industry news

09 JULY 2019

University of Manchester spin-out develops cancer biomarkers SHARE

University of Manchester spin-out Nanoco Technologies is developing new fluorescent biomarkers in a bid to improve detection and treatment of certain deadly cancer types.

To create the biomarkers, the company has leveraged nanomaterials that are commonly used in displays and lighting.

Called quantum dots, the nanomaterials are made from a semiconductor material and approximately 10,000 times smaller than the thickness of a human hair. They are commonly made using toxic materials.

The company’s bio-compatible quantum dots, named VIVODOTS, are currently being studied as fluorescent biomarkers.

Nanoco life science chief technology officer Dr Imad Naasani said: “Quantum dots are fluorescent so, if you hit them with energy, they emit different wavelengths of light. Their properties make them attractive for many uses.

“Because they are very stable, bright and don’t photobleach they can be used for real-time imaging of targeted tissue. We can make them bind to a tumour, for example.”

Naasani added that the materials can be potentially used to track stem cells in the body after injection to find whether they reach targeted tissues.

The company is working on an early and simplified diagnosis of skin cancers and has partnered with the University College London to work on image-guided surgery for pancreatic cancer.

It is hoped that Vivodots nanoparticles could be linked with antibodies and injected into the patient to identify cancerous cells during endoscopies.

They could also have applications in image-guided surgery and be used to kill remaining cells following surgery.

The company, with funding from Innovate UK, is performing early pre-clinical safety studies of its quantum dots and expects them to be available for clinical use in five to seven years.

09 JULY 2019

Mylan HIV Self Test receives WHO prequalification approval

Pharmaceutical company Mylan and medical device maker Atomo Diagnostics have secured World Health Organization (WHO) prequalification approval for an in-vitro HIV rapid diagnostic meant for self-testing.

WHO prequalification is meant to ensure that medical products for high burden diseases meet global standards of quality, safety and efficacy for improving health outcomes and use of health resources.

Manufactured by Atomo Diagnostics, the handheld HIV Self Test has been designed to identify the presence or absence of HIV type 1 and type 2 antibodies via a fingerstick within 15 minutes.

The blood volume required by the qualitative immunoassay is said to be one-fifth of that used in existing tests.

Atomo Diagnostics makes the HIV diagnostic test available through specialist commercialisation partners. In Australia, the test is directly provided by the company.

Mylan collaborated with Atomo Diagnostics in September last year for exclusive commercialisation rights to the test in more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America.

The deal was intended to boost access to HIV self-testing in low and middle-income countries.

Desmond Tutu HIV Foundation executive director Linda-Gail Bekker said: “HIV self-testing can be a game-changer in helping us meet the ambitious UNAIDS 90-90-90 targets, which require that 90% of all HIV positive people know their status by 2020.

“Having more high-quality and user-friendly HIV self-tests on the market, like the Mylan HIV Self Test that has been prequalified by the World Health Organization, will give us a powerful tool in expanding diagnosis and treatment of vulnerable and previously untested populations.”

The HIV Self Test obtained the European CE-Mark in October last year.

05 JULY 2019

Stanford team develops algorithm to predict cancer outcomes

Researchers at the Stanford University School of Medicine have developed a computer algorithm to predict the outcome of a cancer patient during treatment.

Inspired by a sports playbook, the new technology is designed to analyse a range of predictive data, including a tumour’s response to therapy and the blood levels of cancer DNA during treatment.

Named Continuous Individualized Risk Index (CIRI), the tool is intended to offer a single, dynamic risk assessment at any point during a treatment course.

The algorithm has also demonstrated the ability to aid in identifying patients who may benefit from early, more aggressive therapies, as well as those who may be potentially cured by standard methods.

During their study, the team gathered data from people who were previously diagnosed with diffuse large B-cell lymphoma.

As well as initial symptoms such as cancer cell type, tumour size and location from 2,500 DLBCL patients, the researchers obtained information on the amount of tumour DNA circulating in the blood from 132 patients.

Stanford University School of Medicine radiation oncology associate professor Maximilian Diehn said: “What we’re doing now is somewhat like trying to predict the outcome of a basketball game by tuning in at halftime to check the score, or by watching only the tipoff.

“We wanted to learn if it’s best to look at the latest information available about a patient, the earliest information we gathered, or whether it’s best to aggregate all of this data over many time points.”

The collected data was used to train the computer algorithm to identify patterns and combinations that could impact whether a patient lived for at least 24 months after seemingly successful therapy without a relapse.

When tested for predicting prognoses, the new technology was found to have provided a better score compared to previous approaches.

Assessment with data from previously published panels of common leukaemia and breast cancer patients showed that the aggregated approach with CIRI outperformed the standard approaches.

