Panel of experts in healthcare and the clinical laboratory market identify key trends and discuss how innovative medical laboratories are adding value—and getting paid for that value
Effective clinical laboratory leadership in today’s value-based healthcare system means demonstrating value within an integrated delivery network. After all, as fee-for-service payment for clinical lab tests gives way to value-added reimbursement arrangements, all medical laboratories will need to justify their share of a value-based payment.
But how can clinical
laboratories alert physicians and their parent hospitals to the real value they
offer to improve patient outcomes and reduce healthcare costs? Though lab leaders
may understand their medical lab’s complexity, accessibility, and impact, the
question is how to direct the effort. The answer lies in a risk that some laboratory
directors may not have considered.
Value-based healthcare systems include hospital-based medical laboratories as an essential part of their integrated health system. And, to lower the cost of care, healthcare systems involved in value-based care know they must become better at coordinating care and offering precision medicine services to their patients.
Year-by-year, more integrated health systems are learning how to eliminate gaps in care and become more proactive in delivering care that helps keep patients healthy. However, the task of leveraging the clinical laboratory in a strategic approach to demonstrating value in those health systems remains daunting. One of the goals of the Clinical Lab 2.0 model developed by the Project Santa Fe Foundation clinical laboratory organization is to demonstrate how labs can achieve two goals:
Create added-value services that improve patient care; and
Have health insurers, accountable care organizations (ACOs), and health networks pay remuneration to the clinical labs for those added-value services.
Pathologists,
Clinical Chemists, and MTs Leave Thy Medical Labs
Expert panelists of a recent webinar hosted by Dark Daily and sponsored by Sunquest Information Systems suggested ways that clinical laboratories could better position themselves to be an asset for their organizations. One way to do this is to get their clinical pathologists, PhDs, and medical technologists out of the lab and engaged with physicians, nurses, and other clinical staff in specific ways that influence the healthcare organization’s overall performance in delivering better patient outcomes at less cost.
“Our labs have
to be equal partners instead of recipients of where things are going,” he stressed.
“We need to be, if not in the driver’s seat, at least in the front seat.”
Mark Dixon (above), President of the Mark Dixon Group LLC, moderated the webinar, which was sponsored by Sunquest Information Systems and The Dark Report, sister publication of Dark Daily. Dixon has more than 30-years’ experience as a health system CEO and COO. He said TriCore and other labs are succeeding at value-based healthcare using methods that are well-defined and available for all clinical laboratories to learn. For example: TriCore has found that certain health insurers are willing to not only pay their laboratory differently, but also meet with the lab’s pathologists and leaders to negotiate value-based care arrangements. (Photo copyright: Mark Dixon Group.)
Fundamental
Changes That Will Impact All Clinical Laboratories
The panel
speakers discussed how clinical laboratories can strategically position
themselves to be successful in today’s evolving healthcare industry. They
predicted several fundamental changes would take place or continue. These
changes include:
A
continued shift away from pure fee-for-service payment (volume) to value-based
reimbursement that rewards improved patient outcomes;
More
discussion regarding prevention of illnesses, chronic diseases, and personal
responsibility;
More
focus on primary care and proactive care;
Rapid
advances in science and technology that will spark development of new healthcare
applications;
Continued
trend toward consumerism, as more patients pay a larger portion of their
healthcare expenses and shop for hospitals, doctors, and labs; and
Intense
cost pressure on healthcare organizations and their medical laboratories.
It was noted
during the panel discussion that, even as the US spends more than any other
country in the world on healthcare, it has some of the worst overall outcomes.
Customers Rapidly
Becoming Stakeholders
“I always think in terms of stakeholders and the number one
stakeholder for any clinical laboratory or healthcare system is always the
customer,” said Peters. “The lab’s customer is the ordering physician. So, it’s
important that labs ‘speak their language’ and understand that the physician’s
customer is the patient.”
