Pathologist Kingshuk Das, MD, tells jurors he voided 50,000 to 60,000 blood-tests from a two-year period due to unreliable results
As the prosecution in the criminal fraud trial of ex-CEO Elizabeth Holmes closes in on resting its case, a fourth and final former Theranos laboratory director took the stand to describe the problems he encountered when overseeing the startup’s medical laboratory operations.
Los Angeles, Calif., board-certified clinical pathologist Kingshuk Das, MD, testified that he reported directly to Holmes and repeatedly warned her about problems and errors with the company’s Edison blood-testing technology, CNBC reported. While describing the proprietary technology’s reliability issues, Das spoke of one conversation with Holmes in which he pointed out that female patients were receiving test results showing abnormal levels of prostate-specific antigen, or PSA, which typically is associated with the male prostate gland.
“Females should generally not have PSA detectable,” Das said during testimony. He “recalled that Holmes offered an alternate explanation, citing ‘an article or two’ claiming rare breast cancers might cause PSA results in women,” CNBC reported.
Assistant US Attorney Robert Leach, JD then asked Das, “Was that explanation satisfying to you?”
“It seemed implausible,” Das replied.
According to CNBC, Das—who worked at Theranos from March 2016 until June 2018—testified that he “voided every test on the Edison devices from 2014 and 2015” and that he had “explained to Holmes that ‘these instruments were not performing from the very beginning.’
During his testimony, Das explained, “I tried to present it in a more understandable format. I recall [Holmes] offering an alternative explanation,” CNBC reported.
Das testified that “Holmes told him it wasn’t an instrument failure but rather a quality control and quality assurance issue,” CNBC reported.
According to The Wall Street Journal (WSJ), corrected reports were issued to doctors for an estimated 50,000 to 60,000 voided results.
CMS Audit: Theranos Lab Posed ‘Immediate Jeopardy to Patient Health and Safety’
The CMS report stated, “As a result of the survey, it was determined that your facility is not in compliance with all of the conditions required for certification in the CLIA program. … The deficient practices of the laboratory pose immediate jeopardy to patient health and safety,” CNBC reported.
Former Theranos Laboratory Director pathologist Kingshuk Das, MD, testified in the Elizabeth Holmes fraud trial that, when he was hired, he was not told the laboratory had previously been inspected by the Centers for Medicare and Medicaid Services and found deficient. He testified in federal court that he ultimately voided an estimated 50,000 to 60,000 clinical laboratory test results due to the unreliability of the proprietary Edison blood-testing devices. (Photo copyright: LinkedIn.)
Testimony of Four Former Theranos Lab Directors
Das is the fourth Theranos laboratory director to take the stand. He joined the startup in 2016 and was laid off in 2018.
Previous reporting in Dark Daily and our sister publication The Dark Report covered court testimony from the three lab directors who preceded Das (click on names to be taken to those stories):
Lynette Sawyer, DPH, who told jurors she never set foot inside Theranos’ lab while serving as co-director;
Sunil Dhawan, MD, who was former Theranos Chief Operating Officer Ramesh “Sunny” Balwani’s personal dermatologist, and who while Theranos’ lab director worked a total of five to 10 hours and only went to the lab twice; and,
Adam Rosendorff, MD, PhD, a board-certified pathologist, who previously testified he quit Theranos because the technology did not work, CNBC reported.
Rosendorff provided some of the trial’s most explosive news when it was revealed that he was the whistleblower behind The Wall Street Journal’s exposé into Theranos that first raised questions about the startup’s technology and operations.
Defense Claims Holmes Did Not Intentionally Mislead Investors
As noted in The Verge, Holmes’ defense strategy centers on convincing jurors she did not intentionally mislead investors, patients, physicians, and clinical laboratories about Theranos’ proprietary technology, but that she simply failed to achieve the goals she set for Theranos.
“Trying your hardest and coming up short is not a crime,” defense lawyer Lance Wade, JD, told jurors in his opening statement, The Verge reported. “And by the time this trial is over, you will see that the villain the government just presented is actually a living, breathing human being who did her very best each and every day. And she is innocent,” Wade added.
