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Clinical Laboratories and Pathology Groups

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Private Equity Firm General Catalyst to Buy Integrated Delivery Network Summa Health as Testing Ground for New Venture

Switching from non-profit to for-profit may affect how clinical laboratories operate in the new healthcare system

Shifting away from fee-for-service payment models and towards value-based healthcare is the goal of many non-profit hospital systems. One such transformation is underway at Summa Health, one of the largest integrated delivery networks (IDNs) in Ohio. On January 17, venture capital firm General Catalyst announced that its subsidiary—Health Assurance Transformation Corporation (HATCo)—had entered into an agreement to purchase Summa Health.

“HATCo’s investment into Summa Health will drive not only near-term benefit to the organization and the patients it serves but also sustainable, long-term transformation through a true shift to value-based care and access to new revenue streams, resources, innovations, and technologies,” states a General Catalyst news release penned by Marc Harrison, MD, CEO of HATCo.

Harrison was formerly President and CEO of Intermountain Healthcare, a 33 hospital not-for-profit IDN in Salt Lake City, Utah. This is a noteworthy fact because Intermountain Health has a national reputation as an innovative multi-hospital health system. Some observers believe that Harrison’s involvement signals that General Catalyst believes it has a care model that can deliver better patient care in a profitable manner.

“Under its new structure, Summa will become a for-profit organization, and General Catalyst says it will introduce new tech-enabled solutions that aim to make care more accessible and affordable,” CNBCreported.

“This is the first time that anybody has done anything quite like this,” Harrison told CNBC. “There are many digital health solutions that are out there as point solutions. This is the first holistic transformation of a health system to a thoughtful combination of digital and in-person care.”

“Our intent is to build on and augment the system’s considerable strengths. First and foremost, we share Summa Health’s commitment to serving all members of the community,” wrote HATCo CEO Marc Harrison, MD (above), in a news release. “The Summa Health team also shares our belief that achieving healthcare transformation will require a shift to value-based care … Together, we intend to demonstrate that a model that is better for patients can also be good for business, creating a blueprint for other health systems to effectively serve all people in their communities.” How this shift will affect Summa’s clinical laboratories remains to be seen. (Photo copyright: General Catalyst.)

Betting on Healthcare

In 2023, General Catalyst, an American venture capital firm headquartered in Cambridge, Mass., unveiled its Health Assurance Transformation Corporation (HATCo) and began shopping for a health system to buy.

HATCo has 20 healthcare systems in a network that spans 43 states and four countries, according to Healthcare Dive. The company’s news release states it has been focused on three areas since its start-up:

  • Helping its partners on their “transformation journeys.”
  • Using technology to build an “interoperability model.”
  • Planning to “acquire and operate a health system for the long-term.”

“The goal of the purchase is for the health system to act as a proving ground for General Catalyst to test ways to improve hospital operations and patient care, without risk aversion or cash shortfalls, management said,” Healthcare Dive reported.

Thus, the firm’s announcement to purchase a health system last October “sent shockwaves through the healthcare industry” according to Healthcare Dive.

“At its core, General Catalyst’s long-term Health Assurance thesis is that value-based care not only is good for patients, but also can be a successful business model if deployed with innovative technology at meaningful scale. Its rationale for buying a health system is a belief that it can improve on the traditional model of not-for-profit health system governance and management by embedding new incentives,” wrote Christopher Kerns, CEO and co-founder of Washington, D.C-based research firm Union Healthcare Insight, in a blog post analysis.

General Catalyst’s HATCo may offer up “a profit motive, a longer time horizon, and a channel for dozens of innovative companies to demonstrate value,” he noted.

“The single biggest barrier to promising young healthcare companies is an inability to scale. Many of their innovations—in digital health, patient engagement, revenue cycle workflow, etc.—require willing health system partners who are famously conservative in their investments and service providers, and rarely take risks on newbies. The addition of Summa provides an open laboratory for those innovations,” Kerns added.