04 JULY 2019

Nanoprobe development could drive future human-machine interface research

Researchers at the University of Surrey and Harvard University have manufactured scalable nanoprobe arrays small enough to record the inner workings of human cardiac cells and primary neurons.

The ability to read electrical activity from cells is the foundation of many biomedical procedures, including brain activity mapping and neural prosthetics. Developing minimally invasive new tools to read the electric current running within cells – known as intracellular electrophysiology – while still pushing the limits of what is physically possible has the potential to deepen scientists’ understanding of electrogenic cells and their networks in tissues.

This opens the door for new directions in human-machine interfaces.

Harvard University Department of Chemistry professor Charles Lieber said: “The beauty of science to many, ourselves included, is having such challenges to drive hypotheses and future work. In the longer term, we see these probe developments adding to our capabilities that ultimately drive advanced high-resolution brain-machine interfaces and perhaps eventually bringing cyborgs to reality.”

The research, published in the journal Nature Nanotechnology, details how the research team produced an array of the ultra-small U-shaped nanowire field-effect transistor probes for intracellular recording.

Current nanodevices with a similar function have struggled with a trade-off between device scalability and recording amplitude. The research team were able to address this by combining deterministic shape-controlled nanowire transfer with spatially defined semiconductor-to-metal transformation to realise scalable nanowire field-effect transistor probe arrays with controllable tip geometry and sensor size, which enabled the recording of up to 100 mV intracellular action potentials from primary neurons.

University of Surrey Advanced Technology Institute professor Yunlong Zhao said: “Our ultra-small, flexible, nanowire probes could be a very powerful tool as they can measure intracellular signals with amplitudes comparable with those measured with patch clamp techniques; with the advantage of the device being scalable, it causes less discomfort and no fatal damage to the cell. Through this work, we found clear evidence for how both size and curvature affect device internalisation and intracellular recording signal.”

The new device design allows for multiplexed recording from single cells and cell networks and could enable future investigations of dynamics in the brain and other tissues.

03 JULY 2019

Boston Scientific signs bead agreement with Varian SHARE

Boston Scientific has signed an agreement to divest its drug-loadable microsphere and bland embolic bead products to cancer care solutions provider Varian Medical Systems.

Varian is set to pay $90m for the products, which are indicated for the treatment of arteriovenous malformations and hypervascular tumours.

The deal covers Boston Scientific’s drug-loadable Oncozene and Embozene Tandem microsphere as well as bland embolic Embozene bead products.

Oncozene and Embozene microspheres are calibrated microspheres that are engineered to provide better embolization control and improved visualisation during the suspension, noted Boston Scientific.

Varian expects the acquisition of the bead products to boost its new interventional oncology platform while leveraging the products’ regulatory clearances in more than 35 global markets.

Varian Medical Systems president and CEO Dow Wilson said: “This acquisition from Boston Scientific will strengthen Varian’s growing position in the high-value interventional oncology segment and is consistent with our long-term strategy to become a global leader in multidisciplinary, integrated cancer solutions.

“We look forward to completing this acquisition and are excited to add these drug-loadable microsphere and bland embolic bead products to our portfolio to provide our clinical partners with expanded advanced treatment options.”

Varian Medical Systems added that the deal does not include any Boston Scientific operations.

The companies entered transition services agreements to prevent any interruptions to product delivery before Varian implements a manufacturing and distribution plan.

The deal is scheduled to close around August this year and is subject to customary closing conditions, including the US Federal Trade Commission (FTC) approval and the closing of Boston Scientific’s proposed acquisition of BTG for $4.2bn.

The agreement comes after the FTC requested additional information and documentary material from Boston Scientific and BTG in February. In its request, the FTC highlighted Boston Scientific and BTG’s therapeutic beads businesses.

02 JULY 2019

Swiss researchers study personalised neurotechnology stroke therapy

Therapy involving the use of personalised neurotechnology could enable better rehabilitation for severe chronic stroke patients, according to a paper published in the Brain journal by Switzerland-based researchers.

The authors included scientists from the Wyss Center for Bio and Neuroengineering, Scuola Superiore Sant’Anna, Swiss Federal Institute of Technology Lausanne (EPFL), Clinique Romande de Réadaptation and the University of Geneva Faculty of Medicine.

The researchers suggest that personalised neurotechnology treatments such as brain-machine interfaces, robotics and brain stimulation could facilitate the largest therapy effects and success.

In the publication, the researchers highlight the need for longitudinal clinical studies to validate the rehabilitation effects of individual therapies and use of multiple complementary combination therapies over a long duration.

Wyss Center staff engineer and lead author Dr Martina Coscia said: “Our findings show that neurotechnology-aided upper limb rehabilitation is promising for severe chronic stroke patients. However, we also found that the ‘one size fits all’ approach doesn’t lead to the best outcome.

