May 30, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
As healthcare continues to expand outside of traditional environments, clinical laboratories must adapt to providers’ changing needs
Healthcare settings continue to pop up in non-traditional locations. For years, clinical laboratories and anatomic pathology groups have had to adopt to a changing healthcare landscape, such as the trend to move care out of hospitals and doctor’s offices to lower costs and improve access.
In some instances, treating patients in their homes is safer for patients’ health. (See Dark Daily, “Hospital-in-the-Home Shows Promise for Reducing Acute Care Costs; Medical Laboratories Face Uncertainties Concerning Expanding Services to In-Home Environments in Support of Care Providers,” May 2, 2018.) Similarly, receiving care at retail locations such as Rapid Clinics—including clinical laboratory procedures and testing—offers many advantages for busy patients. Dark Daily has reported on these trends as far back as 2011. (See Dark Daily, “More Medical Laboratory Testing Expected as Retail Clinics Change Delivery of Routine Healthcare Services,” October 24, 2011.)
It’s a win-win for healthcare organizations and patients alike that shows no sign of slowing down. Thus, it should come as no shock that retail giant Walmart (NYSE:WMT) would want to remain competitive in this high-value consumer market.
Walmart Continues Expansion into Healthcare Market
Walmart Care Clinics, which are primarily staffed by certified nurse practitioners, are currently operating in Georgia, South Carolina, and Texas, according to Healthcare Finance. Caregivers in those clinics are trained to diagnose and treat a wide variety of basic medical conditions, including:
- Managing chronic conditions;
- Performing lab tests;
- Administering vaccinations;
- Making referrals; and,
- Prescribing medications.
Now, possibly in a bid to compete with CVS and Walgreens, Walmart has announced plans to allocate part of an $11-billion remodeling project to include private consultation rooms in hundreds of its store pharmacies. These rooms will allow customers to have confidential discussions about their medications and healthcare with pharmacists and other pharmacy staff members.
The majority of the store renovations will occur in Florida and Texas where the company has allotted $477 million to remodel 82 stores and add 14 new stores.
Walmart Health App and Wellness Days
Another step Walmart is taking to compete in the healthcare space involves mobile software. In May, Walmart announced it was partnering with digital health company Sharecare to provide employees and community members with access to the Sharecare mobile healthcare app. The app enables users to complete personalized health profiles and track their health.
Walmart Wellness Days are a quarterly in-store event designed to educate community members on ways to make positive changes in their health. Might clinical laboratories one day be performing medical laboratory and pathology testing ordered by physicians and nurse practitioners located in retail Walmart pharmacies? (Photo copyright: Walmart.)
“Walmart is committed to helping our associates, their families, and communities to improve their overall wellbeing through wellness programs,” Jacqui Canney, Executive Vice President and Chief People Officer at Walmart, stated in a press release. “Partnering with Sharecare will provide our associates additional tools to inspire them on their wellness journey, help our programs continue to grow, and be a force for change in the communities we serve.”
Sharecare sees this relationship as both disruptive and transformative, not just for a company’s employees and customers, but for the entire nation.
“As we have learned from our research through the Gallup-Sharecare Well-Being Index, a person’s holistic wellbeing is defined by five essential elements—purpose, social, financial, community, and physical—and when those elements are in alignment, individuals and places exhibit greater adaptability to change, resiliency, and productivity in the workplace, among other benefits,” noted Dan Witters, Research Director for the Gallup-Sharecare Well-Being Index, in the press release. “As the nation’s single largest employer with more than 1.5 million associates, Walmart and Sharecare have the potential to disrupt the status quo of workplace wellness and transform the health not only of the communities in which Walmart operates, but also, ultimately, our country.”
Lofty expectations, to be sure. Nevertheless, for clinical laboratories to remain competitive, they must be prepared to adapt and serve healthcare providers in any location. Increasingly, these caregivers are finding themselves treating patients outside of traditional healthcare environments in locations convenient to healthcare consumers, such as retail environments.
