News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens

Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.

The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices.

Perform a Urinalysis at Home on a Smartphone

Called ScanaFlo, the device can tell from a urine sample if a person is pregnant, diabetic, or has been smoking pot, noted a Tech Crunch report.

ScanaFlo’s small, disposable paddle with multi-colored test strips and built-in QR (quick response) code tests levels of:

• glucose,
• protein,
• blood in urine,
• specific gravity, and,
pH level.

It also tests for pregnancy.

When the reagents react with urine, the results show up as colors on the pee stick. An iPhone app uses these colors to analyze the urine and report results. (Photo copyright Scanadu.)

When the reagents react with urine, the results show up as colors on the pee stick. An iPhone app uses these colors to analyze the urine and report results. (Photo copyright Scanadu.)

Scanadu plans to market the ScanaFlo device to consumers as a personal health-monitoring tool that alerts users there may be a health problem that requires physician attention.

“Consumers don’t have the tools they need to monitor their health and make informed decisions about when they’re actually sick and need to see a doctor,” stated Walter De Brouwer, Ph.D., Founder of Scanadu, in a Scanadu press release. “We want to empower consumers to take control of their health and give them direct access to their personal health-feed.”

This video illustrates Scanadu’s vision for smartphone enabled health-tracking devices. (Video copyright Scanadu.)

Mobile Urine Test Kit Could be Disruptive to Clinical Labs

Scanadu is preparing to seek U.S. Food and Drug Administration (FDA) approval for ScanaFlo, which is currently in the testing phase. Once cleared by the FDA, this inexpensive urine testing platform could present clinical laboratories direct competition, by offering consumers a convenient, low-cost home urinalysis product, and doctors a way to test patients onsite and get immediate lab results.

According to another Scanadu press release, the ScanaFlo could also measure pregnancy complications, such as:

gestational diabetes,
• heart-related kidney problems, and,
• urinary tract infections.

“Today’s urine tests are really hard to use and the results are not easy to interpret,” said Aaron Rowe, Ph.D., a Fitbit research scientist who formerly served as Research Director at Scanadu, in the Scanadu press release. “ScanaFlo will make it simple for pregnant women to monitor themselves for complications between appointments with their doctor.”

Scanadu Scout Enters Clinical Trial

ScanaFlo is Scanadu’s second health-tracking device. The first was the Scanadu Scout, a sensor device that when placed on the forehead monitors, analyzes, tracks and trends the user’s vitals in just 10 seconds. This includes:

• temperature,
• respiratory rate,
pulse oximetry,
• ECG, and,
• systolic and diastolic blood pressures.

Study Participants Help with FDA Approval

Scanadu has already shipped a pre-market investigational version of the Scout to contributors who responded to an Indiegogo crowdingsourcing campaign that raised nearly $1.7 million. Those contributors to the campaign received the early version of the Scout and agreed to take part in a Consumer Health Outcomes Study under way to win FDA approval. Eric Topol, M.D., Director of the Scripps Translational Science Institute in San Diego, California, is managing the study.

Scanadu also raised a total of $14.7 million in Series A funding from various investors to support the company’s marketing strategy, manufacture these mobile diagnostic devices, and see them through FDA clearance, as well as add talent to the Scanadu team.

Jerry Yang, Co-founder of Yahoo, Inc. (NASDAQ: YHOO) and Founding Partner of AME Cloud Ventures (one of Scanadu’s major investors) stated in a Scanadu press release, “Scanadu is right at the heart of the next generation of computing which combines mobility, sensors, cloud and big data.”

Walter De Brouwer, Ph.D

Founder of Scanadu is Walter De Brouwer, Ph.D. (pictured above). He is a respected inventor and serial entrepreneur. In 2013, De Brouwer was a finalist for a World Technology Award in the category of Health & Medicine (Individual). At Scanadu, De Brouwer is developing point-of-care devices for use by consumers that can perform tests using many of the same biomarkers that are found in clinical laboratory tests. (Photo copyright Scanadu.)

Scanadu/ Intelesens Collaborating to Win $10-million Tricorder XPRIZE

Scanadu and Intelesens Ltd., a medical tech company based in Belfast, Northern Ireland, have formed a collaborative team to compete for the $10-million Qualcomm Tricorder XPRIZE by building a device that combines the features of the Scanadu Scout with Intelesens’ Zensor, a device that monitors ECG, heart rate, respiration rate, and motion in real-time. Both devices separately are already finalists in the competition.

Once approved by the FDA, the Scout is expected to retail for about $199.  No pricing is yet available for the ScanaFlo diagnostic device.

—Patricia Kirk

Related Information:

Scanadu Packs More Features into Scanadu Scout; Unveils Design for ScanaFlo

Scanadu’s New Pee Stick Puts the Medical Lab on Your Smartphone

Scanadu Aims to Empower Patients with DIY Vital Signs Device

Scanadu Secures $10.5 Million in Series A Funding from Relay Ventures, Tony Hsieh and Jerry Yang

Scanadu and Zensor Join Forces to Form Team Scanadu/Intelesens in Quest for $10 Million Qualcomm Tricorder XPRIZE

Pathologists and Clinical Lab Scientists: Design a Modern ‘Tricorder’ and You Could Win $10 Million from the XPRIZE Foundation!