The launch of Roferon-A, alpha interferon marked a watershed moment in medicine: the first biotherapeutic to treat cancer, targeting the rare disease hairy-cell leukemia. I remember the packed press conference at The Pierre Hotel in New York City. Thought leaders like Dr. Jerome Groopman inspired awe. Headlines followed. The world paid attention.

That was decades ago. Since then, the biotech sector has evolved from fragile start-up spirit into a multibillion-dollar force. In the eyes of many, what was once miraculous has become mundane. And yet, the science has only grown more awe-inspiring. So why don’t we talk about it that way anymore?

Have we become numb to the very progress that extends and saves lives?

Biotechnology is arguably one of humanity’s most transformative achievements. From precision cancer immunotherapies to gene editing tools like CRISPR, we’ve leapt across medical milestones that were once the stuff of science fiction. CAR-T cell therapy rewrites the body’s immune system; mRNA platforms taught us how to respond to pandemics in real time; and personalized medicine now tailors treatments to the uniqueness of our DNA.

Despite these triumphs, we now face a paradox: the more frequently we succeed, the less exceptional it seems. Biotech, in its reliability, risks becoming background noise.

The danger here isn’t just perception—political, economic, and moral. When we stop being amazed, we stop advocating. And advocacy is essential, because science doesn’t fund itself.

The Birth of a Movement: BIO’s Role in Advancing Innovation

In the early days of this field, the promise of biotech required more than scientific breakthroughs—it demanded an organized, united voice to advocate for science, policy, funding, and public trust. That’s when the Biotechnology (Industry) Innovation Organization (BIO) emerged, uniting a fledgling industry around a shared mission: to promote innovation and ensure that the fruits of biotech reach the people who need them most.

What began as a coalition of pioneers has evolved into one of the most influential global voices for biotechnology. BIO has helped shape legislation, fostered partnerships, supported startups, and advanced equity in access and clinical trials. It has been a tireless advocate for the idea that science serves people—and that innovation without access is innovation incomplete.

As we reflect on biotech’s journey—from niche science to essential public health engine—BIO’s efforts to engage policymakers, educate the public, and convene global stakeholders at events like the annual BIO International Convention, BIO2025 have played a defining role. It’s a reminder that scientific progress is never just about the petri dish. It’s about ecosystems—coalitions of scientists, communicators, investors, and institutions aligned toward a common good.

The Threat of Institutional Apathy

Innovation doesn’t flourish in a vacuum. It requires funding, partnerships, regulatory foresight, and yes, public interest. Today, with DOGE pinching national budgets and partisanship clouding consensus, Federal funding for research is under threat. The National Institutes of Health (NIH), the world’s largest public funder of biomedical research, faces increasingly skeptical eyes and plummeting appropriations.

In parallel, biotech investors—once exuberant—have become cautious. Valuations are down. IPO windows are narrow. Even promising start-ups are forced to downsize or shutter. This isn’t just an economic cycle. It’s a societal test.

If we stop investing in innovation, diseases that could have been conquered will remain entrenched. Rare conditions will stay rare because they’re unprofitable. And the promise of personalized, preventive care will fade back into abstraction. Let’s take stock.

We’ve made incredible strides in HIV, hepatitis C, certain leukemias, and now we see glimpses of progress in previously unyielding diseases like ALS and pancreatic cancer. In some cases, such as HIV, biologics have helped turn some diseases into manageable conditions. Patients who once faced death sentences now live long, productive lives.

But so much work remains. Alzheimer’s disease continues to challenge us. Autoimmune conditions like lupus and Crohn’s demand better solutions. Pediatric rare diseases—often overlooked—leave families desperate for options. And mental health, despite its growing visibility, remains underfunded and underexplored from a biotherapeutic standpoint.

We can’t stop now. The urgency is not over.

Science Needs Storytellers

One of the most potent forces in advancing biotherapeutics isn’t just the lab bench—it’s the lens through which the public sees that bench. This is where communicators come in.

Media, public relations professionals, and advocacy leaders are not passive observers. We are active players in this ecosystem. When we frame scientific progress as human progress, we drive interest, funding, and talent into the field. When we tell stories that connect molecules to people, we give science a face—and a heartbeat.

