This is another example of technology companies working to develop medical laboratory testing that consumers can use without requiring a doctor’s order for the test
Here’s new technology that could be a gamechanger in the fight against COVID-19 if further research allows it to be used in patient care. The goal of the researchers involved is to enable individuals to test for the SARS-CoV-2 coronavirus from home with the assistance of a smartphone app enhanced by artificial intelligence (AI).
Such an approach could bypass clinical laboratories by allowing potentially infected people to confirm their exposure to the coronavirus and then consult directly with healthcare providers for diagnosis and treatment.
The at-home test is being developed through a partnership between French pharmaceutical company Sanofi and San Jose, Calif.-based Luminostics, creator of a smartphone-based diagnostic platform that “can detect or measure bacteria, viruses, proteins, and hormones from swabs, saliva, urine, and blood,” according to the company’s website.
Users who wish to self-test collect a specimen from their nose via a swab and then insert that swab into a device attached to a smartphone. The device uses chemicals and nanoparticles to examine the collected sample. If the individual has the virus, the nanoparticles in the specimen glow in a way visible to smartphone cameras. The device generates data and AI in the smartphone app processes a report. The app informs the user of the results of this COVID-19 test, and it also enables the user to connect to a doctor directly through telehealth video conferencing to discuss a diagnosis.
“This partnering project could lead to another important milestone in Sanofi’s fight against COVID-19,” said Alan Main, Sanofi’s Executive Vice President, Consumer Healthcare, and Chair of the Global Self-Care Federation, in a press release. “The development of a self-testing solution with Luminostics could help provide clarity to individuals—in minutes—on whether or not they are infected.” (Photo copyright: Global Self-Care Federation.)
According to the press release, the diagnostic platform is composed of:
an iOS/Android app to instruct a user on how to run the test, capture and process data to display test results, and then to connect users with a telehealth service based on the results;
a reusable adapter compatible with most types of smartphones; and
consumables for specimen collection, preparation, and processing.
The COVID-19 test results are available within 30 minutes or less after collecting the sample, notes the Sanofi press release. Advantages cited for having a fast, over-the-counter (OTC) solution for COVID-19 testing include:
easy access and availability;
reduced contact with others, which lowers infection risk; and
timely decision-making for any necessary treatments.
The two companies plan to have their COVID-19 home-testing application available for the public before the end of the year, subject to government regulatory clearances. They intend to make their OTC solution available through consumer and retail outlets as well as ecommerce sites.
Can Sound Be Used to Diagnose COVID-19?
Another smartphone app under development records the sound of coughs to determine if an individual has contracted COVID-19. Researchers at the Swiss Federal Institute of Technology Lausanne (École Polytechnique Fédérale de Lausanne or EPFL) in Switzerland created the Cough-based COVID-19 Fast Screening Project (Coughvid), which utilizes a mobile application and AI to analyze the sound of a person’s cough to determine if it resembles that of a person infected with the SARS-CoV-2 coronavirus.
The inspiration for this project came from doctors who reported that their COVID-19 patients have a cough with a very distinctive sound that differs from other illnesses. The cough associated with COVID-19, according the EPFL website, is a dry cough that has a chirping intake of breath at the end.
“The World Health Organization (WHO) has reported that 67.7% of COVID-19 patients exhibit a ‘dry cough,’ meaning that no mucus is produced, unlike the typical ‘wet cough’ that occurs during a cold or allergies. Dry coughs can be distinguished from wet coughs by the sound they produce, which raises the question of whether the analysis of the cough sounds can give some insights about COVID-19. Such cough sounds analysis has proven successful in diagnosing respiratory conditions like pertussis [Whooping Cough], asthma, and pneumonia,” states the EPFL website.
“We have a lot of contact with medical doctors and some of them told us that they usually were able to distinguish, quite well, from the sound of the cough, if patients were probably infected,” Tomas Teijeiro Campo, PhD, Postdoc Researcher with EPFL and one of the Coughvid researchers, told Business Insider.
The Coughvid app is in its early developmental stages and the researchers behind the study are still collecting data to train their AI. To date, the scientists have gathered more than 15,000 cough samples of which 1,000 came from people who had been diagnosed with COVID-19. The app is intended to be used as a tool to help people decide whether to seek out a COVID-19 clinical laboratory test or medical treatment.