—JP Schlingman
Related Information:
Walmart is Remodeling 500 Stores as Part of an $11 Billion Spending Plan—Here’s How Stores Will Change
Walmart Signals Continued Interest in Healthcare Space Through Remodel of Pharmacies
Walmart Partners with Sharecare to Transform the Health and Wellbeing of Their Associates and Communities
Hospital-in-the-Home Shows Promise for Reducing Acute Care Costs; Medical Laboratories Face Uncertainties Concerning Expanding Services to In-Home Environments in Support of Care Providers
More Medical Laboratory Testing Expected as Retail Clinics Change Delivery of Routine Healthcare Services
May 25, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Primary care is shifting from traditional office visits to urgent care and walk-in clinics even as large hospital groups continue to buy up independent physician practices, altering where and from whom clinical laboratories receive referrals and test orders
Medical test ordering and referrals from office-based physicians are the financial foundation of the clinical laboratory industry. Thus, recent trends reshaping how and where physicians practice medicine, and the ownership of their medical groups, could have both beneficial and adverse implications for medical laboratories and anatomic pathology groups.
Primary care doctors who own their own medical practices are disappearing from the healthcare landscape at an impressive rate, as large hospital groups expand their share of the primary care market. According to the New York Times (NYT), in 2010, large hospital groups employed 23% of the nation’s primary care physicians. By 2016, that number had increased to 43%.
However, office visits to primary care physicians fell by 18% between 2012 and 2016, according to a report by Health Care Cost Institute (HCCI). During the same period, visits to specialists rose 31%.
Walk-In and Urgent Care Clinics Replacing Traditional Office Visits
An increasing number of patients are selecting different types of providers when seeking medical care. Convenience, low cost, and shorter wait times have many patients choosing urgent care and retail or walk-in clinics instead of traditional office visits. Dark Daily reported on this growing trend last fall in “Five Reasons Why Retail Clinics Are a ‘Game-Changing’ Threat to Traditional Healthcare Providers That Could Strain Clinical Laboratories and Pathologists.”
The number of retail or walk-in clinics in the United States has increased by 14 times over the past decade, according to Statista, a provider of market and consumer data. In 2008, there were only 200 retail clinics in the country. Current projections indicate there will be 2,800 walk-in clinics located throughout the country by the end of this year.
In 2010, retail clinic sales totaled $518 million. By the end of 2016, retail clinic sales were more than $1.4 billion representing an increase of 20.3% per year during that time period, according to the Kalorama report, “Retail Clinics 2017: The Game-Changer in Healthcare.”
“There is huge consolidation in the market right now,” Jeffrey D. Le Benger, MD, FACS (above), Chief Executive Officer of Summit Medical Group in New Jersey, told the NYT. “Everyone is fighting for the primary care patient.” (Photo copyright: Gannett.)
Retail or walk-in health clinics were originally intended for uninsured and underinsured individuals who sought an affordable option for medical services. These clinics are designed to treat non-emergency situations, such as burns, sprains, and minor infections or illnesses. Services at these clinics are usually administered by a nurse practitioner.
Retail walk-in clinics often are located inside larger, popular stores. Examples include:
Providing 24/7 Healthcare Services at Lower Costs
In contrast, urgent care clinics are equipped to handle more serious, non-emergency injuries and conditions and are generally staffed by physicians. The Urgent Care Association of America states that there are more than 7,500 urgent care centers in the US with an annual revenue of $18 billion. This industry is expected to grow by 5.8% in 2018. The largest urgent care group in the country—MedExpress Urgent Care in Morgantown, W.Va.—has 252 locations in 22 states.
Another growing urgent care center—ZoomCare of Portland, Ore.—has 36 locations in Oregon and Washington State. Services offered include: urgent care, primary care, pediatrics, gynecology, orthopedics, dermatology, dental care, ear nose and throat, chiropractic, podiatry, physical therapy, mental health, immunity, imaging, internal medicine, clinical laboratory, and prescriptions. They offer convenient, extended hours and some locations are open seven days a week.
“Our customers are looking for world-class conveniences,” Albert DiPiero, MD, co-founder and Chief Medical Officer at ZoomCare, told Portland Monthly.
