Another Test to Avoid
|ZYTO Corporation, of Orem, Utah, sells several devices that it claims are useful for determining what dietary supplements, herbs, or homeopathic products might be useful. The devices use a hand cradle (pictured to the right) that relays signals to and from a computer that runs ZYTO's proprietary software. ZYTO claims that the software "sends stimuli to the body using digital signatures that represent actual things" and interprets fluctuations in skin resistance that indicate "the body's degree of preference for the items being assessed." |
ZYTO software is programmed to recommend products from companies selected by the practitioner. In April 2008, 16 such companies were identified as "Strategic Alliance Members" and 44 more as "Supplement Suppliers."  Several of the suppliers are multilevel companies.
Distribution and Marketing
ZYTO's "LSA Pro" and "Balance" systems are marketed to professionals, and its "Compass" system is marketed to MLM distributors and consumers who can lease it for $39.95 per month . The LSA Pro manual states:
Using the principles of biology, quantum physics, and the science of information, we facilitate meaningful communication between computers and the human body that is an evolution of bio-feedback. It is a sequence of elegance--the computer poses the question, the body answers, and not a word is spoken–giving healthcare practitioners a better tool to bring wellness to their patients .
It further states that the device uses galvanic skin response to "measure shifts in the body's stress system and determine balancers that will move the body back to homeostasis." Balancers are said to be "stimuli sent to the body that assist in bringing the body back into homeostasis." They include homeopathic remedies, naturopathic remedies, as well as clinical therapies such as acupuncture and massage therapy .
Testing can be done in the presence of the practitioner or done remotely though the Internet by hooking the hand cradle to the client's computer. The MLM companies using the Compass as a sales tool include Nature's Sunshine and Young Living. A Compass flyer promised "technology that will skyrocket your product sales and have companies rushing to join your downline." 
The LSA Pro displays graphics on the computer screen said to represent the "transparent body," "muscular body," epidermal body," "dermatomes" (to display effects of the vertebrae on the body), teeth (for dental assessments) , "5 element overlay" (for Traditional Chinese medicine assessments), and a "stress profile wheel." According to the company, dots that appear in the graphics reflect whether products are "in range" (suitable for establishing balance) or "out of range" (not suitable).  "LSA" is an abbreviation for "limbic stress assessment."
| The picture to the right shows a screen shot from an LSA Pro Webinar on parasites. The items listed below the human figures are said to represent "Stress Sub-items." The topmost areas to the right are headed "Stressors," and the list at the bottom right is labeled "Balancers." Other Webinars cover attention deficit disorder, autism, constipation, fatigue, fungus, headaches, high blood pressure, inflammation, skin tissues, sleep, and sneezing.
The Balance employs the same technology as the Pro in a greatly-simplified software interface. The Balance begins with a set of preprogrammed stressors to establish which systems need attention, then automatically assesses products designed to support those areas. A former ZYTO officials says that practitioners can learn how to operate the Balance in a few minutes and learn the basics of LSA operation in a single hour, and advanced techniques in a few more .
The strangest statement I have seen about ZYTO devices appears on its commonly asked questions page:
Q. Are the results reproducible?
A. No. In fact we do not expect them to be. In quantum physics this is referred to as quantum indeterminacy in which the observation or measurement itself affects the results. In effect, we have asked the body a question, received the response, and the body's energy has shifted in doing so. However, this does tell us that the first question yields the most accurate response because the body's energy has not yet changed as a result of the question-response event .
ZYTO Corp. was founded by Vaughn R. Cook, OMD. It is publicly held and quoted in Pink Sheets under the symbol ZYTC. Its shares began trading in 2006 at a price of $.70. The price per share was 3 cents on May 24, 2009 and about 8 cents on July 6, 2011. The Compass System Web site states that ZYTO's technology is used by thousands of health professionals around the world, with over 300,000 assessments . Google searches suggest that most of the practitioners in the United States are chiropractors.
The ZYTO Institute (same address and phone number as ZYTO Corp) provides online training. Its Web site offers manuals and many hours of Webinar videos.Most of the Webinars are presented by Jane Oelke, a Michigan practitioner who is said to have a "Ph.D. in Homeopathic Philosophy and Natural Health Sciences" from the Institute of Natural Health Sciences and a "Doctor of Naturopathy" degree from Trinity College of Natural Health. Neither of these schools is accredited by a recognized accrediting agency.