“For now, we have this nice hypothesis. There are other work groups working on more or less the same approach, so we think it has a point,” said Teijeiro Campo. “Soon we will be able to say more clearly if it’s something that’s right for the moment.”
With additional research, innovative technologies such as these could change how clinical laboratories interact with diagnosticians and patients during pandemics. And, if proven accurate and efficient, smartphone apps in the diagnosis process could become a standard, potentially altering the path of biological specimens flowing to medical laboratories.
Price shopping for clinical laboratories and other healthcare services and surgical procedures creates a ‘healthy competitive environment,’ an Optum executive noted
One example, SmartShopper by Vitals (now known as Sapphire Digital) of Lyndhurst, N.J., is a pre-paid employer- or health plan-based program that lets people use mobile phone apps and go online using their computers to check prices and quality ratings for healthcare service providers in their area. The program may also incentivize members to prices shop by offering up to $500 per service for choosing lower-cost providers.
“Today, there is no reason consumers shouldn’t know the price of routine, non-emergency care,” said Heyward Donigan, former President and CEO of Vitals who is now CEO of Rite Aid (NYSE:RAD), in a news release. “Putting consumers in the driver’s seat for making informed healthcare decisions will create a competitive healthcare marketplace that ultimately lowers costs for everyone.”
Does Price Shopping Create a ‘Healthy Competitive Environment’?
Individuals whose health plans or employers have signed up
for SmartShopper can use it to seek out the best prices for routine exams,
preventative exams, imaging scans, and to schedule surgeries. The program’s
provider data is compared by cost and quality based on nationally recognized
metrics and patient reviews.
Some of the largest health insurers in the country, such as Anthem and Highmark, provide price
shopping tools to their clients.
“Up to 7% of overall healthcare spent could be reduced through price transparency tools like SmartShopper,” Becca Lococo, PhD, Vice President, Customer Experience at Optum, told Modern Healthcare. This can create a really healthy competitive environment in an industry where costs are already rising.”
Employers Save Big with Price Shopping
Large companies can reap substantial savings when they
provide their employees with price shopping tools. Employer savings can range
from $1,810 for a round of physical therapy to $80 for a mammogram. Patients,
on average, save $606 for each procedure with SmartShopper, reported Modern
Healthcare.
“Even just one person shopping can make a difference for
that employer in terms of the claims they’d be paying out at the end,” Steve Crist, Vice
President, Commercial Health Plan, Blue
Cross Blue Shield of North Carolina, told Modern Healthcare. “Even
though the employer is paying the incentive, the cost savings more than make up
for it. The ROI on this program is very strong.”
The Vitals SmartShopper Book of Business Report 2017 notes that, between 2014 and 2017, the tool saved employers $40 million and paid out $4.6 million in cash rewards to individual consumers. In 2016 alone, SmartShopper saved employers $15 million and paid out $1.8 million in cash incentives with the average incentive check totaling $85.
The Vitals report also listed the top 10 procedures and the
three-year total cost savings for employers that used SmartShopper. The list
includes clinical laboratory testing as the fifth largest source of savings for
employers that used price-transparency tools as part of their health benefits
programs:
SmartShopper has a configurable list of more than 200
medical procedures and services included in the tool. Sapphire Digital
(formerly Vitals) uses claims data and collaborates with clients to develop the
ideal combination of services to maximize savings for their customers.
“We don’t have to boil the ocean to produce a sizeable reduction in healthcare costs for our employer clients,” said Heyward Donigan, former President and CEO of Vitals and now CEO of Rite-Aid, in the Vitals report. “Focusing on routine, shoppable procedures that are relevant to the demographics of a client’s workforce generates significant savings.” (Photo copyright: Wall Street Journal.)
Price Shopping for Surgery
In 2018, before changing its name to Sapphire Digital, Vitals sold its consumer services division to WebMD. The sale enabled Vitals to focus on enhancing and developing its price transparency tools. The company then launched Medical Expertise Guide (MEG), which uses advanced analytics to create “proprietary Composite Quality Scores for surgeons and facilities to help consumers find the best surgeon and facility combination for their surgery, at a predictable cost,” according to Sapphire Digital’s website.
