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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Multi-channel Smartphone Spectrometer Enables Clinical Laboratory Testing Quickly and Accurately in Remote Regions

Researchers say high accuracy of this $150 portable optical spectrometer enables mobile diagnostic technologies to achieve pathology test results comparable to traditional spectrometers costing far more

What’s the latest thing in a smartphone diagnostic device? It’s a multi-channel smartphone spectrometer! Researchers at Washington State University (WSU) designed the device to detect human cancer biomarkers. It’s hoped that this device can improve cancer detection in rural areas where clinical laboratories may not be easily accessible.

The Multichannel Smartphone Spectrometer (MSS) is a highly accurate, low-cost, portable diagnostic device capable of detecting human cancer biomarkers equally well in rural and busy hospital settings. (more…)

Cleveland Clinic Gives Patients Statewide 24/7 Access to Physicians through Smartphones, iPads, Tablets and Online: Will Telemedicine Also Involve Pathologists?

New service allows patients statewide to access urgent care via telephones and other devices as Cleveland Clinic positions itself to be a 24/7 provider of choice

Urgent care by telephone is the latest patient-centric and customer-friendly medical service to be offered by the Cleveland Clinic. It is also the first 24-hour online statewide healthcare service of its kind in Ohio, a milestone that has implications for pathologists and clinical laboratory executives because lab testing is often required in support of patients wanting access to urgent care, particularly after hours.

Express Care Online (formerly MyCare Online) is the Cleveland Clinic’s new telemedicine service. It enables patients to see a medical professional for urgent matters via computer or smartphone 24 hours a day/seven days a week, according to a Cleveland Clinic statement. (more…)

“Medical Lab for the Home” Device Can Identify Cardiac Markers in Patient’s Blood, Then Relay Information to Physician by Smartphone

New device is designed to perform clinical laboratory testing by using nanoelectronic technology to measure multiple diagnostic parameters in patients’ homes 

Researchers have developed yet another device that takes its readings from a patient’s internal bio-markers. This devices analyzes, then transmits the data directly to doctors’ smartphones to assist in the diagnosis and treatment of disease. Developers say use of this system may potentially enable doctors to treat patients in their homes without meeting with them in person.

Mobile Wireless System Designed to Help Patients with Chronic Illnesses

For pathologists and clinical laboratory managers, this research is another example of how technology can be used to take diagnostic testing out of centralized laboratories and put it closer to the patient. This particular miniature device is part of a mobile wireless system designed to aid the elderly and those with chronic illnesses remain independent by allowing continuous monitoring in the home and helping physicians diagnose problems including myocardial infarction early.

The technology for this home-testing system was co-developed by researchers from Fraunhofer Institute for Applied Information Technology and researchers from Berlin Charité, T-Systems, and multiple international partners in the Federal Ministry of Education and Research (BMBF)/EU-funded project Nanoelectronics for Mobile AAL Systems (MAS). (more…)

Scanadu is Preparing Consumer Self-Test Device for Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests

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. (more…)

Cue’s Smartphone Device Intended to Give Consumers an Inexpensive Way to Perform Certain Medical Laboratory Tests at Home

Company says it will offer five diagnostic tests that are useful to the public and some of these tests are among the highest volume tests performed by clinical labs

Heading to market is another device that works with a smartphone to provide consumers with a way to perform five popular medical laboratory tests. The product was developed by Cue, Inc., which describes itself as an entrepreneurial mobile diagnostics developer.

Cue is an at-home lab test device targeted at consumers. It will be priced at about $300, noted a report published by MobiHealthNews.

“We’re very interested in putting the power of the lab into the consumer’s hands in this new way,” said Clint Sever, Cue Cofounder and Chief Product Officer. However, pending Food and Drug Administration (FDA) clearance, Cue’s device is being presold under an “investigational exception” for $199, with promise of delivery in spring 2015.

Cue Allows Consumers to Perform Five Routine Lab Tests at Home 

Initially, Cue will perform tests for influenza; testosterone; vitamin D; C-reactive protein (a marker for inflammation); and luteinizing hormone (an indicator of a women’s fertility) But that is just for starters.

According to Ayub Khattak, Cue Cofounder and CEO, the company plans to add more medical lab tests in the future. “The large majority of tests you do in the [clinical] lab today, we want to give you access to in your home,” he declared.

Ayub Khattak (pictured above), Cue Cofounder and CEO, says the Cue device will initially preform five routine tests, but other lab tests will be available in the future, (Photo copyright Cue)

Ayub Khattak (pictured above), Cue Cofounder and CEO, says the Cue device will initially preform five routine tests, but other lab tests will be available in the future, (Photo copyright Cue)

In its blog about Cue, IEE Spectrum noted that the first five clinical laboratory tests the company designed to run on its device were selected because these are the most common tests run by labs and, therefore, are the most useful to the public. Sever and Khattak observed in the MobiHealthNews story that all of these tests—except the influenza test—are used in monitoring a patient’s condition and are done regularly.

