Combining consumers’ health data, including clinical laboratory test results, to genetic data for predispositions to chronic diseases could be key to developing targeted drugs and precision medicine treatments
Genetic testing company 23andMe is beta testing a method for combining customers’ private health data—including clinical laboratory test results and prescription drug usage—with their genetic data to create the largest database of its kind.
Such information—stored securely but accessible to 23andMe for sale to pharmaceutical companies for drug research and to diagnostics developers—would place 23andMe in a market position even Apple Health cannot claim.
Additionally, given the importance of clinical lab test data—which makes up more than 70% of a patient’s medical records—it’s reasonable to assume that innovative medical laboratories might consider 23andMe’s move a competitive threat to their own efforts to capitalize on combining lab test results with patients’ medical histories, drug profiles, and demographic data.
23andMe plans to use third-party medical network Human API to collect and manage the data. Involvement in the beta test is voluntary and currently only some of the genetic company’s customers are being invited to participate, CNBC reported.
Apple Healthcare, 23andMe, and Predicting Disease
The announcement did not go unnoticed by Apple, which has its own stake in the health data market. Apple Healthcare’s product line includes:
Mobile device apps for using at point-of-care in hospitals;
iPhone apps that let customers store and share their medical and pharmaceutical histories and be in contact with providers;
ResearchKit, which lets researchers build specialized apps for their medical research;
CareKit, which lets developers build specialized monitoring apps for patients with chronic conditions; and
Apple Watch, which doubles as a medical device for heart monitoring.
What Apple does not have is genetic data, which is an issue.
An Apple Insider post notes, “As structured, 23andMe’s system has advantages over Apple’s system including not just genetic data, but insights into risks for chronic disease.”
This is significant. The ability to predict a person’s predisposition to specific chronic diseases, such as cancer, is at the heart of Precision Medicine. Should this capability become not only viable and reliable but affordable as well, 23andMe could have a sizeable advantage in that aspect of the health data market.
Anne Wojcicki (above) is CEO and co-founder of 23andMe. The genetic company is inviting some of its customers to combine their medical information—including clinical laboratory test results and medication histories—with their stored genetic data. Customers would have access to the combined data and be able to share it with providers. In exchange, 23andMe gets to sell it to pharmaceutical companies and diagnostics developers. If successful and popular with the eight to 10-million peoplewho have reportedly purchased its test kits, 23andMe could produce a significant source of revenue. (Photo copyright: Inc.)
Genetic Test Results Combined with Clinical Laboratory
Test Results
23andMe is hopeful that after people receive their genetic test
results, they will then elect to add their clinical laboratory results, medical
histories, and prescription drug information to their accounts as well. 23andMe
claims its goal is to provide customers with easy, integrated access to health
data that is typically scattered across multiple systems, and to assist with
medical research.
“It’s a clever move,” Ruby Gadelrab, former Vice President of Commercial Marketing at 23andMe who now provides consulting services to health tech companies, told CNBC. “For consumers, health data is fragmented, and this is a step towards helping them aggregate more of it.”
CNBC also reported that Gadelrab said such a database
“might help 23andMe provide people with information about their risks for complex,
chronic ailments like diabetes, where it’s helpful for scientists to access a
data-set that incorporates information about individual health habits,
medications, family history and more.”
Of course, it bears saying that the revenue generated from cornering
the market on combined medical, pharmaceutical, and genetic data from upwards
of 10-million customers would be a sizable boon to the genetic test company.
CNBC reported that “the company confirmed that it’s a
beta program that will be gradually rolled out to all users but declined to
comment further on its plans. The service is still being piloted, said a person
familiar with the matter, and the product could change depending on how it’s
received.”
Will 23andMe Have to Take on Apple?
23andMe already earns a large portion of its revenue through
research collaborations with pharmaceutical companies, and it hopes to leverage
those collaborations to produce new drug therapies, CNBC reported.