“MEG brings consumers information, powered by data and
analytics and supported by personalized service, to help them make quality
healthcare decisions with confidence,” said Donigan, in a news
release. “MEG guides employees to the best care, while helping employers
manage the overall cost-effectiveness of their healthcare program.”
Examples presented in the news release of the “savings per case”
for people using MEG include:
In October 2016, Dark Daily reported on another example of using healthcare transparency tools from Castlight Health. That tool enables Safeway employees to check clinical laboratory prices on their smartphones or computers before selecting where to have tests performed. At that time, Safeway and its employees were able to reduce spending on clinical laboratory tests by 32% in only 24 months by selecting the labs with the lowest prices.
The examples presented above are evidence that price
transparency is gaining a foothold in healthcare. These are early
demonstrations that price shopping tools do help consumers make more informed
decisions when choosing hospitals, physicians, or clinical laboratories. The
trend is for ever-growing numbers of consumers to rely on pricing transparency
tools when selecting their medical care.
Pathologists and clinical laboratories should not ignore
this trend, as it could affect business workflow and revenue streams.
These virtual office visits use artificial intelligence and text messaging to allow real physicians to diagnose patients, write prescriptions, and order clinical laboratory tests
Clinical laboratories may soon be receiving test orders from physicians who never see their patients in person, instead evaluating and diagnosing them through a smartphone app. In response to major changes in the primary care industry—mostly driven by consumer demand—mobile app developers are introducing new methods for delivering primary care involving smartphones and artificial intelligence (AI).
Medical laboratories and pathology groups should prepare for consumers who expect their healthcare to be delivered in ways that don’t require a visit to a traditional medical office. One question is how patients using virtual primary care services will provide the specimens required for clinical laboratory tests that their primary care providers want performed?
Two companies on the forefront of such advances are 98point6 and K Health, and they provide a glimpse of primary care’s future. The two companies have developed smartphone apps that incorporate AI and the ability to interact with real physicians via text messaging.
Virtual Primary Care 24/7 Nationwide
Dark Daily has repeatedly reported that primary care in America is undergoing major changes driven by many factors including increasingly busy schedules, the popularity of rapid retail and urgent care clinics, consumer use of smartphones and the Internet to self-diagnose, and decreasing numbers of new doctors choosing primary care as a career path.
Writing in Stat, two physicians who had just completed internal medicine residencies, explained their own decisions to leave primary care. In their article, titled, “We were inspired to become primary care physicians. Now we’re reconsidering a field in crisis,” Richard Joseph, MD, and Sohan Japa, MD, cited factors that include long hours, low compensation in comparison with specialty care, and deficiencies in primary care training. At the time of their writing they were senior residents in primary care-internal medicine at Brigham and Women’s Hospital in Boston.
They also pointed to a decline in office visits to primary care doctors. “Patients are increasingly choosing urgent care centers, smartphone apps, telemedicine, and workplace and retail clinics that are often staffed by nurse practitioners and physician assistants for their immediate health needs,” they wrote.
One solution to declining populations of primary care physicians is a smartphone app created by Seattle-based 98point6. The service involves “providing virtual text-based primary care across the entire country, 24/7 of everyday,” explained Brad Younggren, MD, an emergency physician and Chief Medical Officer at 98point6, in a YouTube interview. “It’s text-based delivery of care overlaid with an AI platform on top of it.”
The service launched on May 1, 2018, in 10 states and is now available nationwide, according to press releases. 98point6 offers the service through individual subscriptions or through deals with employers, health plans, health systems, and other provider organizations. The personal plan costs $20 for the first year and $120 for the second, plus $1 per “visit.”
Subscribers use text messaging to interact with
an “automated assistant” that incorporates artificial intelligence. While
messaging, they can describe symptoms or ask questions about medical topics.
“After the automated assistant has gathered as many
questions as it deems necessary, it hands [the information] off to a
physician,” Younggren said. In most cases, all communication is via text
messaging. However, the doctor may ask the subscriber to send a photo or participate
in a video meeting.
The doctor then makes a diagnosis and treatment plan. Prescriptions can be sent to a local pharmacy and the subscriber can be referred to a clinical laboratory for tests. LabCorp or Quest Diagnostics are preferred providers, but subscribers can choose to have orders sent to independent labs as well, states the company’s website.