Is the Summa Health Deal Good for Healthcare?

Some in the industry were taken aback by General Catalyst’s announcement.   

“A lot of people feel like a PE (private equity) or venture capital company owning a hospital is kind of like asking Freddy Krueger to come babysit your kids. It just makes people a little nervous, and it doesn’t feel quite aligned with this concept of healthcare being a human right,” John Bass, CEO of Hashed Health, a Nashville, Tenn.-based healthcare venture studio, told CNBC.

Nevertheless, it’s a moot point. HATCo is moving forward with its purchase of Summa Health.

“For this bet to work, Summa will have to be a solid proving ground for [General Catalyst’s] portfolio companies. And that means either Summa itself will have to grow, or it will have to act as a force multiplier for its other value-based portfolio companies to justify the considerable capital expended. I have to say, that’s a tall order, but not an insane one,” said Kerns in the Union Healthcare Insight blog post.

Healthcare managers may find it interesting to follow HATCo and Summa Health on their planned journey. The results may speak for themselves. Either way, clinical laboratories and anatomic pathology group practices in HATCo’s health system may be in for some interesting changes.

—Donna Marie Pocius

Related Information:

Our Acquisition of Summa Health

Summa Health and General Catalyst’s HATCo Announce Plans for Acquisition That Will Transform the Future of Healthcare

General Catalyst to Acquire Ohio Nonprofit Summa Health

The Big Bet of General Catalyst and Summa Health

4 Takeaways on General Catalyst’s Plan to Acquire Summa Health

General Catalyst’s New Health System Company to Acquire Summa Health

Venture Capital’s Firm’s Plan to Buy Nonprofit Hospital System Has Ohio Community on Edge

Intermountain Posts $135M Operating Income

General Catalyst’s HATCo Plans to Purchase Ohio Healthcare System Summa Health

Summa Health Fields Concerns Over General Catalyst Acquisition

Summa Health Sold to General Catalyst’s Health Assurance

Some Experts Predict That Nonprofit Healthcare Models Will Not Survive Healthcare’s Transformation

As mergers and acquisitions of large-scale hospital systems continue, their clinical laboratories feel the pressure of deteriorating finances and ongoing staff shortages

Eroding economics is often the major reason why a health system agrees to be acquired or merged. And, as we reported in “Hospital, Health System Mergers and Acquisitions Impact Clinical Laboratories,” these mergers and acquisitions are occurring at an alarming rate.

In response to the latest National Hospital Flash Report from Kaufman Hall, the financial/performance consulting firm’s Senior Vice President, Eric Swanson, wrote that 2022 was “shaping up to be one of the worst financial years on record for hospitals.

“Expense pressures—particularly with the cost of labor—outpaced revenues and drove poor performance [in hospitals]. While emergency department visits and operating room minutes increased slightly, hospitals struggled to discharge patients due to internal staffing shortages and shortages at post-acute facilities,” Swanson noted.

Like their parent organizations, hospital and health system-based medical laboratories are dealing with ongoing staffing shortages, which Dark Daily covered extensively in multiple ebriefings.

Non-profit healthcare systems are particularly hard hit, leading to merger/acquisition deals that continue the trend of hospital consolidation.

“Consolidation will continue. Here’s the scary part. The old solutions of jacking up treatment volumes and commercial payment rates aren’t working. Evidence of business model failure abounds. A fiscal storm is raging,” David Johnson, CEO, 4sight Health, wrote in an article for the Healthcare Financial Management Association. The results of these business failures have a direct impact on hospital-based medical laboratories as well as clinical laboratories in surrounding areas that service a health system’s physicians. (Photo copyright: 4sight Health.)

‘Unprecedented Challenge for Nonprofit Providers’

In “Cracks in the Foundation—Five Structural Defects Are Undermining Nonprofit Healthcare,” a six-part series he penned for the Healthcare Financial Management Association (HFMA), David Johnson, CEO at 4sight Health, noted that when it comes to nonprofits, five of the healthcare giants have been reporting sizable losses.

