Connect with us

Government

Elementary Claim: Sherlock Gains Patent Rights for Cas12 in Diagnostics

Sherlock says the technology has shown in tests the potential to deliver flexible, high-accuracy, low-cost Cas12-based detection of diseases, including…

Published

8 months ago

on

Bryan Dechairo, PhD, Sherlock Biosciences president and CEO

Sherlock Biosciences has gained U.S. rights to a patent for diagnostic use of a CRISPR system based on the smaller Cas12 enzyme as single RNA-guided endonuclease.

Sherlock—whose co-founders include CRISPR pioneer Feng Zhang, PhD, of the Broad Institute—says its exclusive U.S. rights to U.S. Patent No. 11,584,955, which covers a method for detecting target nucleic acid molecules, leveraging the collateral cleavage activity of a Cas12 protein. Sherlock says the technology has shown in tests the potential to deliver flexible, high-accuracy, low-cost Cas12-based detection of diseases, including malaria, tuberculosis, and COVID-19.

Sherlock boasts that the patent, combined with rights to additional patents issued to the Broad, places the company “at [the] apex of CRISPR-based diagnostics” based on targeting double-stranded DNA through Cas12 and targeting single-stranded RNA through another enzyme, Cas13.

CRISPR diagnostics designed to apply Cas12 and Cas13 is an area where Sherlock has competed head-on with another diagnostic developer—Mammoth Biosciences, co-founded by another CRISPR pioneer, Nobel laureate Jennifer Doudna, PhD. Mammoth has incorporated Cas12 and Cas13 into its proprietary toolbox of novel Cas enzymes—a toolbox that includes Cas14, which targets single-stranded DNA; and Casɸ, which is encoded exclusively in the genomes of huge bacteriophages.

Mammoth has exclusively licensed foundational IP around novel CRISPR Cas12, Cas13, Cas14, and Casɸ systems from the University of California, Berkeley. The systems were discovered in Doudna’s lab.

To use Cas12 within its toolbox, Mammoth would need to license the enzyme from his company, Sherlock president and CEO Bryan Dechairo, PhD, told GEN Edge.

“The patent that’s been issued is something that has very broad claims of amplification with CRISPR-based detection for diagnostics, and has the earliest filing date in the U.S. So based upon that, if people would like to use Cas12 with amplification of DNA, then they would need a license from Sherlock Biosciences,” he said.

Mammoth responded this week through a company statement to GEN Edge that noted: “We have several issued worldwide patents related to Type V and Type VI CRISPR systems that include Cas12, Cas13, Cas14 enzymes, and beyond. More generally, we have a broad and differentiated CRISPR-based IP portfolio across multiple fields of use.”

“We are not currently looking to license IP from third parties in the diagnostics space and we are open to discussions with parties that can leverage Mammoth’s pioneering innovations to benefit patients,” Mammoth added.

Focus on therapeutics

Over the past year two years, Mammoth has evolved into developing both CRISPR-based diagnostics and therapeutics, with growing emphasis on the latter. Late in 2021, Mammoth inked an up-to-$695 million collaboration with Vertex Pharmaceuticals to develop in vivo gene-editing therapies for two undisclosed genetic diseases using Mammoth’s CRISPR systems. And in January 2022, Bayer agreed to use those systems to develop in vivo gene-editing therapies, through a collaboration that could generate more than $1 billion for Mammoth.

The collaborations have already paid off for Mammoth, which received $31 million upfront from Vertex, according to Vertex’s Form 10-K annual report for 2022, and $40 million upfront from Bayer that was disclosed by the pharma giant.

Mammoth is building a pipeline of CRISPR therapies, and has identified several potential therapeutic areas for those treatments—including autoimmune diseases, cardiovascular, hematology, immuno-oncology, liver disease, neurology and neuromuscular diseases, and ophthalmology.

“We’ll start in the liver, and then we’ll move on to other tissues. Some areas that we’re really excited about include muscle and CNS,” Mammoth’s co-founder and CEO Trevor Martin, PhD, told GEN Edge last month.