Younggren claims the company’s physicians can resolve more
than 90% of the cases they encounter. If, however, they can’t resolve a case, they
can refer the patient to a local physician. And because most of 98point6’s
interactions with subscribers are text-based, that messaging serves as reference
documentation for other doctors, he said.
“We’ve set out to dramatically augment the primary-care physician with deep technology by delivering an on-demand primary-care experience,” Robbie Cape (above), CEO and co-founder of 98point6, told Modern Healthcare. (Photo copyright: Seattle Business Magazine.)
The 98point6 physicians are full-time employees and work with the company’s technologists to improve the AI’s capabilities, Younggren said. The company claims its doctors can diagnose and treat more than 400 conditions, including: allergies, asthma, skin problems, coughs, flu, diabetes, high blood pressure, and infections. For medical emergencies, subscribers are advised to seek emergency help locally.
98point6 also can function as a front end for interacting
with patients in health systems that have their own primary-care doctors,
Younggren said. The company’s health system clients “don’t actually have a good
digital primary care front end to deliver care,” he said. “So, we can
essentially give them that, and then we can also get some detailed
understanding of how to coordinate care within the health system to drive
patients to the care that they need.” For example, this can include directing the
patient to an appropriate sub-specialist.
Leveraging Patient Data to Answer Health Questions
K Health in New York City offers a similar service based on its own AI-enabled smartphone app. The app incorporates data gleaned from the records of more than two million anonymous patients in Israel over the past 20 years, explained company co-founder Ran Shaul, co-founder and Chief Product Officer, in a blog post.
The software asks users about their “chief complaint” and
then compares the answers with data from similar cases. “We call this group
your ‘People Like Me’ cohort,” Shaul wrote. “It shows you how doctors diagnosed
those people and all the ways they were treated.”
The K Health app is free, but for a fee ranging from $14 for a one-time visit to $39 for an annual subscription, users can text with doctors, the company’s website states.
Unlike 98point6, K Health’s doctors are employed by “affiliated physician-owned professional corporations,” the company says, not K Health itself.
“The doctor you chat with will discuss a recommended treatment plan that may include a physical exam, lab tests, or radiology scans,” states K Health’s website. “They may send you directly for some of these tests, but others will require you to visit a local doctor.”
These are just the latest examples of new technologies and
services devised to help patients receive primary care. How a patient who uses
a smartphone app gets the necessary clinical laboratory tests performed is a
question yet to be answered.
Clinical laboratory leaders will want to watch this shift in
the delivery of primary care and look for opportunities to serve consumers who
are getting primary care from nontraditional sources.
Another push for price transparency steps up pressure on medical laboratories and anatomic pathology groups to develop compliance strategies
Clinical
laboratories and anatomic
pathology groups are under increasing pressure to develop strategies for
making their test prices more accessible to patients. Those pressures are
likely to grow due to newly proposed federal regulations that aim to allow
patients to compare prices for healthcare services on their smartphones.
This new proposed rule comes less than a year after a rule
involving hospital prices was implemented. As of January 1, 2019, the federal
Centers for Medicare and Medicaid Services (CMS) required
US hospitals to post their prices online. Dark
Daily reported last year about the risks and opportunities posed by
that move.
“In our current health system, there is an asymmetry of information for patients. They have few ways if any to anticipate or plan for costs, lower or compare costs, and, importantly, measure their quality of care or coverage relative to the price they pay. Transparency in the price and cost of healthcare could help address some of those concerns by empowering patients with information they need to make informed decisions,” said Donald Rucker, MD (above), National Coordinator for Health Information Technology (ONC), in remarks delivered to the US Senate. (Photo copyright: ONC.)
Giving Patients Access to Their Health Information
In May, officials with those agencies discussed the
regulations in prepared remarks for a hearing of the HELP committee.
“A central purpose of the proposed [ONC] rule is to
facilitate patient access to their EHI on their smartphone, growing a nascent
patient- and provider-facing app economy,” he said, noting that this access is
impeded by a lack of interoperability between health information systems, as
well as restrictions on information exchange imposed by health IT developers.