In the early days of Roferon-A, calls from a young PR pro would turn out a full-room press conference, launching a wave of national interest. Today, the media landscape is fragmented. Clicks compete with credibility, and sensationalism wins over substance.

That only means our responsibility has grown. We must elevate the authentic voices of scientists, patients and advocates. We must cover biotech stories not just as business news, but as human stories, because they convey the struggle and potential.

Bench to Bedside is a Human Endeavor

Behind every molecular breakthrough is a researcher who missed birthdays to run experiments, a trial participant who volunteered without knowing the outcome, and a caregiver hoping that science can offer one more chance. We cannot allow their efforts to be invisible.

Let us remember that biotherapeutics are not just lab products—they are the embodiment of human hope and courage. Each FDA approval to market is a victory for a company and a patient.

And yet, even as we acknowledge this, we must grapple with another complexity: equity.

Not all communities have equal access to these innovations. Biologics are expensive. Insurance structures are slow to adapt, sometimes even resisting. Global disparities persist. If we believe in the power of biotech, we must also commit to making it accessible, advocating for affordability, inclusive clinical trials and compassionate pricing strategies.

Reclaiming the Wonder

So, where do we go from here?

We start by reawakening awe. As communicators, we must use our platforms to remind the world that biotech is not just another industry—it is a movement, a mission.

We must protect the budgets that sustain research, defend the credibility of science against misinformation, and inspire young minds to enter STEM fields not just for jobs but for the opportunity to change lives.

It starts with how we talk. Let’s use language that evokes possibility. Let’s tell stories that illuminate the patient journey. Let’s spotlight scientists with the same reverence we show to athletes or entertainers.

Biotech Without Borders

The original promise of biotechnology was to break boundaries between disciplines, possibilities, and life and death. That promise is still alive, but it needs guardians.

Now more than ever, biotech needs communicators, policymakers, and citizens who care.

I remember the days when biotech press conferences made front pages. Maybe we’ll never go back to that exact moment. But we can choose to go forward—together—into a future where science is again seen not just as data, but as destiny.

Let’s reclaim the wonder. Let’s continue to give scientists a voice, patients hope, start-up enterprises resources, and policymakers direction.

Because what’s at stake is not just the next miracle drug.  What’s at stake is our collective belief that we can still do miraculous things.

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It wasn’t just about the money, but about data, or rather the harvesting of data, which, if you want to be a stickler about it, is really also just all about making more money. In an industry that relies on data for much of its product development, digital, pharmaceutical, technical or otherwise, he who holds the most data, calls the shots.

Nowhere is this more true than in the field of genomics. The strides we’ve made in the last 10 years alone have revolutionized our ability to analyze and sequence genetic information, or DNA. DNA is the code to the life that flows through your body and your DNA is unique to you. It is your genetic fingerprint and holds the key to diseases, inherited or otherwise, that you may or still will, suffer from.

With each advance in our ability to decode DNA we move closer and closer to identifying key genes responsible for, well, just about everything that occurs in our bodies. We’ve also discovered that having certain genes misfire can predispose us to certain medical conditions and it is not unlikely that, in the near future, this information will allow us, with a fair degree of accuracy, to determine a person’s life span, and more importantly, invent pathways to intervene around suffering and disease.

So why now and why Covid?

Well, we’re now post pandemic, things have moved on, and Covid tests are now available that can be run at home. All good and well, but what happened to the billions of laboratory run PCR swabs we submitted to earlier in the pandemic? While companies undertook to destroy these, at no point did any testing laboratory issue a clear undertaking to not harvest your DNA from said swab.

During the pandemic, almost every American was subjected to a PCR test, sometimes on multiple occasions. Your details, along with your swab, were sent off to a laboratory for testing. I wrote an article on this topic way back in 2020, warning the public of the potential abuse of their data. You can read that piece here.

To think that an opportunity like this, literally a once in a lifetime present for data harvesting, would have been overlooked, is so preposterously naïve as to be laughable.

Which then raises the following questions;

• Who orchestrated the collection of this data? Was it government based, industry based, or a combined effort.
• Your DNA profile would now reside alongside your personal profile (remember, your details were attached to that swab). Who legally owns this DNA profile?
• Are the companies/government willing to issue an assurance as to the ethical use of this data, thereby ensuring you are not discriminated against, based on your DNA profile?
• As the data would have been illicitly harvested without your informed consent, are these questions simply moot, as no one will publicly acknowledge this?