Martin would not disclose details about the Bayer and Vertex collaborations. The CEO did say that Mammoth has set its first area of therapeutic focus on the liver because genome editors have been shown to be successfully transported to cells through delivery modalities that include adeno-associated viruses (AAVs) and some lipid nanoparticles (LNPs).

Mammoth and Sherlock received FDA emergency use authorizations (EUAs) for CRISPR-based COVID-19 diagnostics during the pandemic. Mammoth applied Cas12 in its COVID-19 diagnostic effort that culminated in the SARS-CoV-2 RNA DETECTR Assay, a COVID-19 diagnostic for which UCSF Health Clinical Laboratories was granted an FDA Emergency Use Authorization (EUA) in August 2020.

“We’re not focused on commercializing COVID testing as a company,” Martin said. “First and foremost, we’re a biotech company focused on therapeutics. Beyond that, CRISPR diagnostics is a brand-new method of molecular detection, I think it has exciting applications beyond COVID and respiratory testing, although obviously it has uses there. We’re thinking about it more holistically on the platform side.”

Three months earlier in May 2020, Sherlock became the first company to receive an EUA from the FDA for a COVID-19 diagnostic, namely its Sherlock CRISPR SARS-CoV-2 Kit.

“That’s a nice milestone for CRISPR, but that test did not really compare to PCR,” said Dechairo, who before helming Sherlock served as executive vice president of clinical development with Myriad Genetics during a career in which he held numerous roles at diagnostic as well as therapeutic developers. “For 30 years I spent my whole career in PCR. So, while [the kit] was a great demonstration that CRISPR had the accuracy of PCR, and it could be FDA cleared, it didn’t meet any real target product profile.

“So, when I came to Sherlock, we said, where is CRISPR unique vs. PCR? Where CRISPR’s unique compared to PCR is the ability to decentralize the technology at a very low cost of goods, where anybody else can use it,” Dechairo said. “And that’s when I pivoted the company towards being focused on over the counter, and really decentralizing and democratizing diagnostics around the world.”

Expanding collaboration

The patent covering Cas12 use in diagnostics was applied for by, and is assigned to, Shanghai Tolo Biotechnology, which in 2020 granted Sherlock exclusive U.S. rights to its CRISPR Cas12 (including Cas12a and Cas12b) diagnostic technology. In return, Sherlock granted Tolo exclusive rights to the CRISPR Cas13 SHERLOCK diagnostic platform in Greater China.

Last November, Sherlock and Tolo expanded their collaboration, by granting each other co-exclusive rights to Cas12 and Cas13 CRISPR diagnostic methods in areas of the world outside of the U.S. and Greater China. At the time, Sherlock said the expansion also allowed healthcare practices and others to sublicense rights to the technology for use by labs and hospitals.

The value of the 2022 and 2020 agreements has not been disclosed.

Sherlock says access to both Cas12 and Cas13 enables the company to detect both DNA and RNA

“When we licensed Cas12 from the Broad, we were just saying, ‘Well who has the earliest filing days?’ We found out it wasn’t the Broad—it was Tolo. So we went out and acquired the IP from Tolo, because they had that earliest filing date.”

The technology that Sherlock licenses from the Broad and from Tolo marries amplification with CRISPR detection, and is one of four amplification methods for which Sherlock holds IP rights, Dechairo said.

The other three are:

  • A strand displacement amplification technology, an isothermal application method that works around 50 °C and enables healthcare providers to swab, amplify, engage a lateral flow strip, and read out results in under 15 minutes. Sherlock obtained the technology by acquiring Sense Biodetection for an undisclosed price, a deal announced February 1.
  • An ambient temperature amplification method developed by the lab of Jim Collins, PhD, at the Wyss Institute for Biologically Inspired Engineering at Harvard University. The technology can run at room temperature and offer results in under an hour, Dechairo said. Collins is a co-founder and board member of Sherlock.
  • A synthetic biology approach also developed by Collins’ lab at the Wyss Institute that enables users to detect DNA and RNA and convert it into synthetic proteins. These can then bind on multiple different bands on a lateral flow strip, allowing for highly multiplexed readouts from a single operation.