ZoomCare lists its menu of services/cost for both insured and self-pay patients on its website. Basic medical laboratory tests include:
- Strep-$50;
- Urine-$20;
- Mononucleosis test-$20;
- Pregnancy-$20; and,
- Influenza A/B-$40.
The website states that half of ZoomCare’s medications cost less than $10, and five out of six of the medicines are less than $20.
With such low costs and easy accessibility, it’s understandable why the number of patients seeking care in non-traditional office settings is growing. Clinical laboratories must accept and support these new sites of healthcare delivery to ensure continued procurement of lab test referrals. Staying on top of these trends and adjusting to consumer demand will help labs thrive and survive in healthcare’s ever-changing landscape.
—JP Schlingman
Related Information:
How ZoomCare is Shaking up the Checkup
The Disappearing Doctor: How Mega-Mergers Are Changing the Business of Medical Care
Healthcare Mega Mergers Push Primary Care Clinics Closer to Extinction: Five Takeaways
AETNA and ZoomCare Announce New Accountable Care Collaboration in Oregon
Number of Retail Clinics in the United States from 2008 to 2018
Retail Clinics 2017: The Game-Changer in Healthcare
Urgent Care Industry Hits $18 Billion as Big Players Drive Growth
Five Reasons Why Retail Clinics Are a “Game-Changing” Threat to Traditional Healthcare Providers That Could Strain Clinical Laboratories and Pathologists
May 23, 2018 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Pathologists around the world will be interested to learn that, for the first time in the UK, prostate cancer has surpassed breast cancer in numbers of deaths annually and nearly 40% of prostate cancer diagnoses occur in stages three and four
Early detection of prostate cancer, and the ability to identify its more aggressive forms, are important goals for every nation’s health system. However, a new study in the United Kingdom (UK) will be of interest to all anatomic pathologists handling prostate biopsies. Researchers determined that late diagnosis of prostate cancer is an issue that should be addressed by healthcare policymakers in the UK.
In 2015, deaths due to prostate cancer surpassed those of breast cancer in the UK. According to data from Cancer Research UK, this trend continued into 2016 with 11,631 deaths from prostate cancer and 11,538 deaths from breast cancer. The trend continued even though breast cancer saw roughly 8,000 more new cases in 2015, according to the same data.
Now, a report from Orchid—a UK male cancer charity—highlights a trend that should interest medical laboratories and histopathology (anatomic pathology in the US) groups that analyze prostate cancer samples. They found that 37% of UK prostate cancer cases involved diagnoses in stages three or four.
Late-Stage Diagnosis of Prostate Cancer: The US and UK Compared
“With prostate cancer due to be the most prevalent cancer in the UK within the next 12 years, we are facing a potential crisis in terms of diagnostics, treatment, and patient care,” stated Rebecca Porta, Chief Executive of Orchid, in a press release. “Urgent action needs to be taken now if we are to be in a position to deliver world class outcomes for prostate cancer patients and their families in the future.”
Orchid Chief Executive Rebecca Porta (far right) and her team are shown above receiving a check from the Industrial Agents Society (AIS) to help fund the charity’s research into male specific cancers, such as prostate cancer. (Photo copyright: AIS.)
The latest data from the Centers for Disease Control and Prevention (CDC) on prostate cancer and mortality rates in the US shows an interesting picture. In 2014, 172,258 men received a prostate cancer diagnosis. However, deaths from prostate cancer were at 28,343.
According to Statista, an international statistics portal, the UK is home to more than 32.3-million males. And, Statista’s data shows the US is home to 159.1-million males. This implies that despite the US having nearly five times the number of males, the number of prostate cancer deaths/year in the UK is significantly higher in relation to population size.
Cancer Research UK notes that despite decreasing by 13% in the last decade, prostate cancer mortality rates are still 21% higher than in the 1970s.
Awareness and Early Detection Key Components in the Fight Against Cancer
A study published in BMC Public Health offers one possible explanation for this disparity.
