Forbes Ranks Epic’s Judith Faulkner the Richest Woman in Healthcare in Its 2021 List of 100 Richest Self-Made Women in US

Within the in vitro diagnostics and clinical laboratory space, Bio-Rad’s Alice Schwartz and 23andMe’s Anne Wojcicki also were recognized by Forbes

At $6.5 billion net worth, Forbes, in its 2021 list of the 100 richest self-made women in the US, ranked Judith Faulkner, Chief Executive Officer and founder of Epic Systems Corp., in second place overall. But in the industry of healthcare, she tops the list by far. The next nearest healthcare-related “richest woman” is Alice Schwartz, co-founder of Bio-Rad Laboratories, at $2.9 billion.

Faulkner was surpassed on Forbes’ list only by roofing material magnate Diane Hendricks, co-founder of ABC Supply Co., whose net worth of $11 billion puts her squarely in the top spot.

Richest Self-Made Women in Healthcare

Becker’s Hospital Review highlighted the seven richest “self-made” women who ran healthcare-related companies. They include:

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.

In “Genetic Test Company 23andMe Completes Merger with Richard Branson’s VG Acquisition Corp., Stock Now Trades on NASDAQ,” Dark Daily noted that since the Sunnyvale, Calif. direct-to-consumer (DTC) genetic testing company will now be filing 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.

Judith Faulkner and Alice Schwartz

Judith Faulkner (left), founder and CEO of Epic Systems Corp., and Alice Schwartz (right), co-founder of Bio-Rad Laboratories, ranked 2nd and 10th respectively in Forbes’ list of the top 100 richest self-made women. In healthcare, Faulkner ranks 1st and Schwartz 2nd. Clinical laboratory personnel will likely be familiar with Epic Beaker, which, according to Healthcare IT Leaders, “is Epic’s laboratory information system (LIS) for hospitals, clinics, patient service centers, and reference labs. The software supports common workflows for clinical pathology (CP) labs as well as anatomic pathology (AP) labs.”  (Photo copyrights: HIT Consultant/Science History Institute.)

How did Faulkner Make Epic So Epic?

It all started in 1979 when Faulkner and a colleague invested $70,000 to launch Human Services Computing, which became Epic, noted Forbes in “The Billionaire Who Controls Your Medical Records.”

“I always liked making things out of clay. And the computer was clay of the mind. Instead of physical, it was mental,” Faulkner, who is 77, told Forbes.

Company milestones noted by Forbes include:

  • Inking a deal in 2004 with Kaiser Permanente for a three-year, $400-million project.
  • Moving in 2005 to a corporate campus in southern Wisconsin—an “adult Disney World” with the largest underground auditoriums and more “fantastical” buildings.
  • More recently, AdventHealth of Altamonte Springs, Fla., contracted with Epic for a $650 million remote build and installation.

“Epic’s system has tentacles that go out through amazing networks. You can actually help a person get the care they need wherever they need to get it,” AdventHealth’s CEO Terry Shaw told Forbes.

In about two years, Epic plans to launch an artificial intelligence (AI) Electronic Health Record (EHR) documentation tool aimed at transcribing clinician and patient conversations in real-time, EHR Intelligence reported.

However, Epic may face competition from IT startups in areas including ancillary services, where clinical laboratories, for example, are seeking genomic data storage and introducing new genetic tests, according to Becker’s Hospital Review in its report on analysis by CB Insights, titled, “Unbundling Epic: How The Electronic Health Record Market Is Being Disrupted.”

“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.

“They were at the right place and at the right time as they became pioneers in the industry,” International Business Times (IBT) stated.

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.

Donna Marie Pocius

Related Information

Forbes’ Ranking of the Country’s Most Successful Women Entrepreneurs and Executives 2021

Healthcare’s Richest Self-Made Women, Per Forbes

Epic Systems Founder-CEO Judy Faulkner Wields Great Power and Responsibility in Healthcare IT

Unbundling Epic: How the Electronic Health Record Market is Being Disrupted

The Billionaire Who Controls Your Medical Records

Epic in Process of Developing AI EHR Documentation Assistant

Epic’s Revenue Hit $3.3B in 2020; 10 ways the EHR Giant’s Dominance is Opening Doors for Competition

Bio-Rad Reports Second Quarter 2021 Financial Results

Alice Schwartz Net Worth: Oldest, Richest Woman in U.S. is Worth $2.2B

Genetic Test Company 23andMe Completes Merger with Richard Branson’s VG Acquisition Corp; Stock Now Trades on NASDAQ

Genetic Test Company 23andMe Completes Merger with Richard Branson’s VG Acquisition Corp., Stock Now Trades on NASDAQ

23andMe executives say they plan to leverage their database of millions of customer genotypes ‘to help 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.

Anne Wojcicki

“23andMe is more than just a genetics company. We are an activist brand that is approaching healthcare and drug discovery with the individual at the center, as our partner,” said Anne Wojcicki (above), 23andMe’s co-founder and Chief Executive Officer, during remarks she gave after ringing the opening bell on the company’s first day of public trading, a 23andMe blog post noted. “We are going to continue pioneering a consumer-centered personalized healthcare world. We are going to show that drug discovery can be more efficient when you start with a human genetic insight,” she continued. (Photo copyright: TechCrunch.)

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.

