When patients use telehealth, how do they choose medical laboratories for lab test orders their virtual doctors have authorized?
Doctors On Demand is expanding the nation’s primary care services by launching a virtual care telehealth platform for health insurers and employers. This fits into a growing nationwide trend toward increased use of remote and virtual doctor’s visits. But how should clinical laboratories and anatomic pathology groups prepare for fulfilling virtual doctors’ lab test orders in ways consistent with current scope-of-practice laws?
The rise of virtual care is made possible by innovations in digital
and telecommunication technology. Driven by studies showing more patients are
opting out of conventional primary care visits that take too much time or are
too far away, the healthcare industry is responding by bringing medical
services—including pathology and clinical laboratory—closer to patients through
retail settings and urgent care clinics.
Many pathologists and clinical laboratory managers are unaware of how swiftly patients are becoming comfortable with getting their primary care needs met by other types of caregivers, including virtually. Recently, the Health Care Cost Institute (HCCI) published data showing that visits to primary care physicians declined 18% from 2012 to 2016 among adults under 65 who had employer-sponsored insurance. However, during these same years, visits with nurse practitioners and physician’s assistants increased by 129%!
Another way that providers are making it easier for patients to access healthcare is through the Internet.
Doctor On Demand, a San Francisco-based virtual care provider, is targeting insurers and employers with its Synapse telehealth platform, which integrates into existing health plan networks and enables virtual primary care, according to a news release.
“Through our fully integrated technology platform, we’re putting the patient first and introducing continuity of care not previously available through virtual care solutions,” said Hill Ferguson, CEO of Doctor On Demand in a statement announcing the launch of Synapse on the Humana (NYSE:HUM) health plan network. (Photo copyright: The Business Journals.)
How Synapse Works
Humana is using Synapse in its new On Hand virtual primary
care plan, the news release states. Humana said its members have no copay for
the virtual doctor visits and $5 copays for standard medical laboratory tests
and prescriptions. Synapse’s “smart referrals” function sends referrals to
in-network clinical laboratories, imaging providers, and pharmacies, Healthcare
Dive reported.
“Humana has a deep footprint, and this is a payer looking to create a virtual primary care network as a way to contain cost and thinking about how care is coordinated and delivered,” Josh Berlin, a Principal and Healthcare Co-Practice Leader with advisory firm Citrin Cooperman, told FierceHealthcare.
Changing Primary Care Relationships
Another insurer advancing telehealth is Oscar Health, which offers its own Doctor on Call telehealth platform. The New York City-based health plan reported in a year-end review that 82% of its members had set up a profile that gave them access to a concierge care team and 24/7 telemedicine services, including clinical laboratory test results.
During 2018, Oscar’s concierge teams addressed 1.2 million
questions from 77% of its members, the insurer said.
The graphic above, taken from research conducted by the Health Care Cost Institute (HCCI), shows that while virtual primary care has been expanding, conventional visits to primary care physicians fell 18% from 2012 to 2016 among adults under 65 who had employer-sponsored insurance. Simultaneously, visits with nurse practitioners and physician’s assistants increased by 129%! This indicates a shift in how patients view access to primary care physicians and may explain why telehealth is becoming an attractive option. How will clinical laboratories fit into this new healthcare paradigm? (Photo copyright: HCCI.)
Becker’s Hospital Review reports that telehealth usage by Oscar’s members is five times higher than the average for the healthcare industry.
Will Clinical Laboratories Receive Virtual Referrals?
In a way, it has never been easier for patients to see a
primary care doctor or research symptoms. Additionally, the Internet makes it
possible for patients to self-diagnose, though not always to the benefit of
healthcare providers or the patients.
So, how should clinical laboratories respond to this growing expansion of virtual care doctors? Experts advise lab leaders to reach out to health plans soon and determine their inclusion in virtual healthcare networks. Labs also may benefit by making test scheduling and reporting accessible and convenient to insurance company members and consumers choosing telehealth.
During his keynote presentation at the 24th Annual Executive War College in May, Ted Schwab, a Los Angeles area Healthcare Strategist and Entrepreneur, said, “If you use Google in the United States to check symptoms, you’ll find 350 different electronic applications that will give you medical advice—meaning you’ll get a diagnosis over the Internet. These applications are winding their way somewhere through the regulatory process. (See Schwab’s expanded comments on this trend in, “Strategist Explains Key Trends in Healthcare’s Transformation,” The Dark Report, October 14, 2019.)