The proposed rule will mandate use of common software
standards so that app developers can access health information systems from
different vendors. As a result, patients could choose their own apps to view
their data regardless of which electronic
health records (EHR) system their provider uses. The rule also includes
provisions for dealing with so-called “information blocking”
by vendors, Rucker noted.
If the proposed rule is implemented as currently written,
there would be a need for clinical laboratories and pathology groups to ensure
that their laboratory
information systems (LIS) meet the specifications of the new rule. This may
mean that, along with enabling two-way digital interfaces with physicians’
EHRs, labs also would need to be able to pass data to the apps and mobile
devices used by patients that are covered by the proposed new rule.
“ONC’s proposed rule primarily focuses on clinical data,” he
said. “However, advances in computer science and the maturity of data standards
are accelerating the convergence of medical data with billing and price data.
As such, the rule proposes to include such information as part of a patient’s
EHI that should be available for access, exchange, and use.”
Enabling cost comparisons will allow patients to make
more-informed decisions about their healthcare, Rucker added. But he
acknowledged that implementing this vision won’t be easy.
“Unfortunately, the complex and decentralized nature of how
payment information for healthcare services is currently created, structured,
and stored presents many challenges to achieving price transparency,” he said.
“This entire information chain is geared to retrospective payments rather than
prices.”
Rucker told the HELP committee that the [ONC] will be
seeking public input about how to capture price information and enable price
transparency. Once the rule is finalized and published, providers will have two
years to comply.
Medical Laboratories Need a Strategy for Providing Access
to Patient Records
The proposed CMS rule imposes requirements on payers to
provide electronic access to health claims and other information for their
enrollees.
In her prepared remarks
for the Senate HELP hearing, Kate Goodrich,
MD, Director of the Center for Clinical Standards and Quality (CCSQ) and
CMS Chief Medical Officer, said, “A core policy principle underlying our
proposals is that every American should be able, without special effort or
advanced technical skills, to see, obtain, and use all electronically available
information that is relevant to their health, care, and choices—of plans,
providers, and specific treatment options.”
That’s all well and good, however, as Fred Schulte, a senior
correspondent for Kaiser
Health News, wrote in his coverage of the two proposed rules, “Meeting
these goals could prove to be a tall order.”
He continued, “For well over a decade, federal officials
have struggled to set up a digital records network capable of widespread
sharing of medical data and patient records.” Not to mention the billions of
dollars already spent by the CMS and ONC incentivizing providers to implement
truly interoperable health
information exchange (HIE) systems nationwide.
Nevertheless, pressure for greater consumer data access and
price transparency will likely continue to build across the healthcare
industry, including on medical laboratories. Price transparency as a trend is
making steady forward progress, despite resistance by hospitals, physicians,
medical associations, and others.
All clinical laboratories should have a strategy to make lab
test prices readily available to patients. It is something that will become
common at some future point.
Mobile technology continues to bring clinical-grade medical laboratory testing into patients’ homes, as more do-it-yourself kits receive FDA approval
Recently, the federal Food and Drug Administration (FDA) approved a smartphone-based at-home urine test that enables patients with chronic diseases, urinary tract infections, or high-risk pregnancies to monitor their health using a testing method that’s as easy as taking a smartphone selfie.
This latest breakthrough is another example of how technology is making it possible to move clinical laboratory testing closer to patients—in this instance into their homes. But it’s also taking away some of the urine testing being performed by medical laboratories.
The Dip.io urinalysis test system from Israeli-based Healthy.io received FDA 510(k) clearance for prescription home use. The test is for the semi-quantitative detection of glucose, specific gravity, blood, pH and protein, as well as the qualitative detection of nitrite. Special conditions also mandate in vitro diagnostic use only, according to the 501(k) Substantial Equivalence Determination Decision Summary.
In 2016, the Dip.io testing kit received CE marking, a certification mark that indicates health, safety, and environmental protection standards for products sold within the European Economic Area. And it has International Organization for Standardization (ISO) 13485 certification, making it commercially available in the European Union and the United Kingdom.
“We are incredibly proud of [achieving] this landmark ruling,” Healthy.io Founder and CEO Jonathan (Yonatan) Adiri (above) told MobiHealthNews. “It’s the highlight in a year that has seen us achieve so many of the key tasks we set out to achieve. With seven leading medical partners worldwide, including the UK National Healthcare System [sic] and a growing product portfolio, we’re set to meet 100,000 patients this year.” (Photo copyright: CNBC.)
