As patients become more health conscious, the demand for personalized results from testing labs continues to increase.
Testing labs can be effective resources for practitioners who need answers about their patients’ medical conditions. These labs have the tools needed to perform diagnostic tests with quick results so that practitioners can interpret them and suggest the best course of action for their patients’ treatment. According to Grand View Research, “The global clinical laboratory service market was valued at $200.3 billion (U.S.) in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 4.7 [percent] from 2021 to 2028.” The reason for this expansion is “The increasing burden of chronic diseases and growing demand for early diagnostic tests.” As patients become more health conscious, the desire to prevent, rather than treat disease, is increasing demand for what testing labs have to offer.
Some of the most common reasons why patients seek testing, according to Chad Larson, NMD, DC, clinical education advisor, Cyrex Laboratories (Phoenix, AZ), include “fatigue, pain, inflammation, brain fog, intestinal discomfort, [desire for weight loss], skin problems and disease prevention.” The main causes for these issues, he continued, include “diet, lifestyle and over-dependence on pharmaceutical medications.”
Dr. Ralph Lemus, medical advisory panelist/chief medical officer, UCARI, Inc. (Orlando, FL), elaborated, sharing that “Most patients seek our services that have manifested or shown a multitude of symptoms anywhere from digestive issues, weight fluctuation, headaches, skin problems to mental fatigue and sleep issues.” He continued, “The lifestyle that we live is a major contributor to many of the symptoms we feel. Stress and our food habits are a major contributor to the problems we manifest.”
Dr. Ufuk Nalbantoğlu, co-founder and chief technology officer, Enbiosis Biotechnology (Cambridge, MA), expanded on the digestive issues that patients come in with, adding that they are the most common reasons why patients seek testing. “… As the amount of research on the extensive relationships between the microbiome and various systems in the body continues to grow, microbiome testing is becoming an avenue that many practitioners are choosing because of the profoundly positive impact a balanced gut microbiome can have,” he explained. “The most well-documented systems that are intimately connected include but are not limited to the neurological system, the musculoskeletal system, the skin, the cardiovascular system, metabolism, and perhaps most notably, the immune system.”
Testing labs can be helpful tools for practitioners seeking to develop a personalized treatment plan for their patients. Jennifer Green, ND, DC/chief clinician of naturopathic medicine, NUHS Whole Health Center (Lombard, IL), explained that “Lab tests are primarily used to diagnose a condition, whether it be an acute or chronic issue. If there is an acute issue going on, labs can assist with determining the patient’s current clinical status and identifying the cause of the illness. It can also be used to identify any other issues that may not present with distinct symptoms, such as cardiovascular disease.”
Furthermore, she said, “Labs can also be used for preventative medicine as regular screening to monitor for potential medical issues based on a patient’s personal or family medical history. For example, if there is a family history of hyperthyroidism (overactive thyroid), [a] doctor may order key markers to monitor for this, such as TSH and free T4.”
Lastly, according to Dr. Green, “Labs are also used to monitor a patient’s health status and to determine if any treatment needs to be adjusted. For example, if a patient has high blood glucose, their doctor will make recommendations to help lower their blood sugar. Checking their blood glucose periodically will help see if the patient is improving and the best course of treatment.”
With the growing need for testing labs among practitioners and their patients, it is important that these facilities are easy for practitioners to work with. According to Serena Goldstein, ND (San Francisco, CA), the key points that make a testing lab effective include “third party verification on how it has helped patients and [provided] information overall; certain markers the clinician is looking for in working with a patient; and results come in during a reasonable time period based on the test [performed].”
As testing labs grow in popularity, there are certain trends and expectations with which they need to keep up.
Trends/State of the Market
“I think patients are frustrated with the weak, limited, insurance-approved lab testing that is commonly ordered by their GPs (general practitioners), which are frozen in time without advancements for 50-plus years,” said Dr. Larson. “So, they are willing to come out of pocket hundreds of dollars to get answers from labs that have evolved the science.” Furthermore, he continued, “I think the trend of the ‘quantified self’ have made people interested in data that is generated by their own biology to better improve themselves.”
Dr. Nalbantoğlu offered a different perspective, stating that “because most people have no idea this type of technology exists and this type of truly personalized dietary information is attainable, it feels much like the cell phone market right before smartphones hit the market. We didn’t know what was possible and what we were missing until smart phones were launched—and now we don’t know what we’d do without them!” He continued, “The idea that people can do a simple test that looks at their microbiome blueprint and learn exactly what foods they should be eating as a foundational diet for optimal health and for symptom relief isn’t common knowledge, but could very well be the gold standard in clinical practice in the near future.”