“When compared to analogous countries in Europe, Canada, and Australia, older adults in the UK have markedly different survival outcomes,” noted lead author of the study Sara Macdonald, PhD, Lecturer in Primary Care at the Institute of Health and Wellbeing at the University of Glasgow, Scotland.
“Poorer outcomes in the UK are at least in part attributable to later stage diagnoses,” she explained. “Older adults should be vigilant about cancer. Yet, this is not reflected in the news media coverage of cancer risk. Taken together, invisibility, inaccuracy, and information overload build a skewed picture that cancer is a disease which affects younger people.”
While treatment options have improved in the past decade, early detection is a key part of successful treatment—especially as prostate cancer has both aggressive and slow variants. Effective timely health screening also is of critical concern.
In the US, however, prolific prostatic-specific antigen (PSA) testing and other screenings for chronic disease—particularly within the elderly population—is under increased scrutiny and criticism, which Dark Daily reported on in April. (See, “Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US,” April 11, 2018.)
New Tools to Detect Prostate Cancer
Faster diagnosis and the ability to detect whether a prostate cancer is slow or aggressive could help to shift these numbers around the world.
According to BBC News, the NHS hopes to reduce diagnosis times and make the screening process less invasive by using magnetic resonance imaging (MRI). Hashim Ahmed, PhD, Chairman of Urology, Imperial College London, told BBC News, “Fast access to high-quality prostate MRI allows many men to avoid invasive biopsies as well as allowing precision biopsy in those men requiring it to find high-risk tumors much earlier.”
A team from the University of Dundee is trialing a shear wave elastography imaging (SWEI) process to detect prostate tumors as well. Speaking with The Guardian, team leader and Chair of the School of Medicine at The University of Dundee, Dr. Ghulam Nabi, noted, “We have been able to show a stark difference in results between our technology and existing techniques such as MRI. The technique has picked up cancers which MRI did not reveal. We can now see with much greater accuracy what tissue is cancerous, where it is, and what level of treatment it needs. This is a significant step forward.”
Should these tools prove successful, they might help to reverse current trends in the UK and offer greater insight and options for the histopathology groups there, as well as the medical laboratories, oncologists, and other medical specialists helping to treat cancer.
Until then, raising awareness and streamlining both detection and treatment protocols will remain a critical concern, not just in the UK, but around the world as the human population continues to age.
—Jon Stone
Related Information:
Prostate Cancer: Four in 10 Cases Diagnosed Late, Charity Says
New Report Reveals 4 in 10 Prostate Cancer Cases Are Diagnosed Late and an Impending Crisis in Prostate Cancer Provision
Prostate Cancer Deaths Overtake Those from Breast Cancer
Cutting Prostate Cancer Diagnosis Times
Prostate Cancer on the Rise; Time to Revisit Guidelines?
More High-Risk Prostate Cancer Now in the US than Before
Prostate Cancer Breakthrough as UK Team Develops More Accurate Test
Mass Media and Risk Factors for Cancer: The Under-Representation of Age
Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US
Genetic Fingerprint Helps Researchers Identify Aggressive Prostate Cancer from Non-aggressive Types and Determine If Treatment Will Be Effective
May 16, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Harvard School of Medicine researcher discovers only a fraction of all known human genes are ever included in research studies
It seems every day that diagnostic test developers are announcing new genetic tests for everything from researching bloodlines to predicting vulnerability to specific chronic diseases. However, as most pathologists know, there are more than 20,000 protein-coding genes in the human genome. Thus, an overwhelming majority of genes are not being researched or studied.
That’s according to Peter Kerpedjiev, PhD, a Postdoctoral Fellow at Harvard Medical School in Boston. Kerpedjiev analyzed US National Library of Medicine (NLM) data from its PubMed database. He found that roughly 25% of the articles tagged by the NLM only featured 100 of the 20,000 human genes.
Kerpedjiev studied approximately 40,000 NLM articles that were tagged as describing the structure, function, or location of a particular gene. He then created a list of the top-10 most-studied genes of all time, which contained interesting and unforeseen disclosures.
