For blood brothers Quest and LabCorp this is good news, since the two medical laboratory companies perform most of the testing for the biggest DTC genetic test developers
Should clinical laboratories be concerned about direct-to-consumer (DTC) genetic tests? Despite alerts from healthcare organizations about the accuracy of DTC genetic testing—as well as calls from privacy organizations to give DTC customers more control over the use of their genetic data—millions of people have already taken DTC tests to learn about their genetic ancestry. And millions more are expected to send samples of their saliva to commercial DTC companies in the near future.
This growing demand for at-home DTC tests does not appear to be subsiding. And since most of the genetic testing is completed by the two largest lab companies—Quest Diagnostics (NYSE:DGX) and Laboratory Corporation of America (NYSE:LH)—other medical laboratories have yet to find their niche in the DTC industry.
Another factor is the recent FDA authorization allowing DTC company 23andme to report the results of its pharmacogenetic (PGx) test directly to customers without requiring a doctor’s order. For these reasons, this trend looks to be gaining momentum and support from federal governing organizations.
Dark Daily has
reported on DTC genetic
testing for many years. According to MIT’s Technology Review, 26 million people—roughly
8% of the US population—have already taken at-home DNA tests. And that number
is expected to balloon to more than 100 million in the next 24 months!
“The genetic genie is out of the bottle. And it’s not going
back,” Technology Review reports.
The vast majority of the genetic information gathered goes into the databases of just four companies, with the top two—Ancestry and 23andMe—leading by a wide margin. The other two major players are FamilyTreeDNA and MyHeritage, however, Ancestry and 23andMe have heavily invested in online and television advertising, which is paying off.
In an op-ed response to a NYT editorial that warned readers to avoid 23andMe’s DTC genetic testing, 23andMe CEO and co-founder Anne Wojcicki (above) wrote, “We believe that consumers can learn about genetic information without the help of a medical professional, and we have the data to support that claim.” The FDA agreed and in February approved 23andMe to report pharmacogenetic test results directly to its customers. How this will play out for clinical laboratories remains to be seen. (Photo copyright: Inc.com.)
As more people add their data to a given database, the likelihood they will find connections within that database increases. This is called the Network Effect (aka, demand-side economies of scale) and social media platforms grow in a similar manner. Because Ancestry and 23andMe have massive databases, they have more information and can make more connections for their customers. This has made it increasingly difficult for other companies to compete.
Quest Diagnostics and LabCorp do the actual gene sequencing
for the top players in the DTC genetic testing sector. The expected wave of new
DTC genetic test costumers (74 million in the next 24 months) will certainly
have a beneficial revenue impact on those two lab companies.
Why the Explosion in Genetic
Testing by Consumers?
In 2013, just over 100,000 people took tests to have their
DNA analyzed, mostly using Ancestry’s test, as Dark Daily reported. By 2017, that
number had risen to around 12 million, and though Ancestry still had the
majority market share, 23andMe was clearly becoming a force in the industry,
noted Technology Review.
And now there are several health-related reasons as well. For
example, the study of pharmacogenetics has led clinicians to understand that
certain genes reveal how our bodies process some medications. The FDA’s clearance
allows 23andMe to directly inform customers about “genetic variants that may be
associated with a patient’s ability to metabolize some medications to help
inform discussions with a healthcare provider. The FDA is authorizing the test
to detect 33 variants for multiple genes,” the FDA’s press
release noted.
Controversy Over DTC
Genetic Tests
The use of DTC genetic tests for healthcare purposes is not without scrutiny by regulatory agencies. The FDA removed 23andMe’s original health test from the market in 2013. According to Technology Review, the FDA’s letter was “one of the angriest ever sent to a private company” and said “that the company’s gene predictions were inaccurate and dangerous for those who might not fully understand the results.”
23andMe continues to refine its DTC tests. However, the debate continues. In February of this year, the New York Times (NYT) editorial board published an op-ed warning consumers to be wary of health tests offered by 23andMe, saying the tests “look for only a handful of [genetic] errors that may or may not elevate your risk of developing the disease in question. And they don’t factor into their final analysis other information, like family history.”