Dr. Green opined, “the addition of at-home lab tests, DTC tests (direct to consumer), has helped shape the testing lab industry. Prior to DTC, people were able to do OTC (over-the-counter) tests, such as finger-prick testing for diabetes, but now people are able to order test kits from a company for a variety of tests.” She elaborated, “[Consumers] can get test kits for genome sequencing of DNA, food allergy and sensitivity testing, microbiome analysis, etc. and do the collections themselves (usually a check swab or saliva test) and send the kit back to the company to get results. The accessibility of home kits is more convenient and cost-effective, and it allows patients to screen for health concerns.” Dr. Green also concurred with Dr. Larson, adding that “As technology continues to advance and new tests are developed, the demand increases.”
The Impact of COVID-19 on Testing Labs
COVID-19 also had a significant impact on the testing lab industry. “At the beginning of [the pandemic], people stayed home and didn’t go to their doctor, so the lab industry slowed down during that time,” said Dr. Larson. “However, from what I can tell, there is renewed interest in lab testing and people are eager to get their health back.”
“COVID-19 has brought to light the overwhelming need for immune support and has actually highlighted a direct line between the gut and the immune system,” Dr. Nalbantoğlu stated. “The idea that 70 [percent] of the immune system resides in the gut has been a talking point within natural medicine for years, however, that idea became very real with the spread of COVID-19.”
Dr. Green noted that “The pandemic led to an increased demand for health care resources and laboratory test utilization. There was an increase in volume of lab tests related to diagnosis and management of COVID-19. Lab tests needed to be developed quickly in order to meet the need of detecting COVID-19,” she explained. “The pressure for the demand of testing led to a shortage in test kits, supplies and staff.” However, “There was more funding, which allowed for more innovation in lab technology, which can be utilized for future testing.”
Dr. Lemus explained that “Once the pandemic subsided, many people were confined to their homes and a staggering number of them not only gained weight and increased symptoms of general malaise, but also acquired new intolerances to food and environmental toxins. Many have sought our services to understand what those intolerances are, which helped them in answering the question of ‘why?’”
What Testing Labs Can Offer
Cyrex Labs, according to Dr. Larson, focuses on immune system dysregulation and autoimmunity. “Chronic disease and autoimmune conditions are often addressed with medications that suppress the presenting symptoms, like immunosuppressive, anti-inflammatory corticosteroid medications for pain and inflammation,” explained Dr. Larson. “Cyrex helps providers to uncover the immune system trigger(s) that is causing the immune system to dysregulate, leading to the chronic disease. If the trigger can be identified and removed, the immune dysfunction can be resolved.”
Dr. Larson continued, “Regarding immune system dysregulation and autoimmunity, the focus is around identifying triggers that have caused the immune system to get kicked out of balance. So, common approaches include identifying and treated intestinal permeability (leaky gut), dysbiosis (intestinal microbial imbalance), chemical/heavy metal toxicity and chronic pathogen exposure.”
Enbiosis, according to Dr. Nalbantoğlu, relies on two state-of-the-art technologies. “First, we use next generation DNA and 16S RNA sequencing to gather the raw genetic data, which Enbiosis analyzes using its patented artificial intelligence algorithm that was developed using bioinformatics derived from data collected from the American Gut Project, the Human Microbiome Project and the Flemish Gut Flora Project, in addition to house data of roughly 40,000 people.” The second technology, he continued, “is the Microorganism Nutrient Interaction Database. In short, we use all of the data available relative to the interactions between food and bacteria to determine the best possible foods to modulate the gut.”
The bottom line, said Dr. Nalbantoğlu, is that when it comes to the microbiome, if it is not in balance, the stage is set for every other major system in the body to follow suit. However, “simply knowing your gut is having issues doesn’t mean anything without a strategy to correct it,” he warned. “Understanding exactly which foods to eat abundantly, moderately and which to avoid or minimize in order to modulate, or balance out, the gut microbiome can have far-reaching health implications and has been clinically proven to reduce digestive symptoms in both patients with IBS-M as well as constipation.” Furthermore, “Studies are currently underway to measure the impact of a balanced microbiome on blood sugar and inflammatory skin conditions as well, as the anecdotal evidence has been promising on both fronts.”
Dr. Nalbantoğlu concluded, “When health care providers can confidently recommend a diet that is truly tailored to a person’s microbiome biochemical individuality—which is as unique as a fingerprint—and that can be effectively layered on top of existing diets such as the keto diet, FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols), gluten or lactose free, etc., it changes the entire landscape for using food as medicine. This AI-generated microbiome diet has already proven to help those struggling with digestive challenges, but this type of approach could be foundational for those suffering with any condition that could be connected with the gut microbiome.” Enbiosis is working on using the data within the biobank to drive the next generation of pre-and probiotic development, according to Dr. Nalbantoğlu.
