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

Hosted by Robert Michel
Sign In

Millennials Forge New Paths to Healthcare, Providing Opportunities for Clinical Laboratories

Time, cost, and technology are cited as reasons why Gen Y, or Millennials, choose non-traditional healthcare settings, such as urgent care centers, in greater numbers than other age groups

Younger Americans increasingly seek healthcare through non-traditional means, such as urgent care centers and retail health clinics. This trend among Millennials (AKA, Gen Y) to seek healthcare outside of traditional medical settings could present opportunities for clinical laboratories and anatomic pathology groups that service such providers.

In “For Millennials, a Regular Visit to the Doctor’s Office Is Not a Primary Concern,” the Washington Post (WP) notes that young adults—born between 1981 and 1996—make up the largest generational group in the United States, and that they prefer “convenience, fast service, connectivity, and price transparency.”

The proliferation of retail clinics and urgent care centers demonstrates that those preferences often are not met through a traditional primary care doctor’s office or hospital visit, which Dark Daily has reported on extensively in past years.

“The whole ‘going to the doctor’ phenomenon is something that’s fading away from our generation,” Calvin Brown, a 23-year old graduate of the University of San Diego, told the Washington Post. “It means getting in a car [and] going to a waiting room.”

The WP article is a reposting of a Kaiser Health News article titled, “Spurred by Convenience, Millennials Often Spurn the ‘Family Doctor’ Model.”

To PCP or Not to PCP? That Is the Question

Several polls and surveys in the last few years reveal how young adults are—and are not—choosing to receive care. For example:

  • Kaiser Family Foundation (KFF) polled 1,200 randomly selected people 18-years and older and found that 26% did not have a primary care provider (PCP). And KFF found clear generational differences: 45% of those between 18 and 29 did not have a PCP. But just 28% of those aged 30 to 49 did not have PCPs. KFF concluded that older adults were more likely to have a PCP.
  • The “2017 Consumer Engagement in Health Care Survey” conducted by the Employee Benefit Research Institute (EBRI) and Greenwald and Associates yielded similar results. It found that 33% of people classified as Millennials do not have a primary care doctor, but that only 15% of people aged 50-64 did not have a PCP.
  • The “2016 Health Care Cost and Utilization Report” by the Health Care Cost Institute notes that fewer people overall went to primary care offices from 2012 to 2016. Millennials may be discarding the traditional PCP model, but it seems other age groups also are accessing care in non-traditional ways, as well.
  • The RAND Corporation reported in “The Evolving Role of Retail Clinics” that “Retail clinics typically serve younger adults who do not have a primary care provider,” among other interesting trends about the steady growth of urgent care centers and care centers located in big box stores and pharmacies.

Convenience, Cost, and Connectivity Matter

There are clear reasons younger adults eschew primary care providers. One frequently cited reason is time. It typically takes days or even weeks to be seen by a PCP. Then, there’s the time spent in the waiting room.

Tara Carter, a 20-something young woman living in the Washington, DC, area told Healthline that going to a PCP isn’t an efficient use of her time, and that a retail-type clinic is “sufficient to get the help I need and get out the door and back in bed—without waiting days for an appointment that didn’t fit my schedule.”

Cost also is a factor. With high-deductible health plans becoming more common, especially among lower-income families, pricing transparency of retail clinics is appealing. Millennials report being more comfortable paying $40-90/visit at an urgent care center, than visiting a PCP and not knowing the cost until the bill arrives.

Technology—and their preference for using it—also contributes to Millennials’ choices in PCPs. Telemedicine, for example, is a popular option with young adults. About 40% of Millennials say telemedicine is an “extremely or very important” option, compared to 27% of those who are classified as Gen X, and just 19% of Baby Boomers, according to Healthcare IT News.

Mott-Blair-MD

Kaiser Health News notes that, Mott Blair, MD (above), in Wallace, N.C., adopted technologies in his family medical practice to accommodate millennials. “We do far more messaging and interaction through electronic interface,” he told KHN. “I think millennials expect that kind of connectivity.” He also implemented same-day appointments. (Photo copyright: American Academy of Family Physicians.)

What All This Means for Clinical Laboratories

Clinical labs have, traditionally, been aligned with the primary care provider model. And, as Lab Testing Matters notes, “customer service has historically been assessed by how well the laboratory communicated with the medical staff.”

