Lab Testing Enters a New Era

Lab Testing

 

With the convergence of the mapping of the human genome and pandemic-fueled at-home testing, direct-to-patient lab tests have exploded in popularity.

The at-home diagnostics market in the U.S. is expected to be valued at $8.5 billion by 2030, expanding by 4.5 percent annually.1 Used to assess health status, genetic predispositions, previously undiagnosed medical issues and more, natural practitioners play a vital role in working with patients in interpreting test results.

While some test results offer basic result summaries, it is critical that patients work with practitioners to use results as a baseline from which individualized nutritional and treatment strategies can be developed.

The main categories of at-home diagnostic tests include those for food allergies and chemical sensitivities; cellular health; susceptibility to diseases—including irritable bowel syndrome, Crohn’s disease, thyroid disease, rheumatoid arthritis, connective tissue disease, celiac disease and fibromyalgia—immune-system or inflammatory dysregulation; cardiometabolic health; gastrointestinal health; hormone balance; toxins; nutrigenomics; and more.

There are companies which, in addition to testing services, offer dietary supplements, reagents, custom manufacturing and instruments.

Food Allergies and Sensitivities

With stress and toxic chemicals running rampant, it is perhaps not a complete surprise that food sensitivities, food intolerance and allergies have become increasingly common.

“The increase of food allergies is likely multifactorial in nature,” said Veronica Kent, chief executive officer of Massachusetts-based testing company, Alletess.

“Our modern, industrialized environment has likely increased our susceptibility. In addition, the change in feeding guidelines in the U.S. in 2000, advising delaying the introduction of certain foods, may also have played a part in the ongoing rise of food allergies, since exposure induces tolerance to substances.”

According to Amy Pieczarka, RDN, LDN, director of nutrition services for Florida-based PreviMedica, a testing company that also provides telehealth-accessible nutrition and supplement plans, “The complex interplay of the microbiome, the inflammatory response initiated by the cells of the innate immune system, and intestinal barrier integrity, impact the manifestation of adverse reactions to foods.” She noted that all of these factors play a pivotal role in immune regulation and metabolism of food.

Chad Larson, NMD, DC, clinical advisor to Arizona-based testing company Cyrex Labs, agrees.

“I think the problem is twofold,” said Dr. Larson. “First, foods are becoming more and more processed—the more processed the food is, the further it is from its natural form, and the more likely the immune system is not going to recognize it as food and is going to abnormally react to it. Secondly, there are increasing environmental insults to the intestinal microbiome.”

Testing—The Right Way Involves Practitioners

There are a number of routes that a consumer can order a food intolerance/sensitivities test: direct from a testing company, direct from a testing company with referrals to physicians who are expert in interpreting them, or by doing the tests at their physician’s office. There are pros and cons to each.

“Alletess Medical Laboratory requires that a clinician order laboratory testing,” said Kent. “The value of any laboratory test is understanding the test result and taking positive action.”

“The potential limitation [of at-home testing] occurs when individuals order tests through a company or practitioner who does not provide the necessary guidance and expertise to effectively integrate the test results into a personalized dietary or nutrition plan,” Pieczarka said.

PreviMedica’s sister company, Florida-based Cell Science Systems [CSS] is a “specialized clinical laboratory focused on advancing immunology and cell biology testing, specifically catering to health care professionals who adopt a comprehensive approach to tailor treatment and prevent chronic disease in their patients,” Pieczarka added.

“Complimentary educational sessions offered for health care providers and their patients provide valuable insight on how to best utilize our tests for personalized care plans.”

Food Allergy and Nutritional Status Testing

“ELISA IgG food immune testing is the industry standard for food sensitivity testing,” said Dr. Larson, and “the Chief Science Officer of Cyrex Labs, Aristo Vojdani, PhD, is the original developer of this technology who has been perfecting the laboratory science and techniques for the past 40 years.”

PreviMedica specializes in nutrition and lifestyle guidance. Individuals can order CSS tests directly, said Pieczarka, and the “dedicated PreviMedica Nutrition Team provides personalized nutrition guidance through monthly membership plans.”

Since we now live in the new age of the microbiome, it is perhaps not surprising that a number of microbiome-health tests are available to patients.

