing a contiguous and longitudinal view of the medical condition and patient in real-time in their natural environment.
How is the Healthcare Industry Responding to Digital Biomarkers?
The differences between digital and traditional biomarkers and the potential of digital biomarkers in providing personalized care for patients and increasing efficiency of clinical trials have fueled the interest of digital health and pharma companies alike. As a result, more companies sign agreements and enter partnerships to expand their healthcare offerings through digital biomarkers.
- Digital health companies and digital biomarkers
In December 2019, Diabeloop, a digital health company producing an autonomous diabetes management system for type 1 diabetes, announced a $31 M funding. More recently, in November 2021, this company partnered with Terumo corporation to expand its services in helping diabetic patients to manage their condition more effectively. Element science is another digital health company that started a partnership with several companies, including Deerfield Healthcare, and raised $145.6 M to complete clinical testing of its product, a wearable cardioverter defibrillator that detects and treats lethal heart arrhythmias. In May 2021, Mindstrong, a digital mental health company, that has developed digital biomarkers to assess brain function through individuals’ smartphone behavior, announced $100 M funding.
It is not only digital health companies that have a place in the digital biomarker landscape. Pharma companies have also been investing and forming partnerships in the field. The business focus of pharma companies is changing from a product-based to a more service-oriented model. Therefore, they are now more focused on improving patient experience and outcomes by combining drug therapy with digital health services.
- Pharma companies and digital biomarkers
Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has been collaborating with Huma (formerly Medopad) to work on a digital biomarker for Alzheimer’s disease that provides remote automated evaluations for individuals at risk of Alzheimer’s disease. Roche has also partnered with Nuvoair to make its technology, a digital health platform for assessing lung function at home, accessible to individuals with cystic fibrosis. Biogen and Ad Scientiam have also started a scientific collaboration to develop innovative digital solutions/biomarkers in clinical research in neuroscience.
These are only a few examples of the numerous advances and partnerships that have been happening in the digital biomarker landscape. But why do digital health and pharma companies find digital biomarkers so attractive to invest millions of dollars in them?