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DARK Daily Laboratory and Pathology News

DARK Daily is an e-briefing service providing up-to-the minute news of relevance for anyone working in diagnostic medicine, from clinical laboratories and pathology groups to lab industry suppliers and diagnostic technology companies. DARK Daily is part of The Dark Intelligence Group, Inc. and is dedicated to bringing useful business and management intelligence to laboratory managers, pathologists and diagnostic executives. Our recognized expertise in the strategic direction of laboratory medicine and the management of laboratories is available through DARK Daily, The Dark Report, free White Papers, Lab Resource Directory, the Executive War College on Laboratory and Pathology Management, Lab Quality Confab, and strategic consulting services.

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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

Higher Enrollment in Medicare Advantage Plans Means that More Local Clinical Laboratories and Pathology Groups Lose Access to these Patients

Health insurers offering Medicare Advantage plans are narrowing their networks and favoring the national clinical lab companies over local medical labs and pathology groups

Enrollment in Medicare Advantage health plans is booming. This development is not auspicious for local medical laboratories, hospital lab outreach programs, and anatomic pathology groups because the private health insurers operating these plans typically prefer to contract with national lab companies while narrowing their lab networks.

The mathematics of this trend are simple. As Medicare Advantage enrollment increases, the proportion of patients covered by traditional Medicare Part B fee-for-service shrinks. The consequence is that local labs have fewer Medicare Part B patients to serve and are locked out of providing medical laboratory testing services to Medicare Advantage patients. continue reading

Thomas Jefferson University Study Finds Critical Weakness in Commercially Manufactured Exome-Capture Test Kits Used by Some Medical Laboratories

The four exome test kits examined as part of this study failed to deliver quality results, particularly because they often missed some disease-causing mutations altogether

Human exome sequencing is gaining favor among medical laboratories wanting to use this information for clinical purposes. However, the accuracy of some exome-capture test kits available on the market today has come under question.

A team from the Thomas Jefferson University in Philadelphia surveyed the potential false-negative rate of mutations in 56 disease-causing genes produced by four different commercially available human exome-capture test kits. The researchers found that these test kits failed to deliver quality results, sometimes missing mutations altogether, noted a report published by Medical Daily. continue reading

2014’s Healthcare Price Transparency Report Card Reveals Few States Are Making It Easy and Fast for Consumers to See the Prices Charged by Hospitals, Physicians, and Medical Laboratories

One reason is that the healthcare price websites operated by most states are inadequate, ‘poorly designed or poorly functioning’

Efforts to encourage price transparency at hospitals and other providers are making little progress. That’s one conclusion to be made from the second annual Report Card on State Price Transparency Laws, that gave a failing grade to 45 states.

This information is relevant because more consumers are now enrolled in high-deductible health plans. As a consequence, clinical laboratories and anatomic pathology groups must now handle requests from patients who want to know the cost of their medical laboratory testing in advance of service. As well, many of these consumers want to negotiate prices with their laboratory provider. continue reading

University of Texas Researchers Reveal a Portable Cancer Detection Device with the Potential to Significantly Reduce the Number of Skin Biopsies Sent to Dermatopathologists

Team of bioengineers succeeds in putting three different imaging technologies into a handheld probe that could be used by physicians to assess skin lesions in their offices

Dermatopathologists and pathology practice administrators will be keenly interested in a new, hand-held diagnostic device that is designed to reduce the need for skin biopsies. Because of high volume of skin biopsies referred to pathologists, any significant reduction in the number of such case referrals would have negative revenue impact on medical laboratories  that process and diagnose these specimens.

This innovative work was done at the University of Texas at Austin’s Cockrell School of Engineering. The research team developed a probe that uses three different light modalities to detect melanoma and other skin cancer lesions in real-time, according to a news release.
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