Six-episode show is based on popular ABC Radio podcast “The Dropout,” which focused on the three-year investigation that brought down clinical laboratory test developer Theranos
While former Theranos CEO Elizabeth Holmes awaits the start of her August 31 criminal fraud trial in a federal court in Northern California, one streaming video service is lining up a star-studded cast to tell the story of the Silicon Valley executive’s fall from grace and the demise of her clinical laboratory blood-testing company.
This six-part series is being produced by Hulu, an on-demand video streaming service offering live and on-demand content. Back in 2019, it announced that it would produce the “The Dropout,” a limited series chronicling Holmes’ rise and fall from Founder and CEO of $9 billion tech company Theranos to criminal defendant.
Hulu says the series will launch this fall, so pathologists and medical laboratory managers have time to set their recorders to capture what may be a compelling story of hubris that took investors and the news media on a wild ride. The Theranos publicity machine was so effective that many hospital CEOs went to their clinical laboratory administrators and told them to delay equipment purchases because Theranos would be able to do the same medical laboratory tests at just pennies on the existing lab-cost dollar.
Holmes’ carefully-crafted public image as Theranos’ CEO drew comparisons to the late Apple CEO Steve Jobs, Business Insider noted. This has made her a popular topic not only among clinical laboratory scientists but also Hollywood moviemakers.
“The Dropout” took its inspiration from the ABC Audio podcast of the same name, hosted by ABC Chief Business, Technology and Economics correspondent Rebecca Jarvis. The ABC Audio podcast’s description provides a glimpse into the direction the miniseries will take.
“Money. Romance. Tragedy. Deception. The story of Elizabeth Holmes and Theranos is an unbelievable tale of ambition and fame gone terribly wrong. How did the world’s youngest self-made female billionaire lose it all in the blink of an eye? How did the woman once heralded as ‘the next Steve Jobs’ find herself facing criminal charges—to which she pleaded not guilty—and up to 20 years in jail? How did her technology, meant to revolutionize healthcare, potentially put millions of patients at risk? And how did so many smart people get it so wrong along the way?” the ABC Audio website states.
The Hulu series originally was to star “Saturday Night Live” cast member Kate McKinnon as Holmes but was recast with Amanda Seyfried in the starring role. According to Variety, the series will include a notable lineup of guest stars including:
Naveen Andrews will play former Theranos President and COO Ramesh Balwani, whose own criminal fraud trial is expected to begin early next year.
A release date for the limited series has not yet been announced, Town and Country reported.
Elizabeth Holmes (above), former CEO of now defunct company Theranos, faces 11 counts of fraud for alleged false claims that the clinical laboratory testing company had created a revolutionary finger-prick technology capable of performing a wide range of clinical laboratory tests. Among the charges are two counts of conspiracy to commit wire fraud and nine counts of wire fraud, for which Holmes could serve up to 20 years in jail if found guilty of all charges, according to court documents. She has pleaded not guilty. (Photo copyright: The Wall Street Journal.)
The ‘Real World’ Wall Street Journal Investigation of Theranos and Holmes
Dark Daily has reported extensively on the Holmes/Theranos saga, including the recent development that Holmes’ repeatedly-delayed trial would be pushed back from mid-July to August 31 because Holmes is due to give birth in July.
Theranos’ alleged deceptions first were brought to light in a series of 2015 investigative reports in The Wall Street Journal (WSJ). Then-WSJ investigative reporter John Carreyrou alleged Theranos had not disclosed publicly that the vast majority of its tests were not being done with proprietary technology, but instead with traditional machines purchased from Siemens AG and other companies.
And for those looking for even more drama centered around the Theranos saga, a feature film starring Jennifer Lawrence as Elizabeth Holmes, titled, “Bad Blood,” remains “in development” according to People magazine. Though the project was announced in 2016, filming has yet to begin.
Meanwhile, clinical laboratory scientists will soon get to watch the next “real world” chapter in the Holmes’ saga play out in federal court later this summer. They will also have multiple opportunities in the coming years to be “entertained” by the Theranos scandal on big and small screens.
Boston-based American Robotics is approved to operate its Scout unmanned aircraft in rural areas and below a certain altitude, achieving a milestone that may allow the industry to ‘truly take off’
Routine drone delivery of clinical laboratory specimens and medical supplies moved a step closer to reality with the Federal Aviation Administration’s (FAA) green light to American Robotics (AR) to operate its fully automated drones without on-site pilots or on-the-ground spotters.