“The pairing of proprietary amplification technology from the Wyss Institute, as well as the rapid molecular amplification chemistry gained through our recent acquisition of Sense Biodetection, puts us on track to become a global health leader,” Collins said in a statement.

Dominant and defensible

“This dominant and defensible patent position will allow us to establish the necessary market foothold in the U.S. before we bring our rapid, point-of-need diagnostic tests to the rest of the world,” Collins added.

Given its access to other amplification methods, why did Sherlock pursue IP for CRISPR detection?

“When you amplify things isothermally, you often amplify up a lot of the raw materials, so, you lose some specificity. When you do that at colder and colder temperatures—because we can do that at room temperature—you actually start getting even more background, noise,” Dechairo explained.

“A CRISPR enzyme with its guide RNAs can come in read through all that background, and only read out what is what is positive,” he continued. “When those Cas enzymes 12 and 13 find their target, they then activate, and they start to cleave any nucleic acid in the surrounding liquid, which allows us to use that as a readout for detection, whether that is fluorescently or lateral flow.”

The Sense acquisition, Dechairo noted, also gave Sherlock access to the Cambridge, U.K., company’s Veros platform, which has a lateral flow readout. Veros is a low-cost, instrument-free, disposable device that has been through clinical trials and according to Sherlock has shown very high accuracy and isothermal chemistry.

That device, Sherlock reasons, can help it deliver affordable over-the-counter testing with superior accuracy.

“We have a whole team of AI scientists who have made machine-learning algorithms to develop CRISPR-based diagnostic assays. We’re putting all of that AI into a software package, so that not just Sherlock scientists, but the world’s scientists can design their own CRISPR-based diagnostics and bring them to the market,” Dechairo said.

Sherlock has named its program for that purpose “Rosalind” in tribute to Rosalind Franklin (1920-1958), the British structural biologist whose pioneering work producing x-ray images of DNA was crucial in the discovery of its structure by Francis Crick and James Watson in 1953.

By year’s end, Dechairo said, Sherlock will make the Rosalind software available to scientists worldwide so they can design their own CRISPR assays using the company’s AI software.

Zhang and colleagues at the Broad have been challenged for nearly a decade over patents for CRISPR-Cas9 technology by the University of California (UC), the University of Vienna, and CRISPR pioneer and Nobel co-laureate Emmanuelle Charpentier, PhD, in a bitter battle royal over who invented the gene-editing technology in eukaryotic cells.

Last year, Zhang and the Broad survived a second challenge to their CRISPR-Cas9 patents when the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) decided that the Broad, MIT, and President and Fellows of Harvard College had priority over the Regents of the UC, University of Vienna, and Charpentier in the invention of a single RNA CRISPR-Cas9 system that functions in eukaryotic cells. Charpentier is director and scientific member at the Max Planck Institute of Infection Biology, Berlin.

The post Elementary Claim: Sherlock Gains Patent Rights for Cas12 in Diagnostics appeared first on GEN - Genetic Engineering and Biotechnology News.

Read More

Related Topics:
Continue Reading

International

EUR/AUD bearish breakdown supported by additional China fiscal stimulus and AU inflation

Weak PMI readings from the Eurozone, an increase in China’s budget deficit ratio, and renewed inflationary pressures in Australia may trigger a persistent…

Published

4 hours ago

on

October 24, 2023

By

  • Weak PMI readings from the Eurozone, an increase in China’s budget deficit ratio, and renewed inflationary pressures in Australia may trigger a persistent bearish sentiment loop in EUR/AUD.
  • Watch the key short-term resistance at 1.6700 for EUR/AUD.
  • A break below 1.6250 key medium-term support on the EUR/AUD may trigger a multi-week bearish impulsive down move.

The Euro (EUR) tumbled overnight throughout the US session as it erased its prior gains against the US dollar recorded on Monday, 23 October; the EUR/USD shed -104 pips from yesterday’s intraday high of 1.0695 to close the US session at 1.0591, its weakest performance in the past seven sessions.