This new venture, however, brings 23andMe into competition
with Apple on providing a centralized location from where consumers can access
and share their health data. But it also adds something that Apple does not
have—genetic data that can provide insight into consumers’ predispositions to
certain diseases, which also can aid in the development of precision medicine
treatments for those diseases.
Whether Apple Healthcare perceives 23andMe’s encroachment on
the health data market as a threat remains to be seen.
Nevertheless, this is another example of a prominent company
attempting to capitalize on marketable customer information. Adding medical information
to its collected genetic data could position 23andMe to generate significant
revenue by selling the merged data to pharmaceutical companies and diagnostics
developers, while also helping patients easily access and share their data with
healthcare providers.
It’s a smart move, and those clinical laboratory executives
developing ways to produce revenue from their lab organization’s patient lab test
data will want to watch closely as 23andMe navigates this new market.
Industry analysts speculate that Apple might be planning to enter the EHR and healthcare related markets by transforming mobile technologies into gateway devices connected to providers’ EHR systems and patient data
Imagine a mobile device that monitors vitals while connected in real-time to healthcare providers, electronic health records (EHR), and clinical laboratories. One that measures the physical condition and emotional state of the user by casting light onto skin, and then records and transmits it with a swipe of the touch screen. Would such an innovation change how patients expect to interact with their providers? And how physicians, anatomic pathologists, and medical laboratories receive data from their patients? Certainly.
How this would affect medical laboratories and anatomic pathology groups remains to be seen. But where Apple goes, industries follow. Thus, it’s worth following the company’s activities in the healthcare market.
Bringing Clinical Data, Medical Laboratory Test Results, to iPhone
Mobile devices launched the era of consumer-grade fitness wearables. It’s not uncommon for a smart phone or watch to capture and store a range of health data generated by users. This can include everything from heart rate and sleeping patterns to dietary logs and fertility tracking. But, to date, much of that healthcare data is user generated and does not integrate in any meaningful way with the majority of EHR systems. Nor does it enable communications with primary care providers or diagnostic services—such as medical laboratories or pathology groups.
This may soon change.
According to a CNBC report, a unit at Apple is “in talks with developers, hospitals, and other industry groups about bringing clinical data—such as detailed lab results and allergy lists—to the iPhone, according to a half-dozen people familiar with the team.”
The report states that Apple:
· “Wants the iPhone to become the central bank for health information;
· “Is looking to host clinical information, such as labs and allergy lists, and not just wellness data; and,
· “Is talking with hospitals, researching potential acquisitions, and attending health IT industry meetings.”
Christina Farr, the report’s author, predicts that Apple could be preparing to apply its music industry model to the healthcare industry by, “Replacing CDs and scattered MP3s with a centralized management system in iTunes and the iPod—in the similarly fragmented and complicated landscape for health data.”
At a special event in September, Apple COO Jeff Williams (above) announced Stanford Medicine’s Apple Heart Study, which uses “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation,” and, according to Williams, “notify users.” This is just one of several healthcare-related study collaborations Apple is exploring. It is not known if Apple is looking to collaborate with medical laboratories. (Photo copyright: Apple.)
Apple’s History with Healthcare Related Technology
Taken as a single event, these speculations might not convince industry leaders. However, Apple’s long-term investments and acquisitions show a clear trend toward integrating healthcare data into the Apple ecosystem.
· Unveiled three different APIs—HealthKit, ResearchKit, and CareKit—designed to help capture, analyze, communicate, and integrate healthcare data with the Apple iOS and watchOS ecosystems;
· Engaged with the Argonaut Project and Health Gorilla (a centralized hub of healthcare data and information) suggesting a shift from wearables and basic device-based biometrics toward in-depth reporting, interoperability, and access to third-party healthcare data repositories—such as those in a person’s EHR or medical laboratory portal.
The Future of EHRs or Another Failed Attempt at Innovation?