Clinical laboratories also must be aware of what a
particular healthcare system is trying to accomplish. “Lab leaders should stay
in constant touch with where the market is, where the system is, and where
reform is,” said Oravetz. “And realize there are things that can be done today
to set up for what’s coming tomorrow.”
Terese said that
for a clinical laboratory to survive during this rapid transformation of
the US healthcare system—or at least continue to thrive—it needs to engage with
the strategic and clinical initiatives guiding every health system around the
country. “There is tremendous opportunity for clinical laboratories to not only
support that transition, but to actually help drive it,” he said. “There’s
nothing wrong with thinking of your medical laboratory as a leader of these
initiatives, versus just as a follower of what the organization is doing.”
Key elements of
the webinar that will be of interest to clinical laboratories include:
Examples
of clinical laboratories navigating the transition from volume to value-based
care;
Discussion
and update on fundamental changes coming to the US healthcare industry that
impact clinical laboratories;
The
case for demonstrating the value of clinical labs to healthcare organizations;
and
Eight
ways to elevate the value of clinical labs within an integrated healthcare network.
The experts on this special discussion panel agree that US
healthcare and the clinical laboratory marketplace is in a time of transition.
Pathologists and medical laboratory scientists have an opportunity to position
themselves as leaders and changemakers to the benefit of patients, as well as their
parent hospitals and health networks.
This free webinar can be a critical tool for leadership
training within every clinical laboratory. It can be used to give lab managers
and lab staff fresh insights into the changes happening in healthcare. Insights
that can guide strategic planning and inspire laboratory-led projects to
collaborate with physicians and improve patient care.
Download this webinar for free by clicking here. (Or, copy and paste this URL into your browser: https://darkintelligenceprogramsondemand.uscreen.io/programs/listen-learn-lead-uncover-ways-you-can-position-your-lab-as-a-strategic-pillar-of-the-healthcare-organization.)
Though the field of oncology has some AI-driven tools, overall, physicians report the reality isn’t living up to the hype
Artificial intelligence (AI) has been heavily touted as the next big thing in healthcare for nearly a decade. Much ink has been devoted to the belief that AI would revolutionize how doctors treat patients. That it would bring about a new age of point-of-care clinical decision support tools and clinical laboratory diagnostic tests. And it would enable remote telemedicine to render distance between provider and patient inconsequential.
But nearly 10 years after IBM’s Watson defeated two human contestants on the game show Jeopardy, some experts believe AI has under-delivered on the promise of a brave new world in medicine, noted IEEE Spectrum, a website and magazine dedicated to applied sciences and engineering.
In the years since Watson’s victory on Jeopardy, IBM (NYSE:IBM) has announced
almost 50 partnerships, collaborations, and projects intended to develop
AI-enabled tools for medical purposes. Most of these projects did not bear
fruit.
However, IBM’s most publicized medical partnerships revolved
around the field of oncology and the expectation that Watson could analyze data
and patients’ records and help oncologists devise personalized and effective
cancer treatment plans. Success in helping physicians more accurately diagnosis
different types of cancer would require anatomic pathologists to understand
this new role for Watson and how the pathology profession should respond to it,
strategically and tactically.
But Watson and other AI systems often struggled to
understand the finer points of medical text. “The information that physicians
extract from an article, that they use to change their care, may not be the
major point of the study,” Mark
Kris, MD, Medical Oncologist at Memorial
Sloan Kettering Cancer Center, told IEEE Spectrum. “Watson’s
thinking is based on statistics, so all it can do is gather statistics about
main outcomes. But doctors don’t work that way.”
Ultimately, IEEE Spectrum reported, “even today’s
best AI struggles to make sense of complex medical information.”
“Reputationally, I think they’re in some trouble,” Robert Wachter, MD, Professor and Chair, Department of Medicine, University of California, San Francisco, told IEEE Spectrum. “They came in with marketing first, product second, and got everybody excited. Then the rubber hit the road. This is an incredibly hard set of problems, and IBM, by being first out, has demonstrated that for everyone else.”