Anne Wojcicki, CEO and co-founder of 23andMe, responded with her own op-ed to the NYT, titled, “23andMe Responds: Empowering Consumers.” In her letter, Wojcicki contends that people should be empowered to take control of their own health, and that 23andMe allows them to do just that. “While 23andMe is not a diagnostic test for individuals with a strong family history of disease, it is a powerful and accurate screening tool that allows people to learn about themselves and some for the most common clinically useful genetic conditions,” she wrote.
Nevertheless, privacy concerns remain:
Who owns the results, the company or the
consumer?
Who can access them?
What happens to them a year or five years after
the test is taken?
When they are sold or used, are consumers
informed?
Even as experts question the accuracy of DTC genetic testing
in a healthcare context, and privacy concerns continue to grow, more people
each year are ordering the tests. With predictions of 74 million more tests
expected in the next 24 months, it’s certain that the medical laboratories that
process those tests will benefit.
Customer relationship
management (CRM) plays a critical role in helping providers care for patients
with chronic diseases and clinical laboratories are part of those solutions
Home healthcare continues to boom in the US and more
technology companies each year—including Salesforce—strive to expand their
presence within the industry. This represents a significant shift in site of
service for a substantial and growing number of Americans. Equally true is that
home healthcare is an opportunity for clinical laboratories to serve this
increasing proportion of the American population.
Statistics tell the tale behind the boom in home healthcare.
The Centers
for Disease Control and Prevention (CDC) estimates that six in 10 adults in
the United States suffer from chronic diseases, such as cancer, and four in 10
adults live with two or more chronic illnesses.
This means that among medical laboratories and other
providers servicing the home healthcare industry demand for clinical laboratory
testing will increase.
Last year, approximately $103 billion was spent on home
healthcare services and that number is expected to reach $173 billion by 2026,
according to the Centers for Medicare and
Medicaid Services (CMS). Approximately 7.6 million people in the US now
require some level of in-home medical care. The overall employment of in-home
healthcare providers is projected to grow 41% between 2016 and 2026.
Efficient tools that assist home healthcare organizations and
their providers are critical. Customer
Relationship Management (CRM) platforms that combine data gathered during
office visits with patients’ living and economic situations are proving to be powerful
allies for treating chronic disease populations.
Social Determinants
of Health
One such CRM developer, Salesforce,
is rising to the demand by adding new features to its existing Health
Cloud platform. Originally introduced in 2016 as a way to improve how
healthcare and life sciences organizations connect with patients, this product
is one example of how Silicon Valley companies are attempting to make inroads
within the healthcare sector. Health Cloud’s newest functional upgrades include:
These social determinants of health are typically not
included in health records. But they can be vital information for healthcare
providers. Clinical laboratory managers should pay attention to “social
determinants of health” because this term describes a new dimension in medical
care and how patients with chronic diseases are managed.
“A lot of people in healthcare know about the importance of social determinants of health, but the volume of information is so great that being able to display things clearly and concisely in front of the [providers who] are using it—when they need it—makes it more operant and more prominent in the care of that patient,” Joshua Newman, MD, Chief Medical Officer at Salesforce, told MedCity News. (Photo copyright: San Francisco Business Times/Biz Journals.)
This is a critical factor. Healthcare providers who use Salesforce’s
Health Cloud can now record a patient’s social determinant information—such as,
transportation issues, housing status, and care network—directly into that
patient’s profile. Access to this type of information can give healthcare
professionals a more complete understanding of each patient’s unique situation.
Here are some examples from a Salesforce press
release that illustrate how social-determinants-of-health data can help
patients and care providers:
“A care provider that wants to limit a patient’s
risk for readmission can know if the patient has access to transportation or
the ability to purchase healthy meals.
“A life science organization that wants to help
patients adhere to their therapies, or properly use their medical devices, can
see a patient’s employment status and living arrangements, and thus offer the
necessary level of financial and in-home support.
“A payer organization can deliver personalized
preventative or wellness material to members based on the member’s education or
reading level.”