Schwab advises that in this “time of change” it’s critical
for labs to take proactive measures. “What we know today is that
providers—including clinical laboratories and pathology groups—who do nothing
will get trampled. However, those providers that do something proactively will
most likely be the winners as healthcare continues to transform.”
Clinical laboratories working with AI should be aware of ethical challenges being pointed out by industry experts and legal authorities
Experts are voicing concerns that using artificial
intelligence (AI) in healthcare could present ethical challenges that need
to be addressed. They say databases and algorithms may introduce bias into the
diagnostic process, and that AI may not perform as intended, posing a potential
for patient harm.
If true, the issues raised by these experts would have major
implications for how clinical
laboratories and anatomic
pathology groups might use artificial intelligence. For that reason,
medical laboratory executives and pathologists should be aware of possible
drawbacks to the use of AI and machine-learning
algorithms in the diagnostic process.
Is AI Underperforming?
AI’s ability to improve diagnoses, precisely target
therapies, and leverage healthcare data is predicted to be a boon to precision medicine and personalized
healthcare.
For example, Accenture
(NYSE:ACN) says that hospitals will spend $6.6 billion on AI by 2021. This
represents an annual growth rate of 40%, according
to a report from the Dublin, Ireland-based consulting firm, which states,
“when combined, key clinical health AI applications can potentially create $150
billion in annual savings for the United States healthcare economy by 2026.”
But are healthcare providers too quick to adopt AI?
Accenture defines AI as a “constellation of technologies
from machine learning to natural
language processing that allows machines to sense, comprehend, act, and
learn.” However, some experts say AI is not performing as intended, and that it
introduces biases in healthcare worthy of investigation.
Keith Dreyer, DO, PhD, is Chief Data Science Officer at Partners Healthcare and Vice Chairman of Radiology at Massachusetts General Hospital (MGH). At a World Medical Innovation Forum on Artificial Intelligence covered by HealthITAnalytics, he said, “There are currently no measures to indicate that a result is biased or how much it might be biased. We need to explain the dataset these answers came from, how accurate we can expect them to be, where they work, and where they don’t work. When a number comes back, what does it really mean? What’s the difference between a seven and an eight or a two?” (Photo copyright: Healthcare in Europe.)
What Goes in Limits What Comes Out
Could machine learning lead to machine decision-making that
puts patients at risk? Some legal authorities say yes. Especially when computer
algorithms are based on limited data sources and questionable methods, lawyers
warn.
How can AI provide accurate medical insights for people when
the information going into databases is limited in the first place? Ossorio
pointed to lack of diversity in genomic
data. “There are still large groups of people for whom we have almost no
genomic data. This is another way in which the datasets that you might use to
train your algorithms are going to exclude certain groups of people
altogether,” she told HDM.
She also sounded the alarm about making decisions about
women’s health when data driving them are based on studies where women have
been “under-treated compared with men.”
“This leads to poor treatment, and that’s going to be
reflected in essentially all healthcare data that people are using when they
train their algorithms,” Ossorio said during a Machine Learning for Healthcare (MLHC) conference
covered by HDM.
How Bias Happens
Bias can enter healthcare data in three forms: by humans, by
design, and in its usage. That’s according to David Magnus, PhD, Director
of the Stanford Center for
Biomedical Ethics (SCBE) and Senior Author of a paper published in the New England
Journal of Medicine (NEJM) titled, “Implementing Machine
Learning in Health Care—Addressing Ethical Challenges.”
The paper’s authors wrote, “Physician-researchers are
predicting that familiarity with machine-learning tools for analyzing big data
will be a fundamental requirement for the next generation of physicians and
that algorithms might soon rival or replace physicians in fields that involve
close scrutiny of images, such as radiology and anatomical pathology.”
In a news
release, Magnus said, “You can easily imagine that the algorithms being
built into the healthcare system might be reflective of different, conflicting
interests. What if the algorithm is designed around the goal of making money?
What if different treatment decisions about patients are made depending on
insurance status or their ability to pay?”