The numbers speak volumes. Looking at financial statements from 2022, Ascension, Cleveland Clinic, CommonSpirit Health, Providence, and Mass General Brigham all posted losses of more than $316 million dollars, the HFMA series noted. Two in that group (CommonSpirit and Providence) posted losses over $1.1 billion. Providence’s losses represented only nine months of data from 2022.

So, what’s the problem? In another HFMA article titled, “The End of Traditional Nonprofit Healthcare Business Models?” Johnson wrote, “Even in the best of times, the nonprofit hospital business model has never been robust. Hospitals are capital-intensive, labor-intensive, highly-regulated, low-margin businesses that require high-cost facilities and highly expert personnel to operate.

“Competing mission and business priorities make running nonprofit hospitals even more difficult,” he added. “The existential question is whether current operating losses at nonprofit health systems are aberrant or indicate a broader collapse of their models. I believe it’s the latter. Structural weaknesses, combined with pernicious macro forces, make this a period of unprecedented challenge for nonprofit providers.”

In his “Cracks in the Foundation” series, Johnson lists five “deeply embedded defects in current nonprofit business models.” They are:

  • Artificial economics
  • Needs-services mismatch
  • Brittle business models
  • Regulatory headwinds
  • Inadequate leadership

“Under pressure, health systems are struggling to right the ship, but they are defaulting to old habits,” Johnson wrote. “They’re chasing volume and rates under fee-for-service (FFS) medicine. While this has worked in the past, it is not a viable long-term strategy. Powerful macro forces are aligning against healthcare business practices. Ignoring them won’t make them go away.”

This chart, taken from 4sight Health CEO David Johnson’s HFMA article, shows the five large health systems that showed operating losses in 2022. The numbers displayed are drawn from each health system’s publicly released financial statements for the periods shown, HFMA noted. (Graphic copyright: Healthcare Financial Management Association.)

Deteriorating Outlook for Health Systems

Increased expenses for labor and supplies paired with inflation is what a 2022 Fitch Ratings report cited as contributing to a “‘deteriorating’ outlook for systems,” Healthcare Dive reported.

“Labor will remain the largest hurdle for hospitals this year even as they struggle with inflation and spiking COVID-19 admissions that can dent revenue. The labor story just dwarfs the inflation story,” financial analyst Kevin Holloran, Senior Director and Sector Leader USPF Healthcare at Fitch Ratings, told Healthcare Dive.

Holloran has worked for Fitch since 2017, joining after 14 years at S/P Global Ratings. He has 20-years experience in the healthcare sector. 

Nonprofit hospitals that posted COVID-19-related operating losses are struggling with higher costs for labor and supplies while navigating declining and neutral admission volumes, Healthcare Dive noted, citing that healthcare systems have turned to staffing agencies and contracted labor to counter the loss of burned-out employees who go on strike or who leave healthcare entirely. On a positive note, Holloran sees contract labor use decreasing in the future.

What’s Next?

There’s a steep road ahead for nonprofits but Holloran see positive changes. “We are beginning to come out of the worst of it,” he told Healthcare Dive. However, he added, “Hospitals should not expect to ‘grow [their] way out’ of soaring labor expenses by raising revenues or increasing hospital admissions.”

Like Johnson, Holloran stressed the importance of looking for long-term solutions. With rising expenses, declining revenues, and increased labor costs projected to continue for years, “hospitals are putting recruiting and retention efforts ‘on steroids’ amid challenges,” he noted.

One coming improvement is that hospitals “can look toward commercial payer contracts to ease high expenses,” Holloran predicted.

“Payer contracts fall in the approximately 25% to 30% of non-fixed revenue that hospitals have the ability to control. … The ratings agency [Fitch] now expects to see a shift from long-term contracts to single-year contracts as nonprofits attempt to ease expenses,” Healthcare Dive noted.