Athletes and older men, for instance, want to keep tabs on their testosterone levels. People are interested in Vitamin D because it affects mood. Clinical laboratories perform 70-million Vitamin D yearly, according to Khattak. Inflammation is both a predictor of heart disease and a counter indicator for intense workouts, so if the tests indicated elevated C-reactive protein, a person may want to back off from exercise for a little while, he added. The test for luteinizing hormone tells a woman when she is likely to conceive.

The influenza test, on the other hand, allows parents or other caretakers to check for flu at home, similar to taking a child’s temperature. Sever emphasized that the flu test isn’t meant to replace a doctor visit. “It just gives you more information so you can have an informed conversation with your doctor,” he said.

How the Cue Device Works

The Cue device is about the size of a Rubik’s cube. The test cartridges are about the size of a matchbox. Each cartridge uses blood, saliva, or mucus samples to conduct home lab tests. Each cartridge contains microfluidic channels and the necessary reagents for the test to be performed.

When the cartridge is inserted, Cue prompts the user to collect a sample with the sample wand that is included with the device, explained the IEE Spectrum blog. The testosterone test requires a saliva specimen. The flu test uses a nasal swab, and the other tests require a drop of blood as the specimen.

Once the sample wand is inserted into the cartridge, the reagents combine with the sample inside the cartridge. A sensor then looks for the target molecule, such as testosterone or Vitamin D, and detects the quantity or level. Cue sends this information via Bluetooth to the user’s iPhone or Android smartphone. The smartphone app allows the user to track results over time, and offers suggestions for improving health status. For example, Sever said Cue might recommend specific foods or exercise to boost low testosterone level.

Can Cue Produce More Accurate Tests Than Clinical Laboratories?

Khattak can’t make claims about the accuracy of Cue’s technology because it hasn’t yet been cleared by the FDA, noted the MobiHealthNews story. But the devices inventors believe that Cue tests have the potential to be more accurate than those performed in clinical laboratories, because the human error factor is eliminated.

“What we’ve done is we simplified and automated the whole process,” explained Khattak. “So whereas a lab technician might have 10 steps and they might do 10 of them quite well, those little errors in each of the steps add up. And human error is the largest cause of variation and deviation from standard reproducible results… With us, it is one step. You add the sample, and then you get your results.”

Cue, a modular, Rubik-cube-sized device, uses simple microfluidic laboratory technology to perform five different medical laboratory tests that people routinely have done, including testosterone and vitamin D levels, inflammation, fertility and influenza. The device is being presold under an investigational exception to consumers for $199, with promise of delivery in spring 2015. Once approved by the FDA, the price will be $300. (Photo copyright Cue)

Cue, a modular, Rubik-cube-sized device, uses simple microfluidic laboratory technology to perform five different medical laboratory tests that people routinely have done, including testosterone and vitamin D levels, inflammation, fertility and influenza. The device is being presold under an investigational exception to consumers for $199, with promise of delivery in spring 2015. Once approved by the FDA, the price will be $300. (Photo copyright Cue)

Investors are Successful Tech Entrepreneurs and Diagnostics Experts

Clinical laboratory managers might find it interesting that Cue investors are successful entrepreneurs with expertise in both diagnostics and digital technologies. The investor group includes two University of California, Los Angeles (UCLA) professors, as well as an anonymous private investor, noted MobiHealthNews.

One of the UCLA professors is Aydogan Ozcan, Ph.D., who heads up UCLA Engineering’s Bio- and Nano-Photonics Laboratory. His private company, Holomic, also develops smartphone diagnostic devices. Dark Daily has written about Ozcan’s work. (See Dark Daily, “Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology,” June 25, 2010.)

The other founder is Patrick Soon-Shiong, M.D., a former UCLA Medical Professor, who currently serves on the advisory board of UCLA Engineering’s Institute for Technology Advancement. Known as “LA’s billionaire doctor,” Soon-Shiong, a surgeon-turned-entrepreneur, is co-inventor on more than 40 U.S. and foreign patents and has sold two successful businesses for $8.5 billion.

Last year, Soon-Shiong launched Los Angeles-based Nantworks, LLC, a company that aims to revolutionize medicine by adding “Big Data” to patient care. Soon-Shiong also serves as Providence Health & Services’ Director for Cancer Services and Bioinformatics.

Will Consumers Pay for a Device that Does Medical Lab Tests at Home?

Will consumers be willing to pay $199 for a medical laboratory testing device that hooks up to their smartphone or tablet PC? The founders of Cue will find out next year, assuming that FDA clearance is forthcoming and the device reaches the market. Also, will Cue perform medical lab tests with accuracy that is comparable with that of the nation’s best clinical laboratories? There are many pathologists and lab scientists who will be prepared to challenge that statement.

—By Patricia Kirk

Related Information:

Cue to offer at-home, smartphone connected lab tests

New Gadget Gives Consumers At-Home Lab Tests

New iPhone App Allows Consumers to Test Their Urine on the Go for as Many as 25 Different Diseases

Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology

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