Make no mistake, this was the DNA jackpot and companies may utilize this data to sell you products, refuse you products, refuse you work, refuse you insurance, withdraw your driving license, confiscate any guns you own (as soon as genes are identified that predispose an individual to violence or mental instability), the list is endless and the data worth an untold fortune.

It is, from a financial standpoint, potentially the biggest haul of the pandemic, a gift that will continue to offer returns to companies and governments until you close your eyes one day for the final time, probably on a predetermined day.

So the issue here isn’t really about “IF” your DNA was harvested from the swab you provided, but rather “WHO” now holds that DNA profile. If you’re considering committing a crime, I’d think twice about it, as that single hair you leave behind at the scene will result in the police knocking on your door. Remember, they don’t have to explain how they found you.

Isn’t this a good thing for our health?

It absolutely should be, if the powers that be could be trusted to act ethically with the data. We could identify individuals who are prone to certain diseases and conditions and intervene at an early stage, potentially saving billions of dollars in healthcare. Sadly, trust and ethics, particularly in the case of healthcare and government, were early victims of the pandemic, as the public was lied to, manipulated and then coerced on multiple levels.

Lets take an example. A gene is identified that can predict with 90% accuracy the onset of Disease X in people over the age of 40. Based on the DNA profiles now on record, filters show that 42 million Americans will contract Disease X in the next ten years. A quick calculation shows that treating, rather than preventing the disease will generate 30 times the profit, versus developing a cure.

Sadly, our healthcare systems are not designed for ethics and philanthropy. For the most part, they are FIAT driven systems that pursue profit as their ultimate goal. Only a naïve, well intentioned simpleton would suggest the above example has anything other than one inevitable outcome and it certainly isn’t cure.

The fact that the data has been harvested without your consent is of course, the ultimate red flag. If the public would have stood to only benefit health wise from the sharing of genetic data, don’t you think we would already have volunteered it? No. Deep down inside, we know we can no longer trust the institutions tasked with our wellbeing. They know that we know.

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Inserting Genes into CAR T Cells

Chimeric Antigen Receptor T cell (CAR T) therapy genetically alters a patient’s T cells to recognize cancer cells and subsequently kill them. This engineered recognition relies on hybrid T cell receptors with antibody components to detect antigens, or biological tags, found on the surface of cancer cells (see Figure 1).

Researchers typically incorporate hybrid receptor genes into a CAR T cell via viral gene insertion. Despite its regard as a staple in cell therapy, retroviral gene transfer comes with several drawbacks. Viral vector manufacturing is expensive and time-consuming. The method lacks precision and could potentially allow an unwanted gene entry. Perhaps most limiting, it cannot be personalized to detect uncommon antigens. For this reason, all approved CAR T therapies in circulation target blood cancers that share a common antigen (usually CD19 or BCMA) rather than solid tumors, which greatly vary in antigen presentation. Standardizing a new means to insert genes would improve the accessibility, efficiency and usage of CAR T therapy.

Innovating with CRISPR Gene Editing 

In their Phase I clinical trial, the researchers at PACT Pharma and the University of California, Los Angeles explore the possibility of a different type of CAR T therapy—one that creates a hybrid receptor with CRISPR gene editing. With CRISPR, the team selectively removed native T cell receptor genes and replaced them with new, cancer-fighting alternatives.

The researchers began by searching and isolating a novel T cell receptor from the patient’s own immune system. First, they screened the patients by sequencing DNA from healthy blood samples and tumor biopsies; this step identified mutations which the tumor cells share but cannot be found in normal tissue. Algorithms then predicted which antigens would be present on the tumor.

Next, the team copied the antigens and mixed them with different versions of HLA, a type of molecule needed to present antigens to T cells. This process revealed specific T cells which could react to this particular combination of antigen-HLA. Researchers copied up to three of the highly personalized receptor genes to be integrated into the T cells using CRISPR/Cas9.