While Holmes is not expected to take the stand in her own defense, prosecutors used her own words against her last month when they played audiotapes for the jury of telephone calls Holmes made to investors in 2013. According to KRON4-TV in San Francisco, Holmes told investors Theranos’ revenues would reach $140 million in revenue in 2014, though the company had not recorded any revenue the two prior years.
Legal analyst Michele Hagan, JD, a former San Francisco Assistant District Attorney, told KRON4-TV the audiotapes are likely to impact the jury.
“It’s very powerful testimony when you can use the defendant’s own words, and these audiotapes can incriminate her,” Hagan said.
Holmes, 37, faces maximum penalties of 20 years in prison and a $2.75 million fine if convicted of two counts of conspiracy to commit wire fraud and 10 counts of fraud, plus possible restitution, the Department of Justice has said. Balwani’s criminal fraud trial is scheduled to begin in January 2022.
With the prosecution just inches away from resting its case, clinical laboratory managers and pathologists will not have to wait long to learn if Holmes’ defense team mounts a defense against fraud charges or allows the case to be turned over to the jury.
Several young companies hope to expand the direct-to-consumer test market by introducing new diagnostic tests to serve the women’s health market
Providing women with at-home lab test kits is the goal of a growing class of start-up companies that are bringing to market consumer test kits for a range of health conditions common to women. These companies believe they can shift a substantial volume of such testing away from the nation’s medical laboratories.
Moreover, diagnostic startups that develop at-home direct-to-consumer (DTC) clinical laboratory genetic tests have been hot commodities among venture capitalists and other healthcare investors willing to put tens of millions of dollars into these new firms. The New York Times observed that, until recently, women’s healthcare needs have rarely been the focus of new diagnostic testing companies, but that the situation may be changing.
“Femtech” (short for female technology) products and services that address the health and wellness needs of women is the new buzz word in healthcare. It describes female-focused diagnostic startups aiming at vaginal health and other medical issues that go beyond reproductive health concerns.
This, however, is a dual-edged sword for clinical laboratory leaders. Growth in this segment could lead to new diagnostics tests that boost a medical lab’s bottom line or, conversely, it could reduce revenue as patients self-diagnose urinary tract infections (UTIs), yeast infections, and other conditions through at-home DTC testing.
“The market potential is huge,” Michelle Tempest, MD (above), a partner at the London-based healthcare consulting firm Candesic, told The New York Times. “There’s definitely an increasing appetite for anything in the world which is technology and a realization that female consumer power has arrived—and that it’s arrived in healthcare.” Tempest maintains the women’s health marketplace is ripe for growth, which could mean a boon for clinical laboratory testing and diagnostics designed specifically for women. (Photo copyright: Candesic.)
Vaginal Microbiome At-home Clinical Laboratory Tests in High Demand
One area in particular drawing the attention of several female-led startups is vaginal health. According to an article in Vogue, test developers Juno Bio and Evvy are leading the way with at-home vaginal microbiome tests that let users “know what’s up down there.”
New York City-based Evvy ($129 for a single test or $99 each for four tests per year) uses metagenomic sequencing to identify the bacteria and fungi present in the vaginal microbiome. This information helps customers to understand their levels of protective and disruptive bacteria, which can be associated with everything from reoccurring infections and transmission of sexually transmitted diseases to infertility.
London-based Juno Bio ($149 per test) does not disclose its testing method. It does, however, provide users with a “full vaginal microbiome profile.” The profile is accessed online within a “few days” of returning the vaginal swab sample to the company’s clinical laboratory.
Both companies note that their tests are intended to be used for wellness purposes and are not meant to diagnose or treat disease or substitute for a physician’s consultation.
Gynecologist Oluwatosin Goje, MD, MSCR, FACOG, a reproductive infectious disease specialist at Cleveland Clinic, believes the availability of at-home vaginal microbiome testing will provide valuable information to both women and their doctors.