“It’s a difficult task to inject AI into healthcare, and it’s a challenge. But we’re doing it,” John Kelly III, PhD, (above), Executive Vice President, IBM, who previously oversaw IBM’s Watson platform as Senior Vice President, Cognitive Solutions and IBM Research, told IEEE Spectrum. “We’re continuing to learn, so our offerings change as we learn.” (Photo copyright: IBM.)
Over Promises and Under Deliveries
In 2016, MD Anderson Cancer Center canceled a project with IBM Watson after spending $62 million on it, Becker’s Hospital Review reported. That project was supposed to use natural language processing (NLP) to develop personalized treatment plans for cancer patients by comparing databases of treatment options with patients’ electronic health records.
“We’re doing incredibly better with NLP than we were five
years ago, yet we’re still incredibly worse than humans,” Yoshua Bengio, PhD,
Professor of Computer Science at the University
of Montreal, told IEEE Spectrum.
The researchers hoped that Watson would be able to examine
variables in patient records and keep current on new information by scanning
and interpreting articles about new discoveries and clinical trials. But Watson
was unable to interpret the data as humans can.
IEEE Spectrum reported that “The realization that
Watson couldn’t independently extract insights from breaking news in the
medical literature was just the first strike. Researchers also found that it
couldn’t mine information from patients’ electronic health records as they’d
expected.”
Researchers Lack Confidence in Watson’s Results
In 2018, the team at MD Anderson published a paper in The
Oncologist outlining their experiences with Watson and cancer
care. They found that their Watson-powered tool, called Oncology
Expert Advisor, had “variable success in extracting information from
text documents in medical records. It had accuracy scores ranging from 90% to
96% when dealing with clear concepts like diagnosis, but scores of only 63% to
65% for time-dependent information like therapy timelines.”
A team of researchers at the University of Nebraska Medical Center (UNMC) have experimented with Watson for genomic analytics and breast cancer patients. After treating the patients, scientists identify mutations using their own tools, then enter that data into Watson, which can quickly pick out some of the mutations that have drug treatments available.
“But the unknown thing here is how good are the results,” Babu Guda, PhD, Professor and Chief Bioinformatics and Research Computing Officer at UNMC, told Gizmodo. “There is no way to validate what we’re getting from IBM is accurate unless we test the real patients in an experiment.”
Guda added that IBM needs to publish the results of studies
and tests performed on thousands of patients if they want scientists to have
confidence in Watson tools.
“Otherwise it’s very difficult for researchers,” he said.
“Without publications, we can’t trust anything.”
Computer Technology Evolving Faster than AI Can Utilize
It
The inability of Watson to produce results for medical uses
may be exacerbated by the fact that the cognitive computing technologies that
were cutting edge back in 2011 aren’t as advanced today.
IEEE Spectrum noted that professionals in both
computer science and medicine believe that AI has massive potential for
improving and enhancing the field of medicine. To date, however, most of AI’s
successes have occurred in controlled experiments with only a few AI-based
medical tools being approved by regulators. IBM’s Watson has only had a few
successful ventures and more research and testing is needed for Watson to prove
its value to medical professionals.
“As a tool, Watson has extraordinary potential,” Kris told IEEE
Spectrum. “I do hope that the people who have the brainpower and computer
power stick with it. It’s a long haul, but it’s worth it.”
Meanwhile, the team at IBM Watson Health continues to forge ahead. In February 2019, Healthcare IT News interviewed Kyu Rhee, MD, Vice President and Chief Health Officer at IBM Corp. and IBM Watson Health. He outlined the directions IBM Watson Health would emphasize at the upcoming annual meeting of the Healthcare Information and Management Systems Society (HIMSS).