“The list was surprising,” Kerpedjiev told Nature. “Some genes were predictable; others were completely unexpected.”
Guardian of the Genome
According Kerpedjiev, the top-10 most-studied genes are:
- TP53;
- TNF;
- EGFR;
- VEGFA;
- APOE;
- IL6;
- TGFBI;
- MTHFR;
- ESR1; and,
- AKT1.
Kerpedjiev discovered that the top gene on the list—Tumor protein p53 (TP53)—was mentioned in about 8,500 articles to date, and that it is typically included in about two PubMed papers per day. When he began his research three years ago, TP53 was referenced in about 6,600 articles.
Peter Kerpedjiev, PhD (above), is a Postdoctoral Fellow in the lab of Nils Gehlenborg at Harvard Medical School. Previously, he was a PhD student working on modelling the tertiary structure of RNA molecules at the Theoretical Biochemistry Group at the University of Vienna. (Photo and caption copyright: Gehlenborg Lab.)
The National Library of Medicine describes the TP53 gene as a tumor suppressor that regulates cell division by preventing cells from growing and proliferating too quickly or uncontrolled. It is mutated in approximately half of all human cancers and is often referred to as the “guardian of the genome.”
“That explains its staying power,” Bert Vogelstein, MD, Professor of Oncology and Pathology at Johns Hopkins School of Medicine in Baltimore, Md., told Nature. “In cancer, there’s no gene more important.”
Critical Roles in Prevention/Treatment of Chronic Disease
The remaining genes on the list also have crucial roles in the functioning of the human body and disease prevention and treatment. Below is a brief summary of genes two through 10 on the list:
TNF encodes a proinflammatory cytokine that is part of the tumor necrosis factor superfamily. This family of proteins was originally distinguished by their ability to cause the necrosis of neoplasms. The TNF gene has been a drug target for cancer and inflammatory diseases, such as:
EGFR makes a protein known as the epidermal growth factor receptor, which positions the cell membrane to bind to other proteins outside the cell to help it receive signals to trigger cell growth, division, and survival. At least eight known mutations of the EGFR gene have been associated with lung cancer and often appear in drug-resistant cases of the disease.
Vascular Endothelial Growth Factor A (VEGFA) contains a heparin-binding protein that promotes the growth of blood vessels and is critical for physiological and pathological angiogenesis. Variants of the VEGFA gene have been affiliated with microvascular complications of diabetes mellitus and atherosclerosis.
ApoE produces a protein named Apolipoprotein E, which combines with lipids in the body to form lipoproteins that carry cholesterol and other fats through the bloodstream. ApoE-e3 is the most common allele (a variant of the gene) and is found in more than 50% of the general population. In addition to its role in cholesterol and lipoprotein metabolism, ApoE is also associated with:
- Alzheimer’s disease;
- Age-related hearing loss; and,
- Macular degeneration.
Interleukin 6 (IL6) is a cytokine that is mainly produced at locations of acute and chronic inflammation. Once there, it is secreted into the serum where it incites an anti-inflammatory response. The IL6 gene is connected with inflammation-associated diseases such as:
Transforming Growth Factor Beta 1 (TGFB1) initiates chemical signals that regulate various cell activities including the proliferation, maturation, differentiation, motility, and apoptosis of cells throughout the body. The protein created by TGFB1 is abundant in skeletal tissues and regulates the formation and growth of bones and cartilage. Mutations in the TGFB1 gene have been associated with breast, colorectal, lung, liver, and prostate cancers. At least 12 mutations of this gene are known to cause Camurati-Engelmann disease, which is distinguished by hyperostosis (abnormally thick bones) in the arms, legs, and skull.
MTHFR makes methylenetetrahydrofolate reductase, an enzyme that performs a crucial role in processing amino acids. Polymorphisms of this gene have been linked to risk factors for a variety of conditions including:
- Cardiovascular disease;
- Stroke;
- Hypertension;
- Pre-eclampsia;
- Glaucoma;
- Psychiatric disorders; and,
- Various cancers.
