Companion Diagnostics: An Absolute Necessity for Targeted Therapeutics

A replacement for solid tumor biopsy could be a reality. A baby could be sequenced at birth so that the same could help to lead a healthier life. For each disease expression, genetic testing plays a vital role for more precise tests through better biomarkers that closely match the actual genetic material. The promise of personalized medicine could be only through better diagnostics for the development of safer and efficient therapeutics.

Companion diagnostics are tests or assays IVDs intended for the extraction of a patient’s genetic and genomic characteristics, which help the doctors and physicians to take better decisions for treatment of a specific indication. The US FDA defines it as a medical device that identifies or determines a condition for a therapeutic product. It helps in providing the most likely and successful therapeutic intervention, by getting the information through patient diagnosis. Many pharmaceutical and biotech companies have focused on cost regulations through the development of companion diagnostics, along with a targeted therapeutic area. For this, there has been a significant rise in the partnerships with diagnostic firms, in order to develop and produce such diagnostics, which are more targeted and effective.

How did companies visualize opportunities in therapeutics development through companion diagnostics?

The first companion diagnostics was launched in the 1980s. Its future success relies majorly on the sequencing and development of personalized medicine. In 2014, Illumina introduced a sequencing system, HiSeq X Ten, which reduced the cost of human genome sequencing to USD 1000 only and was acceptable by many families. The system could transcribe almost 18000 human genomes in a year. Companion diagnostics are mainly used in oncology, to scan tumor samples from a large population. Other indications, like the treatment for cystic fibrosis, are also in focus.

The financing environment for diagnostic and research tool companies is also a key factor. Recently, Qiagen collaborated with Centogene, to increase the clinical prediction of rare diseases. Inotrem collaborated with Roche Diagnostics, to develop a companion diagnostic test in the field of septic shock. Although there have been many collaborations, the success rate has been low. For example, Gefitinib, marketed by AstraZeneca, had a disappointing outcome (the drug did not work for 90 % of the patients and gave results. Since then, there have several launches of new therapeutics. One of the recent approvals of diagnostic test by FDA is FoundationOne CDx, by Foundation Medicine, a genomic profiling test for all solid tumors.

Can Companion Diagnostics be a success in the near future?

A report by a market intelligence firm has estimated a CAGR of 35% for the global companion diagnostics market and predicted the market to be worth around USD 26 billion by 2022. Owing to increasing demand for personalized medicines and awareness among the population about the same, the industry has recorded huge growth. The rising cases of cancer globally have also been a major driving factor for this market. With companies increasing their collaborations for better biomarkers and diagnostics, there have high opportunities of its applications in indications other than cancer, like in cardiovascular, neurological diseases, etc.

Some of the major hurdles for this market are high costs associated with the development of therapeutics and diagnostic tests. With the high risk of failure in clinical trials, many companies prefer collaborations to minimize their failure rate. The reimbursement issues in different countries also impede the growth of this market.

Developing Community and Public Health Capacity for Change

March Health Awareness Campaigns

National Colorectal Cancer Awareness Month
Brain Injury Awareness Month
National Kidney Cancer Awareness Month
Multiple Sclerosis Awareness Month
National Myeloma Awareness Month
National Nutrition Month
National Endometriosis Month
Workplace Eye Wellness Month
National Save Your Vision Month
Hemophilia Month
National Chronic Fatigue Syndrome Awareness Month
American Red Cross Month
Learning Disabilities Awareness Month
National Developmental Disabilities Awareness Month
National Eye Donor Month
National Poison Prevention Month
National Professional Social Work Month
Save Your Vision Month

For those in community or public health, the topics in this article will be nothing new-but as busy professionals ourselves, we often find it helpful to be reminded of the basic premises of our chosen fields. It’s so easy in our hectic-and very important-drive to complete work tasks that we lose sight of those core values for which we strive.

There are a growing number of evidence-based interventions for use by community and public health professionals to promote health and prevent disease. [Leeman, Calancie, et al: 2015] These practices have the potential to improve environments, behaviors, and health outcomes in our communities. In order to adopt these practices, however, public health agencies and community partners often need additional tools, strategies, and training to enhance their capacity to improve health outcomes.

