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MX3 Diagnostics Emerges From Stealth Mode With POC Saliva-Based Hydration Test

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NEW YORK – To address a need for effective hydration testing for athletes, MX3 Diagnostics recently emerged from stealth mode with the launch of a saliva-based test that uses a handheld device that can be applied at the point of care.

The saliva test is a microfluidic device that conducts electrochemical measurements of the ionic density, or osmolarity, of saliva, MX3 CEO and Cofounder Michael Luther said in an interview.

It provides an alternate option to blood or urine tests already used to measure and track hydration in athletes, military personnel, and others.

Dehydration, a common occurrence among many athletes, can have harmful effects on physical health and cognition, and hydration status is often overlooked, Luther said.

Austin, Texas-based MX3 said its technology enables lab-quality health diagnostics for health and fitness applications without the complications and costs associated with doing laboratory testing.

In its test, the MX3 Hydration Testing System Pro Version, users touch the tongue to gather a microliter of saliva. An app available for Apple and Android devices stores and tracks hydration information over time, allowing users to personalize their hydration strategies, and a web-based portal enables users to set up and access their hydration information.

Physicians frequently rely on physical exams in assessing dehydration, according to Luther. Professional teams and others frequently use point-of-care urine tests that measure urine specific gravity, he noted. In hospital labs, blood tests are used to measure osmolarity, but the technology developed by MX3 doesn't require testing in a lab, and it's more sensitive to detecting dehydration than urine specific gravity testing, he said.

Researchers at Monash University in Melbourne, Australia conducted an independent validation of the MX3 system on a group of athletes in March. They "observed an excellent correlation between salivary osmolarity readings performed with the handheld MX3 Hydration Testing System and a [US Food and Drug Administration]-registered laboratory benchtop osmometer," according to a report provided to MX3 by Patrick Kwan, a professor of neurology at Monash University, who led the testing. Kwan specializes in research into epilepsy and personalized medicine. He and his colleagues took osmolarity measurements of 20 saliva samples using a benchtop Advanced Instruments micro-osmometer and the MX3 test.

Luther said that the firm has observed similar results while conducting internal validation studies. The firm has launched its hydration testing system for sports and fitness applications, but it also has other applications in mind, including enabling monitoring of hydration status in military personnel, he said.

By reliably assessing hydration status, users — whether they are athletes or military personnel — can adjust fluid intake and activity levels and monitor the effects of hydration over time, he noted. With regular and repeated use, the system enables identifying an optimal hydration zone for each user, making it easy to maintain proper hydration levels for general health and performance, he said.

The company said its hydration testing system has been in use since 2018 to track hydration levels and improve athletic performance by athletes such as Sweden's men's World Cup soccer players and elite endurance runners.

The MX3 hydration testing system is more reliable and easier to implement than urine specific gravity tests that professional teams often use to evaluate levels of hydration, Dale Reese, medical and performance coordinator for the Swedish national soccer team, said in an interview.

Reese began implementing the new test with the Swedish national team in January this year, and he has adopted it for a regional team, IFK Norrköping.

He said it can take about two hours to complete testing for all of his players when he conducts urine specific gravity testing, and they tend to not want to take the tests. By contrast, the MX3 hydration testing system lets players and team officials receive results within minutes, and players are trying out different hydration tactics and competing to get the optimal values, he said.

More important, Reese added, he is using the test to ensure that soccer players start hydrating a few days before a game and to conduct spot tests at halftime during games on players that he suspects may be dehydrated. The results of testing can help coaches decide whether to substitute a player during the second half of a match, he said.

Reese said that variations observed in conducting urine specific gravity testing is eliminated using the MX3 hydration testing system. A variety of issues, such as urinary tract infections, can alter hydration rest results using urine specific gravity as a hydration marker, and in some instances lead to inaccurate results, he said.

MX3 said that the US military is testing the potential of its system to determine dehydration of its personnel in the field, and hospitals in Indonesia and China are validating its use to test hydration levels in children.

The company also is developing the saliva test to measure other health markers including those related to energy levels, exercise workload and recovery, diet, nutrition, sleep, and stress. The current test does not require an approval by the US Food and Drug Administration because it provides health information that carries less risk than that provide by devices that require the regulatory agency's approval, Luther said. However, future tests could require approval, and therefore the firm is discussing regulatory requirements with the FDA, he added.