The Massachusetts-based company becomes the first drone operator to receive an FAA Certificate of Waiver, allowing it to operate its unmanned aircraft “beyond the visual line of sight (BVLOS) of the remote pilot in command.”
According to a news release, “Prior waivers and certifications awarded by the FAA required visual observers (VOs) stationed along the flight path to keep eyes on the airspace at all times, or required other burdensome restrictions such as infrastructure masking. … With this approval, American Robotics’ Scout System is now the first drone technology allowed to continuously operate without this costly human requirement.”
The FAA is restricting American Robotics’ operations to specific rural areas and at altitudes below 400 feet, with a maximum takeoff weight of 20 pounds, The Hill reported. Nevertheless, should AR’s automated Scout System prove safe, pilotless drones may soon be delivering clinical laboratory specimens and supplies to remote areas as well as to more densely populated hospital systems.
The FAA’s Certificate of Waiver is effective until January 31, 2023.
A New Era of Drone Delivery for Hospitals and Clinical Laboratories
Even with the restrictions, the FAA’s decision moves the commercial drone industry ever closer to routine transport of medical laboratory specimens and medical supplies by unmanned aerial vehicles (UAV).
“With these approvals, American Robotics is ushering in a new era of widespread automated drone operations,” Reese Mozer, CEO and co-founder of American Robotics, said in the news release. “Decades’ worth of promise and projection are finally coming to fruition. We are proud to be the first company to meet the FAA’s comprehensive safety requirements, which had previously restricted the viability of drone use in the commercial sector.”
The Wall Street Journal (WSJ) reported that the FAA’s decision signals the agency’s “broader effort to authorize widespread flights by shifting away from case-by-case exemptions for specific vehicles performing specific tasks.” According to the WSJ, the FAA’s approval documents state that American Robotics’ proposed operations will provide the agency with “critical data for use in evaluating BVLOS [beyond the visual line of sight] operations from offsite locations.”
Each American Robotics Scout drone (above) is stored within a weatherproof base station that enables autonomous charging, data processing, analysis, and data transmission. According to the news release, “Once installed in the field, all facets of Scout’s operation are automated, allowing this technology to gather and analyze ultra-high-resolution data multiple times per day for years without expensive human labor.” Clinical laboratory managers will want to watch for progress in using drones to deliver medical supplies. (Photo copyright: American Robotics.)
FAA Approval a ‘Game Changer’
In its quest to receive FAA approval, American Robotics completed a four-year testing program around its Scout line of UAV products. According to the company, Scout systems flew as many as 10 automated missions per day in 2020 for industrial and agricultural customers in multiple states capturing a variety of advanced data.
The Scout system addresses safety concerns by using acoustic detect-and-avoid technology to maintain a safe distance from other aircraft while also avoiding birds or other potential obstacles.
“The commercial drone industry is growing quickly and providing significant benefits to the American public, but enabling expanded operations beyond visual line of sight is critical for the industry to truly take off,” Lisa Ellman, JD, Partner at Hogan Lovells and Executive Director of the Commercial Drone Alliance, said in the news release.
“Automated beyond visual line of site operations are particularly important to opening the commercial sectors to the drone economy, including the agriculture and industrial verticals. Key to these operations is the use and FAA acceptance of new and innovative safety technologies, such as detect and avoid sensors and software-enabled automation.”
The agricultural and energy industries are seen as key beneficiaries of this latest FAA action. Lance Ruppert, Director of Agronomy Marketing and Technology at Growmark Inc., a leading US grower cooperative, calls the American Robotics’ approval a “game changer.”
“Our interest in American Robotics’ technology started with the desire to have a drone imagery solution that was reliable, scalable, and executed with minimal human resources,” Ruppert said in the news release. “This technology, along with the FAA approvals to operate it without humans on the ground, is key to making drones a widespread reality in our industry.”
Drone Delivery of Clinical Laboratory Specimens Worldwide
And past Dark Daily ebriefings reported on drone delivery of medical supplies being conducted in Virginia, North Carolina, Australia, Switzerland, and Rwanda. With potentially fully automated systems just around the corner, there’s no question the use of drones to transport critical medical supplies and biological specimens is poised for an amazing breakthrough.
While the FAA’s approval of the first fully automated commercial drone flights may not have an immediate impact on clinical laboratories, the increasing use of commercial drones brings drone transportation of lab specimens and other medical supplies one step closer to reality.