In addition to the possibility of algorithm bias, the
authors of the NEJM paper have other concerns about AI affecting
healthcare providers:
“Physicians must adequately understand how
algorithms are created, critically assess the source of the data used to create
the statistical models designed to predict outcomes, understand how the models
function and guard against becoming overly dependent on them.
“Data gathered about patient health, diagnostics,
and outcomes become part of the ‘collective knowledge’ of published literature
and information collected by healthcare systems and might be used without
regard for clinical experience and the human aspect of patient care.
“Machine-learning-based clinical guidance may
introduce a third-party ‘actor’ into the physician-patient relationship, challenging
the dynamics of responsibility in the relationship and the expectation of
confidentiality.”
“We need to be cautious about caring for people based on what algorithms are showing us. The one thing people can do that machines can’t do is step aside from our ideas and evaluate them critically,” said Danton Char, MD, Lead Author and Assistant Professor of Anesthesiology, Perioperative, and Pain Medicine at Stanford, in the news release. “I think society has become very breathless in looking for quick answers,” he added. (Photo copyright: Stanford Medicine.)
Acknowledge Healthcare’s Differences
Still, the Stanford researchers acknowledge that AI can
benefit patients. And that healthcare leaders can learn from other industries,
such as car companies, which have test driven AI.
“Artificial intelligence will be pervasive in healthcare in a
few years,” said
Nigam Shah, PhD, co-author of the NEJM paper and Associate Professor of Medicine at Stanford, in the news release. He added that healthcare leaders need to be aware of the “pitfalls” that have happened in other industries and be cognizant of data.
“Be careful about knowing the data from which you learn,” he
warned.
AI’s ultimate role in healthcare diagnostics is not yet fully
known. Nevertheless, it behooves clinical laboratory leaders and anatomic
pathologists who are considering using AI to address issues of quality and
accuracy of the lab data they are generating. And to be aware of potential
biases in the data collection process.
Medical laboratories that develop appropriate clinical strategies may find opportunities to leverage several new technologies expected to have a big impact on providers
Industry experts often speculate how developing technologies will impact healthcare. However, clinical laboratory leaders may be surprised by how much blockchain, medical malls, and Uber Health are expected to alter healthcare delivery in the next decade.
An article in FierceHealthcare states that “Healthcare is on the cusp of a technology revolution. Technology is primed to disrupt healthcare more explosively than it has any other industry.”
Medical advancements certainly impact clinical laboratories
and anatomic pathology groups, and any acceleration in these developing
technologies applied to healthcare will certainly be of interest to lab leaders
who want to ensure their labs are ready.
Blockchain Provides Healthcare Security, Privacy, and
Interoperability
Authored by Sloan Gaon, CEO, PulsePoint, the FierceHealthcare article predicts that blockchain will be an important feature in the future of healthcare. It will allow patients to have an online, accurate health record that is accessible only to necessary parties in real time. Consumers will be able to maintain, control, and share their data as they wish while increasing the security, privacy, and interoperability of their health information.
“A primary care physician could access a complete medical history of the member, while the radiologist could be limited to only the specifics he or she needs to perform the task at hand. For each, it’s about accessing the right data at the right time, and the blockchain technology could enable this type of specific ‘need-to-know’ medical history access,” wrote Bruce Broussard, President and CEO of Humana in a LinkedIn article.
The blockchain records can be shared among a network of
computers and kept secure via cryptography. And the
technology allows for easy transferability among different networks, improving
performance and outcomes for patients. Broussard also stated that blockchain
technology will provide more efficient payment for insurance claims.
“With transparency and automation, greater efficiencies will
lead to lower administration costs, faster claims, and less money wasted.
Blockchain enables claims to be paid without an intermediary, since health plan
members are connecting directly with their providers. These consumers can also
access their permanent electronic health records in a secure fashion, enabling
them to have a real-time understanding of their health,” he wrote.
Should blockchain achieve widespread adoption as a platform
for patient health information, the clinical laboratory industry will need to
address the problem of different test methodologies and different reference
ranges for test results. If blockchain makes it feasible to bring all pieces of
a single patient’s cumulative health data into a single record, then clinical
labs will need to address that problem in an effective way.