IBM Watson Health is “using our presence at HIMSS19 this
year to formally unveil the work we’ve been doing over the past year to
integrate AI technology and smart, user-friendly analytics into the provider
workflow, with a particular focus on real-world solutions for providers to start
tackling these types of challenges head-on,” stated Rhee. “We will tackle these
challenges by focusing our offerings in three core areas. First, is management
decision support. These are the back-office capabilities that improve
operational decisions.”
Clinical laboratory leaders and anatomic pathologists may or
may not agree about how Watson is able to support clinical care initiatives.
But it’s important to note that, though AI’s progress toward its predicted
potential has been slow, it continues nonetheless and is worth watching.
Especially for busy hospital emergency departments, avoiding blood culture contamination is a constant challenge for those tasked with collecting blood culture specimens
Better, faster diagnosis and treatment of sepsis continues to be a major
goal at hospitals, health networks, and other medical facilities throughout the
United States. Yet microbiologists
and clinical
laboratory managers continue to be frustrated with how frequently
contaminated blood culture specimens show up in the laboratory.
A recent poll of more than 200 healthcare professionals who
attended a
sponsored webinar hosted by Dark Daily, showed that nearly 10% of
those who responded reported an overall blood culture contamination rate in
their hospitals at above 4%.
However, the arrival of new technology may provide hospital
staff with a way to reduce contamination rates in blood culture specimens, in
ways that improve patient outcomes.
The effectiveness of a new tool, the Steripath Initial Specimen Diversion
Device (ISDD), is being demonstrated in a growing number of prominent
hospitals in different regions of the United States. What will be particularly
intriguing to clinical laboratory professionals is that the ISDD is capable of
collecting blood while minimizing the problems caused by human factors, micro-organisms,
and skin plugs or fragments. This device was developed by Magnolia Medical Technologies
of Seattle, Wash.
The ISDD isolates the initial 1.5
to 2.0 mL aliquot of the blood culture sample, which is most likely to be
contaminated with microscopic skin fragments colonized with bacteria. The device diverts this initial aliquot into a sequestration
chamber, mechanically isolating it from the rest of the sample, and then
automatically opens an independent sterile pathway into blood culture collection
bottles.
Such technology may be welcomed by medical laboratory
professionals based in hospitals and other healthcare facilities. That’s
because it is the lab staff that typically identifies a contaminated blood
culture specimen and must go back to the nurses, staffers, and physicians on
the wards to have them redraw an acceptable specimen that will produce an
accurate, reliable result. Patients under these circumstances generally
continue on unnecessary broad-spectrum antibiotics, and their length of stays
have been reported to increase by two days on average.
Problem of Decentralized Phlebotomy
One problem contributing to high blood culture rates is
that, in many hospitals and health networks, phlebotomy has been decentralized
and is no longer managed by the clinical laboratory.
“I’ve seen the havoc decentralized phlebotomy wreaks on contamination rates of blood culture rates,” stated Dennis Ernst, Director of the Center for Phlebotomy Education based in Mio, Mich. “That staffing model, which swept through the hospital industry in the late 1990s, may have looked good on paper, but I can count the number of facilities that have successfully decentralized on the fingers of one hand. And I don’t know of any decentralized setting that has an acceptable blood culture contamination rate.”
Dennis Ernst, MT(ASCP), NCPT(NCCT) (above), Director of the Center for Phlebotomy Education, shared his expertise during a recent webinar hosted by Dark Daily. Ernst considers blood culture contamination to be among the “low-hanging fruit” in every medical laboratory that can be easily and permanently corrected with the proper approach. (Photo copyright: Dennis Ernst.)
Ernst, a medical
technologist and educator, has seen the
difficulty in lowering contamination rates in a decentralized,
multidisciplinary workforce. He has worked for more than 20 years advocating
for best practices in the diagnostic blood collection industry and has helped clinical
laboratory facilities achieve a 90% reduction in their contamination rates. Ernst considers blood
culture contamination to be among the “low-hanging fruit” in every laboratory
that can be easily and permanently corrected with the proper approach.