Yesterday’s resurgence of the USD dollar strength has been attributed to a robust set of October flash manufacturing and services PMI data from the US in contrast with weak readings seen in the UK and Eurozone that represented stagflation risks.

Interestingly, the Aussie dollar (AUD) has outperformed the US dollar where the AUD/USD managed to squeeze out a minor daily gain of 21 pips by the close of yesterday’s US session. The resilient movement of the AUD/USD has been impacted by positive news flow out from China, Australia’s key trading partner.

China’s national legislature has just approved a budgetary plan to raise the fiscal deficit ratio for 2023 to around 3.8% of its GDP which was above the initial 3% set in March and set to issue additional sovereign debt worth 1 trillion yuan in Q4. This latest round of additional fiscal stimulus suggests that China’s top policymakers are expanding their initial targeted measures to address the ongoing severe liquidity crunch in the domestic property market as well as to reverse the persistent weak sentiment inherent in the stock market.

In addition, the latest set of Australia’s inflation data surpassed expectations has also reinforced another layer of positive feedback loop in the Aussie dollar which in turn may put Australia’s central bank, RBA on a “hawkish guard” against cutting its policy cash rate too soon.

The less lagging monthly CPI Indicator has risen to an annualized rate of 5.6% in September, above consensus estimates of 5.4%, and surpassed August’s reading of 5.2% which has translated into a second consecutive month of uptick in inflationary growth.

In the lens of technical analysis, a potential bearish configuration setup has emerged in the EUR/AUD cross pair from a short to medium-term perspective.

Major uptrend phase of EUR/AUD is weakening

.

Fig 1: EUR/AUD medium-term trend as of 25 Oct 2023 (Source: TradingView, click to enlarge chart)

Even though the price actions of the EUR/AUD have been oscillating within a major ascending channel since its 25 August 2023 low of 1.4285 and traded above the key 200-day moving average so far, the momentum of this up movement is showing signs of bullish exhaustion.

Yesterday (24 October) price action ended with a daily bearish reversal “Marubozu” candlestick coupled with the daily RSI momentum indicator that retreated right at a significant parallel resistance in place since March 2023 at the 65 level which suggests a revival of medium-term bearish momentum.

EUR/AUD bears are now attacking the minor ascending support

Fig 2: EUR/AUD minor short-term trend as of 25 Oct 2023 (Source: TradingView, click to enlarge chart)

The EUR/AUD has now staged a bearish price action follow-through via the breakdown of its minor ascending support from its 29 September 2023 low after a momentum bearish breakdown that was flashed earlier yesterday (24 October) during the European session as seen from the 4-hour RSI momentum indicator.

Watch the 1.6700 key short-term pivotal resistance (also the 50-day moving average) for a further potential slide toward the intermediate supports of 1.6460 and 1.6320 in the first step.

On the other hand, a clearance above 1.6700 invalidates the bearish tone to see the next intermediate resistance coming in at 1.6890.

Read More

Continue Reading

International

GigXR partners with NUS Medicine to deliver holographic clinical scenarios for gastroenterology training

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University…

Published

5 hours ago

on

October 24, 2023

By

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), one of the world’s leading medical schools, to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers evidence-based, robust clinical simulations that present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world.

Credit: Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), and GigXR

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), one of the world’s leading medical schools, to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers evidence-based, robust clinical simulations that present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world.

Going beyond linear step-based training traditionally seen with virtual reality (VR), HoloScenarios: Gastrointestinal uses mixed reality (MR) to simulate the entire patient journey, while including branching logic to catalyze variance in learning experiences. From taking basic medical history to performing invasive testing and emergency procedures, the new module empowers learners to master vital medical decision-making and manual skills as they would see them in real-life clinical scenarios and patient care.

HoloScenarios: Gastrointestinal is created in collaboration with renowned medical professionals and educators from NUS Medicine who specialize in the fields of Gastrointestinal (GI) Surgery and holographic medical training. The module is delivered by the Gig Immersive Learning Platform, the enterprise-scale platform enabling the creation, curation, and sharing of immersive training applications and modules made by the world’s preeminent healthcare institutions and MR developers.