In his FierceHealthcare article, Sloan Gaon, CEO of PulsePoint, said “Technology will drive innovation, automation, transparency and efficiency, rendering the current healthcare landscape unrecognizable. As technology garners healthcare’s gold seal of approval, its effects will upend the industry, shrinking costs and improving outcomes.”
Medical Malls a Win-Win for Healthcare Providers and
Retail Locations
With big shopping malls dying due to economic recessions and the emergence of online retail destinations, property owners are seeking new tenants. In the summer of 2017, there were still about 1,100 malls remaining in the US, however, a quarter of them were at a risk of closing within five years, Time noted that year.
As healthcare organizations expand, there is an overwhelming
need for suitable space that is accessible for consumers at a reasonable price.
Fading shopping malls with their convenient locations, sturdy foundations, and
large parking lots could fill that gap.
In February of 2017, Avita Health System opened a boutique hospital in a space once occupied by an anchor store in a mall located in Ontario, Ohio. The healthcare provider purchased a 185,000 square-foot space that was formerly a Lazarus department store.
Mansfield News Journal reported that when the hospital opened, it included a walk-in clinic, an emergency room, surgical suites, pre-operative and post-operative areas, an onsite pharmacy, imaging services, a clinical laboratory, and 30 acute care beds.
Other services, including a Level II Cath lab, a maternity center, and the installation of a 3T Magnetic Resonance Imaging (3T MRI) machine, have been added since the facility opened. And there’s room for more expansion at the site.
Vanderbilt Medical Group (VMG) now occupies the entire second level of One Hundred Oaks Mall, in Nashville, Tenn. Their services at the once-struggling retail shopping center include 22 specialty clinics in 450,000 square feet of space designed by architecture firm Gresham Smith.
Patients can pick up a pager at the VMG facility and then
shop on the lower level while waiting to be paged to see a healthcare
professional or receive test results.
“More important than the significant increase in our available clinical space is the overall concept and design which is focused on providing our patients, faculty, and staff with a new paradigm for health and wellness. The convenience, accessibility, and innovative ways of providing care for our patients are a true transformation of both the architecture and the way our patients experience healthcare,” said Cyril Stewart, former Director of Facility Planning for Vanderbilt University Medical Center (VUMC) in a testimonial on the Gresham Smith website.
Non-Emergency Medical Transportation and Uber Health
Kaiser Family Foundation (KFF) reported in 2016 that “Medicaid’s non-emergency medical transportation (NEMT) benefit facilitates access to care for low income beneficiaries who otherwise may not have a reliable affordable means of getting to healthcare appointments. NEMT also assists people with disabilities who have frequent appointments and people who have limited public transit options and long travel times to healthcare providers, such as those in rural areas.”
The Hospital and Healthsystem Association of Pennsylvania (HAP) reported that an average of 3.6 million Americans miss their healthcare appointments annually due to lack of or unreliable transportation. These missed appointments can cause an avalanche of future problems, including increased visits to emergency rooms, extended hospital stays, and higher costs for providers.
“If there are people who are missing their appointments because they’re using an unreliable bus service to get to and from their healthcare provider, this is a great solution for them,” Christopher Weber, General Manager and Senior Project Manager at Uber Health, told The Verge. “The types of individuals this is valuable for really is limitless.”
Uber health’s mobile device application (app) enables patients and healthcare providers to schedule non-emergency medical transportation for medical appointments within a few hours or up to a 30-day notice. It is also available both as an online dashboard and as an application-programming interface (API) for software developers to integrate the service into their proprietary healthcare tools.
An Uber
(NYSE:UBER) account is not required, as notifications about rides can be sent
to patients via text messages.
Clinical laboratory leaders may want to develop strategies
around these three predictions to increase business and maximize profits. Since
more healthcare organizations will soon be linked via blockchain, and an
increased number of consumers could start using non-emergency medical
transportation, such as Uber Health, to get to medical appointments, becoming
familiar with these technologies could prove to be beneficial to labs.
In addition, medical facilities cropping up in former mall
spaces will require medical laboratories to be onsite to support care and
provide lab test results within an acceptable turnaround time.
This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices
It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg).
In September, Bloomberg reported that 17 former Orig3n employees said the company’s Deoxyribonucleic acid (DNA) tests sometimes failed to deliver the intended results or were often contaminated or inaccurate. The individuals had been employed by the company as managers, lab technicians, software engineers, marketers, and salespeople between 2015 and 2018.