In a letter, Congress urged the HHS Secretary to conduct “vigorous oversight and enforces full compliance with the final rule”
Analysis of more than 3,100 hospital websites by The Wall Street Journal (WSJ) has found “hundreds” containing embedded code that prevents search engines from displaying the hospitals’ prices. This is contrary to the Hospital Price Transparency Final Rule (84 FR 65524), passed in November 2019, which requires hospitals to “establish, update, and make public a list of their standard charges for the items and services that they provide,” including clinical laboratory test prices.
“Hundreds of hospitals embed code in their websites that prevented Alphabet Inc.’s Google and other search engines from displaying pages with the price lists,” the WSJ reported. “Among websites where [the WSJ] found the blocking code were those for some of the biggest US healthcare systems and some of the largest hospitals in cities including New York and Philadelphia.”
Additionally, the WSJ found hospitals were finding ways to “hide” the price lists they did display deep within their websites. The prices can be found, but the effort involves “clicking through multiple layers of pages,” on the providers’ websites, the WSJ added.
Lawmakers Put Pressure on CMS
The WSJ report drew the attention of federal lawmakers who weighed in on the current state of hospital price transparency and on the WSJ’s findings in a letter to Xavier Becerra, Secretary of the federal Department Health and Human Services (HHS).
In their letter, members of the Congressional Committee on Energy and Commerce called for HHS “to revisit its enforcement tools, including the amount of civil penalty, and to conduct regular audits of hospitals for compliance.”
Committee members wrote, “The Hospital Price Transparency Final Rule requires hospitals to make public a machine-readable file containing a list of all standard charges for all items and services and to display charges for the hospital’s 300 most ‘shoppable’ services in a consumer-friendly format. We are concerned about troubling reports of some hospitals either acting slowly to comply with the requirements of the final rule or not taking any action to date to comply.”
The letter, which was signed by the committee’s Chairman Frank Pallone (D, New Jersey) and Committee Ranking Member Cathy McMorris Rodgers (R, Washington State), cited the WSJ investigation as well as other analyses of price transparency at US hospitals.
Cynthia Fisher (above), founder of Patient Rights Advocate, told The Wall Street Journal, “In the past there was absolutely no power for the consumer. It was like highway robbery being committed every day by the healthcare system.” Now, Fisher added, “it’s the American consumer who is going to drive down the cost of care.” Clinical laboratories will note that consumer demand for, and federal regulation of, price transparency is not limited to hospitals. All healthcare providers need procedures in place that comply with federal guidelines for transparency. (Photo copyright: Morning Consult.)
Additional Studies Show Major Hospitals “Non-Compliant”
One such study cited by the Congressional committee in its letter to HHS was conducted by Health Affairs, which looked into transparency compliance at 100 hospitals. In a blog post, titled, “Low Compliance from Big Hospitals on CMS’s Hospital Price Transparency Rule,” the study authors wrote “our findings were not encouraging: Of the 100 hospitals in our sample, 65 were unambiguously noncompliant.
“Of these 65,” they added:
“12/65 (18%) did not post any files or provided links to searchable databases that were not downloadable.
“53/65 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges (n = 46) or were in some other way noncompliant (n = 7).
“We are troubled by the finding that 65 of the nation’s 100 largest hospitals are clearly noncompliant with this regulation. These hospitals are industry leaders and may be setting the industrywide standard for (non)compliance; moreover, our assessment strategy was purposefully conservative, and our estimate of 65% noncompliance is almost certainly an underestimate,” Health Affairs concluded.
A previous similar investigation by The Washington Post called compliance by hospitals with the pricing disclosure rules “spotty.”
So, why is complying with the federal price transparency rule so challenging for the nation’s largest hospitals? In its reporting on the Wall Street Journal analysis, Gizmodo wrote, “we’ve seen healthcare providers struggle to implement the new law due, in part, to how damn ambiguous it is. Past reports have pointed out that the vague requirements hoisted onto hospitals as part of these new rules often result in these pricing lists being difficult—if not downright—impossible to find, even if the lists are technically ‘machine-readable’ and ‘on the internet.’”
“Meanwhile,” Gizmodo continued, “as [the WSJ] points out, the order doesn’t specify exactly how much detail these hospitals are even supposed to offer on their pricing sheets—meaning that it’s up to the hospitals whether they want to include rates pertaining to specific health insurance plans, or whether they want to simply include different plan’s rates in aggregate.”
And in their letter to HHS, the Congressional committee wrote, “… some hospitals are providing consumers a price estimator tool instead of providing the full list of charges and payer-negotiated rates in one file, and some are making consumers fill out lengthy forms for estimates. Some hospitals also are providing the data in a non-useable format or failing to provide the codes for items and services.”