“Gastrointestinal pathologies can be complex and challenging to diagnose. This module will allow learners to form a deeper understanding and appreciation of the gastrointestinal tract, especially the three-dimensional understanding of anatomy and body functions,” said Associate Professor Alfred Kow Wei Chieh from the school’s Department of Surgery and Assistant Dean (Education) at NUS Medicine. “We believe mixed reality is the next evolution in healthcare training, and collaborating with immersive platform innovators like GigXR helps us to bring this vital content to more learners globally and, ultimately, improve patient care.”

With international medical and surgical credentials that include MBBS (S’pore), M Med (Surg), FRCSEd (Gen Surg), FAMS, and FACS, Associate Professor Kow has trained thousands of healthcare professionals and advanced surgical fellows. He received the 2023 REAL Advancing in Liver Transplantation Award for his contributions to global liver transplantation education and is a founding member of The Holomedicine® Association.

“GigXR has one of the most advanced and comprehensive platforms in mixed reality, especially in medical training, and enables the exchange of developments, innovation, and expertise with a wider community across Asia and beyond,” added Associate Professor Kow. He is also the Head and Senior Consultant of the Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, at Singapore’s National University Hospital (NUH), the teaching hospital of NUS Medicine.

The new module also delivers enhanced realism in training learners to more accurately diagnose and treat acute gastrointestinal diseases. Whereas VR has been widely used in gastroenterology training for linear step-based skills, such as in endoscopic procedures, it is limited in its ability to simulate fully realized clinical scenarios. Holographic patient simulation in MR merges hyper-realistic holograms in physical learning spaces that accurately reflect the clinical environment and tools with which learners will care for real patients.

With HoloScenarios: Gastrointestinal, learners can interact with the holographic simulated patients, holographic medical equipment, instructors, and each other. This allows them to master both technical and soft skills, such as patient empathy and team communication, in hyper-realistic, safe-to-fail environments that reduce cognitive load. If the holographic patient displays the need for further care, such as a definitive surgery, learners can discuss a definitive treatment plan.

To gain a deeper evaluation of outward symptoms, co-located learners can safely walk around the patient hologram that is displayed on top of their real-world surroundings. Whereas VR locks learners into a virtual “box,” MR enables clear visibility and awareness of physical surroundings. This allows learners to move freely without fear of physical collisions and safety so they can fully focus on learning key gastrointestinal treatment, diagnostic, and communication skills with peers and instructors.

“In healthcare, educators are not only trying to help learners master and retain vital knowledge, but recall and apply it when a patient’s life may be at risk,” said Dr. Gao Yujia, MBBS (S’Pore), MRCS, FRCSEd, Consultant and Assistant Group Chief Technology Officer at Singapore’s National University Health System, and Vice Chairman of The Holomedicine® Association. “With HoloScenarios: Gastrointestinal, learners will have the ability to not only visualize the presentation of a given disease in 3D but better understand how to apply key learnings in the clinical context and within team environments.” Dr Gao is also the Director of Undergraduate Medical Education for Surgery at NUS Medicine.

With scenarios across gastrointestinal pathologies that include gastrointestinal bleeding, intestinal obstruction, and chronic liver failure, learners can master complex and potentially critical situations. They can learn, for example, how to stabilize patients who are dehydrated, bleeding, or septic, as well as the types of diagnostic procedures that may then be required to get a definitive diagnosis. Using mixed reality headsets or any Android, iOS smartphone or tablet, learners can access HoloScenearios: Gastrointestinal from anywhere for remotely distributed, yet highly immersive simulation.

“Immersive technology has accelerated the sharing of expertise for teaching, training, and simulation. Mixed reality, with its natural propensity to facilitate hyperrealistic, safe, and collaborative learning, continues to accelerate both the quality and scale of training outcomes,” said Jared Mermey, CEO of GigXR. “We are immensely proud to partner with NUS Medicine which has been at the forefront of adopting mixed reality in both clinical and educational use cases. By bringing their esteemed expertise onto our platform with the co-creation of HoloScenarios’ newest module, we believe clinical breakthroughs in diagnosing and treating gastrointestinal diseases will take a giant leap forward.”