It appears that, for the foreseeable future, clinical laboratories will continue to feel the pressures brought on by mergers and acquisitions as the healthcare industry struggles to find solutions to the economic downturn and loss of qualified staff following the COVID-19 pandemic.

—Kristin Althea O’Connor

Related Information:

Hospital, Health System Mergers and Acquisitions Impact Clinical Laboratories

Kaufman Hall National Hospital Flash Report

Cracks in the Foundation—Five Structural Defects Are Undermining Nonprofit Healthcare

The End of Traditional Nonprofit Healthcare Business Models?

Nonprofit Hospitals, Hammered by Soaring Expenses, Have ‘Deteriorating’ Outlook: Fitch

Walgreens Continues Expansion into Primary Care as VillageMD Acquires Starling Physicians Group with 30 Locations in Connecticut

Expect there to be more clinical laboratory testing at pharmacies as retail pharmacy chains expand their primary care offerings

Walgreens Boots Alliance (NASDAQ:WBA) of Deerfield, Illinois, continues to expand its primary care footprint with VillageMD’s latest acquisition of Starling Physicians, a multi-specialty physicians group with 30 locations in Connecticut, according to a VillageMD news release. Walgreens is the majority owner of VillageMD, which now has more than 700 medical centers, Healthcare Dive noted.

This deal continues the trend of corporations acquiring physician practices. Already, the majority of physicians are employees, not partners in a private practice physician group. Under corporate ownership, these physician groups often decide to change their clinical laboratory providers. For that reason, managers and pathologists at local medical laboratories will want to explore how they might provide daily lab testing services to the corporate owners of these primary care clinics.

The Hartford Business Journal called VillageMD’s acquisition of Starling Physicians—which is subject to a state investigation for possible certificate-of-need requirement—one of Connecticut’s “more high-profile healthcare merger and acquisition deals in Connecticut in recent years.”

Starling Physicians locations offer full primary care services, as well as specialties that include geriatrics, endocrinology, nephrology, ophthalmology, and cardiology.

The Starling Physicians group acquisition comes just a few months after  

VillageMD paid $8.9 billion for Summit Health-CityMD of Berkeley Heights, New Jersey, with primary care services in the Northeast and Oregon. Walgreens invested $3.5 billion in that transaction, a Summit Health news release noted.

These acquisitions by Walgreens/VillageMD provide opportunities for local clinical laboratories to serve the physicians in these practices, though the operations may have a different patient flow and work process than traditional family practice clinics located in medical offices around community hospitals.

Tim Barry

“Starling shares our vision of being a physician-led model and they provide care in a compassionate and exceptional way to all the patients they serve. By integrating primary care with specialty care, we are able to optimize access to high-quality care for our patients,” said Tim Barry (above), CEO and Chair of VillageMD in the news release. “This is a natural extension of our growth in the Northeast, including our recent acquisition of Summit Health-CityMD. Together, we are transforming the way healthcare is delivered in the United States.” Clinical laboratories in these areas will want to develop a strategy for serving the physicians practicing at these non-traditional locations. (Photo copyright: The Business Journals.)

Primary Care at Retail Locations a Growing Trend

Dark Daily and its sister publication The Dark Report have reported extensively on the growing trend by pharmacy chains and other retail superstores to add primary care services to their footprint.

In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” The Dark Report covered how Walgreens had disclosed that it would spend $5.2 billion to acquire a 63% interest to become the majority owner of VillageMD. Fierce Healthcare reported that “[Walgreens] planned to open at least 600 Village Medical at Walgreens primary-care practices across the country by 2025 and 1,000 by 2027.”