UCARI, according to Dr. Lemus, “utilizes Bioresonance Technology to understand which foods, environmental elements and nutritional imbalances affect us in our bodies. We provide clients a clear understanding of what foods are causing any symptoms that the person may be manifesting. Sometimes, a person does not yet feel any symptoms but the body is starting to reject certain foods that are causing harm.” The same goes for environmental aspects, he added. “Sometimes, we place certain creams, perfumes, colognes or even oils and they themselves are causing a disruption in the body that prevents it from working correctly.”
Dr. Lemus concluded, “With the UCARI Comprehensive Intolerance Test, health care practitioners can identify foods and environmental toxins are present and address each one. Ideally, the rotation or elimination of certain foods must be considered. Not all foods should be removed completely from one’s diet—the majority of the time, a simple food rotation diet can simply eliminate a number of issues and restore the person’s ability to feel better within days.”
Dr. Goldstein uses tests when she is “trying to discern between different organ systems or, depending on the patients’ concern, find something, [such as] a value marker that could be of help or a clue in understanding [a patient’s] story or history.” She stated that there are a few testing labs that she uses, with those tending to be “broad spectrum in offering different ways of testing, whether it’s over a period of a few days, multiple or single collections, or type of collection (i.e., blood or urine).” She also finds it helpful if she can speak with a clinician “who can help guide me toward a particular test, as well as let me know some of the key aspects mentioned.”
Dr. Green stated that “A testing lab is effective if the lab provides accurate test results and there is a quick turnaround time for getting results. These are based on a few factors. For example, advanced testing instruments increase the accuracy of results. The availability of these tests is also important. If the laboratory has a wide range of tests, there is a better chance of being able to order the test(s) you are looking for.” However, she noted, “Some labs offer a smaller range of tests, but these labs are typically specialized, which is something that the doctor may be looking for.”
Additionally, Dr. Green believes that a testing lab “needs to have appropriate certification and accreditation for lab testing to be effective. “CLIA (Clinical Laboratory Improvement Amendments of 1988) certification ensures that a laboratory follows federal requirements needed for testing performed on human specimens, which means that the facility maintains a standard of clinical laboratory quality.”
Dr. Green has used testing labs since she started her practice and has used several different companies. “I work with a general clinical laboratory as well as functional and integrative medicine lab companies. The general clinical laboratory allows me to order common diagnostic tests, such as a CBC, CMP, lipid panel, etc. These labs also have a quick turnaround time for results and are very helpful if I need results fast.” The functional and integrative lab companies provide more specialized tests, “such as food sensitivity panels, micronutrient testing or digestive analysis, etc. These are more specific tests that take a little longer to receive results, but help to further assess the patient’s concerns.”
Advice for Practitioners
“The right lab tests can help you remove diagnostic guesswork and allow you to be more of a sharpshooter with your therapeutic recommendations as opposed to using a shotgun approach,” said Dr. Larson. “The best way for [practitioners] to incorporate lab testing is to get thoroughly educated on what the lab tests are providing, how to interpret the results, how to explain it to the patient and how to make recommendations based on the results.”
Dr. Nalbantoğlu stated “Whether a practitioner relies on allergy testing, application of a certain diet such as keto, Mediterranean, gluten free, vegan/vegetarian, FODMAP or paleo, the Enbiosis AI-generated microbiome diet can effectively be layered on to further refine the most ideal foods for that person’s system.” The company also offers the Enbiosis Meal App, which features full meals from kitchens throughout the world that would specifically benefit each patient.
“With the use of UCARI’s Comprehensive Intolerance Test, a practitioner can truly understand what foods, environmental and external factors are causing issues for the practitioner’s patients,” explained Dr. Lemus. “A health care practitioner can easily incorporate [the test] by going to [our website] and creating a professional account. Once [a practitioner] sends their patients’ hair samples, they will receive a professional report that can be shared with the patient and begin treatment and a food rotation diet.”
Dr. Lemus recommended that “Each health care practitioner must understand the biological makeup of each of their patients. Understanding which food intolerances and what specifically they have affected is a key component to the wellness of the patient.” Furthermore, “The practitioner should be the one to select the correct supplement or natural remedy or combination to assure the success of their patient. After reviewing our test, many practitioners utilize a digestive enzyme, perhaps prebiotics and probiotics or a combination of all to increase the patient’s biodome and recover the patient’s health. Each patient is different and how and what they should be taking should be at the practitioner’s discretion.”
Healthy Take Aways
• According to Grand View Research, “The global clinical laboratory service market was valued at $200.3 billion (U.S.) in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 4.7 [percent] from 2021 to 2028.”
• Some of the most common reasons why patients seek testing include fatigue, pain, inflammation, brain fog, intestinal discomfort, [desire for weight loss], skin problems and disease prevention.
• The main causes for these issues include diet, lifestyle and over-dependence on pharmaceutical medications.