Clinical Laboratories Must Comply with Price Transparency Rules
Clearly, transparency in healthcare has a long way to go. Nevertheless, hospital medical laboratory leaders should expect reinforcing guidance from CMS on making price information on commonly used clinical laboratory tests fully accessible, understandable, and downloadable.
As Dark Daily noted in previous coverage, consumer demand for price transparency is only expected to increase. Clinical laboratories need to have a strategy and process for helping consumers and patients see test prices in advance of service.
Might this be a sign that AI platforms like Watson still cannot diagnose the wide range of patients’ conditions as accurately as a board-certified clinical pathologist?
Computer technology evolves so quickly, products often become obsolete before fulfilling their expected potential. Such, apparently, is the case with Watson, the genius artificial intelligence (AI) brainchild of International Business Machines Corp. (IBM) which was going to revolutionize how healthcare providers diagnose disease. In some areas of healthcare, such as analyzing MRIs and X-rays, AI has been a boon. But from a business perspective, Watson has failed to turn a profit for IBM, so it has to go.
In February, The Wall Street Journal (WSJ) reported that IBM is looking to sell its Watson Health unit because it is not profitable, despite bringing in $1 billion annually in revenue. The sale of Watson Health, the article states, would be aligned with IBM’s goal of streamlining the company and focusing its energies on cloud computing and other AI functions. Because one goal of the Watson project was to give physicians a tool to help them diagnose patients more accurately and faster, the problems that prevented Watson from achieving that goal should be of interest to pathologists and clinical laboratory managers, who daily are on the front lines of helping doctors diagnose the most challenging cases.
In a follow-up article, titled, “Potential IBM Watson Health Sale Puts Focus on Data Challenges,” the WSJ wrote, “… some experts found that it can be difficult to apply AI to treating complex medical conditions. Having access to data that represents patient populations broadly has been a challenge, experts told the Journal, and gaps in knowledge about complex diseases may not be fully captured in clinical databases.”
“I believe that we’re many years away from AI products that really positively impact clinical care for many patients,” Bob Kocher, Partner at Venrock, a venture-capital firm that invests in healthcare IT and related services, told the WSJ.
IBM Watson was promoted as a major resource to help improve medical care and support doctors in making more accurate diagnoses. However, in “IBM’s Retreat from Watson Highlights Broader AI Struggles in Health,” the WSJ reported that “IBM spent several billion dollars on acquisitions to build up Watson [Health] … a unit whose marquee product was supposed to help doctors diagnose and cure cancer … A decade later, reality has fallen short of that promise.”
IBM initially created Watson (above center) to be an AI tool capable of a wide variety of applications, starting with answering questions. In January 2011, Watson made headlines when it defeated previous Jeopardy champions Ken Jennings (left) and Brad Rutter (right) on the popular television game show.After its triumph, IBM announced it would transition Watson for use in medical applications and promoted it as a major resource to help improve medical care and support healthcare professionals in making more precise diagnoses. The company called its new division IBM Watson Health and stated that massive data sets would be the key to accomplish its healthcare mission. That same year, The Dark Report had an IBM executive do a presentation about Watson Health at the Executive War College on Laboratory and Pathology Management. (Photo copyright: CBS News.)
Watson’s Successes and Failures in Healthcare
During the years following Watson’s Jeopardy win, Watson Health made some positive advances in the fields of healthcare data analytics, performance measurements, clinical trial recruitment, and healthcare information technology (HIT).
However, Watson Health also experienced some high-profile failures as well. One such failure involved a collaboration with MD Anderson Cancer Center, established in 2013, to help the health systems’ oncologists develop new tools to benefit cancer patients. MD Anderson ended the relationship in 2018 after spending more than $60 million on the project, citing “multiple examples of unsafe and incorrect treatment recommendations,” made by the Watson supercomputer, Healthcare IT News reported.
Watson Health later readjusted the development and sales of its AI drug discovery tools and altered its marketing strategy amid reports of disappointing sales and skepticism surrounding machine learning for medical applications.
Underestimating the Challenge of AI in Healthcare
Since its inception, Watson Health has achieved substantial growth, mainly through a series of acquisitions. Those targeted acquisitions include:
Merge Healthcare, a healthcare imaging software company that was purchased for $1 billion in 2015,
Phytel, a health management software company that was purchased for an undisclosed amount in 2015,
Explorys, a healthcare analytics company that was purchased for an undisclosed amount in 2015, and
Truven Health Analytics, a provider of cloud-based healthcare data, analytics, and insights that was purchased for $2.6 billion in 2016.