“One statistic we’ve heard over and over again is that the American Society of Microbiology established the ‘threshold’ for blood culture contamination to be 3%,” Ernst said. “I believe strongly that a 1% contamination rate or less is what should be required and that it’s not only achievable, but sustainable.”
Regardless of
staffing mix, blood culture contamination is a common problem in the emergency
department, Ernst explained during his presentation, “Evidence-Based
Technology to Reduce Blood Culture Contamination, Improve Patient Care, and
Reduce Costs in Your Clinical Lab or Hospital,” which is available
free for streaming.
Improving Patient Care and Reducing Avoidable Costs
With unnecessary
antibiotic use, increased length of stay, and the cost of unnecessary
laboratory testing at issue, hospitals are tracking blood culture collection
results and exploring ways to reduce episodes of blood culture contamination. On these and other healthcare quality
improvement aims, providers are publishing study results on contamination
reduction and potential direct and indirect hospital cost savings. For example:
At the University of Nebraska, a
prospective, controlled, matched-pair clinical study showed an 88% reduction in
blood culture contamination with a 12-month sustained rate of 0.2% when
Steripath was used by phlebotomists in the ED. The author estimated the institution
would save approximately $1.8 million if the technology was adopted
hospitalwide, reported an article in Clinical
Infectious Diseases in July 2017.
Florida-based Lee
Health system’s microbiology laboratory reported an 83% reduction in
contamination rates comparing their standard method to ISDD for a seven-month
trial period. Their systemwide potential cost avoidance estimates ranged from
$4.35 million to nearly $11 million, reported an article in the Journal of Emergency
Nursing in November 2018.
Researchers from Massachusetts General reported that
ISDD is the single most effective intervention so far explored for reducing
costs related to false-positive blood cultures, potentially saving the typical
250- to 400-bed hospital $1.9 million or $186 per blood culture and preventing
34 hospital-acquired conditions (including three C.
difficile cases). The recent article “Model to Evaluate the Impact of
Hospital-based Interventions Targeting False-Positive Blood Cultures on
Economic and Clinical Outcomes” in the Journal
of Hospital Infection explains more.
Blood Facilities Should be Tracking Their Contamination
Rate
One of the biggest challenges faced during blood sample
collection is making sure an organism is not inadvertently introduced into the
blood. Therefore, importance has been placed on clinical laboratories and other healthcare providers
developing policies and procedures to limit the introduction of likely
contaminants.
“I believe most places monitor blood culture contamination,
but they are not doing much that is effective to reduce it,” Ernst said.
“That’s a real problem.”
To assist healthcare providers in blood culture quality
improvement, the free webinar, “Evidence-Based Technology to Reduce Blood
Culture Contamination, Improve Patient Care, and Reduce Costs in Your Clinical
Lab or Hospital,” available on-demand through Dark Daily, can be
downloaded by clicking here,
or by pasting the URL “https://darkintelligenceprogramsondemand.uscreen.io/programs/evidence-based-technology-to-reduce-blood-culture-contamination-improve-patient-care-and-reduce-costs-in-your-clinical-lab-or-hospital”
into a web browser.
This program, which polled more than 200 healthcare
professionals, explores the clinical and economic significance of blood culture
contamination, the downstream impact of false-positive blood cultures, and case-study
evidence of sustained reductions in contamination.
Kaiser
Health News (KHN) recently
reported on investigations by the OIG into hospitals allegedly offering
unusually high salaries and other perks to specialists because they attract highly
profitable business.
Wheeling, KHN reported, paid one anesthesiologist $1.2
million per year, which, Rau notes, is higher than the salaries of 90% of the
pain management specialists around the country. Rau went on to describe how
Wheeling also paid one obstetrician-gynecologist $1.3 million per year, and a
cardiothoracic surgeon $770,000 per year along with 12 weeks of vacation time.
