HomeScienceGeneticsGenetic testing: a new door to opportunities, challenges in preventive healthcare

Genetic testing: a new door to opportunities, challenges in preventive healthcare

Since the Covid-19 pandemic, people’s perception of healthcare has changed. While the top 10 causes of death in India are still non-communicable diseases such as diabetes, heart disease and respiratory disease, they are easily preventable/manageable if addressed at an early stage through essential screening and regular consultation. In addition, routine testing can reduce the severity of rare conditions, including autoimmune deficiencies, and also help reduce cancer-caused mortality.

Preventive health care focuses on early detection of future health problems and protects patients against possible diseases. The goal is to alert people to possible outcomes and occurrences of a particular disease or condition before it happens. It helps identify and minimize risk factors associated with potential diseases, overall health improvement, and early detection of disease through screening. Preventive tests include tests such as blood tests for sugar and cholesterol, tests to diagnose heart disease, pressure monitoring, cancer screening, Pap smears, HIV, etc. Breast cancer is an example that is common among the female population. In 2020, there were 2.3 million affected women worldwide. Regular mammography exams can help detect cancer early, reducing the number of deaths. Toddlers are given vaccinations such as DPT, BCG, Chickenpox, Hepatitis A&B, Polio and MMR to boost immunity and prevent disease. Most recently, vaccines have been used to fight the Covid-19 pandemic.

The preventive care sector quickly captures the imagination of the industry. This has also led to an exponential increase in market size. Globally, the market was estimated at $3,411.99 billion in 2021. It is expected to grow further at a CAGR of 8.32% to reach $5,512.89 billion by 2027. In 2019, preventive health care in India accounted for about 11% of total health expenditure. It is estimated to grow by 27.3% in 2020-25 to $197 billion by 2025. This has attracted more market players in the field and helped consumers with cost-effective alternatives to preventive healthcare.

Strong fundamentals support this growth. Preventive health care is developing rapidly and exponentially. There has been a paradigm shift in infrastructure, engineering, manpower, equipment and efficiency in conducting these tests or studies. Technology has changed the game for the industry. Faster and faster tests, with quick results, have enabled doctors to easily identify and address underlying medical conditions. In addition, test results have become much more accurate with advances in technology.

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Analyzing and comparing healthcare data in parallel because of the huge existing healthcare database has also helped enormously. Digital access to this data has even more advantages. Advances in artificial intelligence, analytics, digitization and deep learning have enormous potential to understand and interpret big data used in preventive screening. Another important factor is people’s growing tendency towards healthier lifestyles, which motivates them to take proactive measures to monitor their health indicators. Preventive health care has been shown to significantly reduce health care costs, making health care accessible to those who may not be able to afford expensive treatments.

Genetic screening is a specific area of ​​preventive health care that is growing rapidly. It can reveal changes in genetic makeup and gene mutations, which can cause future medical conditions. It identifies changes in chromosomes, genes or proteins and unravels huge information by analyzing an individual’s DNA. A sample of blood, hair, skin, amniotic fluid (the fluid that surrounds a fetus during pregnancy), or other tissues is used for genetic testing. The research is presented in the form of a report after a thorough evaluation of the results. There are multiple types of genetic tests available and more are being developed. Prenatal examination and testing in newborns are also at your disposal.

Western countries have seen an increase in gene testing, creating huge databases produced with sequence variation in the human genome. This, in turn, has led to progressively making genome tests more accurate with predictions. However, there is a lack of data specific to the Indian population that can help predict disease accurately. The United States of America Preventive Services Task Force has recognized the benefits of genome testing, such as reducing disease risk and aiding in diagnosis. As a result, genomic testing is available both clinically and through direct-to-consumer testing. The National Human Genome Research Institute, located in the US, conducts numerous research projects in this area. Furthermore, numerous authorities, such as the Food and Drug Administration, the Centers for Medicare and Medicaid Services and the Federal Trade Commission, regulate genetic testing in the US.

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In India, an entity engaged in genetic or biological research or research services using laboratory or medical equipment may qualify as a clinical institution and may be required to comply with the legal framework accordingly.[1] The Clinical Establishment Act in particular is a central piece of legislation. However, because health is a state subject, some states have mirrored their clinical establishment laws to central law, while some states have their own clinical establishment laws that differ from central law. The compliance process would differ from state to state in this regard.

It is important to keep in mind that if any device, instrument, device, device, implant, material, etc., is used independently or in conjunction with software to investigate the anatomy or physiological processes of humans, it qualifies as a medical device and the manufacture or import of such devices must be done under applicable regulations.[2] All medical devices are subject to a comprehensive set of regulations that focus in particular on the quality and safety of these devices. The definition and scope of these rules have expanded by leaps and bounds with recurring reports from the ministry.

In addition, when collecting, receiving, storing, transporting, treating, disposing or handling biomedical waste in any form, these entities conducting genetic testing must ensure proper compliance with biomedical rules and guidelines to ensure safe treatment and disposal. of such waste. material.[3] Biomedical waste for this purpose is all waste generated during the diagnosis, treatment or immunization of humans. It also has an additional environmental conservation perspective.[4]

Genetic testing can reveal data about a person’s family history, paternity and maternity, medical history, predisposition to certain diseases, certain traits, etc. This can be very sensitive to the person. Medical history is considered sensitive information by law and must be treated with caution and in accordance with applicable law.[5]

Informed consent plays a crucial role. Consent must be given and the necessary respect for physical autonomy must be ensured. The ethical standards[6] The existing India for doctors has clear requirements for obtaining the correct informed consent, in some cases even written consent from the concerned patient or relatives. These are derived from the long-standing principles of respecting autonomy.

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Physicians should exercise caution and adhere to ethical standards while recommending lab testing. Ethical standards do not recommend routine testing.[7] The proper standard of care should be taken when dealing with such genetic testing in India.

Indian authorities have become increasingly interested in genetic testing in recent years. An ICMR accredited body was investigating genome sequencing for the genetics of type 2 diabetes. If genetic testing develops as expected, we may see a robust legal framework in this area in the future. The industry can take initiatives of its own accord and voluntarily devise a best practice manual or standardization of guidelines to regulate the field. This creates trust with the public. In the coming years, advances in genetic testing could lead to widespread application in understanding cancer, rare diseases and common non-communicable diseases such as obesity, diabetes and cardiovascular disease. In the future, there is an opportunity to create genetic wearables, digital tools, etc. to make users aware of any genetic changes. Such information can also be used to create personalized medicines. The possibilities are endless.

As of today, anyone interested in delving deeper into preventive health care can perform genetic testing at their own discretion, without referral to a doctor. But once the result is known, he/she may need to see a qualified physician or genetics expert to understand the results and take action in the future. The person may also need to undergo further diagnostic tests to come to a concrete conclusion about the person’s health status. This makes the field of genetic testing interdisciplinary in nature. Now it’s up to leading physicians to adapt to this change and seize the opportunity to help patients. This may require a revision and upgrade of medical knowledge for physicians to keep up with developments in the field.

Preventive health care and, in particular, genetic testing is constantly changing and making significant progress. The journey is not without difficulties. There are as many challenges as there are opportunities. Only time can tell how well equipped we are to adapt to these changes. The organizations operating in the area must exercise caution and comply with applicable laws and regulations to ensure proper business operations.

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