Apple isn’t the only company to attempt such a system. Other efforts include Microsoft’s Health Vault and Google’s now shuttered Google Health. Another CNBC article notes that Amazon is also researching healthcare related options. “The new team is currently looking at opportunities that involve pushing and pulling data from legacy electronic medical record systems,” stated Farr. “The group is also exploring health applications for existing Amazon hardware, including Echo and Dash Wand.”
However, where most services fail to gain traction is user engagement. After all, if a system isn’t widely used or fails to offer benefits over existing systems, patients and service providers are not likely to go through the process of switching systems. Speaking with CNBC, Micky Tripathi, President and CEO of the Massachusetts eHealth Collaborative notes, “At any given time, only about 10% to 15% of patients care about this stuff. If any company can figure out engagement, it’s Apple.”
According to comScore, 85.8-million people over the age of 13 already own an iPhone in the US. The upcoming facial recognition features on Apple’s iPhone X might also provide the added security needed for those questioning the safety of their data. Should Apple succeed, communicating data between clinical laboratories, physicians, and patients might be both convenient and fast. More importantly, it might be the universal platform that finally provides health data access across the entire care continuum, while simultaneously improving access to providers and empowering healthcare consumers.
Of course, this is a few years from reality. But, we can speculate … would innovative medical laboratories have their patients’ lab test data hosted in the Cloud in such a way that patients and providers could access it securely, along with other protected clinical records?
Imagine how this would enable patients to have their complete medical record traveling with them at all times.
Many aspects of traditional clinical laboratory pathology testing remain rooted to cancer care even as the cancer care industry embraces precision medicine, and digital pathology testing and interpretation
There’s good news for anatomic pathologists worried about the future of the pathology profession. A recent survey of oncology program participants in the United States determined that Precision Medicine—and the need for precision diagnostics—will be one of the top trends that significantly reshape how cancers are diagnosed and treated in the US.
Some of these five trends indirectly impact clinical laboratories and pathology groups by directly affecting the healthcare practices of hospitals and private practice doctors who order medical laboratory tests for their cancer patients.
Lindsey Conway, Managing Director, Research and Insights Division, for The Advisory Board, covered five of the top trends she says will “shape the business of cancer care in 2017,” which MedCityNews reported. They include:
One of the trends involves increased use of specialized diagnostic tests that identify genetic mutations to help ensure cancer drugs and therapies are precisely targeted to a patient’s specific needs. This is a critical element of precision medicine.
Here are brief run-downs on each of the five trends:
Precision Medicine in Clinical Laboratory Cancer Care
The survey found precision medicine to be among the top trends impacting the cancer care business in 2017. This will be of particular interest to pathologists and clinical laboratory leaders who provide services to oncologists and cancer patients.
ACCC’s press release states: “By taking the pulse on issues such as program mergers and acquisitions, clinical pathways usage, and precision medicine and immunotherapy, ACCC can continue to provide needed resources to its members.”
The Advisory Board is a respected “think tank” that uses research, technology, and consulting to aid healthcare organizations. And, the ACCC is an advocacy and education organization for cancer care professionals.
“We are all betting big on the promise of precision medicine,” declared Conway, in the MedCityNews story. She noted, however, specific challenges related to precision medicine. They include:
Drawing on the AB/ACCC findings, MedCityNews noted that about 69% of cancer care consumers who use the Internet in healthcare decision-making are likely to change providers who receive negative online reviews.
These findings are not lost on cancer center administrators and medical directors who, according to an Advisory Board news release announcing the results of a survey of 250 cancer program leaders, have “increased interest in cancer patient consumerism—mainly around how to identify patient priorities and market cancer program services directly to patients.”
Telehealth Takes Cancer Care Virtual
Telehealth (AKA, Telemedicine) involves telecommunications and information technologies (IT), such as video, audio, and Internet-based software, to bring healthcare services to resource strapped remote and rural environments. One example of telemedicine that is focused on cancer care is the Breast Cancer Ally mobile app. Developed by Michael Sabel, MD, FACS, Associate Professor of Surgery and Chief of Surgical Oncology at the University of Michigan Medical School (U-M), Breast Cancer Ally is “an information and symptom management tool specially designed [to help] patients through every stage of breast cancer treatment.” The app is available for use by U-M Comprehensive Cancer Care Center patients.