In each of those cases, the whistleblower who prompted the qui tam investigation reported
that the specialists’ various departments were frequently in the red, reported KHN.
“The problem, according to the government, is that the
efforts run counter to federal self-referral bans and anti-kickback laws that
are designed to prevent financial considerations from warping physicians’
clinical decisions,” wrote Rau.
Wheeling not only contests the lawsuits brought against it,
but also has filed a countersuit against the whistleblower. KHN said the
hospital claims “its generous salaries were not kickbacks but the only way it
could provide specialized care to local residents who otherwise would have to
travel to other cities for services such as labor and delivery that are best
provided near home.”
“We are confident that, if this case goes to a trial, there will be no evidence of wrongdoing—only proof that Wheeling Hospital offers the Northern Panhandle Community access to superior care, [and] world class physicians and services,” KHN reported Gregg Warren (above), Vice President of Marketing and Public Relations at Wheeling Hospital, saying in a statement. (Photo copyright: LinkedIn.)
OIG’s Fraud and Abuse Laws: A Roadmap for Physicians
The KHN article mentions
five laws the OIG lists on
its website that are particularly important for physicians to be aware of. They
include the:
False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims.
Anti-Kickback Statute: states that paying for referrals is illegal, that physicians can’t provide free or discounted services to uninsured people, and that money and gifts from drug and device makers to physicians are prohibited.
Stark Law(physician self-referral): says that referrals to entities with whom the physician has a familial or financial relationship are off-limits.
Exclusion Statue: describes who cannot participate in federal programs, such as Medicare.
Civil Monetary Penalties Law: authorizes the Secretary of Health and Human Services, which operates the OIG, to impose penalties in cases of fraud and abuse that involve Medicare or Medicaid.
“Together, these rules are intended to remove financial
incentives that can lead doctors to order up extraneous tests and treatments
that increase costs to Medicare and other insurers and expose patients to
unnecessary risks,” KHN said.
Other Hospitals Under Investigation
Wheeling Hospital is not the only healthcare institution
facing investigation. The Dallas
Morning News (DMN) reported on a case involving Forest
Park Medical Center (FPMC) in Dallas that resulted in the conviction of
seven defendants, including four doctors. Prosecutors outlined the scheme in
court, saying that FPMC illegally paid for surgeries.
“Prosecutors said the surgeons agreed to refer patients to
the Dallas hospital in exchange for money to market their practices,” DMN
reported, adding “Patients were a valuable commodity sold to the highest
bidder, according to the government.”
One of the convicted physicians, Michael Rimlawi, MD,
told DMN, “I’m in disbelief. I thought we had a good system, a fair
system.” His statement may indicate the level to which some healthcare
providers at FPMC did not clearly understand how anti-kickback laws work.
“The verdict in the Forest Park case is a reminder to
healthcare practitioners across the district that patients—not payments—should
guide decisions about how and where doctors administer treatment,” US Attorney Erin Nealy Cox told DMN.
Know What Is and Is Not a Kickback
Both the Wheeling Hospital investigation and the Forest Park
Medical Center case make it clear that kickbacks don’t always look like
kickbacks. Becker’s Hospital Review
published an article titled “Four
Biggest Anti-Kickback Settlements Involving Hospitals in 2018” that details
cases in which hospitals chose to settle.
These four incidents involved hospitals in Tennessee,
Montana, Pennsylvania, and New York. This demonstrates that kickback schemes
take place nationwide. And they show that violations of the Stark Law, the
False Claims Act, and the Anti-Kickback Statute can happen in numerous ways.
Whether in a clinical laboratory or an enterprisewide health
network, violating laws written to prevent money—rather than appropriate
patient care—from being the primary motivator in hiring decisions, may result
in investigation, charges, fines, and even conviction.