With younger consumers taking a more active role in defining quality in healthcare, the definition of customer service is changing.

There are some things that labs can do to win the business of Millennials:

  • Provide patients access to their test results;
  • Accept requests from patients for interpretation of those results;
  • Allow patients to request tests without orders from a doctor;
  • Encourage interaction through patient portals;
  • Train lab personnel to communicate with patients;
  • Remain aware of the power of social media; and,
  • Recognize that millennials value price transparency, including lab test prices.

Price transparency is likely to continue gaining importance, as well as precision medicine. Clinical laboratories are, in many ways, well-positioned to serve Millennials. Establishing clear lines of communication, making it easy to access services, and adopting a wider definition of customer service are the paths forward for those pathology labs aiming to serve younger patients.

—Dava Stewart

Related Information:

For Millennials, a Regular visit to the Doctor’s Office Is Not a Primary Concern

Spurred by Convenience, Millennials Often Spurn the ‘Family Doctor’ Model

2016 Health Care Cost and Utilization Report

The (Family) Doctor Isn’t In: Millennials Are Rejecting Primary Care Physicians

The Evolving Role of Retail Clinics

Millennials Demand Telehealth in a Move Away from Traditional Primary Care Model

The Latest Thing Millennials Are Killing? The Primary Care Doctor

 

FDA Clears AI Device for Diagnosis of Diabetic Retinopathy; Is this Favorable for Use of AI in Digital Pathology?

FDA clearance of a cloud-based, AI system capable of diagnosing diabetic retinopathy using retinal images highlights the potential for deep learning and algorithmic analysis to assist and, in some cases, replace diagnosticians in medical tests

While clinical laboratories and anatomic pathologists have seen an increasing amount of research and concepts related to artificial intelligence (AI) for diagnostic purposes, few technologies have reached a point where they are ready for clinical applications.

However, the FDA’s recent clearance of the IDx-DR AI diagnostic system from IDx Technologies Inc. of Coralville, Iowa, through the De Novo premarket review pathway, illustrates how image-based AI systems might one day help clinicians, anatomic pathologists, and other care providers diagnose disease and guide therapy decisions.

Already in use at University of Iowa Hospitals and Clinics (UIHC), the device uses cloud computing and algorithms to “autonomously analyze images of the retina for signs of diabetic retinopathy,” according to the IDx website.

This allows IDx-DR to provide a screening decision roughly 20 seconds after image capture.

The IDx-DR system

The IDx-DR system (above) delivers a binary result. When signs of diabetic retinopathy are present, the system recommends a follow-up with an ophthalmologist. If it detects no signs of the condition, the system recommends a follow-up screening in one year. All of this happens without input from a clinician or the services of a medical laboratory. (Photo copyright: Modern Healthcare.)

In a clinical study involving 900 participants published in Nature, a similar AI system achieved 87.2% sensitivity and 90.7% specificity in the detection of diabetic retinopathy, exceeding pre-specified primary endpoint goals.

“AI tools can help physicians handle a lot more data a lot more quickly and help them prioritize,” Susan Etlinger, an industry analyst with the Altimeter Group, told Modern Healthcare. “Theoretically, that could give a family physician a lot more tools in [his/her] toolbox to be able to run an initial diagnostic on somebody and then refer that person for additional treatment.”

Full Integration Shows Promise for Streamlining AI and Diagnostics Workflows

The ability to reach a diagnosis without a clinician already holds potential to drastically impact the workflows and services of medical laboratories and other diagnosticians. However, IDx Technologies also showed how AI might influence data interfacing, while explaining to Modern Healthcare how they have integrated IDx-DR with the electronic health record (EHR) systems of UIHC.

“No one has ever integrated a diagnostic system where there’s no human involved,” noted Michael Abramoff, MD, PhD, Chief Executive Officer and founder of IDx. “We’re ramping up slowly because we want to make sure we work out all the kinks with the EHR and the workflow.”

Once the AI system analyzes images captured by a Topcon TRC-NW400 non-mydriatic retinal camera, results are then automatically communicated to an EHR using Health Level-7 (HL7) interfacing. The entire process is automated once the image is captured.