Estrogen Receptor 1 (ESR1) is a ligand-activated transcription factor that is significant for hormone and DNA binding. Estrogen and its receptors are crucial for sexual development and reproductive functions. They also can affect pathological processes including breast and endometrial cancers and osteoporosis.
AKT1 provides instructions for producing a protein known as AKT1 kinase that is located in many cell types throughout the body and is essential for the development and function of the nervous system. This gene belongs to a classification of genes known as oncogenes, which when mutated have the potential to cause normal cells to turn cancerous.
We Don’t Know What We Don’t Know
“It’s revealing how much we don’t know about because we just don’t bother to research it,” noted Dr. Helen Anne Curry, Senior Lecturer and Historian of Modern Science and Technology at the University of Cambridge, UK, in the Nature article. As far back as 2010, Dark Daily reported on university researchers predicting massive growth in anatomic pathology and clinical laboratory diagnostic testing based on the human genome.
How Kerpedjiev’s discovery might impact future genetic diagnostic test development remains to be seen. It will, however, be fascinating to see how this top-10 list of the most studied genes will change over time and how medical laboratory genetic testing may be affected.
—JP Schlingman
Related Information:
The Most Popular Gene in the Human Genome
Top 10 Genes in the Human Genome (by Number of Citations)
Explore the Normal Functions of Human Genes and the Health Implications of Genetic Changes
Stanford Study Shows How Pathologists May Eventually Use the Whole Human Genome for Diagnostic Purposes
May 14, 2018 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Management & Operations
Genetic counselors struggle to explain direct-to-consumer genetic test data—or correct provider misinterpretations of results—while often encountering resistance and anger from patients who don’t accept their counseling
Healthcare consumers who want to know more about their family’s genealogy are purchasing direct-to-consumer (DTC) home genetic tests in record numbers. It is a trend that worries some medical laboratory professionals and certain federal government agencies.
MIT Technology Review (MIT) dubbed 2017, “The year consumer DNA testing blew up.” As a result of record-breaking sales of DTC genetic testing last year, about 12-million people have now been tested, MIT reported. “The inflection pointed started in the summer of 2016, and from there it’s gone into the stratosphere,” David Mittelman, PhD, Molecular Biophysics, told MIT.
Clearly, consumers are becoming comfortable with the concept of genetic testing on themselves and their family members. However, major issues—such as who owns genetic information and how patient privacy is protected—have yet to be resolved.
Dark Daily recently reported that more than 1.5 million kits were sold by Ancestry.com during the four-day Black Friday/Cyber Monday weekend prior to Christmas 2017. That e-briefing also explored related privacy issues and informed readers about efforts by federal lawmakers to explore genetic testing companies’ privacy and disclosure practices.
According to a news release, by the end of November, sales of AncestryDNA kits exceeded the total number of subscribers the Utah-based company had when it started the year. Now, more than seven million people are in Ancestry’s database.
Meanwhile, 23andMe, a personal genomics company established in 2006, has genotyped more than three million people worldwide. In addition to an ancestry test, it offers a health and ancestry service providing information on genetic health risks, carrier status, traits, wellness, and ancestry, according to the company’s website.
Experts Concerned About Privacy and Use of ‘Raw’ DNA Data
“2018 will bring a regular drumbeat of new experiences and enhancements across both DNA and family history,” Howard Hochhauser, Ancestry’s Interim Chief Executive Officer, predicted in the news release.
However, a recent study published in Translational Behavioral Medicine (TBM) which noted the robust sales of DTC genetic tests in 2017, also called attention to a new concern surrounding the impact of “raw” DNA interpretation results.
“People often enter the direct-to-consumer market for recreational purposes, such as learning about their ancestry. Yet, what we started seeing was that these same individuals subsequently come across third-party interpretation services where they proceeded to learn more about their ‘raw’ DNA made available by the ancestry testing companies,” stated Catharine Wang, PhD, Boston University (BU) Associate Professor of Community Health Sciences, and the study’s lead author, in a BU statement.
The study cited sales of DTC genetic tests at $99 million in 2017 and explored potential negative implications of consumers’ access to “raw” DNA data.
