Also listed by Forbes was Anne Wojcicki, CEO and founder of 23andMe, a personal genomics and biotechnology company. Wojcicki’s net worth of $1.1 billion puts her in the 25th position, according to Forbes.
“I think that what will happen is that a few of them will do very well. And the majority of them won’t. “It’s not us as much as the health systems who have to respond to the patient saying, ‘Send my data here,’ or ‘Send my data there,’” Faulkner told Forbes.
Bio-Rad’s Alice Schwartz an IVD ‘Pioneer’
As Faulkner rose to prominence in healthcare IT, Alice Schwartz of Bio-Rad Laboratories found massive success in the in vitro diagnostics industry.
She and her late husband, David, started Bio-Rad with $720 in 1952 in Berkeley, Calif. They were intent on offering life science products and services aimed at identifying, separating, purifying, and analyzing chemical and biological materials, notes the company’s website.
Bio-Rad Laboratories (NYSE:BIO and BIOb) of Hercules, Calif., offers life science research and clinical diagnostic products. The company’s second quarter (Q2) 2021 net sales were $715.9 million, an increase of about 33% compared to $536.9 million in Q2 2020, according to a news release. Its Clinical Diagnostics segment Q2 sales were $380 million, an increase of 34% compared to 2020.
Norman Schwartz, the founders’ son, is Bio-Rad’s Chairman of the Board,
President, and CEO. However, at age 94, Alice Schwartz, the oldest person on Forbes’ richest self-made women list, “has no sign of stopping soon,” IBT reported.
Lists are fun. Medical laboratory and diagnostics professionals may admire such foresight and perseverance. Judith Faulkner and Alice Schwartz are extraordinary examples of innovative thinkers in healthcare. There are others—many in clinical laboratories and pathology groups.
23andMe executives say they plan to leverage their database of millions of customer genotypes ‘tohelp accelerate personalized healthcare at scale,’ a key goal of precision medicine
In what some financial analysts believe may be an indication that popularity of direct-to-consumer (DTC) genetic testing among customers who seek info on their ethnic background and genetic predisposition to disease is waning, personal genomics/biotechnology company 23andMe announced it has completed its merger with Richard Branson’s VG Acquisition Corp. (NYSE:VGAC) and is now publicly traded on NASDAQ.
According to a 23andMe news release, “The combined company is called 23andMe Holding Co. and will be traded on The Nasdaq Global Select Market (“NASDAQ”) beginning on June 17, 2021, under the new ticker symbol ‘ME’ for its Class A Common shares and ‘MEUSW’ for its public warrants.”
Now that it will file quarterly earnings reports, pathologists and clinical laboratory managers will have the opportunity to learn more about how 23andMe serves the consumer market for genetic types and how it is generating revenue from its huge database containing the genetic sequences from millions of people.
After raising $600 million and being valued at $3.5 billion, CNBC reported that 23andMe’s shares rose by 21% during its first day of trading.
Might the quick rise in its stock price be a sign that 23andMe—with its database of millions of human genotypes—has found a lucrative path forward in drug discovery?
23andMe says that 80% of its 10.7 million genotyped customers have consented to sharing their data for research, MedCity News reported, adding that, “The long-term focus for 23andMe still remains using all of its accumulated DNA data to strike partnerships with pharmaceutical companies.”
Time for a New Direction at 23andMe
While 23andMe’s merger is a recent development, it is not a surprising direction for the Sunnyvale, Calif.-based company, which launched in 2006, to go.
Even prior to the COVID-19 pandemic, both 23andMe and its direct competitor Ancestry had experienced a decline in direct-to-consumer testing sales of at-home DNA and genealogy test kit orders. This decline only accelerated during the pandemic.
Meanwhile, 23andMe Therapeutics, a division focused on research and drug development, has been on the rise, Bloomberg News reported. On its website, 23andMe said it has ongoing studies in oncology, respiratory, and cardiovascular diseases.
“It’s kind of an ideal time for us,” Wojcicki told Bloomberg News.
“As an early investor, I have seen 23andMe develop into a company with enormous growth potential. Driven by Anne’s vision to empower consumers, and with our support, I’m excited to see 23andMe make a positive difference to many more people’s lives,” he added.