“It’s a powerful tool because it enables us to look at the entire microbial community through metagenomics and decipher how the overall composition might be affecting symptoms and infections, as well as determine the best treatment pathway,” Goje, an Evvy Medical Advisor, told Vogue. “Understanding the complete vaginal microbiome allows us to be good antibiotic stewards and only administer antibiotics when needed. Patients can also retest remotely to understand how antibiotics and other treatments impacted their vaginal microbiome.”
Evvy, which offers women an at-home vaginal microbiome test (above) that can provide insights into chronic vaginal infections and proclivity to contract sexually transmitted diseases and other women’s health issues, is one of several women-led diagnostic start-ups focused on women’s health. (Photo copyright: Evvy.)
Removing the Discomfort of Shopping for Women’s Health Products
Jamie Norwood and Cynthia Plotch, co-founders of Stix, a supplier of women’s health products and education, launched their company with a product line of at-home pregnancy and ovulation tests. They have since expanded their offerings to include urinary tract infection (UTI) and yeast infection testing and treatments.
“You can test, relieve, treat, and help prevent future infections—all from the comfort of your own home,” Norwood, told Vogue. She emphasized that this is the kind of experience healthcare consumers are demanding in today’s ever-growing direct-to-consumer clinical laboratory testing landscape. “Agonizing over confusing over-the-counter products in the drugstore aisles, or bending over backwards to pick up a prescription at the pharmacy, just isn’t cutting it for Millennial and Gen Z consumers.”
According to WebMD, yeast infections are a chronic problem for many women. While 75% of women will get at least one yeast infection in their lifetime, up to 8% get more than four a year. In addition, the federal Centers for Disease Control and Prevention (CDC) points out that bacterial vaginosis is the most common vaginal condition in females ages 15-44.
Lola Priego, is CEO and founder of blood test company Base, which sells at-home saliva and finger-prick blood tests to monitor hormone levels, vitamin levels, neurotransmitters, and blood cell markers to improve everything from sleep and diet to sex drive. She predicts direct-to-consumer testing will become as common as fitness watches.
“Eventually, at-home lab testing will be another readily-used tool, similar to your health-tracking wearables, that helps us optimize for a well-rounded healthy lifestyle in a more individualized way,” Priego told Vogue.
Femtech a ‘Significantly Underdeveloped’ Market
In its latest Analyst Note, financial data firm PitchBook maintained that the market for female health products is poised for growth. TechCrunch, which reviewed PitchBook’s analysis of female-focused health products, reported that Femtech remains a “significantly underdeveloped” slice of health-tech spending.
While women spend an estimated $500 billion annually on medical expenses, only 4% of research and development money is targeted at women’s health, PitchBook noted. In its analysis, Pitchbook predicted the global market for female-focused health products will reach $3 billion by the end of 2030. By comparison, that segment of the healthcare market totaled $820.6 million last year.
“While we still view Femtech as a niche industry, we believe secular drivers could help propel new growth opportunities in the space,” PitchBook analysts wrote. “These include the increasing representation of women in the venture-backed technology community, rising awareness and acceptance of women’s health issues, and the growing prevalence of infectious diseases among women in some countries in Africa and Asia.
“Furthermore, while the majority of Femtech products have traditionally focused on reproductive health, we believe new approaches to women’s health research will help open the door to new products and services,” they noted.
Clinical laboratory leaders will be wise to carefully watch the growth of at-home DTC tests and products targeted at female healthcare consumers since fewer trips to physicians’ offices may mean fewer test orders for local labs.
At the same time, the opportunity exists for innovative pathologists and lab managers to develop digital services that allow consumers who are self-testing to store their home-test results in the lab’s app. They can then receive relevant insights from clinical pathologists to help them fully understand the implications of the test results.
Citizens claiming racial diversity increased by 276% in the 2020 census, leading experts to wonder if racial diversity is increasing or if people are simply electing to identify as such and how this trend will affect healthcare
Once again, we see another unexpected consequence to expanded DNA testing done by consumers for their own interests and needs. As NPR recently reported in “The Census Has Revealed a More Multiracial US. One Reason? Cheaper DNA Tests,” the growing trend of ordering low-cost direct-to-consumer (DTC) genetic testing to identify cultural heritage (where a family came from) and genealogy (to connect with extant family members) has educated healthcare consumers more about their cultural roots.
