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

Hosted by Robert Michel

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

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Technologies on IBM’s 5-in-5 List Could Impact Pathology and Clinical Laboratories

This year, one of IBM’s closely-watched picks of the technologies most likely to have the greatest impact on society is the medical lab-on-a-chip

Clinical laboratory testing and diagnostics are one of the five technologies included in IBM’s 2017 list of the technologies it predicts will have the greatest impact on society during the next five years. Of equal interest to medical laboratory professionals is that several of the other technologies included in IBM’s list have the potential be used in medical laboratories and anatomic pathology groups.

IBM Research, corporate research laboratory for parent company IBM (NYSE:IBM), has more than 3,000 researchers working in 12 labs on six continents. Each year the lab releases a list of five technologies it forecasts will have the greatest influence on how our bodies, minds, society, and the planet, develop over the next five years. The list is called “5-in-5” and has been released annually for the past 10 years by the tech giant. (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

Meet the Nation’s Top 10 Healthcare Systems for Quality

Advanced use of EHRs is one characteristic of nation’s quality leaders

It’s a new study and ranking of top-performing health systems that Dark Daily readers will find interesting and useful. Thomson Reuters announced its latest Top 10 rankings, and identified three main ingredients for attaining higher-quality outcomes. They were: 1) a corporate-level coordinating committee; 2) ample involvement in planning from front-line caregivers; and a system-wide electronic health record system (EHR).

Thomson-Reuters evaluated 252 health systems, representing 1,720 hospitals. Its findings were published exclusively in Modern Healthcare. Its rating was based on five clinical performance measures: mortality, complications, patient safety, length-of-stay and use of evidence-based medicine. No attempt was made to measure financial performance. The health systems study used 2007 information from two public databases, the Medicare Provider Analysis and Review and Center for Medicare and Medicaid Services’ Hospital Compare.
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CDC Data Shows Why Clinical Labs Continue to Identify Cases of A/H1N1 Flu

Clinical labs continue see higher-than-normal flu activity in what is typically the off-season

New cases of A/novel H1N1 continue to show up in the United States and worldwide. It means that influenza activity at clinical laboratories is higher than normal for this time of year. These continuing influenza cases affirm why public health officials expect a busy flu season this fall and winter.

In fact, data from the federal Centers for Disease Control and Prevention (CDC) show that overall influenza activity decreased in the United States in recent weeks compared to late April and early May. At the same time, the novel A/H1N1 flu has spawned a second flu season this year, extending into the summer months of 2009.

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As WHO Declares Flu Pandemic, Public Health Lab Trainers Gather in Orlando

Public health lab training professionals expanding educational offerings for lab industry

It was inspired timing last week that brought together the nation’s public health laboratory training professionals in Orlando, Florida, just as the World Health Organization (WHO) announced its decision on Thursday to declare influenza A/H1N1 as the first influenza pandemic in 41 years.

This conference was organized by the National Laboratory Training Network (NLTN), in association with the Association of Public Health Laboratories (APHL) and the Centers for Disease Prevention and Control (CDC). Approximately 100 public laboratory professionals from across the United States were in attendance.

The first keynote speaker was May C. Chu, Ph.D., who works in the Directors Office of the World Health Organization and is involved in laboratory testing activities that include epidemic and pandemic alert and response. Chu discussed the Global Outbreak and Response Network that WHO established on a voluntary basis in 2000. It has 120 participating institutions. She described how improved collaboration among health authorities around the world is helping to accelerate the identification of outbreaks like SARS (in 2003) and influenza A/H1N1 (in 2009).

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