“Our industry continues to centralize and integrate patient
data, but it is critical that we stay focused on improving the patient
experience,” noted Ashwini
Zenooz, MD, in the press release. Zenooz is Salesforce’s Senior Vice
President and General Manager, Global Healthcare and Life Sciences. “By surfacing
critical factors of a patient’s life in a single view, we empower care
providers to personalize patient care experiences and improve outcomes.”
Many
existing CRM products cannot collect data from a variety of sources and then
sort and analyze that information to provide users with actionable
intelligence. Salesforce is attempting to fill that void among health and
medical software products with Health Cloud.
“Healthcare has been slower culturally, politically, and
socially to share their data. But what we’re seeing now is even those
organizations that have historically not shared their data are realizing they
can do a better job if they do,” Newman told MedCity News.
Outside Hospital Care
Increasing
Salesforce has also added a service it calls the Connected
Patient Journey to its Health Cloud platform. This service is an
integration between Health Cloud and Salesforce marketing, which can
personalize information given to patients based on their unique health needs.
Using this feature allows providers to build patient lists and use marketing techniques
to reach patients who would most benefit from specific campaigns and
information.
“The general overarching theme that unites all of these
innovations is that care is gravitating increasingly toward the home or outside
of the hospital and the doctor’s office,” said Newman.
Whether in-hospital or in-home, clinical laboratory tests play
a critical role in healthcare services. The ability for clinical laboratories
to enter patients’ test results data directly into CRM systems like Health
Cloud could help providers utilizing those systems better assist patients with
chronic diseases.
In this second installment of a two-part briefing, the impact of the Affordable Care Act on healthcare spending by businesses and consumers during the past eight years is assessed
No single piece of legislation during the Obama Administration generated more controversy than the Affordable Care Act (ACA), which became law in 2010. It was touted by proponents within and without the administration as the needed solution to the nation’s healthcare problems.
The two biggest problems with healthcare in the United States are probably the sustained year-over-year growth in total healthcare spending and the large number of Americans who lack adequate health insurance. At the time that the ACA was signed into law by President Obama, there were assurances that this law would help solve both problems.
Thus, at the end of the Obama Administration’s eight years in office, both academic experts and journalists are writing their assessment about how the ACA has changed healthcare in the United States. This is a high-interest subject for medical laboratories and pathology groups, hospitals and health systems, and physicians. (more…)
FDA issues press release following clearance of a clinical lab test to detect genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae
Clearance by the US Food and Drug Administration (FDA) of a new rapid, multi-marker genetic test designed to identify bacteria that are resistant to Carbapenem antibiotics was considered significant enough that the federal agency issued a press release announcing that the test was cleared and now available for use by physicians and clinical laboratories in the United States.
In the race to develop molecular assays and genetic tests for infectious disease that deliver improved sensitivity and specificity with a faster time-to-answer, this new test offers all three benefits. Results are available in just 48 minutes, for example.
Some cancer researchers worry that these patients may not benefit from such clinical laboratory testing because effective therapeutic drugs don’t exist for their cancers
What can be more patient-centric than for a medical laboratory company to offer free genetic tests for cancer? That’s the strategy of a firm in Canada that is offering free cancer genomics testing to 1,500 cancer patients. However, some cancer researchers responded to this offer with skepticism.
In March, Contextual Genomics of Vancouver, British Columbia, began providing its cancer genomics test free to the first 1,500 patients whose oncologists submitted tumor samples. These specimens would be tested using the company’s Find It hotspot cancer panel.
“You could call it marketing, but it’s making this test available to people who haven’t had access to it before,” stated Chris Wagner, Contextual Genomics President and CEO, in a CBC News Canada interview.
Contextual Genomics says its Find It test focuses on “90 hotspots across 29 known cancer genes and analyzes seven exons of three genes,” with the specific genes and mutations selected because they are “actionable and can potentially direct patient treatment, indicate prognosis, and support diagnosis.” Oncologists that participate in this commercial pilot program will receive a comprehensive report that interprets the sequencing results. The report also identifies any approved drugs or clinical trials that target the patient’s gene mutations. (more…)