“We were especially interested in the downstream implications of receiving unexpected disease risk information from these newer services that subsequently lead consumers to seek out a genetic counselor’s consult,” Wang noted.
Catharine Wang, PhD (above), Associate Professor of Community Health Sciences at Boston University and lead author of the study, notes, “There are a lot of people saying, ‘I’m smart enough to make decisions; give me the information and get the doctors out of the way. But they’re making some serious decisions about their health after seeing only part of the picture.” (Photo copyright: Boston University Research.)
After Getting DNA Data, Consumers Turn to Interpretation Services, Genetic Counselors
The research team surveyed 85 genetic counselors. Fifty-three percent of them reported meeting with DTC test costumers who had accessed ‘raw’ DNA data and used genetic interpretation companies, which are not regulated by the US Food and Drug Administration (FDA), to get more information about themselves. However, results of the sessions were not always positive for either patients or counselors.
According to the study, counselors reported their biggest challenge as “undoing misinterpretations and correcting patient beliefs about their raw DNA results.”
The study noted, “When genetic counselors tried to clarify misunderstandings, patients were not only resistant but sometimes appeared hurt and frustrated that counselors were not taking their results seriously.”
Other negative experiences counselors reported while interpreting “raw” DNA test results for patients include:
- “Time required to review and understand interpretation reports;
- “Feeling ill equipped and uncomfortable providing the service;
- “A lack of supportive organizational structure; and,
- “[Having to] correct a patient’s misunderstanding, following a primary care physician’s misinterpretation of her raw DNA results.”
“Counselors expressed concern about the quality of the raw data and the clarity and usefulness of interpretation reports. Efforts to better support both consumers and genetic service providers are needed to maximize the effective translation of genome-based knowledge for population health,” the study authors concluded.
Providers Should Improve Ability to Help Patients with DTC Genetic Data
In a MedCity News blog post, Peter Hulick, MD, Director of Personalized Medicine, NorthShore University HealthSystem, called for healthcare providers to assist patients who are dealing with new DTC genetic services and possible data overload.
“Findings show having widespread access to personal genetic information—without the knowledge of how to interpret results—can lead to problems ranging from misinterpretation to emotional distress,” he noted. “The medical community must work harder and smarter to incorporate this information into practice and empower patients as consumers and partners in healthcare decision-making.”
Anatomic pathologists and clinical laboratory leaders also should acknowledge and monitor consumers’ growing interest in these tests. Once patients’ have their DNA sequenced, the likelihood they will seek to know their predisposition to diseases is high and increasing. Thus, opportunities exist for medical laboratories to help physicians and consumers interpret DTC test results.
—Donna Marie Pocius
Related Information:
2017 Was the Year Consumer DNA Testing Blew Up
AncestryDNA Breaks Holiday Sales Record; Black Friday-Cyber Monday
At-Home Genetic Testing Leads to Misinterpretations of Results
The Impact of Raw DNA Availability and Corresponding Online Interpretation Services: A Mixed Methods Study
Consumer Interest in Genetic Testing is Exploding: Are Providers Ready?
Confronting Cancer
Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data Should be Handled, Secured, and Kept Private
May 11, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Chronic disease monitoring at home has become a boon to patients as well as hospitals that are finding cost savings in programs designed to monitor/treat patients at external locations
Many clinical pathologists and medical laboratory scientists will be wary about the news that a California company wants to have cancer patients do their own CBCs at home, and that a device to enable such testing is being prepped to go through the FDA clearance process.
Home-based medicine care and chronic disease therapy treatments are gaining in popularity. Patients, understandably, would prefer to stay in the comfort of their homes then be exposed to stressful, germ-laden healthcare environments. And healthcare providers are finding cost savings in home-healthcare programs, which Dark Daily recently reported.
However, each new breakthrough in home medical care impacts clinical laboratories when specimen collection, near-patient medical laboratory testing, and therapy administration/monitoring shifts from traditional healthcare environments to home settings.