Such knowledge, NPR speculates, is allowing people to complete their census survey with more accurate “heritage” classifications.
The last US census showed an interesting change compared to previous census surveys. More Americans identified themselves as racially diverse than in previous censuses. Scientists in multiple specialty areas—including demographics, sociology, genetics, and more—are asking why.
According to federal Census Bureau data, in the most recent census, people who identify as more than one race rose by 276%! Scientists are only just beginning to hypothesize the reasons for this increase, but three potential factors, NPR reported, have emerged:
More children are being born to parents who identify with racial groups that are different from one another.
People are reconsidering what they want the government to know about their identities, according to Duke University Press.
The increased incidence of DNA testing for cultural heritage may be an additional factor in the different ways people identified themselves during the census, driving its popularity, NPR noted. More people are purchasing at-home DNA tests to learn where their ancestors lived and came from, and their family’s genealogy.
“Exactly how big of an effect these tests had on census results is difficult to pin down,” NPR reported. “But many researchers agree that as the cost of at-home kits fell in recent years, they have helped shape an increasing share of the country’s ever-changing ideas about the social construct that is race.”
How the Census Alters Government Policy
Pew Research noted that, although only about 16% of Americans have taken an ancestry DNA test, the marketing efforts of “companies such as 23andMe and Ancestry.com, which operates the AncestryDNA service, should not be underestimated,” NPR reported. They have a wide reach, and those efforts could be impacting how people think about race and ethnic identity.
For most of human history, social experience and contemporary family history have been the drivers of how people identified themselves. However, low-cost DTC genetic testing may be changing that.
“The public has kind of taken in the notion that you can find out ‘who you are’ with a test that’s supposed to analyze your genes,” Jenifer Bratter, PhD (above), a Professor of Sociology at Rice University who studies multiracial identity, told NPR. “What that does for anyone who does work in racial identity and racial demography is cause us to think through how genetic ideas of race are in public circulation.” Desire by healthcare consumers to know their risk for chronic disease has already driven a marked increase in demand for low-cost DNA testing, which has also affected the types of test orders clinical laboratory are receiving from doctors. (Photo copyright: Rice University.)
One concern that sociologists and demographers have about this trend is that the US census is an important tool in policy, civil rights protections, and even how researchers measure things like healthcare access disparities.
“You’re going to have a lot more people who are not part of marginalized groups in terms of their social experiences claiming to be part of marginalized groups. When it comes to understanding discrimination or inequality, we’re going have very inaccurate estimates,” says Wendy Roth, PhD, Associate Professor of Sociology, University of Pennsylvania, told NPR.
They developed the “genetic options” theory, “to account for how genetic ancestry tests influence consumers’ ethnic and racial identities.” They wrote, “The rapid growth of genetic ancestry testing has brought concerns that these tests will transform consumers’ racial and ethnic identities, producing “geneticized” identities determined by genetic knowledge.”
However, a more healthcare-related motivation for taking a DTC DNA test is to learn about one’s potential risks for familial chronic health conditions, such as cancer, heart disease, and diabetes, etc.
“Whether that occurs through your primary care doctor, your large integrated health network, or your payor, I think there will be profound changes in society’s tolerance for using genetics for prevention,” he told GenomeWeb.
Regardless, as Dark Daily reported in 2020, sales of genetic tests from Ancestry and 23andMe show the market is cooling. Thus, with less than 20% of the population having taken DNA tests, and with sales slowing, genetics testing may not affect responses on the next US census, which is scheduled for April 1, 2030.
In the meantime, clinical laboratory managers should recognize how and why more consumers are interested in ordering their own medical laboratory tests and incorporate this trend into their lab’s strategic planning.
Medical laboratory company’s patients in Southwest England previously had tested positive for COVID-19 ona Lateral Flow Device
If providing accurate test results is key to maintaining trust with healthcare consumers, a private COVID-19 testing laboratory in the United Kingdom (UK) may have permanently damaged its reputation after reporting an estimated 43,000 false negative COVID-19 RT-PCR (polymerase chain reaction) test results over a five-week span between September 8, 2021, and October 12, 2021.
