Diagnostics: The Front Line in Early Detection

With an ageing, increasingly urbanized population, the country is facing an unprecendented challenge in the tackling of obesity-related chronic illnesses, which are pushing the already stretched healthcare budget to breaking point. In addition, emerging infectious diseases such as influenza A H1N1 and Chikungunya fever require modern techniques to be identified and studied thoroughly. In the current medical environment, there is a greater need than ever to develop more sophisticated diagnostic methods and to make them available for people to be diagnosed in a timely manner. This is aimed at alleviating the strain on overburdened areas of the health system, such as primary clinics and hospitals, and shift focus onto preventative care and early detection.

In 2012, the global market for diagnostics represented US$45.6 billion and is expected to grow by 7% annually over the next five years according to Frost and Sullivan. At this point the US and Europe account for 60% of this market. In developing countries diagnostics growth is led by the local government’s need to provide access to quality healthcare, but it is being hampered by budget cuts and regulatory hurdles. Diagnostics is a rather large area that comprises several different methods and strategies. Carlos Hernández Alvarez, Regional Director of Siemens Diagnostics Hispanoamerica, explains that there are three general methods for diagnostics: “the first method, which focuses on the physical test from a physician, is a technique that is rarely used nowadays. The other two methods are much more popular through imaging techniques or through clinical tests.” The latter is constantly being updated and new tests are under perpetual development to facilitate and speed up diagnosis. For some diseases a timely diagnostics may be the difference between life and death.

One of the biggest costs for the health system in Mexico is obesity-related diabetes, with 6.4 million people suffering from this disease according to ENSANUT. On the surface, diagnostics may seem problematic due to the costs associated with research and equipment, but a study published by the NIH found that pre-emptive eye tests to diagnose chronic diseases, such as diabetes, meant a decrease in overall health costs for the patient, less absenteeism and a reduced likelihood of employment being terminated. Moreover, a study carried out by the Epidemiology and Health Services Research Unit of IMSS in 2010 found that for each US$1 invested in prevention through the pre-diabetes and hypertension program PREVENIMSS, between US$84 and US$323 would be saved over a twenty year period. The study concluded that there was also still room for government investment in prevention and diagnostics.

There are significant opportunities for the diagnostics segment in Mexico. For instance, late HIV testing comprises 50% of all new identified seropositive cases in Mexico. In addition, 50% of breast cancer patients are diagnosed at stages three and four of the disease according to the National Institute of Public Health (INSP), and 14,000 new cases of prostate cancer are diagnosed annually, of which 8,000 are in advanced stages. A study aimed at describing the prevalence of early diagnosis and treatment of hypertension in Mexico found that 47.3% did not know they had this condition.

Diagnostics companies such as Grupo Diagnóstico PROA, Quest Diagnostics, Laboratorios Dr. Moreira, Laboratorio Médico Polanco, Check-Up Center, and Analitek are emerging as market leaders in preventative medicine in Mexico. Much of the diagnostic technology such as tomography has been in use for decades, but only recently has its value been capitalized upon, as health professionals realize that long-term savings of early diagnostics outweigh the initial costs. Laboratory chains for diagnostics are growing steadily in Mexico and their value proposition is based on easy access, certifications, and customer-oriented services. Economies of scale and knowhow have also been key in their growth.

Developments in the in vitro diagnostics segment – molecular diagnostics for infectious diseases, chronic diseases, oncology, and genetic testing – has made it possible to detect diseases in a more accurate and effective way. Félix Valverde Espinoza, Regional Director of Quest Diagnostics Mexico, states that “a growing worldwide trend is the rise in molecular and DNA-based tests.” These can comprise clinical tests for several viruses and bacteria and are of utmost importance to the population. For instance, in 2009 the Institute of Diagnostic and Epidemiological Reference (InDRE), the Mexican counterpart of the Center for Disease Control (CDC), required rapid implementation of protocols for the detection of AH1N1, popularly known as swine flu to measure and control the outbreak in Mexico. Other new developments are tests for the detection of HIV and the Human Papillomavirus (HPV) with the objective of identifying several strains. For example, the FDA approved a new assay for the differentiation of HIV-1 and HIV-2 antibodies, and HIV-1 p24 antigen in July 2015. HIV-1 is the most common strain of HIV worldwide and HIV-2 is most commonly found in West Africa, but cases of HIV-2 have been identified in other countries. Differentiating between both strains is important as, while both diseases show the same symptoms, they progress at different rates and thus require different treatment schemes. This test, the BioRad BioPlex 2200 HIV AgAb assay, can be applied to children over two years of age, adults, and pregnant women. It can also be used to screen organ donors. As for HPV tests, the cobas HPV Test which simultaneously detects 14 different high-risk HPV types provides specific information on HPV16 and HPV-18. This test amplifies DNA using Polymerase Chain Reaction (PCR) and nucleic acid hybridization to identify high risk types at infection levels. It is meant to be used as a primary screening tool for cervical cancer and, if results are positive, it should be followed by a colposcopy.

The completion of the Human Genome Project in 2003 has been a catalyst for an overhaul of the diagnostics industry, heralding the introduction of a new, more accurate form of diagnostics based on genomic sequencing. The global genomic mapping project streamlined the diagnostic processes, facilitating a more comprehensive understanding of diseases, allowing physicians to prescribe appropriate treatments and more accurately predict potential side effects, as well as permitting the scientific community to identify mutations linked to fatal diseases such as cancer. In addition, the project led to the Mexican Genome Diversity Project, which was completed in 2009 and produced findings that revealed inherent differences in Mexican Mestizo DNA that make the population more susceptible to certain chronic diseases. This also resulted in significant implications for personalized treatment, recognizing that genetic make-up not only differs from population to population, but also on an individual level, and the smallest unique mutations can mean that a viable treatment option for one person is ineffective or even detrimental to another. The development of genomic mapping on a wider scale will not only encourage increased access to preventative medicine, but also a more targeted and accurate means of diagnosis, minimizing the possibility of complications during treatment.

Among the first applications of personalized medicine investigations is trastuzumab, a monoclonal antibody used to treat a specific form of breast cancer in which the HER2 protein is over-expressed. This type of breast cancer represents 30% of all cancers of this type and generally does not respond to standard therapy. Other such examples include Zykadia, a drug that has been approved recently in Mexico, developed to treat non-small cell lung cancer (NSCLC) caused by a defect of the anaplastic lymphoma kinase positive gene (ALK+). While NSCLC represents about 85% of lung cancers, only approximately 5% of patients’ tumors are ALK+. Personalized medicine can also be used in other areas, such as cardiovascular diseases. The main method to prevent rejection of a heart transplant was an endomyocardial biopsy, an invasive procedure that cannot be used on all patients. Now, genetic tests performed on a blood sample are a noninvasive alternative to manage the care of post-transplant patients.

Mexico is moving forward in the acquisition of new technologies for diagnosis. Although initially costly, advanced diagnostic methods such as genomic sequencing and preemptive tomography testing can reduce the long term financial demands on the health service. Moreover, the negative implications associated with manual diagnostics could be avoided and human error could be even further minimized, along with time consuming traditional diagnostic techniques such as differential diagnosis and pattern recognition. With an emphasis on diagnostic R&D, the medical industry could be revolutionized to the point of longer life-expectancy, shorter waiting times, and an optimization of services at a lower cost within both the public and private sectors.