“If we’re going to solve the healthcare pricing problem,
these kinds of practices are going to have to go away,” Vikas Saini, MD, President
of the Lown Institute, a Massachusetts
nonprofit that advocates for affordable care, told KHN.
Though these recent OIG investigations target hospitals,
clinical laboratory leaders know from past experience that they also must be
vigilant and ensure their hiring practices do not run afoul of anti-kickback
legislation.
Following the raid, the company’s co-founders resigned
from the board of directors
Microbiome testing company, uBiome, a biotechnology developer that offers at-home direct-to-consumer (DTC) test kits to health-conscious individuals who wish to learn more about the bacteria in their gut, or who want to have their microbiome genetically sequenced, has recently come under investigation by insurance companies and state regulators that are looking into the company’s business practices.
CNBC
reported that the Federal Bureau of
Investigation (FBI) raided the company’s San Francisco headquarters in
April following allegations of insurance fraud and questionable billing
practices. The alleged offenses, according to CNBC, included claims that
uBiome routinely billed patients for tests multiple times without consent.
Becker’s
Hospital Review wrote that, “Billing documents obtained by The Wall Street
Journal and described in a June 24 report further illustrate uBiome’s
allegedly improper billing and prescribing practices. For example, the
documents reportedly show that the startup would bill insurers for a lab test
of 12 to 25 gastrointestinal pathogens, despite the fact that its tests only
included information for about five pathogens.”
Company Insider Allegations Trigger FBI Raid
In its article, CNBC stated that “company insiders”
alleged it was “common practice” for uBiome to bill patients’ insurance
companies multiple times for the same test.
“The company also pressured its doctors to approve tests
with minimal oversight, according to insiders and internal documents seen by CNBC.
The practices were in service of an aggressive growth plan that focused on
increasing the number of billable tests served,” CNBC wrote.
FierceBiotech reported that, “According to previous
reports, the large insurers Anthem, Aetna, and Regence BlueCross BlueShield
have been examining the company’s billing practices for its physician-ordered
tests—as has the California Department of Insurance—with probes focusing on
possible financial connections between uBiome and the doctors ordering the
tests, as well as rumors of double-billing for tests using the same sample.”
Becker’s Hospital Review revealed that when the FBI
raided uBiome they seized employee computers. And that, following the raid,
uBiome had announced it would temporarily suspend clinical operations and not
release reports, process samples, or bill health insurance for their services.
The company also announced layoffs and that it would stop
selling SmartJane and SmartGut test kits, Becker’s reported.
uBiome Assumes New Leadership
Following the FBI raid, uBiome placed its co-founders Jessica
Richman (CEO) and Zac
Apte (CTO) on administrative leave while conducting an internal
investigation (both have since resigned from the company’s board of directors).
The company’s board of directors then named general counsel, John Rakow, to be interim CEO,
FierceBiotech
reported.
John Rakow (center) is shown above with uBiome co-founders Jessica Richman (lower left) and Zac Apte (lower right). In a company statement, Rakow stressed that he believed in the company’s products and ability to survive the scandal. His belief may be based on evidence. Researchers have been developing tests based on the human microbiome for everything from weight loss to predicting age to diagnosing cancer. Such tests are becoming increasingly popular. Dark Daily has reported on this trend in multiple e-briefings. (Photo copyrights: LinkedIn/uBiome.)
After serving two months as the interim CEO, Rakow resigned
from the position. The interim leadership of uBiome was then handed over to
three directors from Goldin
Associates, a New York City-based consulting firm, FierceBiotech
reported. They include:
SmartFlu: a nasal microbiome swab that detects bacteria and viruses associated with the flu, the common cold, and bacterial infections.
What Went Wrong?
Richman and Apte founded uBiome in 2012 with the intent of
marketing a new test that would prove a link between peoples’ microbiome and their
overall health. The two founders initially raised more than $100 million from
venture capitalists, and, according to PitchBook,
uBiome was last valued at around $600 million, Forbes
reported.
