Medical devices are increasingly being used in-house worldwide, with a global value exceeding US$254 billion. Mexico accounts for a significant 8.66% of this market, corresponding to manufacturing and amounting to US$22 billion. Over the past decade, the Mexican medical device industry has experienced rapid growth, even outpacing that of other countries, with a CAGR of just over 9% in exports.
Given this market value and the 10 million monthly consultations in the clinics attached to pharmacies, it is difficult not to bet on the push for devices in primary care and early detection in very specific cases. These include immunological tests for the detection of occult blood in feces, which is very useful in the determination of gastrointestinal (GI) bleeding in various GI disorders, such as diverticulitis, colitis, polyps, and colorectal cancer.
Subsequent developments in agglutination to the guaiac method, developed by Izaac van Deen, have yielded test methods more sensitive to low concentrations of human hemoglobin in stool. Clinical study results indicate that test results are positive in only 50-60% of patients with colorectal cancer and only 25-30% of patients with polyps. Therefore, a more sensitive means or method for detecting occult blood in stool is important. A one-step method currently available detects lower levels of occult blood in stool than standard guaiac tests by employing an immuno-specific sandwich method that is unaffected by ingested peroxidase, animal blood, or ascorbic acid.
Colorectal cancer is one of the leading causes of cancer-related morbidity and mortality worldwide.
Key features:
+Slow progression from adenomatous polyps
+Can remain asymptomatic for years
+High probability of cure if detected in early stages
Clinically relevant data:
+Most cases are diagnosed after age 50.
+Screening can reduce mortality by 30–60%.
+The goal of screening is to detect microscopic bleeding associated with premalignant or malignant lesions.
Early detection of colorectal cancer allows for the identification of premalignant lesions and cancer at curable stages. Immunochemical fecal occult blood tests (iFOB/FIT) are an effective, non-invasive, and accessible tool for population screening programs.
The immunological test allows the detection of human hemoglobin in feces with high sensitivity, facilitating screening in asymptomatic patients or in initial evaluation in medical consultation.
Average risk population:
+Screening is recommended starting at age 45.
Relevant risk factors:
+Family history of colorectal cancer
+Personal history of polyps
+Inflammatory bowel disease
+Diet high in processed meats
+Obesity
+Sedentary lifestyle
+Smoking
+Type 2 diabetes
Warning signs:
+Change in bowel habits
+Rectal bleeding
+Iron deficiency anemia
+Unexplained weight loss
+The presence of these symptoms requires direct diagnostic evaluation (colonoscopy).
This technology is the same as that used in population screening tests in countries with advanced healthcare systems, and it is supported by regulatory authorities such as the FDA and COFEPRIS. Its use allows for the identification of colon and rectal lesions at early stages, often before symptoms appear, which is crucial for the prevention of colorectal cancer.
The advantages of making devices like the iFOBTest readily available to the public include the ability to perform the test at home, it’s painless, non-invasive, and provides results in just a few minutes. This makes it an ideal tool for people at average risk who want an accessible, reliable, and quick way to monitor their gut health.
Its clinical value lies not only in detecting the problem, but in doing so early. Detecting occult blood can be the first step in preventing a benign lesion from developing into cancer. Therefore, having this test once a year can save lives, especially in populations without immediate access to colonoscopy or without obvious symptoms.
The work of pharmacy-affiliated clinics in primary healthcare and the use of medical device technology will facilitate the early detection of serious symptoms for more patients. These initiatives will soon be strengthened in our country with the collaboration of distributors and pharmacy associations, all of whom are interested in helping those patients who are not receiving timely healthcare services.