As knowledge of the human genome grows, healthcare and treatment models are transitioning from a "one-size-fits-all" approach to precision medicine. Precision medicine, tailoring treatments based on patients’ genetic profile, is bringing targeted therapies to market, with more than 25 new drugs approved by the Center for Drug Evaluation and Research since 2014.1
As precision medicine continues to develop, its success depends on the development of effective companion diagnostic (CDx) devices. These devices aggregate genomic, clinical and lifestyle data to determine selection and dosage for patients as well as providing early device efficacy data. Due to their importance, there has been a rise in CDx development. In 2013, there were 226 CDx collaborations — up from eight in 2009.2
While precision medicine is often associated with oncology, newfound relationships between the genome and disease progression is expanding it beyond that field. According to the Diaceutics Group, two-thirds of drugs currently in Phase III clinical trials are for non-oncology areas, such as cardiovascular disease, central nervous system (CNS) and infectious diseases.
Cardiovascular Diseases
The primary goal of CDx devices for cardiovascular disease is to minimize patient effort and provide customized care. Wearable sensors can collect data and monitor patients’ cardiac status in real-time. For example, Medtronic’s recent pacemaker combines predictive analytics and AI algorithms to automatically adjust the pacing rate to suit a patient’s conditions.
Moreover, the FDA has allowed glucose monitoring systems to transmit real-time glucose readings to a smartphone every five minutes. This allows patients to use the system to monitor blood sugar levels or be integrated with an automated insulin dosing system to release insulin as blood sugars rise.
Neurological Disorders
CNS disease progression has a strong genetic correlation, providing an opportunity to use precision medicine and CDx devices to create better diagnostic tools — especially with nearly 25% of patients with Alzheimer’s disease having been misdiagnosed.3 New technologies, such as brain amyloid and tau imaging, and improved biomarker identification with targeted therapies can provide a route towards enhanced tools for disorders like Schizophrenia, Parkinson’s, and Alzheimer’s.
Infectious Diseases
Heavy use of antibacterial agents, although critical in saving many lives, has caused a host of problems. Their unrestricted use has resulted in an antibacterial resistance crisis and the shortened lifespan of drugs. Precision medicine is being employed as one part of a larger effort to combat this crisis.
Precision medicine has facilitated the emergence of tools such as monoclonal antibodies and single-pathogen agents, which can help the development of antimicrobials that specifically target resistant pathogens. Additionally, CDx tests and data-based insights can precisely evaluate a patient’s condition to enable selection of treatment plans according to their particular infection.
Future Opportunities
Precision medicine and CDx devices are still relatively new developments in the healthcare industry. Many medical and diagnostic device companies have entered the growing market in a variety of therapeutic areas to increase the clinical success of targeted therapies and reduce global healthcare costs. However, there remains a large opportunity for device manufacturers and companies to develop innovative solutions.
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Sources
1. Woodcock, Janet. “Two Recent Scientific Advances Underscore an Encouraging Future for
Precision Medicine at FDA.” FDA Voice. 11 July 2017. https://blogs.fda.gov/fdavoice/index.php/tag/precision-medicine/
2. Deloitte Center for Health Solutions. “Healthcare and Life Sciences Predictions 2020: A Bold
Future?”https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/healthcare-and-life-sciences-predictions-2020.pdf
3. Fischer, Corrine E, et al. “Determining the impact of psychosis on rates of false-positive and false-negative diagnosis in Alzheimer's disease.” Alzheimer's & Dementia: Translational Research & Clinical Interventions, vol. 3, no. 3 Sept. 2017, pp. 385-392. https://doi.org/10.1016/j.trci.2017.06.001