Nevertheless, new devices that enable chronic disease patients to monitor and report findings to care providers continue to be developed and embraced by healthcare consumers.
Complete Blood Count at Home
One such device from Athelas, a diagnostic test developer based in Mountain View, Calif., makes it easier and less expensive for patients undergoing cancer therapy to monitor their complete blood counts (CBC) at home without the need to travel to a doctor or medical laboratory to have the blood work performed, Medgadget reported. The device, which is undergoing the FDA Class 2 clearance process, enables patients to test their complete blood count (CBC) in the privacy of their own homes and report the results to their oncologists.
Athelas co-founders Tanay Tandon (left) and Deepika Bodapati (right) secured $3.7 million in funding from Sequoia Capital, Y Combinator, and NVIDIA, to produce their blood analysis device. (Photo copyright: Sina.)
To use the Athelas device, patients perform a simple finger prick and place a drop of blood on a proprietary testing strip. The strip is then inserted into the device where the blood is analyzed. Patients can view their lab-grade blood test results in about a minute.
Information gathered by the device can be sent to Android or iOS devices/apps and also to the patient’s doctor. The process allows patients and their doctors to receive frequent updates for monitoring treatments and disease progression and precisely observe changes in immune health.
According to Athelas, in about 60 seconds the blood analyzer provides accurate reading for:
“Athelas is bringing cancer patients a quick and reliable way to test their blood levels from within their home,” noted Alfred Lin, partner at Sequoia, in a statement. “Their new platform empowers patients to confidently monitor their condition and will cut down on unnecessary urgent care visits. We believe in Tanay and Deepika’s bold vision to transform at-home blood tests into an easy and accurate diagnostics tool that’s as trusted as a thermometer.”
The home-testing platform will cost consumers $20 per month, which Athelas hopes will eventually be covered by insurance companies.
Additional Benefits to At-Home Monitoring
The Athelas device also has functions beyond chronic disease monitoring. It can be used to determine if a viral or bacterial infection is present in an individual. In addition, the company is currently testing the machine with 100 patients at risk for a cardiac event to evaluate whether or not it can predict such an event days before it occurs.
“There’s a lot of research out there that shows inflammatory markers inside your own body will spike a couple days in advance,” Tandon told TechCrunch.
In the video above, Deepika Bodapati, co-founder of Athelas, describes how the diagnostic device operates. Click on the image above to view the video. (Video copyright: TechCrunch.)
The Athelas device is not yet cleared to market by the Food and Drug Administration (FDA) and more clinical research may be needed to validate the efficacy of the product. Athelas is currently loaning the device to cancer patients for the purpose of monitoring their chemotherapy progress, and is conversing with healthcare professionals, hospitals, and pharmaceutical companies regarding the benefits of the device.
Other CBC Devices
In 2017, Sysmex America announced it had received clearance from the FDA for the Sysmex XW-100 hematology analyzer, the first CBC system that allows in-house staff to perform CBC tests at Clinical Laboratory Improvement Amendments (CLIA)-waived locations. The Dark Report reported on this last year. (See TDR, “FDA Clears Waived CBC For Near-Patient Testing,” November 20, 2017.”
The XW-100 device enables physicians to perform in-office blood tests and receive results in as little as three minutes. This allows treatment plans to be initiated without interacting with clinical laboratories, which clearly impacts test ordering and lab revenue.
At-home and onsite blood testing devices serve an important role in patient care and provide healthcare professionals with expeditious and convenient test results. However, with the arrival of these new technologies, clinical laboratories will need to find new ways to bring value to physicians who employ them in their offices.
—JP Schlingman
Related Information:
Athelas Device Provides Accurate CBC Testing—From Home
Athelas Launches a New Type of Blood Testing Device for the Home
Precise Blood Testing from a Fingerprick? Tanay Tandon and Deepika Bodapati Think It’s Possible
Athelas Releases Automated Blood Testing Kit for Home Use
Athelas Announces $3.7m Funding Led by Sequoia Capital
Primary Care Doctors Can Provide Blood Test Results in Minutes, Onsite, With New Sysmex XW-100