Figure 2 illustrates the subsequent process. The CRISPR/Cas9 interface knocked out two T cell receptor genes, TRCα and TRCβ (see Figure 3), and replaced them with three new receptor genes in a single step—decidedly more efficient than sourcing and cultivating retroviruses for gene transfer, as is currently standard in CAR T therapy.

The researchers multiplied the T cells to great numbers. Finally, the patients underwent lymphodepletion chemotherapy before receiving up to three doses of their personalized CRISPR/CAR T cell infusion.

The post Teaming Up Two Biotech Winners to Fight Cancer: CRISPR and CAR T appeared first on Medika Life.

Researchers find that combining novel gene-editing CRISPR technology with CAR T therapy could simplify and improve CAR T therapy in one fell swoop.

Traditional CAR T Therapy 

A remarkable feat in cancer care, today people with difficult-to-treat blood cancers can receive CAR T therapy, a personalized “drug” made from their own immune cells. Chimeric Antigen Receptor T cell (CAR T) therapy relies on extracting a patient’s immune cells and modifying them in the lab with a new, synthetic receptor.

The new receptor allows the white blood cell to target and destroy cancer cells once re-infused back in the bloodstream. Evoking the patched image of a mythical chimera, these receptors merge signaling machinery typical of a T cell with an antibody-derived detection region to create a powerful “living drug” which continually expands inside the body. Figure 1 highlights the basic design of a CAR T cell, while Figure 2 illustrates the step-by-step process in more depth.

Gene Editing with Viral Vectors 

To craft CAR T cells, the very genes of the T cells must be altered to express the chimeric antigen receptor. Gene editing, therefore, provides the foundation for the therapy.

Integrating CAR genes normally requires the use of a viral vector. Retroviruses in particular have the unique ability to insert and meld their own foreign genetic material into human cells permanently. This allows viruses to use host machinery to produce viral proteins.

Scientists have repurposed this strength to deliver CAR genes into T cells. An inactivated form of the virus is filled with genetic material which encodes for CAR. The desired genes are then transferred from the virus into the T cells through a process called transduction (see Figure 3). As if reading biological instructions, the T cell uses the genetic information to construct the receptor before expressing it onto the cell surface.

MORGAN AND BOYERINAS

The industry standard may depend on viral vectors, but the procedure lacks in some aspects. This stage of the CAR T process is the most time-consuming and expensive; it can take a year or longer to produce a batch of viral vectors, and can cost up to $50,000 per dose. For these reasons researchers now hope to turn to CRISPR technology, a recent scientific breakthrough in gene editing, to resolve these issues.

Enter CRISPR/Cas9 Gene Editing 

CRISPR originates from organisms such as bacteria and plays a major role in their defense. The acronym CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats—in essence, they are short, repeating DNA sequences which read the same forwards or backwards, similarly to words such as “MADAM” or “DEED.” Sandwiched between these repeats are protospacers, a genetic history of viruses the bacteria encounters (see Figure 5).

When a virus tries to insert its genetic information into the bacteria, the bacteria can recognize the sequence from its protospacer catalog. The bacteria transcribes the protospacer DNA into RNA; this RNA guides enzymes such as Cas9 to the viral DNA to cut and deactivate it.

The same CRISPR/Cas9 interface can also snip human DNA. As seen in Figure 6, an RNA guide can be made to cut DNA at a specific site. The broken DNA, eager to repair itself, can easily adopt a new DNA sequence in that location.

Translating this concept to CAR T therapy, researchers could modify T cell DNA directly to express a new receptor. Synthesizing an RNA guide is cheaper and more efficient than cultivating retroviral vectors. If successful, CRISPR could simply solve two major drawbacks associated with CAR T therapy: price and time-to-delivery.

LABIOTECH

Conclusion 

CAR T therapy, although a triumph of human engineering in its own regard, still has room for improvement. There is potential to propel CAR T design forward by integrating contemporary innovations such as CRISPR/Cas9 technology. Although this method still requires T cell manipulation outside the body, this change could streamline the process while becoming more accessible. The most critical step now is to test the feasibility of this concept. The next installment in the series will explore the latest clinical results from PACT Pharma and the University of California, Los Angeles on their CRISPR/CAR T dual interface.