The former employees claimed that Orig3n “habitually cut
corners, tampered with or fabricated results, and failed to meet basic
scientific standards,” Bloomberg reported. The individuals also stated
that advice intended to be personalized to individual consumers’ genetic
profiles was often just generic information or advice that had no scientific
basis.
According to Bloomberg, the individuals also alleged
that Orig3n’s lab was careless in its handling of genetic samples in several
ways, including:
Multiple samples being labeled with the same
barcode;
DNA and blood samples for stem cell bank
misplaced or mixed up;
No controls to ensure accuracy;
Handling methods that could lead to
contamination; and
Fabricating results when a test outcome was
unclear.
The former employees also stated that “Orig3n ran tests without proper authorization in its lab at the 49ers’ stadium, and that managers regularly compelled them to write positive reviews of Orig3n’s tests on Amazon.com and Google to offset waves of negative feedback,” Bloomberg reported.
“Accurate science didn’t seem to be a priority. Marketing
was the priority,” said a former lab technician who spoke with Bloomberg
on the condition of anonymity. Orig3n denied the accusations in a statement,
describing them as “grossly inaccurate,” and claimed the former employees were
simply disgruntled.
“In some cases, former employees are former employees for a reason,” Orig3n Chief Executive Officer Robin Smith told Bloomberg. “We’ve found after employees are gone that they have not done things appropriately.”
In 2018, NBC Chicago(NBC) conducted an investigation into various consumer DNA testing kits. NBC sent DNA samples to several different testing companies. This included non-human samples, which NBC’s investigators had obtained from a female Labrador Retriever.
With the exception of Orig3n, all of companies identified
the DNA as non-human and did not process the kits. Orig3n did, however, process
the canine DNA. It then returned a seven-page analysis that suggested the
subject of the sample “would probably be great for quick movements like boxing
and basketball, and that she has the cardiac output for long endurance bike
rides or runs,” NBC reported.
This would be funny if it weren’t so concerning.
Following reports that it had processed dog DNA, Orig3n stated
it had made changes and improvements to the company’s testing methodologies. Smith
also stated Orig3n’s lab protocols had been improved as well.
“Sometimes we look at the accuracy of things and go, ‘Man,
that’s not working,’” Smith told Bloomberg. “Our approach and our
philosophy is [sic] to constantly improve the products.”
Serious Accusations of Clinical Laboratory Malfeasance
Founded in 2014 with the intent of creating the world’s largest stem cell bank, by 2016, Boston-based Orig3n had refocused its attention on the burgeoning field of direct-to-consumer DNA testing. On its website, Orig3n sells several DNA-testing kits with varying costs.
Orig3n’s attempt to offer free genetic tests to large numbers of people at a professional sporting event in the fall of 2017 may be what caught the attention of federal investigators and led to a deeper investigation. Dark Daily previously covered this controversy, which centered around Orig3n’s plan to distribute free genetic testing kits to fans at a Baltimore Ravens football game.
In that situation, state and federal healthcare regulators blocked the giveaway over concerns about protected health information (PHI). Now, Orig3n is being accused of questionable business practices by 17 of its former employees.
The former employees’ statements that the company’s genetic
testing lab did not follow appropriate test protocols—and that it allegedly
mishandled specimens and even reported false test results—are serious
allegation of malfeasance and warrants an investigation.
Pathologists and clinical laboratory managers know that patient
harm can potentially result from inaccurate genetic test results if used for
clinical purposes. Dark Daily will continue to follow the investigation
into Orig3n.
Sale of respected laboratory information system company may be an early sign that investors believe clinical laboratories and pathology groups are ready to upgrade their LISs and add needed capabilities
In the past 10 years there has been little disruption to the
laboratory
information systems (LIS) market that clinical
laboratories and anatomic
pathology groups use. Yet, over that same 10-year period, almost every
hospital and physician group practice adopted an electronic
health system (EHR), primarily because of federal financial incentives that
encouraged such adoption.
For medical
laboratories and pathology groups, this widespread—nearly
universal—adoption of EHRs by the nation’s hospitals and physicians was
disruptive. Labs were required to expend resources building digital interfaces
to the EHRs of their parent hospitals and client physicians to support
electronic test ordering and test reporting.