In “With Consumer Demand for Ancestry and Genealogy Genetic Tests Waning, Leading Genomics Companies Are Investigating Ways to Commercialize the Aggregated Genetics Data They Have Collected,” Dark Daily reported how, “faced with lagging sales and employee layoffs, genomics companies in the genealogy DNA testing market are shifting their focus to the healthcare aspects of the consumer genomics data they have compiled and aggregated.”

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.

“There are huge growth opportunities ahead,” said Richard Branson, founder of the Virgin Group, which sponsors the special-purpose acquisition company (SPAC) VG Acquisition Corp., in the 23andMe news release.

In a VG Acquisition Corp. news release, Branson said, “Of the hundreds of companies we reviewed for our SPAC, 23andMe stands head and shoulders above the rest.”

“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. 

—Donna Marie Pocius

Related Information

23andMe Successfully Closes its Business Combination with VG Acquisition Corp.

23andMe to Merge with Virgin Group’s VG Acquisition Corp. to Become Publicly-Traded Company Set to Revolutionize Personalized Healthcare and Therapeutic Development through Human Genetics

Ringing in 23andMe’s Next Chapter

Genetic Testing Company 23andMe Rises in First Trade After Richard Branson SPAC Merger

Four Takeaways From 23andMe’s SPAC Deal

23andMe DNA Testing Firm Goes Public Following Branson Deal

Global Direct-to-Consumer Genetic Testing Market

With Consumer Demand for Ancestry and Genealogy Genetic Tests Waning, Leading Genomics Companies Are Investigating Ways to Commercialize the Aggregated Genetic Data They Have Collected

Consumer Genetic Testing Company 23andMe to Merge with Sir Richard Branson’s VG Acquisition Corp and Go Public

Consumer Genetic Testing Company 23andMe to Merge with Sir Richard Branson’s VG Acquisition Corp. and Go Public

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.

One such visionary is billionaire Richard Branson, founder of the multinational venture capital conglomerate Virgin Group (VG). Branson’s VG Acquisition Corp. (NYSE:VGAC), a special purpose acquisition company (SPAC), announced it is merging with 23andMe of Sunnyvale, Calif., to create a publicly-traded company with the New York Stock Exchange ticker symbol ME.  

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.

CEO Anne Wojcicki headshot
“As a fellow industry disruptor as well as an early investor in 23andMe, we are thrilled to partner with Sir Richard Branson and VG Acquisition Corp. as we approach the next phase of our business, which will create new opportunities to revolutionize personalized healthcare and medicine,” 23andMe co-founder and CEO Anne Wojcicki (above) said in the press release. “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. Through a genetics-based approach, we fundamentally believe we can transform the continuum of healthcare.” (Photo copyright: Inc. magazine.)

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.

—Andrea Downing Peck

Related Information:

23andMe to Merge with Virgin Group’s VG Acquisition Corp. to Become Publicly Traded Company Set to Revolutionize Personalized Healthcare and Therapeutic Development through Human Genetics

23andMe Go Public with Richard Branson Backed SPAC

GSK and 23andMe Sign Agreement to Leverage Genetic Insights for the Development of Novel Medicines

23andMe Lays Off 100 People, CEO Anne Wojcicki Explains Why

FDA Grants 23andMe Clearance to Offer Interpretive Drug Information for Two Medications

Fears over DNA Privacy as 23andMe Plans to Go Public in Deal with Richard Branson

23andMe to Go Public as $2.5 Billion Company via Branson Merger

23andMe Invites Customers to Add Health and Drug Data to Stored Genetic Test Results, Encroaching on Markets Where Both Apple and Clinical Laboratories Generate Revenue

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 people who 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.

—JP Schlingman

Related Information:

23andMe is Moving into Apple’s Territory with a Pilot to Pull in Medical Data, Not Just DNA

23andMe Venturing onto Apple’s Turf with Health Data Collection

Give All the Data

23andMe Already Has Millions of People’s DNA. Now It Wants Their Health Data Too.

23andMe Wants to Collect Users’ Medical Data, Stepping into Apple’s Territory

Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, But Which Will Impact Clinical Laboratories the Most?

Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients

Popularity of Direct-To-Consumer Genetic Tests Still Growing, Regardless of Concerns from Provider and Privacy Organizations

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.

How will clinical pathology laboratories ultimately be impacted?

Data, Data, Where’s the Data?

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.

Given the reports of privacy concerns and the difficulty removing one’s genetic data from the Internet once it is online, why are people so eager to spit in those little tubes? There are several reported reasons, including:

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.

-Dava Stewart

Related Information:

More than 26 Million People Have Taken an At-Home Ancestry Test

How a DNA Testing Kit Revealed a Family Secret Hidden for 54 Years

23andMe Sells Data for Drug Search

Why You Should Be Careful About 23andMe’s Health Test

23andMe Responds: Empowering Consumers

Police Are Using Genetic Testing Companies to Track Down Criminals

The Problems with Ancestry DNA Analyses

FDA Authorizes 23andMe to Report Results of Direct-to-Consumer Pharmacogenetics Test to Customers without a Prescription, Bypassing Doctors and Clinical Laboratories

Erasing ‘DNA Footprint’ from the Internet Proves Difficult for Consumers Who Provide Data to Genetic Testing Companies

FDA Authorizes First Direct-To-Consumer Test for Detecting Genetic Variants That May Be Associated with Medication Metabolism

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