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Just transplanting an animal’s organ into a human will not work. The person’s immune mechanisms will immediately reject the transplanted organ. So, what is to be done? The key is to genetically engineer the animal to produce organs that are less likely to be rejected. In the last 20 years, there’s been substantial progress on the research front to produce genetically modified pigs. Why pigs? Pig organs are about the same size as human organs but also share many physiologic similarities.

Recent technologies, including CRISPR, have allowed more possibilities to genetically engineer the pig’s genome. A few specific genes have been identified that are critical. Some were modified and some inactivated, called “knocked out.” It’s not just a matter of changing the pig’s genetics, but it’s also having a very specific anti-rejection drug combination. This includes the standard drugs used to prevent rejection of human organs and a specially designed monoclonal antibody against a part of the immune system called CD 40. This monoclonal antibody has been found to be essential and critical to the successful transplantation of a heart in the nonhuman primate model with animals maintained without rejection for upwards of 900 days.

In September 2021, a xenograft kidney from a genetically engineered pig was placed in a brain-dead patient still on life support. It was observed for 58 hours at the New York University Langone Hospital Center with the family’s permission to study for evidence of function and rejection. As a result, the surgical and research team, led by Dr. Robert Montgomery, himself a donor heart transplant recipient, were able to obtain critical information about the pig organ after transplantation. “Whole-body donation after death for the purpose of breakthrough studies represents a new pathway that allows an individual’s altruism to be realized after brain death declaration in circumstances in which their organs or tissues are not suitable for transplant.”

On Friday, January 7, Bartley Griffith, MD, Muhammad Mohiuddin, MD, and an extensive team of multi-specialties successfully implanted a genetically modified pig heart obtained from the Revivicor company. Revivicor created the genetically modified pig and hence the heart to the investigators’ specifications. This included modifying ten genes with three knocked out that lead to antibody development and one knocked out that controls the pig organs’ growth. The patient will also receive various anti-rejection drugs plus the monoclonal antibody aimed at CD40.

The patient, a 57-year-old man, was on life support and not eligible for a human donor organ. His projected lifespan was in days to weeks. He understood the risks of the procedure and that it was a first-time human experiment. But as he said before surgery, “It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice… I look forward to getting out of bed after I recover.”

The Food and Drug Administration (FDA,) having reviewed the research data, authorized the procedure “for compassionate use” on New Year’s Eve. As of Tuesday, January 12, the patient was doing well with no evidence of rejection. Only time will tell if he will make a full recovery and have his pig heart perform for many years.

Dr. Griffith is a cardiovascular surgeon with years of experience in transplanting human hearts and lungs. He has been working on xenotransplantation for over a decade. Dr. Mohiuddin joined with Dr. Griffith at the University of Maryland School of Medicine and Medical Center about five years ago to further pursue his research from the National Institutes of Health. He and colleagues developed the initial techniques to prevent rejection by gene modifications and anti-rejection drugs.

Together Griffith and Mohiuddin established the Xenotransplantation Center with Griffith as clinical director and Mohiuddin as scientific director. But, of course, there is a large team, not just the two of them. The Center investigators received a $15.7 million sponsored research grant to evaluate Revivicor genetically-modified pig hearts in further baboon studies. Last week’s surgery was the current culmination of those studies with a first in human heart xenotransplantation.

A new dawn has likely arrived for organ transplantation. But, of course, this was only the first patient. It remains to be seen how effective it will be in this man or how effective it will be in others treated with other genetically engineered pig organs like kidneys, pancreas, or lungs. But without question, it’s an exciting time with transplant-waiting individuals having a new potential on the horizon for returning to a reasonably normal life.

Stephen C Schimpff, MD, MACP, is a quasi-retired internist, professor of medicine, former CEO of the University of Maryland Medical Center, and author of Longevity Decoded — The 7 Keys to Healthy Aging and his co-authored book with Dr. Harry Oken BOOM — Boost Our Own Metabolism

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Date of Release: Dec. 4, 2020 

SAN FRANCISCO /PRNewswire/ — Imagine swabbing your nostrils, putting the swab in a device, and getting a read-out on your phone in 15 to 30 minutes that tells you if you are infected with the COVID-19 virus. This has been the vision for a team of scientists at Gladstone Institutes, University of California, Berkeley (UC Berkeley), and University of California, San Francisco (UCSF). And now, they report a scientific breakthrough that brings them closer to making this vision a reality.