“IBM’s Watson Health business came together as a result of several acquisitions,” said Paddy Padmanabhan, founder and CEO of Damo Consulting, a firm that provides digital transformation strategy and advisory services for healthcare organizations. “The decision to sell the business may also have to do with the performance of those units on top of the core Watson platform’s struggles,” he told Healthcare IT News.
It should be noted that these acquisitions involved companies that already had a product in the market which was generating revenue. So, the proposed sale of Watson Health includes not just the original Watson AI product, but the other businesses that IBM put into its Watson Health business division.
Padmanabhan noted that there are many challenges for AI in healthcare and that “historical data is at best a limited guide to the future when diagnosing and treating complex conditions.” He pointed to the failure with MD Anderson (in the use of Watson Health as a resource or tool for diagnosing cancer) was a setback for both IBM and the use of AI in healthcare. However, Padmanabhan is optimistic regarding the future use of AI in healthcare.
“To use an oft-quoted analogy, AI’s performance in healthcare right now is more akin to that of the hedgehog than the fox. The hedgehog can solve for one problem at a time, especially when the problem follows familiar patterns discerned in narrow datasets,” he told Healthcare IT News. “The success stories in healthcare have been in specific areas such as sepsis and readmissions. Watson’s efforts to apply AI in areas such as cancer care may have underestimated the nuances of the challenge.”
Other experts agree that IBM was overly ambitious and overreached with Watson Health and ended up over-promising and under-delivering.
“IBM’s initial approach misfired due to how the solution AI was trained and developed,” Dan Olds, Principal Analyst with Gabriel Consulting Group, told EnterpriseAI. “It didn’t conform well to how doctors work in the real world and didn’t learn from its experiences with real doctors. It was primarily learning from synthetic cases, not real-life cases.”
Was Watson Already Obsolete?
Another issue with Watson was that IBM’s marketing campaign may have exceeded the product’s design capabilities. When Watson was developed, it was built with AI and information technologies (IT) that were already outdated and behind the newest generation of those technologies, noted Tech Republic.
“There were genuine AI innovation triggers at Watson Health in natural language processing and generation, knowledge extraction and management, and similarity analytics,” Jeff Cribbs, Research Vice President at Gartner Research, told Tech Republic. “The hype got ahead of the engineering, as the hype cycle says it almost always will, and some of those struggles became apparent.”
Can Artificial Intelligence Fulfill its Potential in Healthcare?
The fact that IBM is contemplating the sale of Watson Health is another illustration of how difficult it can be to navigate the healthcare industry in the US. It is probable that someday AI could make healthcare diagnostics more accurate and reduce overall costs, however, data challenges still exist and more research and exploration will be needed for AI to fulfill its potential.
“Today’s AI systems are great in beating you at chess or Jeopardy,” Kumar Srinivas, Chief Technology Officer, Health Plans, at NTT DATA Services told Forbes. “But there are major challenges when addressing practical clinical issues that need a bit of explanation as to ‘why.’ Doctors aren’t going to defer to AI-decisions or respond clinically to a list of potential cancer cases if it’s generated from a black box.”
And perhaps that is the biggest challenge of all. For doctors to entrust their patients’ lives to a supercomputer, it better be as good as the hype. But can AI in healthcare ever accomplish that feat?
“AI can work incredibly well when it’s applied to specific use cases,” gastroenterologist Nirav R. Shah, MD, Chief Medical Officer at Sharecare, told Forbes. “With regards to cancer, we’re talking about a constellation of thousands of diseases, even if the focus is on one type of cancer. What we call ‘breast cancer,’ for example, can be caused by many different underlying genetic mutations and shouldn’t really be lumped together under one heading. AI can work well when there is uniformity and large data sets around a simple correlation or association. By having many data points around a single question, neural networks can ‘learn.’ With cancer, we’re breaking several of these principles.”
So, in deciding to divest itself of Watson Health, IBM may simply be as prescient now as it was when it first embraced the concept of AI in healthcare. The tech giant may foresee that AI will likely never replace the human mind of a trained healthcare diagnostician.
If this proves true—at least for several more years—then board-certified clinical pathologists can continue to justifiably refer to themselves as “the doctor’s doctor” because of their skills in diagnosing difficult-to-diagnose patients, and because of their knowledge of which clinical laboratory tests to order and how to interpret those test results.
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.
“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.