Report Bullish on Consumer Genetic Testing
Despite the apparent saturation of the direct-to-consumer (DTC) genetic testing market, and consumers’ concerns about privacy, Infiniti Research reported that worldwide sales of DTC tests “are poised to grow by $1.39 bn during 2021-2025, progressing at a CAGR [compound annual growth rate] of over 16% during the forecast period.”
“This study identifies the advances in next-generation genetic sequencing as one of the prime reasons driving the direct-to-consumer genetic testing market growth during the next few years. Also, reduction in the cost of services and growing adoption of online service platforms will lead to sizable demand in the market,” the report states.
Clinical laboratory leaders will want to stay abreast of 23andMe rise as a publicly-traded company. It will be interesting to see if Wojcicki’s vision about moving therapies into clinics in five years comes to fruition.
The merger is expected to boost investment in 23andMe’s consumer health and therapeutics businesses
After years of spectacular growth, the popularity of direct-to-consumer (DTC) genetic testing is beginning to wane. Nevertheless, opportunities still exist in the DTC genetic testing market for visionaries with funds to invest.
In a VG press release, Branson states his reason for the merger. “Of the hundreds of companies we reviewed for our SPAC, 23andMe stands head and shoulders above the rest,” he said. “As an early investor, I have seen 23andMe develop into a company with enormous growth potential. Driven by [CEO Anne Wojcicki’s] vision to empower consumers, and with our support, I’m excited to see 23andMe make a positive difference to many more people’s lives.”
According to a 23andMe press release, the deal values the company at approximately $3.5 billion and will net the consumer genetics and research company as much as $759 million in additional cash. Wojcicki and Branson each invested $25 million themselves as part of the $250 million fund to take the company public.
Participation in Research Key to Future of DTC Genetics Testing
Though DTC genetic testing kit sales have slowed in recent years for both 23andMe and rival Ancestry, Wojcicki believes the company’s database of 10 million customers—with 80% of customers agreeing to participate in research—is the key to its future.
“We have always seen health as a much bigger opportunity” than genealogy, Wojcicki told The Wall Street Journal (WSJ).
According to the WSJ, 23andMe customers fill out more than 30,000 surveys each day on health and related issues. With that information, the company has determined its database includes 1.7 million people with high cholesterol, nearly 1.6 million with depression and 539,000 with Type 2 diabetes, information that is highly valued by medical researchers and those running clinical trials.
Personalizing Healthcare through DTC Genetic Testing
Wojcicki expects the merger will propel the consumer DNA-testing company into personalized medicine and therapeutics. “We have always believed that healthcare needs to be driven by the consumer, and we have a huge opportunity to help personalize the entire experience at scale, allowing individuals to be more proactive about their health and wellness,” Wojcicki said in a statement. “Through a genetics-based approach, we fundamentally believe we can transform the continuum of healthcare.”
In August 2020, the US Food and Drug Administration “granted 23andMe a 510(k) clearance for a pharmacogenetics report on two medications—Clopidogrel, prescribed for certain heart conditions, and Citalopram, which is prescribed for depression,” 23andMe announced in a blog post.
“This impactful pharmacogenetics information can now be delivered without the need for confirmatory testing, a testament to the clinical validity of 23andMe results,” said Kathy Hibbs, 23andMe Chief Legal and Regulatory Officer, in the blog post. “23andMe remains the only company with direct-to-consumer pharmacogenetic reports cleared by the FDA.”
23andMe’s trove of genetic data already has netted it a partnership with GlaxoSmithKline (GSK). According to a GSK press release, in 2018, the two companies signed a four-year research and development agreement. The collaboration targets novel medicines and potential cures using human genetics as the basis for discovery.
COVID-19 Boosts 23andMe’s Sales
During a joint interview with Branson in Bloomberg News about the merger, Wojcicki said, “COVID-19 has really opened up doors.” Now more than ever, she said, people are interested in preventative healthcare. “I’ve had this dream since 2003 that genetics would revolutionize healthcare and that’s really the era I see we can now usher in,” she added.
As 23andMe pushes further into personalized therapeutics, clinical laboratories and pathology groups would be wise to watch and see if this new entrant accelerates healthcare’s shift to the precision medicine model of personalized care.
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.
Genetic Test Results Combined with Clinical Laboratory
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
“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
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
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.
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.
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
Controversy Over DTC
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
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
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.