One of the major hurdles to combating the COVID-19 pandemic and fully reopening communities across the country is the availability of mass rapid testing. Knowing who is infected would provide valuable insights about the potential spread and threat of the virus for policymakers and citizens alike.

Yet, people must often wait several days for their results, or even longer when there is a backlog in processing lab tests. And, the situation is worsened by the fact that most infected people have mild or no symptoms, yet still carry and spread the virus.

In a new study published in the scientific journal Cell, the team from Gladstone, UC Berkeley, and UCSF has outlined the technology for a CRISPR-based test for COVID-19 that uses a smartphone camera to provide accurate results in under 30 minutes.

“It has been an urgent task for the scientific community to not only increase testing, but also to provide new testing options,” says Melanie Ott, MD, PhD, director of the Gladstone Institute of Virology and one of the leaders of the study. “The assay we developed could provide rapid, low-cost testing to help control the spread of COVID-19.”

The technique was designed in collaboration with UC Berkeley bioengineer Daniel Fletcher, PhD, as well as Jennifer Doudna, PhD, who is a senior investigator at Gladstone, a professor at UC Berkeley, president of the Innovative Genomics Institute, and an investigator of the Howard Hughes Medical Institute. Doudna recently won the 2020 Nobel Prize in Chemistry for co-discovering CRISPR-Cas genome editing, the technology that underlies this work.

Not only can their new diagnostic test generate a positive or negative result, it also measures the viral load (or the concentration of SARS-CoV-2, the virus that causes COVID-19) in a given sample.

“When coupled with repeated testing, measuring viral load could help determine whether an infection is increasing or decreasing,” says Fletcher, who is also a Chan Zuckerberg Biohub Investigator. “Monitoring the course of a patient’s infection could help health care professionals estimate the stage of infection and predict, in real time, how long is likely needed for recovery.”

A Simpler Test through Direct Detection

Current COVID-19 tests use a method called quantitative PCR—the gold standard of testing. However, one of the issues with using this technique to test for SARS-CoV-2 is that it requires DNA. Coronavirus is an RNA virus, which means that to use the PCR approach, the viral RNA must first be converted to DNA. In addition, this technique relies on a two-step chemical reaction, including an amplification step to provide enough of the DNA to make it detectable. So, current tests typically need trained users, specialized reagents, and cumbersome lab equipment, which severely limits where testing can occur and causes delays in receiving results.

As an alternative to PCR, scientists are developing testing strategies based on the gene-editing technology CRISPR, which excels at specifically identifying genetic material.

All CRISPR diagnostics to date have required that the viral RNA be converted to DNA and amplified before it can be detected, adding time and complexity. In contrast, the novel approach described in this recent study skips all the conversion and amplification steps, using CRISPR to directly detect the viral RNA.

“One reason we’re excited about CRISPR-based diagnostics is the potential for quick, accurate results at the point of need,” says Doudna. “This is especially helpful in places with limited access to testing, or when frequent, rapid testing is needed. It could eliminate a lot of the bottlenecks we’ve seen with COVID-19.”

Parinaz Fozouni, a UCSF graduate student working in Ott’s lab at Gladstone, had been working on an RNA detection system for HIV for the past few years. But in January 2020, when it became clear that the coronavirus was becoming a bigger issue globally and that testing was a potential pitfall, she and her colleagues decided to shift their focus to COVID-19.

“We knew the assay we were developing would be a logical fit to help the crisis by allowing rapid testing with minimal resources,” says Fozouni, who is co-first author of the paper, along with Sungmin Son and María Díaz de León Derby from Fletcher’s team at UC Berkeley. “Instead of the well-known CRISPR protein called Cas9, which recognizes and cleaves DNA, we used Cas13, which cleaves RNA.”

In the new test, the Cas13 protein is combined with a reporter molecule that becomes fluorescent when cut, and then mixed with a patient sample from a nasal swab. The sample is placed in a device that attaches to a smartphone. If the sample contains RNA from SARS-CoV-2, Cas13 will be activated and will cut the reporter molecule, causing the emission of a fluorescent signal. Then, the smartphone camera, essentially converted into a microscope, can detect the fluorescence and report that a swab tested positive for the virus.

