Number of patients eligible for genome-driven oncology therapy is increasing, but the percentage who reportedly benefit from the therapy remains at less than 5%
Advances in precision medicine in oncology (precision oncology) are fueling the need for clinical laboratory companion diagnostic tests that help physicians choose the best treatment protocols. In fact, this is a fast-growing area of clinical diagnostics for the nation’s anatomic pathologists. However, some experts in the field of genome-based cancer treatments disagree over whether such treatments offer more hype than hope.
Prasad and his colleagues evaluated 31 US Food and Drug
Administration (FDA) approved drugs, which were “genome-targeted” or
“genome-informed” for 38 indications between 2006 and 2018. The researchers
sought to answer the question, “How many US patients with cancer are eligible
for and benefit annually from genome-targeted therapies approved by the US Food
and Drug Administration?”
They found that in 2018 only 8.33% of 609,640 patients with
metastatic cancer were eligible for genome-targeted therapy—though this was an
increase from 5.09% in 2006.
Even more telling from Prasad’s view, his research team concluded
that only 4.9% had benefited from such treatments. Prasad’s study found the
percentage of patients estimated to have benefited from genome-informed therapy
rose from 1.3% in 2006 to 6.62% in 2018.
“Although the number of patients eligible for genome-driven treatment has increased over time, these drugs have helped a minority of patients with advanced cancer,” the researchers concluded. “To accelerate progress in precision oncology, novel trial designs of genomic therapies should be developed, and broad portfolios of drug development, including immunotherapeutic and cytotoxic approaches, should be pursued.”
The graph above is based on data from a study published in Science titled, “Estimation of the Percentage of US Patients With Cancer Who Benefit from Genome-Driven Oncology,” co-authored by Vinay Prasad, MD, MPH, et al. (Image copyright: Science.)
A Value versus Volume Argument?
Hyman, who leads a team of oncologists that conduct dozens
of clinical trials and molecularly selected “basket studies” each year,
countered Prasad’s assertions by noting the increase in the number of patients
who qualify for precision oncology treatments.
As reported in Science, Hyman said during his AACR
presentation that Sloan Kettering matched 15% of the 25,000 patients’ tumors it
tested with FDA-approved drugs and 10% with drugs in clinical trials.
“I think this is certainly not hype,” he said during the
conference.
Hyman added that another 10% to 15% of patient tumors have a
DNA change that matches a potential drug tested in animals. He expects “basket”
trials to further increase the patient pool by identifying drugs that can work
for multiple tumor types.
The US National Institute of Health (NIH) describes “basket studies” as “a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into ‘baskets.’ Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly.”
Are Expectations of Precision Medicine Exaggerated?
A profile in MIT Technology Review, titled, “The Skeptic: What Precision Medicine Revolution?,” describes Prasad’s reputation as a “professional scold” noting the 36-year-old professor’s “sharp critiques of contemporary biomedical research, including personalized medicine.” Nevertheless, Prasad is not alone in arguing that precision oncology’s promise is often exaggerated.
“Like most ‘moonshot’ medical research initiatives,
precision medicine is likely to fall short of expectations,” Joyner wrote.
“Medical problems and their underlying biology are not linear engineering
exercises and solving them is more than a matter of vision, money, and will.”
“Although some niche applications have been found for
precision medicine—and gene therapy is now becoming a reality for a few rare
diseases—the effects on public health are miniscule while the costs are astronomical,”
they wrote.
Hope for Precision Medicine Remains High
However, optimism over precision oncology among some industry leaders has not waned. Cindy Perettie, CEO of molecular information company Foundation Medicine of Cambridge, Mass., argues genome-directed treatments have reached an “inflection point.”
“Personalized cancer treatment is a possibility for more patients than ever thanks to the advent of targeted therapies,” she told Genetic Engineering and Biotechnology News. “With a growing number of new treatments—including two pan-tumor approvals—the need for broad molecular diagnostic tools to match patients with these therapies has never been greater. We continue to advance our understanding of cancer as a disease of the genome—one in which treatment decisions can be informed by insight into the genomic changes that contribute to each patient’s unique cancer.”
Prasad acknowledges genome-driven therapies are beneficial for some cancers. However, he told MIT Technology Review the data doesn’t support the “rhetoric that we’re reaching exponential growth, or that is taking off, or there’s an inflection point” signaling rapid new advancements.
“Right now, we are investing heavily in immunotherapy and heavily in genomic therapy, but in other categories of drugs, such as cytotoxic drugs, we have stopped investigating in them,” he told Medscape Medical News. “But it’s foolish to do this—we need to have the vision to look beyond the fads we live by in cancer medicine and do things in a broader way,” he added.
“So, I support broader funding because you have to sustain
efforts even when things are not in vogue if you want to make progress,” Prasad
concluded.