The most effective prevention strategies actively engage the communities they are intended to serve. Effective health promotion and health-enhancing social change require communities to identify, plan, channel resources, and take action. The concept that a community is the solution to its own problems is not new. There is considerable support for designing community-based interventions to improve the health behaviors and overall health status of community members. According to Sotomayor, Pawlik, and Dominguez in the journal Preventing Chronic Disease, “These community-based interventions are important because health disparities and the high rate of chronic diseases in minority populations, particularly among those who are poor and lack access to community resources, are not likely to be prevented without them.” [Sotomayor, Pawlik, and Dominguez: 2007]

The U.S. Office of Disease Prevention and Health Promotion’s Healthy People 2020 strives to

Identify nationwide health improvement priorities.
Increase public awareness and understanding of the determinants of health, disease, and disability and the opportunities for progress.
Provide measurable objectives and goals that are applicable at the national, State, and local levels.
Engage multiple sectors to take actions to strengthen policies and improve practices that are driven by the best available evidence and knowledge.
Identify critical research, evaluation, and data collection needs.

Many health prevention and promotion consultants stress the importance that local leaders play in building community health. The Healthy People 2020 toolkit Identifying & Engaging Community Partners, answers the question “How Do You Define Meaningful Citizen Participation?” in this way:

Power to make decisions and affect outcomes
Citizen driven; from the community up, not top down
Proactive, not reactive
Encourages and facilitates broad community involvement
Inclusive, not exclusive; accessible to all
Balanced representation in the participation process; not just major “partners”
Consensus-oriented decision making Compromise; give and take
Opportunities for involvement in all levels of activity, which include creating a vision, planning, prioritizing, deciding, evaluating [ODPHP: 2010]

Building strong relationships with necessary community partners can be time consuming. Facilitating meetings to allow the meaningful participation outlined above requires a particular, practiced set of skills. Here’s where a community health consultant could be extremely valuable. Each community health consultant is different, of course, but in general he or she will have significant experience with the following tasks:

Developing health education and promotion programs, such as school or community presentations, workshops, trainings, etc.
Writing and formatting health education materials, such as reports, bulletins, and visual aids, to address public health concerns.
Developing working relationships with agencies and organizations interested in public health.
Designing and conducting evaluations to assess the quality and performance of health communication and education programs.
Collaborating with community groups and public health officials to identify community health needs and the availability of services needed.
Writing press releases and public service announcements, conducting media campaigns, or maintaining program-related Web sites.
Developing grant proposals to obtain funding for health education programs and related work.

Drug Tracker: Clinical Trial Management

Clinical trial management system is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. This system maintains and manages performing, planning and reporting functions, along with the relevant information of participants, like contact information, tracking deadlines, and milestones.

The system comprises of protocol development, site selection & trial preparation, subject identification & enrolment, collection, monitoring & processing of data, data analysis & reporting, pharmacovigilance, and submission for review. Data is collected during the process of trials and is stored in the database. The data is then reviewed to decide upon the safety parameter of the drug.

How is clinical trial management useful?

· Real-time Insights into Operations: It is a system that provides a central place for recording operational activity, which offers easy access to important information.

· Stronger Financial management: It supports consistency in budgeting across the enterprise and provides access to all financial information.

· Increased staff efficiency: It reduces duplicate data entry, and thus only relevant information is present in the software. This saves time for the staff and increases accuracy and consistency of data.

They are experiments done in clinical research to determine medicines or procedures that will/will not benefit the patient. Chronic heart ailments, cancer, diabetes, stroke, and arthritis have long-lasting effects, persistent for more than three months after treatment. Globally, chronic diseases kill more than 38 million people each year. Cardiovascular diseases account for most deaths, approximately 17.5 million people annually, followed by cancers (8.2 million), respiratory diseases (4 million), and diabetes (1.5 million). These four groups account for 82% of the chronic disorder mortalities. New medicines and procedures need to be developed to tackle these diseases. In addition to this, communicable diseases, like Ebola, swine flu, etc. still do not have effective cures. Owing to all these factors, the number of clinical trials performed has increased significantly in the past decade.