“The general advantages of AI include automation of certain tasks. This automation allows for increased scale, i.e. increased access, to a service. For systems like IDx-DR, it also allows talent to shift focus to other high priority areas.” Maia Hightower, MD, Chief Medical Information Officer and Chief Population Health Officer for University of Iowa Healthcare, told Digital Journal. “Healthcare is an industry where there is a critical shortage of key talent including medical assistants, nurses, and physicians. AI helps to detect both operational and clinical high-risk areas so that limited resources can be targeted to areas of highest need or greatest return.”

The process used by UIHC highlights potential benefits for medical laboratories as AI continues to impact diagnostic workflows and information processing. The ability to streamline workflows and offload repetitive tasks to automation or AI could allow skilled laboratory workers to further focus on diagnosing complex or difficult cases.

Ryan-Amelon-PhD-IDx

“Due to the highly robotic nature of the camera and the fully autonomous diagnosis, virtually anyone in a healthcare setting can be trained to operate IDx-DR,” Ryan Amelon, PhD, Director of Research and Development at IDx told Digital Journal. “The result is displayed to the user in under a minute or inserted directly into the EMR. The entire patient experience is roughly five minutes.” (Photo copyright: LinkedIn.)

Applying AI to More types of Medical Diagnoses

In an editorial published in NPJ Digital Medicine, Pearse Keane, MD, a clinician scientist at the National Institute for Health Research (NIHR) in the UK, and Eric J. Topol, MD, Director of the Scripps Translational Science Institute (STSI) and Executive Vice President at Scripps Research Institute, posted questions concerning the IDx-DR system and its FDA clearance.

According to Healthcare IT News, key concerns includes:

  • A relatively small sample size to determine diagnostic accuracy;
  • The ability of clinics to incorporate retinal screening into their practices; and,
  • The ability for IDx-DR to detect diabetic neuropathy when patients present other more severe retinal conditions.

Despite these concerns, Keane and Topol note, “While it is always easy to be critical of studies that forge new ground, it is important to applaud the authors for this pivotal work.”

For anatomic pathology laboratories, the IDx-DR system represents a proof of concept that AI and deep learning can analyze medical images—in this case, retinal photographs—and work alongside or in place of trained professionals to make decisions and guide the diagnosis process. How long before similar AI diagnostic systems find their way into clinical laboratories?

“Although deep learning will not be a panacea, it has huge potential in many clinical areas where high dimensional data is mapped to a simple classification and for which datasets are potentially stable over extended periods,” Keane and Topol concluded in their editorial. “As such, it will be incumbent on healthcare professionals to become more familiar with this and other AI technologies in the coming years to ensure that they are used appropriately.”

—Jon Stone

 

Related Information:

AI Alone Now Making the Diagnosis

Pivotal Trial of an Autonomous AI-Based Diagnostic System for Detection of Diabetic Retinopathy in Primary Care Offices

FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

With an Eye to AI and Autonomous Diagnosis

AI Diagnostic Tool Plows through FDA Clearance, But Some Experts Not Convinced

New AI System That Tests for Diabetic Eye Disease

University of Iowa Healthcare Rolls Out First Autonomous AI Diagnostic System Cleared by the FDA

FDA Greenlights Tool for Automated Detection of Diabetic Retinopathy in Primary Care

The FDA Just Opened the Door to Let AI Make Medical Decisions on Its Own

AI Can Deliver Specialty-Level Diagnosis in Primary Care Setting

U.S. FDA Approves AI Device to Detect Diabetic Eye Disease

 

McKinsey and Company Report Highlights Precision Medicine’s Advancements in Integrating Genetic Testing Results with Electronic Medical Records

New McKinsey report offers three market trends that could help clinical laboratories position themselves as front-runners in the race toward precision medicine 

With federal Medicare reporting and reimbursement programs now weighted heavily toward precision medicine practices that involve genetic testing to reveal predispositions to certain diseases, the trend is widely recognized as the future of U.S. healthcare. But are clinical laboratories and anatomic pathology groups prepared to take advantage of the accelerating reporting and reimbursement requirements that go with it?

A report from global management consulting firm McKinsey and Company provides insights into how integrating genetic test results data into electronic medical records (EMRs) will impact the future of precision medicine (AKA, personalized medicine).