For now, Immensa Health Clinic Ltd., a subsidiary of DNA testing company Dante Labs, had its testing operations suspended on October 15 while the UK Health Security Agency (UKSA) investigates the cause of false negative PCR test results from the company’s lab in Wolverhampton, England. The test results went out to people who previously had tested positive for COVID-19 on a lateral flow device (LFD).
“We have recently seen a rising number of positive LFD results subsequently testing negative on PCR. As a result of our investigation, we are working with NHS Test and Trace and the company to determine the laboratory technical issues which have led to inaccurate PCR results being issued to people. We have immediately suspended testing at this laboratory while we continue the investigation,” said Will Welfare, MBChB, Public Health Incident Director, UK Health Security Agency, in a UKHSA statement.
“There is no evidence of any faults with LFD or PCR test kits themselves and the public should remain confident in using them and in other laboratory services currently provided,” he added.
UK Government Officials Question How Lab Won Lucrative COVID-19 Testing Contracts
Immensa was awarded a £119 million (US$163.37 million) coronavirus testing contract by the British government in October 2020, just months after it was founded by Andrea Riposati, owner/CEO of Dante Labs, which has clinical laboratories in the UK, Italy, and the United Arab Emirates. The company’s corporate headquarters are in New York City while its scientific operations are based in the UK.
“Serious questions have to be asked about how this private firm—[which] didn’t exist before May 2020—was awarded a lucrative £120 million (US$164.64 million) contract to run this lab,” Member of Parliament (MP) Jonathan Ashworth (above), Labor Party Shadow Health Secretary, told The Guardian. “From duff PPE [personal protective equipment] to failing test kits, ministers have sprayed around tax money like confetti and utterly failed to deliver the service people deserve,” he added. (Photo copyright: The Mirror.)
NHS Test and Trace, the government program to track and help prevent the spread of COVID-19, has advised people who received the false test results, but who may still be infectious, to be retested.
In responding to the UKHSA’s action, Riposati pointed to Immensa’s track record and reiterated the laboratory’s emphasis on quality.
“We are fully collaborating with UKHSA on this matter. Quality is paramount for us,” Riposati said in the UKHSA statement. “We have proudly analyzed more than 2.5 million samples for NHS Test and Trace, working closely with the great teams at DHSC and UKHSA. We do not wish this matter or anything else to tarnish the amazing work done by the UK in this pandemic.”
Clinical Laboratories Not Accredited to Perform COVID-19 Testing
However, on October 18, 2021, The Guardian reported that the Immensa Health Clinic was not accredited by the UKAS, the UK’s independent accreditation service, before being appointed to perform COVID-19 testing. Dante Labs also has not been awarded UKAS accreditation, according to the newspaper report.
Government officials previously maintained that Immensa was “accredited to all of the appropriate standards.”
Immensa first made headlines in January 2021 when The Sun published an expose´ that included video of employees fighting, drinking, and bragging about watching porn while working at the clinical laboratory.
News of the testing failure at Immensa caused Tory MP Nigel Mills to tell The Sun, “This place should have been shut down for good when The Sun ran its [original] story. It is shocking it has been allowed to remain open and now there is an enormous mess.
“It’s a disgrace,” he added. “If shortcomings have emerged in the process here—which I strongly imagine they have—then heads should roll. The investigation should widen out and an audit should be carried out into other testing companies.”
Dante Labs Under Other Investigations
Immensa’s parent company, Dante Labs, is also under investigation in the UK due to concerns the company “may be treating its customers unfairly.”
A statement from the UK Competition and Markets Authority (CMA), outlined the UK government’s probe into Dante Labs. The statement cited the lab for:
Potentially not delivering PCR tests and/or results on time or at all,
Failing to respond to complaints or provide proper customer service,
Refusing or delaying refunds when requested, and
Providing terms and conditions that may unfairly limit consumers’ rights.