However, because that wave of EHR adoption is now over,
clinical labs and pathology groups have an opportunity to assess the current
state of the health
information technology (HIT) that they use daily, primarily in the form of
the classic laboratory information system that handles nearly all the primary
functions needed to support testing and other operational needs.
This opportunity to help medical laboratories enhance and/or
upgrade the capabilities of their laboratory information systems may be one
motivation behind the recent sale of a well-known LIS company.
Private Equity Firm Buys Orchard Software
On Oct. 7, 2019, Orchard Software Corporation of Carmel,
Ind., announced its acquisition by Franciscan Partners, a private equity firm
based in San Francisco.
Orchard Software, founded in 1993, has grown steadily over
the past 20 years, primarily by serving physician office laboratories,
community hospital labs, and independent clinical laboratory companies. With each
stage of growth, Orchard added functionality to its LIS and related software
offerings and moved up-market to serve larger hospitals and larger labs.
The purchase price and the terms of the sale were not
announced. Orchard’s Founder, President and CEO, Rob Bush, will retire. The new
CEO is Billie Whitehurst, who came to Orchard from Netsmart Technologies, where she was Senior
Vice President. The remainder of Orchard’s management team will be kept in
place.
“Francisco Partners will provide capital and expertise to enable Orchard to grow at a faster pace and continue to develop its newer web-based products in an industry that has lagged behind in adoption of cloud-based software,” says Rob Bush (above), Orchard Software’s Founder and exiting CEO, in a press release. (Photo copyright: Twitter.)
Is the LIS Market Heating Up?
What makes the purchase of Orchard by a multi-billion-dollar
private equity company noteworthy is the fact that it is the first significant
transaction in the LIS sector probably since the mid-2000s, which saw several
significant mergers and acquisitions.
Other acquisitions or investments involving LIS companies
need to happen before it would be appropriate to say that investor interest in
the LIS sector is heating up. However, it is accurate to say that many
professional investors will be watching to see whether Franciscan Partners
succeeds with its investment in Orchard Software. If Orchard’s revenue and
operating profits increase substantially in the next few years, that may
encourage other investors to look for LIS companies and products that they can
buy.
If this were to happen, that would be a positive development
for both clinical laboratories and anatomic pathology groups, because these
investors would have a motive to add new functions and capabilities to their
LIS products. It would also wake up a sector of lab information technology that
has been relatively quiet for several years.
The 80 scientists and engineers that comprise the consortium believe synthetic biology can address key challenges in health and medicine, but technical hurdles remain
Synthetic biology now has a 20-year development roadmap. Many predict this fast-moving field of science will deliver valuable products that can be used in diagnostics—including clinical laboratory tests, therapeutics, and other healthcare products.
Eighty scientists from universities and companies around the world that comprise the Engineering Biology Research Consortium (EBRC) recently published the 20-year roadmap. They designed it to “provide researchers and other stakeholders (including government funders)” with what they hope will be “a go-to resource for engineering/synthetic biology research and related endeavors,” states the EBRC Roadmap website.
Medical laboratories and clinical pathologists may soon have new tools and therapies for targeting specific diseases. The EBRC defines synthetic biology as “the design and construction of new biological entities such as enzymes, genetic circuits, and cells or the redesign of existing biological systems. Synthetic biology builds on the advances in molecular, cell, and systems biology and seeks to transform biology in the same way that synthesis transformed chemistry and integrated circuit design transformed computing.”
Synthetic biology is an expanding field and there are predictions that it may produce research findings that can be adapted for use in clinical pathology diagnostics and treatment for chronic diseases, such as cancer.
Another goal of the roadmap is to encourage federal
government funding for synthetic biology.
“The question for government is: If all of these avenues are now open for biotechnology development, how does the US stay ahead in those developments as a country?” said Douglas Friedman, EBRC’s Executive Director, in a news release. “This field has the ability to be truly impactful for society and we need to identify engineering biology as a national priority, organize around that national priority, and take action based on it.”
Designing or Redesigning Life Forms for Specific
Applications
Synthetic biology is an interdisciplinary field that combines
elements of engineering, biology, chemistry, and computer science. It enables
the design and construction of new life forms—or redesign of existing ones—for
a multitude of applications in medicine and other fields.