The report, titled, “Genetic Testing: Opportunities to Unlock Value in Precision Medicine,” notes, “Advanced analysis of genomic data integrated with electronic medical records and other data sets, combined with effective reimbursement strategies and full data-regulatory compliance, will distinguish winning diagnostics companies.”

Data/Costs Impact Profitability/Payments to Providers, including Medical Labs

The McKinsey report lists “three major trends that will affect the market for genetic testing.” They include:

  • “Data integration and analytics to realize the value of data have become increasingly important for the healthcare delivery value chain;
  • “Payers are facing increasing pressure on costs and looking for new opportunities to control them; and,
  • “The US reimbursement landscape, which drives the profitability of most diagnostics players, is gradually evolving.”

These market trends may provide a roadmap for labs working to position their business in a healthcare industry where genetic sequencing, the data it produces, and evolving reimbursement methods affect a clinical laboratories financial well-being.

The Value of Genetic Test Data

Personal health data derived from genetic sequencing has value at the individual patient’s level when linked with other health indicators, as recent deals between direct-to-consumer (DTC) genetics testing companies—such as 23andMe—and various pharmaceutical companies demonstrate.

And, as artificial intelligence continues to be integrated into medical diagnostic technology, such data becomes even more valuable.

“Genetic testing, along with the current blooming of “omics” technologies, will continue to drive the pace of precision medicine. In this golden age of bioinformatics, the reimbursement landscape is evolving. The winners will gain first-mover advantages by seamlessly integrating existing big genetic or molecular data with electronic medical records—in full accordance with data privacy laws—to validate tests clinically and analytically through real-time advanced analytics,” the McKinsey report predicts. (Image copyright: MTB Europe.)

There is strong movement toward integrating genetic information into electronic medical records, as the National Institutes of Health (NIH) eMERGE program clearly demonstrates.

The Electronic Medical Records and Genomics (eMERGE) Network brings together researchers from genomics, statistics, clinical settings, and other areas of expertise in order to “develop, disseminate, and apply approaches to research that combine biorepositories with electronic medical record systems,” according to NIH’s website.

Similar efforts are underway through the National Human Genome Research Institute’s IGNITE (Implementing Genomics in Practice) program and the PREDICT (Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment) program, launched in 2010 by Vanderbilt University.

However, data-privacy laws also are becoming stricter. HIPAA (Health Insurance Portability and Accountability Act) and GDPR (General Data Protection Regulation) strictly regulate the collection, retention, and sharing of patient data. Medical laboratories working to derive value from such data should ensure their processes are well within the letter of those laws.

Controlling the Impact of Cost and the Expense of Genetic Testing

In every area of healthcare, there are increasing pressures related to cost and genetic sequencing is no exception. McKinsey offers two reasons that payers are feeling the pinch:

  • Costs are growing faster than insurance premiums; and,
  • There are more innovative genetic and genome sequencing tests.

Payers hope that “innovative” genetic tests can lead to therapies or even cures that lower the cost of healthcare. However, a plethora of factors influence the development of genetic sequencing technology. Nevertheless, consumer demand is driving the costs down.

DTC genetic testing companies are leveraging these lowered costs. However, they also have other revenue streams—marketing their customers’ data, for example.

Although it may seem that 23andMe’s business model derives most of its revenue from selling its genotyping kits, that’s just one of the company’s revenue streams. In 2015, biotechnology company Genentech and DTC genetic testing company 23andMe reached a $60 million deal that gave Genentech access to test results data derived from 23andme customers who had previously signed agreements allowing their data to be used for research.

Dark Daily recently reported on one DTC genetic test customer who attempted to get her test results removed entirely from the Internet. (See, “Erasing ‘DNA Footprint’ from the Internet Proves Difficult for Consumers Who Provide Data to Genetic Testing Companies,” December 24, 2018.)

Opportunities for Clinical Labs

The three market trends included in the McKinsey report provide some guidance for clinical laboratories and genetic testing companies strategizing to be on the cusp of precision medicine.

Medical laboratories that integrate their data with physicians’ practice EHRs will be rewarded with first-mover status as genetic testing continues to evolve and become more recognized as a critical clinical tool. Additionally, clinical laboratories will play a key role in helping physicians prove medical necessity for genetic tests.