According to The Guardian, Dante Labs’ US operation also faced scrutiny in 2018 after the company admitting it had sent five used DNA test kits to people containing the saliva of other people. Dante Labs maintained its shipping company was the cause of the error.
US Labs Also Face Scrutiny over False Negative Test Results
Since the outbreak of SARS-CoV-2 in early 2020, there have been only a limited number of news accounts about clinical laboratories that reported a substantial number of inaccurate COVID-19 test results, either in the United States or the United Kingdom. In the US, there has been more news coverage of the federal Department of Justice (DOJ) prosecuting lab owners and related parties for submitting fraudulent claims for COVID-19 tests.
But the absence of those news accounts does not mean that there have been no incidents in the US where a lab testing company reported significant numbers of inaccurate COVID-19 test results.
In 2020, for example, Dark Daily reported on how Abbott Lab’s ID NOW COVID-19 rapid molecular test faced scrutiny over false negatives resulting in the FDA issuing a public warning about the point-of-care test’s accuracy after receiving 15 “adverse event reports” indicating some patients were receiving “false negative results.”
Then on June 22, 2020, KHN reported that the FDA had “received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19.”
The UK lab’s failures are simply the latest example of how inaccurate test results erode the trust of healthcare consumers and draw the ire of politicians and government regulators. In this case, however, poor government oversight of a newly minted COVID-19 testing laboratory should face equal scrutiny.
Newly combined digital pathology, artificial intelligence (AI), and omics technologies are providing anatomic pathologists and medical laboratory scientists with powerful diagnostic tools
Add “spatial transcriptomics” to the growing list of “omics” that have the potential to deliver biomarkers which can be used for earlier and more accurate diagnoses of diseases and health conditions. As with other types of omics, spatial transcriptomics might be a new tool for surgical pathologists once further studies support its use in clinical care.
Among this spectrum of omics is spatial transcriptomics, or ST for short.
Spatial Transcriptomics is a groundbreaking and powerful molecular profiling method used to measure all gene activity within a tissue sample. The technology is already leading to discoveries that are helping researchers gain valuable information about neurological diseases and breast cancer.
Marriage of Genetic Imaging and Sequencing
Spatial transcriptomics is a term used to describe a variety of methods designed to assign cell types that have been isolated and identified by messenger RNA (mRNA), to their locations in a histological section. The technology can determine subcellular localization of mRNA molecules and can quantify gene expression within anatomic pathology samples.
In “Spatial: The Next Omics Frontier,” Genetic Engineering and Biotechnology News (GEN) wrote, “Spatial transcriptomics gives a rich, spatial context to gene expression. By marrying imaging and sequencing, spatial transcriptomics can map where particular transcripts exist on the tissue, indicating where particular genes are expressed.”
In an interview with Technology Networks, George Emanuel, PhD, co-founder of life-science genomics company Vizgen, said, “Spatial transcriptomic profiling provides the genomic information of single cells as they are intricately spatially organized within their native tissue environment.
“With techniques such as single-cell sequencing, researchers can learn about cell type composition; however, these techniques isolate individual cells in droplets and do not preserve the tissue structure that is a fundamental component of every biological organism,” he added.
“Direct spatial profiling the cellular composition of the tissue allows you to better understand why certain cell types are observed there and how variations in cell state might be a consequence of the unique microenvironment within the tissue,” he continued. “In this way, spatial transcriptomics allows us to measure the complexity of biological systems along the axes that are most relevant to their function.”
“Although spatial genomics is a nascent field, we are already seeing broad interest among the community and excitement across a range of questions, all the way from plant biology to improving our understanding of the complex interactions of the tumor microenvironment,” George Emanuel, PhD (above), told Technology Networks. Oncologists, anatomic pathologists, and medical laboratory scientists my soon see diagnostics that take advantage of spatial genomics technologies. (Photo copyright: Vizgen.)
According to 10x Genomics, “spatial transcriptomics utilizes spotted arrays of specialized mRNA-capturing probes on the surface of glass slides. Each spot contains capture probes with a spatial barcode unique to that spot.