In 2009, Alternative Growth Streams of Woodstock, Georgia offered ZYTO practitioners a "comprehensive set of business-building marketing tools designed exclusively to empower you to get more clients and make more money with your ZYTO technology." The tools included an e-mail mailer, direct marketing mailers, and patient handouts. The e-mailer promised that ZYTO assessments will "help you cut down on the time it takes to get better" and "improve your chances of not getting sick in the first place."
ZYTO devices can be purchased or leased with a monthly fee. Its license agreements state that "Purchaser is aware that the purpose of the equipment is to assess the body’s response to certain computer generated stimuli called ‘virtual stressors’, and is not used to diagnose, treat, or cure health conditions or diseases."  ZYTO's definition of "stress" differs from popular usage and refers to "the body’s system to maintain balance or homeostasis by counteracting stressors," which include bacteria, injuries, allergies, lack of sleep, toxins, emotional strain, traumatic events, and "even the requirements of our physical systems (like digestion, adjusting blood pressure, etc.) which are exacerbated by poor health and lack of fitness." 
ZYTO claims that its devices are comparable to a printed health questionnaire and the pen the patient uses to fill in the blanks. It further claims to have "received documentation from Underwriters Laboratories (UL), a registered FDA consulting organization, stating that ZYTO’s technology is not a medical device and therefore does not require FDA registration." 
I do not believe that is correct. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic Act, the FDA will consider it to be a medical device subject to regulatory controls. The official definition of a device is:
- an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is . . . .
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which [is not a drug]. 
Under federal law, "intended use" is determined from the facts surrounding the device's marketing. It is not determined primarily by the language the manufacturer uses to describe what the device does. If a device requires software to function, the software must also be considered in determining intended use. I assume that ZYTO Corporation realized this because it did register with the FDA and received 510(k) clearance to market the device for "the measurement of galvanic skin response."  It remains illegal for any such device to be marketed as a diagnostic instrument, but FDA device regulators have demonstrated little interest in them.
ZYTO customers are led to believe and clearly expect its devices to assess the functioning of their body and to suggest products that can improve it. I believe that the FDA would consider the assessments to be a form of diagnosis and the the selection of products to be a form of treatment. I do not believe that using evasive language to describe its procedures can enable ZYTO to nullify its regulatory obligations. The claim that ZYTO devices are equivalent to a history form is preposterous because fill-in forms do not send and receive electrical signals from the body or make product recommendations intended to improve body functions.
ZYTO training videos also advise practitioners to be careful to use language that does not violate laws against unlicensed practice. However, state laws generally consider making health assessments and product recommendations to be diagnosis and treatment regardless of what the practitioner calls them.
The Bottom Line
Skin resistance to an electric current has no value in the diagnosis or treatment of disease. A device claimed to provide information or help with the management of hundreds of diseases and conditions could not be validated without a mountain of evidence substantiating usefulness and reliability. X-ray equipment is approved, for example, because the relationships between x-ray findings and physical findings have been studied in countless millions of cases. As noted above, however, ZYTO's results are not reproducible, which means that they cannot be validated!
ZYTO scans have no proven practical value and could cause large amounts of time and money to be wasted by people who believe the speculations.
- 16 commonly asked questions about ZYTO technology. ZYTO Corp. Web site, accessed May 24, 2009.
- "The Balance is the most advanced automated nutraceutical prioritization system of its kind." HealthEvolution Technologies, April 17, 2008.
- Network marketing and sales tool. Compass System Web site, accessed May 24, 2009.
- LSA Pro 2008 User Guide. Orem, Utah: ZYTO Corp., 2007.
- Compass flyer. ZYTO Corp., copyright 2008.
- Purchase. Bioenergetic Technology Web site, accessed May 26, 2009.
- Questions frequently asked about our technology. Zyto Corp. Web site, accessed May 24, 2009.
- Compass licensing agreement. Accessed online on May 25, 2009.
- Stress is your friend. Bioenergetic Technology Web site, accessed May 26, 2009.
- Pink Sheets, Section One, Issuer's initial disclosure obligations. Undated, issued during 2008.
- Is the product a medical device? FDA Web site, March 1, 2010.
- 510(k) Summary. K11308, Aug 30, 2011.
This article was revised on December 21, 2012.