—Dava Stewart

 

Related Information:

Genetic Testing: Opportunities to Unlock Value in Precision Medicine

Electronic Medical Records and Genomics (eMERGE) Network

Implementing Genomics in Practice (IGNITE)

Personalized Drug Prescribing Program Expands, Upgrades

Trends in Microbiology

From Theory to Practice: Translating Whole-Genome Sequencing (WGS) into the Clinic

Erasing ‘DNA Footprint’ from the Internet Proves Difficult for Consumers Who Provide Data to Genetic Testing Companies

Singapore University Researchers Unveil Portable $1 Point-of-Care Testing That Speedily Tests for Multiple Diseases

Hand-held tests developed from the work of the NUS BIGHEART team could help caregivers in remote areas diagnose disease quickly, accurately, and inexpensively

There is great demand in Asia for diagnostic tests that are cheap, accurate, and have a fast time to answer. Especially in Asia’s remote and mobile clinics where caregivers need immediate access to clinical laboratory test results at the time of patients’ visits.

Researchers at the National University of Singapore (NUS) have unveiled just such a test that could eventually be performed at the point-of-care using smartphones for disease detection and analysis.

Dark Daily has reported many times on new clinical laboratory tests that use smartphones in past e-briefings. They are among the most significant developments to impact the pathology industry in our times.

According to the NUS researchers, their test can screen, detect, and analyze multiple diseases through a nucleic acid test platform. Best of all, the test costs less than $1, operates at room temperature, and takes about 30 minutes to an hour to uncover diseases.

NUS published the study in Nature Communications.

Researchers Aim to Simplify Complex Lab Testing

“Rapid, visual detection of pathogen nucleic acids has broad applications in infection management,” the researchers wrote in their study. They found that a screening device using molecular agents to detect disease-specific molecules has implications for a range of diseases: from Zika and Ebola to hepatitis, dengue, malaria, and cancers, according to a news release.

The NUS researchers dubbed their creation enVision (enzyme-assisted nanocomplexes for visual identification of nucleic acids).

2018-0918-enVision-graphic

The enVision microfluidic system (above) consists of a series of enzyme–DNA nanostructures to enable target recognition, target-independent signaling, and visual detection. The common cartridge houses the universal signaling nanostructures, which are immobilized on embedded membranes, for target-independent signaling and visual detection. The platform is designed to complement the modular enVision workflow. (Image and caption copyright: National University of Singapore.)

“Conventional technologies—such as tests that rely on polymerase chain reaction to amplify and detect specific DNA molecules—require bulky and expensive equipment, as well as trained personnel to operate these machines. With enVision, we are essentially bringing the clinical laboratory to the patient,” said Nicholas Ho, PhD, an NUS Biomedical Institute for Global Health Research and Technology (BIGHEART) Research Fellow and study co-first author, in the news release.

Shao-Lab-NUS-BIGHEART-enVision

NUS BIGHEART researchers include Assistant Professor Huilin Shao, PhD, at center holding the enVision cartridge, with Nicholas Ho, PhD, to the left and Lim Geok Soon, PhD, to the right. They tested the performance of enVision on human papillomavirus (HPV), a sexually transmitted infection and primary cause of cervical cancer. HPV has more than 100 subtypes of which 15 are malignant. The researchers studied samples from 35 NUS patients. (Photo copyright: National University of Singapore.)

“HPV is a global epidemic. While mostly benign, some of these infections can progress to cause deadly cervical cancer,” they wrote in Nature Communications. “Point-of-care testing that can distinguish the infection subtypes, and be performed at the patient level, could bring tremendous opportunities for patient stratification and accessible monitoring and is associated with better health outcomes.”

NUS researchers found that the enVision platform had a 95% accuracy rate in screening for HPV, as compared to conventional lab testing, according to Singapore’s Straits Times.

“While laboratory tests can detect one to two HPV strains, the kit is able to detect over 10 strains and has better coverage for each strain,” said Assistant Professor Huilin Shao, PhD, NUS BIGHEART, in the Straits Time article.

How Does it Work? 

The test’s steps, according to an NUS News article, include:

  • The tiny plastic chip holds the sample (blood, urine, or saliva) for analysis, along with a DNA “molecular machine” to recognize genetic sequences;
  • This sample is channeled to a common signal cartridge containing another DNA molecular machine;
  • Visual signals are evidence of disease-specific molecules and an assay turns from colorless to brown if disease is present;
  • Further analysis, potentially using a smartphone app, could delve into the extent of an infection.