“When tissue is attached to the slide, the capture probes bind RNA from the adjacent point in the tissue. A reverse transcription reaction, while the tissue is still in place, generates a cDNA [complementary DNA] library that incorporates the spatial barcodes and preserves spatial information.
“Each spot contains approximately 200 million capture probes and all of the probes in an individual spot share a barcode that is specific to that spot.”
“The highly multiplexed transcriptomic readout reveals the complexity that arises from the very large number of genes in the genome, while high spatial resolution captures the exact locations where each transcript is being expressed,” Emanuel told Technology Networks.
Spatial Transcriptomics for Breast Cancer and Neurological Diagnostics
In that paper, the authors wrote “we envision that in the coming years we will see simplification, further standardization, and reduced pricing for the ST protocol leading to extensive ST sequencing of samples of various cancer types.”
Spatial transcriptomics is also being used to research neurological conditions and neurodegenerative diseases. ST has been proven as an effective tool to hunt for marker genes for these conditions as well as help medical professionals study drug therapies for the brain.
“You can actually map out where the target is in the brain, for example, and not only the approximate location inside the organ, but also in what type of cells,” Malte Kühnemund, PhD, Director of Research and Development at 10x Genomics, told Labiotech.eu. “You actually now know what type of cells you are targeting. That’s completely new information for them and it might help them to understand side effects and so on.”
The field of spatial transcriptomics is rapidly moving and changing as it branches out into more areas of healthcare. New discoveries within ST methodologies are making it possible to combine it with other technologies, such as Artificial Intelligence (AI), which could lead to powerful new ways oncologists and anatomic pathologists diagnose disease.
“I think it’s going to be tricky for pathologists to look at that data,” Kühnemund said. “I think this will go hand in hand with the digital pathology revolution where computers are doing the analysis and they spit out an answer. That’s a lot more precise than what any doctor could possibly do.”
Spatial transcriptomics certainly is a new and innovative way to look at tissue biology. However, the technology is still in its early stages and more research is needed to validate its development and results.
Nevertheless, this is an opportunity for companies developing artificial intelligence tools for analyzing digital pathology images to investigate how their AI technologies might be used with spatial transcriptomics to give anatomic pathologists a new and useful diagnostic tool.
Federal prosecutors moved past the testimony of the pathologist who served for a time as the CLIA laboratory director at Theranos to provide evidence of a second unauthorized use by Theranos of a pharmaceutical company’s intellectual property
Building their case against former Theranos CEO Elizabeth Holmes, federal prosecutors filled the witness stand in recent days with corporate executives, representatives of powerful government figures, and others who testified they were lured to invest in the startup by false claims and flimsy promises from the now-defunct clinical laboratory company and its founder.
Since the criminal fraud trial against Holmes began 10 weeks ago, prosecutors have alleged Holmes, 37, knowingly mislead investors, clinical laboratories, patients, and healthcare providers about the capabilities of the company’s proprietary Edison blood-testing technology. Her defense team has argued that a failed business venture does not make Holmes a criminal.
Holmes has pleaded not guilty to 10 counts of wire fraud and two counts of conspiracy to commit wire fraud.
Safeway CEO Testifies to Being Misled by Holmes
In testimony for the prosecution, former Safeway CEO Steven Burd told the jury how his company relied on Holmes’ boasts and statements about Theranos’ technology when signing nearly $400 million in contracts with Theranos. These contracts included remodeling 969 stores to create both blood collection sites and mini-clinical laboratories housing Edison blood-testing units.
Today, many of these Safeway grocery stores are leasing those patient service centers to such medical laboratory companies as Labcorp and Quest Diagnostics.
CNN reported that Burd acknowledged being impressed by Holmes’ ability to command a room. “There are very few people that I’ve met in business that I would actually say were charismatic,” testified Burd, comparing her favorably to four US presidents he had met. “She was clearly charismatic. She was very smart.”
However,CNBC noted that Burd’s frustration with Holmes and Theranos grew as delays mounted and a trail of clinical laboratory testing using the Edison devices within Safeway’s corporate headquarters proved unsuccessful.