According to Dr. Larson, “Cyrex Labs Array 2 features a marker called lipopolysaccharides (LPS), which, if elevated, indicates three key things: 1. There is dysbiosis in the intestinal microbiome, as LPS is produced by non-beneficial gram-negative bacteria; 2. Elevated LPS also reveals a significant source of inflammation that can not only induce local inflammation in the GI (gastrointestinal) tract but also organ systems outside the intestines and 3. Elevated serum antibodies reacting to LPS also indicates compromise of the intestinal barrier (leaky gut).”

Health and Medical Diagnostics

Some companies specialize in testing nutritional factors in chronic illnesses, such as fibromyalgia and autism, etc. They may offer metabolic tests, such as immune deficiency evaluation, glutathione levels, metal toxicity, etc.

Alletess, for example, offers tests for markers of connective-tissue disease, thyroid disease, rheumatoid arthritis and celiac disease, noted Kent.

“CardioMetaboliQ LLC pairs the proprietary nutritional formula MetaVasc Capsules with the CardioMetaboliQ Home Blood Test,” said Steven P. Bennett, DC, president of California-based Intuitive Nutrients.

“Our goal with both the test kit and the supplement is the same; that is, comprehensively addressing the broad spectrum of cardiovascular, hepatic and metabolic physiology that make up cardiometabolic health, from both a diagnostic and therapeutic perspective.”

The Alcat Test for Food and Chemical Sensitivities identifies “individual triggers for chronic immune activation potentially contributing to autoimmune issues as well as poor GI health and associated symptoms,” according to Pieczarka, whose CSS sister company also offers CICA, Celiac, IBS and Crohn’s Array tests.

CSS also offers a MethylDetox Profile test, which, Pieczarka noted, “provides insight into methylation-related genetic polymorphisms that, if not supported properly with nutrition, can lead to impaired methylation and a wide variety of conditions.”

A one-of-a-kind panel for immune system balance, added Dr. Larson, is the Lymphocyte Map. “This is a very comprehensive evaluation of many interconnected immune markers to provide the clinician with a detailed understanding of the current state of the patient’s immune system—the L-Map features markers such as T Cells, B cells, TH1, TH2, CD4, CD8, TH17, regulatory T cells, NK cells and many others.”

All chronic conditions begin upstream, according to Yael Joffe, PhD, founder and chief science officer of Washington state-based testing company, 3X4 Genetics. “When there is any impact on how optimally our core systems function, an individual will develop, over time, a number of chronic symptoms and conditions—genetics is the blueprint for an individual that determines how metabolic processes may be impacted.”

When evaluating nutritional factors that contribute to disease it is “imperative to consider genetic variants that may impact how genes affect nutrients and core cellular processes—genetics are invaluable in determining other lab tests that offer additional insights.”

“Cyrex specializes in chronic immune system dysregulation and autoimmunity,” Dr. Larson noted. “The main panel that evaluates for autoimmune reactivity is Array 5, which includes autoantibodies reacting to a broad variety of tissues and organ systems.”

“The chemical/heavy metal screen Cyrex offers is called Array 11. The unique thing about Array 11 is that it measures antibodies reacting to a broad variety of chemicals, like phthalates, benzene, bisphenol A (BPA), and mercury—as opposed to just looking at the levels of chemicals, it measures the immune system reactivity to the chemicals (loss of immune tolerance).”

Regarding nutritional factors, Pieczarka noted that, “The CSS Cellular Micronutrient Assay (CMA) assesses insufficiencies of vitamins, minerals, amino acids and other nutrients; the Redox Assay measures the overall antioxidant function of the individual’s immune cells; and the Antioxidant Protection Assay (APA) identifies specific antioxidant nutrients and botanicals that [can] significantly improve the individual’s antioxidant capacity and protect their cells from oxidative damage.”

According to Pieczarka, “Each person’s nutrient needs are unique. These [assays] provide information regarding long-term nutrient status within cells as opposed to short-term nutrient status outside of cells which serum testing shows.”

Patients can work with their practitioners, said Pieczarka, to identify contributors to nutrient insufficiencies and less than ideal antioxidant capacity, so that appropriate strategies for repletion and individualized antioxidation can be implemented.

Nutrigenomics can help us delve into cellular health, genetic dispositions and more.

“Nutrigenomics is a missing piece in every patient’s puzzle—understanding an individual’s genetic blueprint means understanding who they are and how they respond to diet, lifestyle, exercise, stress, toxins and trauma,” observed Dr. Joffe.