“The first machine is a recognition nanostructure which detects specific genetic sequences that relate to different kinds of diseases—the pathogens, bacteria, or viruses for example—and produces a signal,” Ho told NUS News. “It pairs up with what we call an amplifier nanostructure which takes that signal, amplifies it and turns it into a color read-out.”

The researchers note that more studies on other diseases are needed before marketing of the test kit, which they developed over 18 months. The NUS team also sees opportunities to enable better image capabilities and analysis algorithms through smartphone applications (apps).

“Large cohort studies on the detection of pathogen nucleic acids across a spectrum of diseases (e.g., other infections, cancers, inflammatory disorders) using various biological specimens (e.g., tissue, blood, urine) could be performed to validate the clinical utility of the enVision technology for diverse visual detection,” they concluded in Nature Communications.

As healthcare resources become limited and populations continue to grow, studies into portable, low-cost testing become more critical. Clinical laboratories performing tests in rural, outlying areas of the world will especially benefit from the work of researchers like the NUS BIGHEART team at University of Singapore.

—Donna Marie Pocius

Related Information:

New Test Kit Invented by NUS Researchers Enables Quick, Accurate, and Inexpensive Screening of Diseases

Cheap Portable Screening Kit for Multiple Diseases in the Works

Visual and Modular Detection of Pathogen Nucleic Acids with Enzyme-DNA Molecular Complexes

72 Cents Test Screens for Diseases in Less Than an Hour

enVisioning Future Disease Diagnostics

New Fast Inexpensive Mobile Device Accurately Identifies Healthcare-acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

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

Erasing ‘DNA Footprint’ from the Internet Proves Difficult for Consumers Who Provide Data to Genetic Testing Companies

Direct-to-consumer testing companies’ privacy policies leave many consumers unaware their genetic information may be shared with third parties

Clinical laboratories and anatomic pathologists that perform genetics testing know they are responsible for protecting their patients’ privacy and securing the test results data. However, when it comes to direct-to-consumer (DTC) testing companies, patient privacy is not so clearly defined. This leave some patients vulnerable when their health data gets loose on the Internet.

One example involves a Bloomberg reporter who attempted to erase her genetic footprint online and found it to be very difficult to accomplish completely. She published her results in “Deleting Your Online DNA Data Is Brutally Difficult.”

The Bloomberg report provides medical laboratory managers and owners with another example of the importance of staying current with federal and state laws governing the privacy of patients’ protected health information (PHI).

Erasing Genetic Data Footprint ‘Not So Easy,’ Notes Bloomberg Reporter

In her article, Bloomberg health reporter Kristen V. Brown detailed her attempt to delete her genetic information from the websites and databanks of nearly a dozen genetic testing companies where she had shared her genetic information, while writing articles for various publications. They included:

  • Ancestry;
  • 23andMe; and,
  • Helix.

In an article for Bloomberg, Future of Health reporter Kristen V. Brown (above) said, “Recently, I started feeling uneasy about how freely my DNA data flowed. So, I decided to try to erase my DNA data footprint from all the websites and databases and laboratories in which it was stored. It turns out that isn’t so easy.” (Photo copyright: Cayce Clifford/Bloomberg.)

Privacy Policies of DTC Genetics Companies ‘Well Short of Ideal’

Interest in direct-to-consumer genetic testing is booming, with dozens of companies offering tests ranging from helping consumers understand their genetic information and ancestral background to receiving wine recommendations tailored to taste preferences and DNA data. Healthcare market research firm Kalorama Information estimates the market for such testing will reach $310 million by 2022.

DTC customers sign agreements allowing genetics testing companies to use their DNA data for selected services. However, “informed consent” must be given for companies to use consumer data for third-party research projects, whether academic or commercial. These consent agreements typically also address the risk of data becoming public as the result of a security breach.

However, for research published in Cornell Journal of Law and Public Policy, James Hazel, PhD, JD, a Post-Doctoral Fellow at Vanderbilt University Medical Center, and Christopher Slobogin, Milton Underwood Professor of Law at Vanderbilt University, surveyed the privacy policies of 90 U.S. direct-to-consumer genetic-testing companies. They concluded most of the privacy policies “fall well short of ideal.”