Is precision oncology a fad? Dark Daily has covered the advancements in precision medicine extensively over the past decade, and with the launch of our new Precision Medicine Institute website, we plan to continue reporting on further advancements in personalized medicine.
Time will tell if precision oncology can fulfill its
promise. If it does, anatomic pathologists will play an important role in
pinpointing patients most likely to benefit from genome-driven treatments.
One thing that the debate between proponents of precision
medicine in oncology and their critics makes clear is that more and better
clinical studies are needed to document the true effectiveness of target
therapies for oncology patients. Such evidence will only reinforce the
essential role that anatomic pathologists play in diagnosis, guiding
therapeutic decisions, and monitoring the progress of cancer patients.
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.
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.
Methods that target the causes of acidity could become part of precision medicine cancer treatments and therapies
Researchers at Massachusetts
Institute of Technology (MIT) have found that acidic environments enable
tumor cells to strengthen through protein production. And that when acidic surfaces
extend beyond a tumor’s interior, and come into contact with healthy tissue,
cancer can spread.
The results of their study will interest anatomic
pathologists who review tissue biopsies to diagnose cancer and help identify
the most effective therapies for cancer patients. Currently, there are no new clinical
laboratory tests under development based on MIT’s research.
The researchers published their findings in the journal Cancer Research. Their paper also
shared how tumor acidity can be identified and reversed.
“Our findings reinforce the view that tumor acidification is an important driver of aggressive tumor phenotypes, and it indicates that methods that target this acidity could be of value therapeutically,” noted Frank Gertler, PhD (above), in a news release. Gertler is an MIT Professor of Biology, a member of MIT’s Koch Institute for Integrative Cancer Research, and a Senior Author of the study. (Photo copyright: MIT News.)
Acidity is a Tumor Cell’s
Friend
Acidity results from lack of oxygen in tumors and enables
tumor cell growth. “Acidification of the microenvironment plays established roles
in tumor progression and provides a hostile milieu that advantages tumor cell
survival and growth compared to non-cancerous cells,” the researchers wrote in Cancer Research.
In their study, the MIT scientists sought to learn:
What areas of a tumor are actually acidic?
How does acidosis propel cells to
invade surrounding healthy tissues?
They used a nanotechnology platform
called pHLIP (pH Low
Insertion Peptide) to sense pH at the surface of cancer cells and then insert a
molecular probe into the cell membranes. “This brings nanomaterial to close
proximity of cellular membrane,” noted a research study
conducted at the University of Rhode Island by scientists who developed the
pHLIP technology.
Medical News Today reported that the MIT scientists
used pHLIP to map the acidity in human breast cancer tumors implanted in mice.
When it detected a cell in an acidic environment, pHLIP sent a small protein
molecule into the cell’s membrane. The scientists found that acidosis was not
confined to the oxygen-rich tumor core. It extended to the stroma, an important boundary
between healthy tissue and malignant tumor cells.
“We characterized the spatial characteristics of acidic
tumor microenvironments using pHLIP technology, and demonstrated that
tumor-stroma interfaces are acidic, and that cells within the acidic front are
invasive and proliferative,” the scientists wrote in Cancer Research.
What Stimulates
Acidity and How to Reverse It?
The MIT researchers sought the reasons, beyond hypoxia, for
high acidity in tumor tissue.
“There was a great deal of tumor tissue that did not have
any hallmarks of hypoxia that was quite clearly exposed to acidosis. We started
looking at that, and we realized hypoxia probably wouldn’t explain the majority
of regions of the tumor that were acidic,” Gertler pointed out in the MIT news
release.
So what did explain it? The researchers pointed to aerobic
glycolysis, a “condition in which glucose is converted to lactate in the presence
of oxygen,” according to an article published by StatPearls. “Cancer
stem cells (CSC) within a tumor are notorious for aerobic glycolysis. Thus,
extensive aerobic glycolysis has been indicative of aggressive cancer,” the
paper’s authors noted.
During their study, the MIT scientists found:
Cells at the tumor surface shifted to aerobic
glycolysis, “a type of metabolism that generates lactic acid, making way
for high acidity,” and
“Tumor acidosis gives rise to the expression of molecules
involved in cell invasion and migration. This reprogramming, which is an
intracellular response to a drop in extracellular pH, gives the cancer cells
the ability to survive under low-pH conditions and proliferate,” said Nazanin Rohani, PhD, former
postdoctoral researcher in the MIT Koch Institute for Integrative Cancer
Research, and Lead Author of the study, in the news release.
Could a Reduction in Acidity Reverse Tumor Growth?
In another experiment, the researchers fed sodium
bicarbonate (baking soda) to mice with breast or lung tumors. The tumors became
less acidic and metastatic.
“It adds to the sense that this pH dynamic is not permanent.