“Knowing an individual’s genetic blueprint enables a practitioner to know where to start, and to know what they don’t know; clinical gems that can fine-tune and personalize their clinical intervention. Furthermore, nutrigenomics helps practitioners choose the most precise functional tests to order, and to provide targeted supplementation. Nutrigenomic insights enables the practitioner to reduce the trial and error in working with a patient, getting to the answers in the most effective way.”

What Sets Each Testing Company Apart?

“Cyrex was, and continues to be, an industry disruptor,” added Dr. Larson. “Each array represents a first-to-industry evaluation for the key triggers that chronically dysregulate people’s immune systems: 1. Barrier system breakdown (Arrays 2, 22, and 20 [blood-brain barrier]), 2. Food-immune reactivity (Arrays 3x, 4, and 10), 3. Chemical-immune reactivity (Array 11), and 4. Pathogen-immune reactivity (Array 12).

“Founded in 1980, Alletess Medical Laboratory has been providing allergy and immunology testing services to clinicians worldwide,” noted Kent.

“Our highly knowledgeable staff, cutting-edge medical technology, and customized wellness programs allow us to provide high-quality laboratory testing and services to our clients. Our Pathology and Lab Leadership teams are always available for consultations. Both providers and patients can schedule a Zoom [call] with our registered dietitians. And our turnaround time for testing is five to seven days.”

3X4 Genetics is not just another genetic test, said Dr. Joffe. “We offer a full genomics solution, everything we do focuses on clinical translation; we provide pathway-based analysis, grouping genes together to identify the impact of genes on 36 different metabolic processes; and our report provides an easy-to-use and engaging experience for practitioners and their patients.

“Furthermore, we provide the gold standard for nutrigenomic education and mentorship and a significant community that brings all of these things together; no matter your journey in genetics so far, 3X4 Genetics will guide you in your learning journey, and in offering value to your patients.”

“While we realize that every physiology is somewhat unique, the area of cardiometabolic dysfunction is consistent in its etiologies to the extent that a standardized approach can benefit a substantial portion of the patient population,” said Dr. Bennett. “As such, in the typical integrative holistic practice, a sizable percentage of patients can potentially benefit from the CardioMetaboliQ Home Blood Test and MetaVasc nutritional supplementation.”

Pieczarka noted, “CSS offers a range of tests that allow health care practitioners and their patients to pinpoint underlying triggers of health concerns, determine an individual’s ideal food repertoire, determine genetic variants that may require tailored support, and identify nutrient insufficiencies that may indicate the need for targeted supplementation.”

“Practitioners and patients are not on their own with the implementation of the CSS test results—there is a great deal of educational support provided by the CSS and PreviMedica Team to assist them in this regard. The PreviMedica Team provides customized meal planning services that practitioners can seamlessly integrate into their nutrition plans.”

Final Thoughts About At-home Diagnostics

“We all know that nutrition is biochemistry, one size does not fit all, and individualization is crucial to be on the path to optimal health,” observed Pieczarka. “We all respond differently to what we ingest, and our nutrient needs are unique as well.”

References

1 Vision Research Reports. Home Diagnostics Market Size to Reach US$ 8.5 Billion by 2030 [Report]. June 3, 2022. Available at: www.visionresearchreports.com/home-diagnostics-market/38739.

Healthy Take Aways

• With the convergence of the mapping of the human genome and pandemic-fueled at-home testing, direct-to-patient lab tests have exploded in popularity.
• The at-home diagnostics market in the U.S. is expected to be valued at $8.5 billion by 2030, expanding by 4.5 percent annually.
• The main categories of at-home diagnostic tests are for: food allergies and chemical sensitivities; cellular health; susceptibility to disease; immune-system or inflammatory dysregulation; cardiometabolic health; gastrointestinal health; hormone balance; toxins; and nutrigenomics.
• It is critical that patients work with practitioners to interpret test results as a baseline for effective treatment.
• One size does not fit all—we all respond differently to what we ingest—thus, our nutrient needs and our genetic predispositions are unique.

For More Information:

3X4 Genetics, https://3x4genetics.com/
Aletess Medical Laboratory, https://foodallergy.com/
Cell Science Systems, https://cellsciencesystems.com/
Cyrex Labs, www.cyrexlabs.com
Intuitive Nutrients, https://intuitivenutrients.shop/
PreviMedica, http://previmedica.com
Rupa Health, https://www.rupahealth.com/