Designed specifically for pedagogy, the Gig Immersive Learning Platform is trusted by over 70 enterprise-scale healthcare institutions across four continents to build full immersive curricula utilizing a robust content catalog – all of which is managed from a single dashboard. Third-party content developed by leading 3D medical partners, including DICOM Director, 3D4Medical by Elsevier, and ANIMA RES, seamlessly integrates with the platform to provide complementary, in-depth anatomy applications that empower learners with a broader physical context for the pathologies that they study.

“The Gig Immersive Learning Platform has quickly become the premier educational, social network for sharing healthcare training expertise in the immersive format, spanning global healthcare institutions and the Department of Defense to content developers and enterprises large and small,” said David King Lassman, Founder of GigXR. “HoloScenarios: Gastrointestinal marks the latest milestone in our rapidly expanding catalog, which now boasts a dozen different licensable training modules that span holographic simulated patients, clinical scenarios, anatomy, pathophysiology, and 3D medical imaging.”

NUS joins the University of Cambridge and Cambridge University Hospitals (CUH) NHS Foundation Trust, University of Michigan, and Morlen Health, a subsidiary of Northwest Permanente, P.C., as the world-class institutions partnering with GigXR to co-create holographic healthcare training. These simulations include modules centered around Respiratory diseases, Basic Life Support, Advanced Cardiac Life Support, Neurology scenarios, and now, with NUS, Gastrointestinal diseases.

GigXR and NUS Medicine plan to launch HoloScenarios: Gastro in Spring 2024. For more information on GigXR, visit GigXR.com or email sales@gigxr.com. For more information on NUS, visit nus.edu.sg.

Read More

Continue Reading

International

Public support for extending the 14-day rule on human embryo research indicated by foundational dialogue project

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded…

Published

7 hours ago

on

October 24, 2023

By

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded Human Developmental Biology Initiative (HDBI). The HDBI is an ambitious scientific endeavour to advance our understanding of human development. The dialogue project, which was co-funded by UKRI Sciencewise programme, engaged a diverse group of the public to consider how early human embryo research can be used to its fullest, the 14-day rule and the fast-paced field of stem cell-based embryo models.

Credit: Dr Matteo Molè (Babraham Institute)

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded Human Developmental Biology Initiative (HDBI). The HDBI is an ambitious scientific endeavour to advance our understanding of human development. The dialogue project, which was co-funded by UKRI Sciencewise programme, engaged a diverse group of the public to consider how early human embryo research can be used to its fullest, the 14-day rule and the fast-paced field of stem cell-based embryo models.

Headline findings include:

  • Appetite for review of the 14-day rule: Participants recognised that extending the 14-day rule could open up ways to achieve benefits in fertility and health, with participant support for reviewing this, including national discussion.
  • Confidence in regulation: There was a high level of confidence in how human embryo research is regulated, despite a low level of awareness of the regulators and statutes themselves. This included strong desire to see robust regulation governing any changes to the 14-day rule and further regulation for the use of stem cell-based embryo models.
  • Support for improved fertility and health outcomes: The strongest hopes for future human embryo research were where new knowledge would deliver improvements in understanding miscarriage, preventing health conditions such as spina bifida and raising the success rates of IVF procedures.
  • Concerns about genetically engineering humans: The public expressed concerns on the application of developments in this field to genetically alter or engineer humans.

The dialogue engaged a group of 70 people broadly reflective of the UK population in over 15 hours of activities including a series of online and face-to-face workshops with scientists, ethicists, philosophers, policy makers and people with relevant lived experience (such as embryo donors from IVF procedures).

Dr Peter Rugg-Gunn, scientific lead for the HDBI and senior group leader at the Babraham Institute, said: “Recent scientific advances bring incredible new opportunities to study and understand the earliest stages of human development. To ensure this research remains aligned with society’s values and expectations, we must listen and respond to public desires and concerns. This public dialogue is an important first step and as a scientist I am reassured by the findings but there is still a long way to go to fully understand this complex issue.” 