“The language in their policies permits selling or sharing information with third parties in many cases. That could be, in theory, anyone,” Hazel told Bloomberg.

Hazel explained that because DNA information gets shared anonymously with third parties, it typically is not possible to purge information from all the secondary companies or research institutions that have received the data.

“They’ve already bundled it with other users’ data and stripped it of your name and aggregated it, and either sold it or shared it with other third parties,” he told Bloomberg.

CLIA Requirements and Stored DNA Data

Brown discovered that not only was deleting her data difficult, having her samples destroyed was next to impossible because she had consented for her information to be shared with other companies.

She was able to delete her Ancestry.com information with just a click, but a required phone call to have her sample destroyed ended in the request still being “in process” a week later. Because she had agreed to share information from the DNA sample she provided to 23andMe, the company told Brown they were unable to fully delete her data due to federal and state regulations.

“The federal Clinical Laboratory Improvement Amendments (CLIA) of 1988 and California laboratory regulations require the lab store your de-identified genotyping test results and to keep a minimal amount of test result or analysis information,” 23andMe stated. “Our laboratory will retain your genetic information and a randomized identifier on their secure servers for a limited period of time—10 years pursuant to CLIA regulations.”

Of the companies Brown contacted, only one told her it could delete her information entirely, leaving Brown to conclude that once DTC customers share their DNA information, it no longer belongs to just them.

“When you delete your DNA information, you are mainly hiding your information from yourself,” she wrote in Bloomberg.

Lawmakers Get Involved

Dark Daily has covered issues related to DTC genetic testing and clinical laboratories in many e-briefings. Now, lawmakers are responding to growing pressure from consumers demanding DTC genealogy and genetic testing companies identify and resolve privacy and security issues.

“Much more often than not, Congress acts after the horse is out of the barn,” U.S. Rep. Dave Loebsack of Iowa told STAT. “I want to try to partner with genetic testing services to address any potential challenges before there are actually breaches of trust.”

And last year, U.S. Senator Charles Schumer of New York called on the Federal Trade Commission to investigate genetic testing companies’ privacy policies and standards for sharing consumer DNA information.

“When it comes to protecting consumers’ privacy from at-home DNA test kit services, the federal government is behind,” Schumer said in a statement. “Besides, putting your most personal genetic information in the hands of third parties for their exclusive use raises a lot of concerns, from the potential for discrimination by employers all the way to health insurance.”

As the spotlight increases on DTC genetic testing companies’ use of their customers’ DNA data, medical laboratories and anatomic pathology practices should prepare to answer patients’ requests for information on policies that protect their privacy and data, and the state and federal regulations restricting sharing of information.

—Andrea Downing Peck

Related Information:

Deleting Your Online DNA Data Is Brutally Difficult

Who Knows What, and When?: A Survey of the Privacy Policies Proffered by U.S. Direct-to-Consumer Genetic Testing Companies

Lawmakers Press Genetic Testing Companies for Details on their Privacy Policies

The Golden State Killer Case Was Cracked with a Genealogy Website. What Does that Mean for Genetic Privacy?

Charles Schumer: Popular at Home DNA Test Kits Are Putting Consumer Privacy at Great Risk

Rutgers University Researchers Develop Desktop Venipuncture Robot Capable of Drawing Blood Samples and Rendering Analyses Outside of Medical Laboratories

Robotics combined with microfluidic systems continue to push traditional clinical laboratory testing and procedures toward physician’s offices and other point-of-care settings

Researchers at Rutgers University have developed a new venipuncture robot that can not only draw blood and perform medical laboratory tests, but also provide immediate analyses of blood samples at point-of-care locations, such as clinics, private doctor’s offices, and rural environments.

It’s a development that could give clinical laboratories new opportunities to support physicians. But, should blood labs, phlebotomists, and medical technologists feel threatened by this development?

“This device represents the holy grail in blood testing technology,” said Martin L. Yarmush, MD, PhD, Bioengineer and Translational Scientist, Professor in the Department of Biomedical Engineering at Rutgers University, and senior author of the study, in a news release. “Integrating miniaturized robotic and microfluidic (lab-on-a-chip) systems, this technology combines the breadth and accuracy of traditional blood drawing and laboratory testing with the speed and convenience of point-of-care testing.”