It’s reversible. I think that’s an important addition to an ongoing discussion
about the role of pH in tumor behavior,” said Ian Robey, PhD, in an
MITblog
post. Robey is a Research Assistant Professor, Department of Medicine
at the University of Arizona, and Full Investigator at the Arizona Cancer Center. He was not
involved in the MIT research.
Spreading the Word on
How Cancer Spreads
The MIT study is important—not only to anatomic pathologists—but
also to oncologists and cancer patients worldwide. Cancer is not simple to
diagnose and treat. The MIT study may provide important insights into targeting
cancer care and precision
medicine treatments.
Researchers at UC Berkley developed new ways to use CRISPR as a genetic “search engine” in addition to a cut and paste tool
Clinical pathology laboratory professionals have long been aware of the potential diagnostic properties related to CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology. Now, new tests using the gene-editing tool show that potential is being realized.
One example involves using CRISPR to detect diseases in Nigeria, where a Lassa fever epidemic has already led to the death of 69 people this year alone. According the journal Nature, this diagnostic test “relies on CRISPR’s ability to hunt down genetic snippets—in this case, RNA from the Lassa virus—that it has been programmed to find. If the approach is successful, it could help to catch a wide range of viral infections early, so that treatments can be more effective and health workers can curb the spread of infection.”
Researchers in Honduras and California are working on similar projects to develop diagnostic tests for dengue fever, Zika, and the strains of human papillomavirus (HPV) that lead to cancer. There’s also a CRISPR-based Ebola test pending in the Democratic Republic of Congo.
These new genetic tests, which may be as simple as at-home
pregnancy tests to use, could save many lives throughout the world. They will
give medical laboratories new tools for diagnosing disease and guiding
therapeutic decisions.
Shift in How
Researchers View CRISPR
“We really think of CRISPR fundamentally as a kind of search engine for biology—like Google for biology—rather than [a kind of] word processing tool, although it’s really good at that too,” Trevor Martin, PhD, co-founder and CEO of Mammoth Biosciences, told CRISPR Cuts, a Synthego CRISPR podcast.
Professor of Biochemistry and Molecular Biology, and Li Ka
Shing Chancellor’s Professor in Biomedical and Health.
Martin’s statement represents a shift in how researchers are thinking about CRISPR. At first, CRISPR was seen as a tool for cutting and pasting genetic material. Scientists could tell it to find a target DNA sequence, make a cut, and paste in something different. However, by thinking of the tool as a search engine, CRISPR’s tremendous diagnostic potential becomes apparent.
“This is a very exciting direction for the CRISPR field to
go in,” Doudna told Nature.
Martin told CRISPR
Cuts that diagnostics is “fundamentally a search problem,” adding, “Now you
can program [CRISPR] to find something, and then tell you that result.”
Doudna notes in Technology Networks that, “Mammoth’s technology exemplifies some of the most urgent, impactful, and untapped potential in the CRISPR space.”
Fehintola Ajogbasile (above), a graduate student at the African Centre of Excellence for Genomics of Infectious Diseases in Nigeria, uses a CRISPR diagnostic test to look for Lassa virus in a blood sample. Similar clinical pathology laboratory tests are becoming available in the US as well. (Photo and caption copyright: Nature/Amy Maxmen.)
Investors See
Economic Benefits of CRISPR
The potential financial and economic impact of simple-to-use CRISPR-based diagnostic tools is considerable. Technology Networks notes that the diagnostics market is estimated at $45 billion, and that venture capital firms Mayfield, First Trust Mid Cap Core AlphaDEX Fund (NASDAQ:FNX), and 8VC have all invested in Mammoth Biosciences.
Although the diagnostics market is huge, a critical aspect
of the Lassa fever diagnostic test the Nigerian researchers are developing is
that it will be as accurate as conventional clinical laboratory testing
methods, but much simpler and less expensive.
Dhamari Naidoo, a technical officer at the World Health Organization (WHO) told Nature that researchers often fail to think about the fact that new technology must be affordable for use in low-income countries.
About a dozen diagnostic tests for Ebola have been
developed, according to Naidoo, but only two have been used recently in the
Democratic Republic of Congo, where the virus is resurging, due to economic
concerns. To be useful, medical laboratory tests in low-income countries must
be affordable to license and distribute, and critically, the manufacturers must
identify a market large enough to motivate them to make and distribute such
diagnostic tests.
Future Directions for
CRISPR and Clinical Pathology
Researchers first discovered what would come to be known as CRISPR in the early 1990s. However, it wasn’t until 2012 – 2013 that scientists used CRISPR and Cas9 for genome editing, a Broad Institute CRISPR timeline notes.
Now, researchers around the world are finding innovative
ways to employ the technology of CRISPR to detect disease in some of the most
remote, challenging areas where diseases such as Lassa fever, Zika, and dengue
fever among others, have devastated the populations, as Dark Daily has previously reported.
What’s next for clinical and pathology laboratories and
CRISPR? We’ll let you know.