Another recent example comes from the Wyss Institute at Harvard. Scientist there developed a direct-to-consumer molecular diagnostics platform called INSPECTR that, they say, uses programmable synthetic biosensors to detect infectious pathogens or host cells.
The Wyss Institute says on its website that the platform can
be packaged as a low-cost, direct-to-consumer test similar to a home pregnancy
test. “This novel approach combines the specificity, rapid development, and
broad applicability of a molecular diagnostic with the low-cost, stability, and
direct-to-consumer applicability of lateral flow immunoassays.”
In March, Harvard announced that it had licensed the technology to Sherlock Biosciences.
Howard Salis, PhD (above), Associate Professor of biological engineering and chemical engineering at Pennsylvania State University (Penn State), co-chaired the EBRC Roadmapping Working Group that produced the roadmap. In a Penn State news story, Salis explained synthetic biology’s potential. “There are both traditional and startup companies leveraging synthetic biology technologies to develop novel biotech products,” he said. “Organisms that produce biorenewable materials; diagnostics to detect the Zika virus, Ebola and tuberculosis; and soil bacteria that fix nitrogen into ammonia for improved plant growth.” (Photo copyright: Twitter.)
Fundamental Challenges with Synthetic Biology
The proponents of synthetic biology hope to make it easier
to design and build these systems, in much the same way computer engineers
design integrated circuits and processors. The EBRC Roadmap may help scientist
worldwide achieve this goal.
However, in “What is Synthetic/Engineering Biology?” the EBRC also identifies the fundamental challenges facing the field. Namely, the complexity and unpredictability inherent in biology, and a limited understanding of how biological components interact.
The EBRC roadmap report, “Engineering Biology: A Research
Roadmap for the Next-Generation Bioeconomy,” covers five categories of applications:
Health and medicine are of primary interest to pathologists.
Synthetic Biology in Health and Medicine
The Health and Medicine section of the report identifies
four broad societal challenges that the EBRC believes can be addressed by
synthetic biology. For each, the report specifies engineering biology
objectives, including efforts to develop new diagnostic technologies. They
include:
Existing and emerging infectious diseases: Objectives include development of tools for treating infections, improving immunity, reducing dependence on antibiotics, and diagnosing antimicrobial-resistant infections. The authors also foresee tools for rapid characterization and response to “known and unknown pathogens in real time at population scales.”
Non-communicable diseases and disorders, including cancer, heart disease, and diabetes: Objectives include development of biosensors that will measure metabolites and other biomolecules in vivo. Also: tools for identifying patient-specific drugs; tools for delivering gene therapies; and genetic circuits that will foster tissue formation and repair.
Environmental health threats, such as toxins, pollution, and injury: Objectives include systems that will integrate wearable tech with living cells, improve interaction with prosthetics, prevent rejection of transplanted organs, and detect and repair of biochemical damage.
Healthcare access and personalized medicine: The authors believe that synthetic biology can enable personalized treatments and make new therapies more affordable.
Technical Themes
In addition to these applications, the report identifies
four “technical themes,” broad categories of technology that will spur the
advancement of synthetic biology:
Gene editing, synthesis, and assembly: This refers to tools for producing chromosomal DNA and engineering whole genomes.
Biomolecule, pathway, and circuit engineering: This “focuses on the importance, challenges, and goals of engineering individual biomolecules themselves to have expanded or new functions,” the roadmap states. This theme also covers efforts to combine biological components, both natural and non-natural, into larger, more-complex systems.
Host and consortia engineering: This “spans the development of cell-free systems, synthetic cells, single-cell organisms, multicellular tissues and whole organisms, and microbial consortia and biomes,” the roadmap states.
Data Integration, modeling, and automation: This refers to the ability to apply engineering principles of Design, Build, Test and Learn to synthetic biology.
The roadmap also describes the current state of each
technology and projects likely milestones at two, five, 10, and 20 years into
the future. The 2- and 5-year milestones are based on “current or recently
implemented funding programs, as well as existing infrastructure and facilities
resources,” the report says.
The longer-term milestones are more ambitious and may
require “significant technical advancements and/or increased funding and
resources and new and improved infrastructure.”
Synthetic biology is a significant technology that could
bring about major changes in clinical pathology diagnostics and treatments.
It’s well worth watching.