“What really makes this test unique is that it uses a one-step reaction to directly test the viral RNA, as opposed to the two-step process in traditional PCR tests,” says Ott, who is also a professor in the Department of Medicine at UCSF. “The simpler chemistry, paired with the smartphone camera, cuts down detection time and doesn’t require complex lab equipment. It also allows the test to yield quantitative measurements rather than simply a positive or negative result.”

The researchers also say that their assay could be adapted to a variety of mobile phones, making the technology easily accessible.

“We chose to use mobile phones as the basis for our detection device since they have intuitive user interfaces and highly sensitive cameras that we can use to detect fluorescence,” explains Fletcher. “Mobile phones are also mass-produced and cost-effective, demonstrating that specialized lab instruments aren’t necessary for this assay.”

Accurate and Quick Results to Limit the Pandemic

When the scientists tested their device using patient samples, they confirmed that it could provide a very fast turnaround time of results for samples with clinically relevant viral loads. In fact, the device accurately detected a set of positive samples in under 5 minutes. For samples with a low viral load, the device required up to 30 minutes to distinguish it from a negative test.

“Recent models of SARS-CoV-2 suggest that frequent testing with a fast turnaround time is what we need to overcome the current pandemic,” says Ott. “We hope that with increased testing, we can avoid lockdowns and protect the most vulnerable populations.”

Not only does the new CRISPR-based test offer a promising option for rapid testing, but by using a smartphone and avoiding the need for bulky lab equipment, it has the potential to become portable and eventually be made available for point-of-care or even at-home use. And, it could also be expanded to diagnose other respiratory viruses beyond SARS-CoV-2.

In addition, the high sensitivity of smartphone cameras, together with their connectivity, GPS, and data-processing capabilities, have made them attractive tools for diagnosing disease in low-resource regions.

“We hope to develop our test into a device that could instantly upload results into cloud-based systems while maintaining patient privacy, which would be important for contact tracing and epidemiologic studies,” Ott says. “This type of smartphone-based diagnostic test could play a crucial role in controlling the current and future pandemics.”

About the Research Project

The study entitled “Amplification-free detection of SARS-CoV-2 with CRISPR-Cas13a and mobile phone microscopy,” was published online by Cell on December 4, 2020.

Other authors of the study include Gavin J. Knott, Michael V. D’Ambrosio, Abdul Bhuiya, Max Armstrong, and Andrew Harris from UC Berkeley; Carley N. Gray, G. Renuka Kumar, Stephanie I. Stephens, Daniela Boehm, Chia-Lin Tsou, Jeffrey Shu, Jeannette M. Osterloh, Anke Meyer-Franke, and Katherine S. Pollard from Gladstone Institutes; Chunyu Zhao, Emily D. Crawford, Andreas S. Puschnick, Maira Phelps, and Amy Kistler from the Chan Zuckerberg Biohub; Neil A. Switz from San Jose State University; and Charles Langelier and Joseph L. DeRisi from UCSF.

The research was supported by the National Institutes of Health (NIAID grant 5R61AI140465-03 and NIDA grant 1R61DA048444-01); the NIH Rapid Acceleration of Diagnostics (RADx) program; the National Heart, Lung, and Blood Institute; the National Institute of Biomedical Imaging and Bioengineering; the Department of Health and Human Services (Grant No. 3U54HL143541-02S1); as well as through philanthropic support from Fast Grants, the James B. Pendleton Charitable Trust, The Roddenberry Foundation, and multiple individual donors. This work was also made possible by a generous gift from an anonymous private donor in support of the ANCeR diagnostics consortium.

About Gladstone Institutes

To ensure our work does the greatest good, Gladstone Institutes focuses on conditions with profound medical, economic, and social impact—unsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with UC San Francisco.

Sources

Gladstone Institutes: Julie Langelier | julie.langelier@gladstone.org | 415.734.5000

UC Berkeley: Kara Manke | kjmanke@berkeley.edu | 415.502.4608

SOURCE Gladstone Institutes; University of California, Berkeley

Related Links

https://gladstone.org

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