The report is exceedingly timely, following notable scientific advances in human developmental biology presented at conferences and in leading scientific journals in recent months. As well as generating excitement in scientific fields and with the public, announcement of these breakthroughs also prompted some concerns and criticisms, with the view that these findings raised significant ethical issues. The dialogue provides insight into public considerations following deliberation on early human embryo research. The hope is that it will act as a foundational reference point that others in the sectors can build upon, such as in any future review of the law on embryo research.

Professor Robin Lovell-Badge, co-chair of the HDBI Oversight group, senior group leader and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute, said: “We have learnt a lot about human development before 14 days, but there are areas of investigation that could change how we understand development, and associated diseases, that lie beyond our current window of knowledge. Despite low awareness of current laws, members of the public quickly recognised many of the critical issues researchers are keenly aware of when it comes to growing embryos beyond the current limit. This dialogue also reinforced the fact that the public are in support of research that will yield better health outcomes, and in this case, increase the success of IVF procedures.

Other countries will be looking to the UK to see how we deal with the 14-day rule; we are not there yet with any mandate to make a change, but this does give a strong pointer. The next step will be to delve deeper into some of the topics raised through this dialogue as they apply to specific areas of research, as well as feeding into policy changes.”

The 14-day rule and the regulation of stem cell-based models

When considering the regulation of research involving human embryos, the dialogue explored participant’s views on the 14-day rule. Introduced in 1990, the 14-day rule is a limit enforced by statute in the UK. It applies to early human embryos that are donated by consent to research and embryos that are created for research from donated sperm and eggs. It limits the amount of time early human embryos can be developed in a laboratory for scientific study to 14 days after fertilisation. Due to technical advances, it is now possible to grow embryos in the lab past 14 days, but researchers are not allowed to by the law. If the law changed, it would open up this ‘black box’ of development with researchers able to investigate this crucial time in development from 14-28 days after fertilisation.

Professor Bobbie Farsides, co-chair of the HDBI Oversight group and Professor of Clinical and Biomedical Ethics at the Brighton and Sussex Medical School, said: “It has been a fascinating experience to support HDBI in the undertaking of this exercise.  I commend the participants for the care and mutual respect they have shown throughout. Their engagement and commitment to a subject few of them had previously considered allowed for a wide range of views to be expressed and considered. I hope the scientists involved will be encouraged by the high level of interest in their work, and will want to keep the public conversation going around these important subjects.”

The dialogue included participant discussion on what a change to the 14-day rule might look like, and identified points that should be considered, such as defining what the benefits of extending the rule would be and potential mis-alignment with human embryo research regulations in other countries.

Participants acknowledged the astonishing possibilities of stem cell-based embryo models. The majority of participants would like to see these models further regulated. Work in establishing potential governance mechanisms is already underway. In recognition of the need for additional guidance and regulation in this area, the Cambridge Reproduction initiative launched a project in March 2023 to develop a governance framework for research using stem cell-based embryo models and to promote responsible, transparent and accountable research.

Future steps

A key outcome from the public dialogue is the identification of areas for further exploration, with participants proposing how future national conversations might be shaped. It is hoped that the project acts as a reference base for both widening engagement with the subject and also prompting deeper exploration of areas of concern.

Dr Michael Norman, HDBI Public Dialogue coordinator and Public Engagement Manager at the Babraham Institute, said: “This dialogue shows that people want the public to work closely with scientists and the government to shape both future embryo research legislation and scientific research direction. It is crucial that others in the sector build on these high quality, two-way engagement methodologies that allow for a genuine exchange of views and information to ensure that the public’s desires and concerns are listened to and respected. Transparency and openness around science is vital for public trust and through this we, as a society, can shape UK research in way that enriches the outcomes for all.”

Public Participant (Broad public group, south) said: “I do think that an extension of this public dialogue, and educating a wider society has a benefit in itself. This is really complex and sensitive and the wider you talk about it before decisions are made, the better.”

Read More

Continue Reading

Trending