In “Retail Chain Pharmacies Add CLIA-Waived Point-of-Care Blood Testing and Other Preventive Health Services to Their In-store Offerings,” we reported how eTrueNorth, a pharmacy‐based clinical laboratory services network headquartered in Mansfield, Texas, had partnered with Walmart (NYSE:WMT), Winn-Dixie, Kroger (NYSE:KR), and other retailers to offer their employees CLIA-waived point-of-care testing, preventive health services, wellness screenings, and other medical laboratory testing services through its eLabNetwork chain of retail pharmacies.

And in “Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare/Telehealth Provider, a Step with Implications for Clinical Laboratory Testing,” Dark Daily pointed out that clinical laboratories need strategies to serve customers accessing healthcare in non-traditional settings, particularly as Walmart and the national retail pharmacy chains continue to expand the clinical services offered in their retail stores.

VillageMD

VillageMD is a primary care provider with same-day appointments, telehealth virtual visits, in-home care, and clinical laboratory diagnostic testing such as blood tests and urinalysis. Many VillageMD practices are located in buildings next door to Walgreens sites throughout the United States. (Photo copyright: Walgreens.)

Other Retailers Investing in Primary Care

Other retailers have recently taken deeper dives into healthcare as well.

According to Forbes, “The acquisition comes amid a flurry of acquisitions across the US for doctor practices, which are being purchased at an unprecedented pace by large retailers like Walgreens Boots Alliance, CVS Health, Amazon, and Walmart. Meanwhile, medical care providers owned by health insurers like UnitedHealth Group’s Optum and Cigna’s Evernorth are also in the doctor practice bidding war.”

In “Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare/Telehealth Provider, a Step with Implications for Clinical Laboratory Testing,” Dark Daily reported on Walmart Health’s acquisition of MeMD, which was subsequently renamed in May to Walmart Health Virtual Care.

And in February, CVS announced plans to acquire for $10.6 billion Oak Street Health, a Chicago-based primary care company with 169 medical centers across 21 states that plans to have more than 300 centers by 2026.

Do Clinical Laboratories Want Retail Customers?

The question of whether clinical laboratories should pursue retail customers is at this point academic. Consumer demand is driving the change and labs that don’t keep up may be left behind.

“The trend of putting full-service primary care clinics in retail pharmacies is a significant development for the clinical laboratory industry,” wrote Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “These clinics will need clinical lab tests and can be expected to shift patients away from traditional medical clinic sites for two reasons—lower price and convenience—since this new generation of primary care clinics will be located around the corner from where people live and work.”

Thus, healthcare system laboratories or large reference labs may want to reach out to Walgreens, CVS, Amazon, and Walmart for test referrals. These and other large retailers are investing heavily in the belief that consumers will continue to seek convenience in their healthcare.   

—Donna Marie Pocius

Related Information:

VillageMD Acquires Starling Physicians and Broadens its Footprint in the Northeast

Regulator Opens Inquiry into VillageMD-Starling Physicians Deal

VillageMD Acquires Summit Health-CityMD, Creating One of the Largest Independent Provider Groups in the US

Clinical Laboratory Trends: By 2027 Walgreens Wants 1,000 Primary Care Clinics

Walgreens-backed VillageMD Acquires Connecticut Medical Group

Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare

CVS Health to Acquire Oak Street Health

CVS Reports $2.3B Q4 Profit, Will Buy Oak Street Health

Clarapath Acquires Crosscope, Bridging Histology Automation with Digital Pathology

Clarapath is working to automate manual processes in histology while also capturing data to better inform clinical laboratories

Looking to provide an end-to-end digital pathology solution, medical robotics maker Clarapath has acquired Crosscope, a medical artificial intelligence (AI) software company that develops AI-powered telepathology for medical image information extraction and precision medicine diagnostics.

The deal will enable Crosscope’s digital pathology platform to layer around Clarapath’s histology automation hardware, a combination that could improve quality and efficiencies in diagnostic services for future customers, according to a Clarapath press release.