Nevertheless, as a company, uBiome’s future is uncertain. Of
greater concern to clinical laboratory leaders is whether at-home microbiology
self-test kits will become a viable, safe alternative to tests traditionally performed
by qualified personnel in controlled laboratory environments.
The researchers unveiled a diagnostic device that uses microfluidic technology to identify cell types in blood by their size. The device also “can isolate individual cancer cells from patient blood samples,” according to a news release.
The ability to isolate circulating tumor cells could enable clinical laboratories to perform diagnostic cancer tests on liquid biopsies and blood samples. Dark Daily reported on various studies involving liquid biopsies—an alternative to invasive and costly cancer diagnostic procedures, such as surgery and tissue biopsies—in previous e-briefings.
“This new microfluidics chip lets us separate cancer cells from whole blood or minimally diluted blood. Our device is cheap and doesn’t require much specimen preparation or dilution, making it fast and easy-to-use,” said Ian Papautsky, PhD, Professor of Bioengineering at University of Illinois at Chicago, in the news release. He is shown above with members of the Papautsky Lab, which has been developing “microfluidic systems and point- of-care sensors for public health applications.” (Photo copyright: University of Illinois at Chicago.)
Searching for ‘Purity’
The UIC and QUT researchers were motivated by the
information-rich nature of circulating tumor cells. They also saw opportunity
for escalated “purity” in results, as compared to past studies.
In the paper, they acknowledged the work of other scientists
who deployed microfluidic technology affinity-based methods to differentiate
tumor cells in blood. Past studies (including previous work by the authors)
also explored tumor cells based on size and difference from white blood cells.
“While many emerging systems have been tested using patient samples, they share a common shortcoming: their purity remains to be significantly improved. High purity is in strong demand for circulating tumor cell enumeration, molecular characterization, and functional assays with less background intervention from white blood cells,” the authors wrote in their paper.
How the Device Works
The scientists say their system leverages “size-dependent
inertial migration” of cells. According to the news release:
Blood passes through “microchannels” formed in
plastic in the device;
“Inertial migration and shear-induced diffusion”
separate cancer cells from blood;
Tiny differences in size determine a cell’s
attraction to a location; and
Cells separate to column locations as the liquid
moves.
In other words, the device works as a filter sorting out, in
blood samples, the circulating tumor cells based on their unique size, New
Atlas explained.
93% of Cancer Cells Recovered by Device
When the researchers tested their new device:
Researchers placed 10 small-cell-lung cancer cells into five-milliliter samples of healthy blood;
The blood was then flowed through the device; and
93% of the cancer cells were recovered.
“A 7.5 milliliter tube of blood, which is typical volume for
a blood draw, might have 10 cancer cells and 35- to 40-billion blood cells. So,
we are really looking for a needle in a haystack,” Papautsky stated in the news
release.
The graphic above illustrates how, in the lab, the microfluidic device enabled the researchers to separate out cancer cells in six of the eight lung cancer samples they studied. (Graphic copyright: Ian Papautsky, PhD/University of Illinois at Chicago/New Atlas.)
“We report on a novel multi-flow microfluidic system for the
separation of circulating tumor cells with high purity. The microchannel takes
advantage of inertial migration of cells. The lateral migration of cells
strongly depends on cell size in our microchannel, and label-free separation of
circulating tumor cells from white blood cells is thus achieved without
sophisticated sample predation steps and external controls required by
affinity-based and active approaches,” the researchers wrote in their paper.
The researchers plan wider trials and the addition of
biomarkers to enable cancer DNA detection, New Atlas reported, which described
the UIC/QUT study as part of a “new wave of diagnostics.”
With so much focus on liquid biopsy research, it may be
possible for medical laboratories to one day not only diagnose cancer through
blood tests, but also to find the disease earlier and in a more precise way
than with traditional tissue sample analysis.