“I think whenever you start something new you’re going to have some rough spots, but we continued to have rough spots,” Burd stated in the CNBC coverage. “We had samples that were lost, we had [clinical laboratory test] results that didn’t make any sense.”
In cross examination, defense attorneys worked to refute allegations the grocery chain was misled prior to partnering with Theranos. Burd acknowledged Safeway did “at least 100” hours of due diligence before executing its 2010 contract with the startup and knew Theranos’ medical laboratory testing technology never had been tested at scale, CNBC reported. Safeway ended its failed partnership with Theranos in 2015.
Former Walgreens CFO also Testifies to being Misled
When former Walgreens Chief Financial Officer Wade Miquelon took the stand, he testified Walgreens also was persuaded by Theranos’ Edison-device claims when partnering with the company in 2013.
According to the WSJ, like Safeway, Walgreens had vetted Theranos without extensively examining or testing the Edison blood-testing device, which Theranos claimed could quickly and accurately run 200 clinical laboratory diagnostic tests using a finger-stick of blood.
Instead, Walgreens had relied on the opinions of staff healthcare experts and outside experts, none of whom fully tested the technology, the WSJ stated.
In recent coverage of the Elizabeth Holmes federal fraud trial, The Wall Street Journal reported retired United States Marine Corps four-star general Jim Mattis (above)—who also was a former Theranos board member and investor—testified that “he and other board members were blindsided to learn in 2015 that the company hadn’t been conducting all of its blood tests using its proprietary technology.” Clinical laboratory leaders who have been following the rise and fall of Theranos know the company claimed its Edison blood testing device could perform as many as 200 tests on a single fingerstick of blood. (Illustration copyright: Vicki Behringer/Reuters.)
Other Investors Testify to Being Dupped by Holmes
Major retailers were not the only ones taken in by the Theranos hype. Jurors also heard testimony from Lisa Peterson, Managing Director, Global Private Equity at Ottawa Avenue Private Capital, a Division of RDV Corp., a holding of the billionaire family of former Education Secretary Betsy DeVos.
After meeting with Holmes, during with which a DeVos family member had her blood tested, RDV doubled the amount of its planned investment from $50 million to $100 million, The Wall Street Journal reported. Peterson testified they were not told there were issues with the Edison device.
According to CNN, Peterson testified that she had trusted the information Theranos and Holmes provided, which included a Theranos-generated report boasting a Pfizer logo that touted the Edison’s “superior performance” and “excellent accuracy.”
However, in earlier court testimony, a Pfizer scientist stated the pharmaceutical giant opted not to partner with Theranos after finding the report’s conclusions “not believable.” He also testified that Holmes did not have permission to use the Pfizer logo.
Another wealthy individual duped by the now defunct blood-testing company was former estate attorney Daniel Mosley, JD, a partner at the law firm Cravath, Swaine and Moore LLP. Mosley testified he invested $6 million in Theranos after being introduced to the startup by ex-Secretary of State Henry Kissinger, a onetime Theranos board member.
According to The Wall Street Journal, Mosley pitched the Theranos venture to several of his clients, including the Walton and DeVos families. Mosley and five of his clients invested a total of $384 million in Theranos, an amount equal to more than half of the company’s $730.1 million 2014 funding round, the WSJ stated.
Mosley told jurors he believed the claims Theranos had told investors. “Did I think I had inaccurate information? No,” he testified.
Second Pharmaceutical Company Claims Unauthorized Use of Intellectual Property
Jurors also learned about a second Theranos-produced investor document that included an unauthorized pharmaceutical company logo. In this instance, Holmes had allegedly attached to a Walgreens email a Theranos report bearing dual Schering-Plough and Theranos logos.
Cullen said Holmes “almost exclusively” answered her questions, but her responses were “cagey.” Cullen testified she had no knowledge that anyone at Schering-Plough had endorsed the report’s conclusion that Theranos’ blood tests provided “accurate and precise results.”
With the Holmes defense team still awaiting its turn to present evidence in US District Court, trial testimony is expected to continue into December. This means clinical laboratory managers and pathologists will have plenty of informative Dark Daily ebriefings to look forward to on this intriguing fraud trail.