Clarapath’s goal with its products is to automate certain manual processes in histology laboratories, while at the same time reducing variability in how specimens are processed and produced into glass slides. In an exclusive interview with Dark Daily, Eric Feinstein, CEO and President at Clarapath said he believes the resulting data about these activities can drive further changes.

“A histotechnologist turns a microtome wheel and makes decisions about a piece of tissue in real time,” noted Feinstein, who will speak at the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management on April 25-26 in New Orleans. “All of that real-time data isn’t captured. Imagine if we could take all of that data from thousands of histotechnologists who are cutting every day and aggregate it. Then you could start drawing definitive conclusions about best practices.”

Eric Feinstein

“Clarapath’s foundation is about creating consistency and standardizing steps in histology—and uncovering the data that you need in order to accomplish those goals as a whole system,” Eric Feinstein (above), CEO and President at Clarapath told Dark Daily. “A histology lab’s workflow—from when the tissue comes in to when the glass slide is produced—should all be connected.” Many processes in histology and anatomic pathology continue to be manual. Automated solutions can contribute to improved productivity and reducing variability in how individual specimens are processed. (Photo copyright: Clarapath.)

Details Behind Clarapath’s Deal to Acquire Crosscope

As part of its acquisition, Clarapath of Hawthorne, New York, has retained all of Crosscope’s employees, who are located in Mountain View, California, and Bombay, India. Financial terms of the deal were not disclosed.

Clarapath’s flagship histology automation product is SectionStar, a tissue sectioning and transfer system designed to automate inefficient and manual activities in slide processing. The device offers faster and more efficient sample processing while reducing human involvement. Clarapath expects SectionStar be on the market in 2023. The company is currently taking pre-orders. 

Meanwhile, Crosscope developed Crosscope Dx, a turnkey digital pathology solution that provides workflow tools and slide management as well as AI and machine learning to assist pathologists with their medical decision-making and diagnoses.

Adoption of Digital Pathology and Automation Can Be Challenging

Digital pathology has experienced growing popularity in the post-COVID-19 pandemic world. This is not only because remote pathology case reviews have become increasingly acceptable to physicians but also because of the ongoing shortages in clinical laboratory staffing.

“A pain point today for clinicians and laboratories is labor. That’s across the board,” Feinstein said. “We can help solve that with SectionStar.”

In “Recent Separate Business Transactions by Fujifilm and GE Healthcare Suggest Bullish Outlook for Faster Adoption of Digital Pathology,” Dark Daily reported that vendors have their eyes open for deals and partnerships in digital pathology.

Feinstein does not believe adoption of digital pathology and histology automation is proceeding slowly, but he does acknowledge barriers to healthcare organizations installing the technologies.

“There are lots of little things that—from a workflow perspective—people have outsized expectations about,” he explained. “Clinicians and administrators are not used to innovating in a product sense. They may be innovating on how they deliver care or treatment pathways, but they’re not used to developing an engineering product and going through alpha and beta stages. That makes adopting new technology challenging.”

Medical laboratory managers and pathologists interested in pursuing histology automation and digital pathology should first determine what processes are sub-optimal or would benefit from the standardization hardware and software can offer. Being able to articulate those gains can help build the case for a return on investment to decision-makers.

Another resource to consider: Feinstein will speak about innovations for remote histology laboratory workers at the upcoming Executive War College for Clinical Laboratory, Diagnostics, and Pathology Management on April 25-26 in New Orleans. His session is titled, “Re-engineering the Classic Histology Laboratory: Enabling the Remote Histotechnologist with New Tools That Improve Productivity, Automate Processes, and Protect Quality.”

Scott Wallask

Related Information:

Clarapath Acquires Crosscope and Combines Tissue Processing Robotics with AI Powered Digital Pathology for Building the Lab of the Future

Histopathology is Ripe for Automation

UCLA’s Virtual Histology Could Eliminate Need for Invasive Biopsies for Some Skin Conditions and Cancers

2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management Announced for April 25-26

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

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