“This is disease-specific technology that helps patients navigate the multiple facets of medical care by delivering information and tools based on the appropriate stage of treatment,” U-M noted in a statement.
Navigating the Care Continuum
Driven by a need to guide more cancer patients throughout their treatment, the University of Alabama at Birmingham (UAB) is taking its navigation program to a national level, according to a UAB statement.
UAB’s partner in the Patient Care Connect Program (PCCP) is Guideway Care, a resource for personal guidance in cancer treatment and recovery. Guideway Care offers communication protocols and technology for assisting people following a cancer diagnosis.
According to UAB results, compared to non-navigated cancer patients the PCCP participants experienced:
· 55% less hospitalizations;
· 29% fewer emergency room visits;
· 60% less intensive care unit admissions; and,
· 45% reduction in Medicare costs.
“The PCCP is a model of navigation that supports patients throughout the cancer care continuum and may be a mechanism to extend palliative and support care more fully into the community,” wrote UAB-affiliated authors in a JAMA Oncology article.
“Overall, cost reductions were driven by substantial declines in hospitalizations and clinic-based services,” they concluded.
Ramona Colvin (standing) and Myeisha Hutchinson, patient navigators with UAB’s Patient Care Connect program, work together to help patients through their cancer journey. (Photo and caption copyright: UAB News.)
Healthcare Reimbursement and Reform
Insurance company programs intended to lower cancer care costs that operate concurrent with congressional lawmakers’ healthcare reform efforts are receiving increased scrutiny.
One relevant example of a payer plan aimed at increasing value is Anthem’s Cancer Care Quality Program. It enables participating oncologists to compare cancer care pathways and become eligible for additional $350 a month in reimbursements for each patient being treated.
“Private payers have been on the forefront of designing value-driven ways to pay for cancer care, but we’re not going to arrive at a satisfying payment solution any time soon,” stated Conway in the MedCityNews article.
Trends Can Guide Medical Laboratory Leaders
The findings of the AB/ACCC study affirm the important role that pathologists will have as precision medicine transforms cancer care. After all, it is pathologists who diagnose the primary cancer, and it is pathologists who conduct specialized testing to identify genetic mutations that would make a patient’s cancer vulnerable to a specific drug or therapy. Pathologists also have a role in monitoring the cancer patient’s treatment.
Thus, it is important for clinical laboratory leaders to acknowledge what their cancer care colleagues perceive as trends and topics of interest. Pathologists and medical laboratory leaders who provide services to oncologists and cancer patients should note these trends and related programs and research. Healthcare navigation and telemedicine applications, for example, could be ways for pathologists to collaborate with oncologists in outreach to cancer patients.
Researchers, including pathologists, can use Apple’s ResearchKit app to help collect and share genetic information about cancers and other diseases while building a huge genome database
By providing tools to allow users to be more productive in working with healthcare big data, several Silicon Valley giants hope to increase their presence in medical services. The latest company to enter the field is Apple Computers (NASDAQ:AAPL). In March it announced the availability of ResearchKit, an open-source software framework that turns the iPhone into a research tool.
Pathologists and clinical laboratory scientists have a stake in the healthcare big data trend, since more than 70% of the typical patient’s permanent medical record consists of medical laboratory test data. Thus, the products introduced by Apple, Google, and other Silicon Valley firms that are designed to help physicians and other professionals work with healthcare big data have the potential to transform the way value is harvested from these data sets.
Apple’s strategy is to support researchers. Its ResearchKit is designed to be an open-source software framework that turns the iPhone into a research tool. It enables development of apps that help medical researchers recruit study subjects and collect health information through iPhone’s sensors and surveys. Because it is an open-source platform, researchers also can create apps for Android and Windows devices. (more…)
Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens
Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.
The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices. (more…)