Smartphone app with backend cloud-based server; and,
User manual.
Combining a urine sample kit and testing strips with color recognition, computer vision, and artificial intelligence (AI) has enabled Healthy.io to offer patients the ability to take what it calls a “medical selfie.” The test kit achieved more than 99% usability across age groups from 18 to 80.
“The process for the user is very simple,” Adiri told VentureBeat. “We like to say ‘If you can text, you can test.’ The user simply opens the app and is walked through the process step by step—aided by our chatbot nurse named Emily.”
According to Adiri, “the user opens the kit, fills the cup,
dips the stick, and, places it on our patented color-board. After waiting for
60 seconds (timed within the app) both the color-board and dipstick are scanned,
similar to how a QR code is scanned. The image is normalized and data points
are sent to our cloud, where they are classified into the correct clinical
result.”
Adiri notes that one significant aspect of the Healthy.io
device is it uses a standard urinalysis dipstick.
“It is important to first note that we haven’t tampered with the standard urine dipstick,” Adiri told VentureBeat. “It has been a tried and tested diagnostic tool for decades and is well established across many clinical pathways. We test for ketones, leukocytes, nitrites, glucose, protein, blood, specific gravity, bilirubin, urobilinogen, and pH. These indicators span a wide range of pathologies, from urinary tract infection to ketosis, kidney disease, health in pregnancy, and bladder cancer.”
The Healthy.io app integrates Dip.io (above) into the clinical process by automatically sending results to the patients’ electronic health records for physician review. The results may necessitate a follow-up clinical laboratory urine culture test to determine whether bacteria or other organisms are present in the urine. (Image copyright: Science and Enterprise.)
Adiri told VentureBeat that his company will be bringing an albumin-to-creatinine ratio (ACR) test to market as well. He says the test is “critical” for as many as 76 million Americans with diabetes, hypertension, and other medical issues who undergo urine testing looking for signs of chronic kidney disease. Healthy.io is also planning to release a skincare test.
“We see a leap forward in smartphone hardware that happens
roughly every four years. Our urinalysis product would not have been possible
five years ago because the image quality of smartphone cameras simply wasn’t
good enough,” he noted.
Other Clinical Lab
Grade Urine-testing Kits
Healthy.io received the FDA’s 510(k) approval on July 18,
2018. And as of February, 2019, the company has raised $18 million in venture
capital funding, according to VentureBeat, which reports that
100,000 patients in Europe and Israel are already using Dip.io.
“We know that most patients with kidney disease and protein in their urine are untested and therefore go undiagnosed,” Josef Coresh, MD, PhD, professor of epidemiology, medicine, and biostatistics at Johns Hopkins Bloomberg School of Public Health, and head of Healthy.io’s clinical advisory board, told VentureBeat. “[This] technology—[which] directly [connects] patients at home with the medical system—is a gamechanger addressing a big need.”
According to mHealth Intelligence, Dip.io is reportedly one of the first Class II medical devices the FDA has approved for use with optical equipment designed by a third party, such as a smartphone.
But it’s not the only at-home clinical-grade urine testing kit in the market. California-based inui Health, formerly known as Scanadu, announced the launch of its own clinical-grade home urine analysis platform last year. Its FDA-approved kit includes a dippable paddle that measures five key biomarkers (protein, glucose, leukocytes, nitrites, and ketones) in urine and uses a smartphone app to provide results directly to patients within one minute. Results may be shared with providers via a HIPAA compliant system.
As more diagnostic tests become available for home-use, anatomic
pathology and clinical laboratories should work closely with healthcare
providers to ensure patients who use these new tools receive the proper interpretation
guidance and follow-on diagnostic or monitoring tests they need.
The flood of new diagnostic technologies undergoing research
and moving toward regulatory approval should motivate medical laboratory
managers and clinical pathologists to rethink their lab’s business and clinical
strategies. The goal would be to identify ways to offer these new diagnostic
tools so that labs can deliver more value to physicians, patients, and
payers—value for which clinical labs can be reimbursed under new payment
models.