Dark Daily has reported on several “lab-on-a-chip” systems (or other types of “lab-on-a-” test devices) in past e-briefings. However, those devices for the most part are administered as part of procedures performed at clinical laboratories. Now comes a device that could make it feasible for doctors to perform some traditional clinical laboratory procedures in-office, while patients are still present. Such an innovation, if embraced, could impact clinical lab workflows and revenues.

The Rutgers researchers published their findings in Technology, an online scientific journal.

Rutgers Researchers Goal: ‘Nobody Touches a Needle’

Diagnostic blood testing is the most commonly performed medical test in the world, and the results influence most healthcare treatment decision-making. Traditionally, the success rate of manually drawing blood samples depends upon the skill of the clinician and the physiology of the patient. By locating the blood vessels before the venipuncture, the researchers expect their device to prevent stressful multiple blood-draw attempts, bruising, and injuries to arm nerves.

Martin-Yarmush-MD-PhD

“There are about two billion blood draws done in the U.S. alone each year,” Martin L. Yarmush, MD, PhD (above), Bioengineer and Translational Scientist at Rutgers University and senior author of the study, told Smithsonian Magazine. “It is the number one patient injury procedure. It’s also the number one clinical injury procedure. The device is meant to take over such that nobody touches a needle.” (Photo copyright: Rutgers University.)

The end-to-end tabletop device includes an image-guided robot for extracting blood samples from veins, a sample-handling module, and a centrifuge-based blood analyzer. The venipuncture robot works by first utilizing a combination of near-infrared and ultrasound imaging to locate blood vessels in a patient. The device then creates a 3D image of the vessels before sticking the patient with a needle to collect a blood sample.

The robot potentially could make it easier and faster to obtain blood samples from patients, particularly for patients where traditional blood draws can be difficult, such as children and the elderly.

“We wanted to create a device that would perform venipuncture procedure with little to no human involvement, thus minimizing human error,” Yarmush told Smithsonian Magazine. “As such, our automated device requires little to no training, allowing it to be easily adapted to any clinical environment.”
Rutgers-University-blood-test-robot

The Rutgers venipuncture robot (above) contains a centrifuge-based analyzer capable of performing instant blood analyses, such as white blood cell counts and hemoglobin measurements. Immediate readings could mean that medical practices won’t need to send blood samples to a clinical laboratory for analysis. (Image copyright: Rutgers University/Smithsonian Magazine.)

Protecting Phlebotomists as well as Patients

The researchers also hope their robot could help prevent accidental needle sticks to phlebotomists. According to a study published in Mayo Clinic Proceedings titled, “Phlebotomists at Risk,” a hard-working phlebotomist may perform as many as 10,000 venipunctures annually. The median needlestick injury rate is about 1 per 10,000 venipunctures, so a dedicated phlebotomist could experience one accidental percutaneous blood exposure per year.

The researchers tested their prototype on “tissue-like” artificial arms containing tubes filled with blood-like substances. They hope to begin performing clinical trials on the venipuncture robot within the next year and aspire to establish other uses for the device.

“When designing the system, our focus was on creating a modular and expandable device,” Max Balter, PhD, stated in the news release. Balter led the study while a graduate research fellow at Rutgers. He is currently a senior research and development engineer at Medtronic. “With our relatively simple chip design and analysis techniques, the device can be extended to incorporate a broader panel of tests in the future.”

Such a device could provide valuable and rapid test results in emergency settings such as ambulances, emergency departments, and army medical facilities. The robot also would be a boon to rural/remote settings located far from a clinical lab, as well as regions that suffer from a shortage of trained medical personnel and critical resources.

A cost-effective, reliable phlebotomy robot could be a valuable asset for clinical laboratories in the future as well. However, were such a device to find a place in clinical care, it could reduce the demand for phlebotomists. It could also accelerate the trend of moving traditional clinical laboratory testing to doctor’s offices, clinics, and remote point-of-care settings.

—JP Schlingman

Related Information:

Automated Robotic Device for Faster Blood Testing

A Robot May One Day Draw Your Blood

Automated End-to-end Blood Testing at the Point-of-care: Integration of Robotic Phlebotomy with Downstream Sample Processing

Phlebotomists at Risk

Rutgers Researchers Develop Automated Robotic Device for Faster Blood Testing

;