“We suggest a move towards a personalised combination of neurotechnology-based stroke rehabilitation therapies, ideally in a home-based environment where prolonged therapy is more feasible than in a clinic.

“We believe that by sequentially introducing stroke therapies according to individual progress, we could allow patients to continue their recovery beyond what is possible today.”

Commonly, stroke leads to impaired upper arm function. Rehabilitation therapies are known to be majorly effective in the first three months following a stroke, after which the chances of further natural recovery are considered limited.

During the research, the scientists reviewed effectiveness data from 64 clinical studies of upper limb neurotechnology-based therapies in chronic stroke patients.

This included data on robotics, functional electrical stimulation of muscles, brain stimulation and brain-computer interfaces, along with their use in combination.

Based on the findings, the team believes that a synergistic approach could pave the way for new treatments.

The researchers are set to launch a clinical trial to evaluate personalised therapy, specifically intended to maximise therapy effects in individual patients.

01 JULY 2019

UK scientists create mini MRI scanner to detect knee injuries

A research team from Imperial College London has created a mini MRI scanner with the potential to enable quick and accurate diagnosis of knee injuries.

Designed to fit around a patient’s leg, the new device is said to use ‘magic angle’ effect to help detect knee conditions such as anterior cruciate ligament injuries.

Components of the knee joints are unclear in existing MRI scans, noted Imperial College London’s MSK Lab researcher and radiographer Dr Karyn Chappell.

Chappell said: “Knee injuries affect millions of people – and MRI scans are crucial to diagnosing the problem, leading to quick and effective treatment. However we currently face two problems: connective tissue in the knee is unclear on MRI scans, and people are waiting a long time for a scan.”

To address such challenges, the researchers leveraged the magic angle effect in the new device.

The team noted that this approach allows easy orientation of the magnetic field, which is not possible with existing, expensive hospital MRI scanners.

Chappell added: “Previously the magic angle phenomenon was thought of as a problem, as it could mean medical staff mistakenly thinking the knee is injured.

“However, I realised that if we took a number of scans around the knee, we could use the signal produced by the magic angle effect to build a clear picture of the knee structures.”

When tested in a proof-of-concept study involving animal knee joints, a prototype of the mini MRI scanner was observed to facilitate the accurate identification of ligament and tendon damage.

The team intends to further their research, which was funded by the National Institute for Health Research, into human trials as well as to other joints such as ankles, wrists and elbows.

It is expected that the device’s small size would allow use in local clinics and GP surgeries.

28 JUNE 2019

Microfluidic chip could revolutionise stem cell production

Scientists based at EPFL’s Institute of Bioengineering in Lausanne, Switzerland have simulated aspects of embryo formation inside a microfluidic chip, setting the stage for fabricating functional tissues and organs for drug testing and transplantation.

In a developing embryo, stem cells receive a highly dynamic range of concentrated signalling molecules called morphogens, which tell the pluripotent stem cells what kind of specialised tissues and cells to become.

One issue clinicians face when attempting to construct tissues in vitro is how to present morphogens to the cultured cells, where the time and dose is vital.

The EPFL team discovered that this could be mitigated by growing the stem cells in a microfluidic device, a chip with small channels that allow for the precise control of tiny amounts of fluid. Using these channels, they were able to expose the stem cells to very carefully controlled concentration gradients of various morphogens.

EPFL professor Matthias Lütolf said: “Simply exposing a collection of stem cells to a single concentration of a morphogen ends in uncontrolled morphogenesis because the cells lack important instructions.”

The results of the controlled microfluidic morphogen exposure were impressive: the cells developed and organised themselves into domains of different cells types depending on the concentration of morphogens they were exposed to, just like they do in the body.

They were able to successfully mimic aspects of gastrulation, an early stage of embryonic development, paving the way for growing specific human tissues in the lab in a more controlled manner.

EPFL scientist Dr Andrea Manfrin said: “We hypothesized that engineering an artificial signaling center ‘ex vivo’ could allow us to steer the self-organization of a stem cell population towards a desired outcome. This has obvious advantages for tissue and organ engineering.”

Stem cells grown on the microfluidic chip in this way could provide the opportunity to develop new tools for drug testing and regenerative medicine. It could also enable scientists to study processes related to developmental biology and provide alternatives to animal experimentation in certain areas of research.

Lütolf, who is already working with groups at the Lausanne University Hospital and beyond to generate miniaturised organs from patient-derived cells, said: “One of our long-term goals is to engineer organs for transplantation. We are still far from growing functional organs in a dish; but recent progress in stem cell biology and bioengineering make me optimistic that this can become a reality. The key is to better understand how cells themselves build tissues and organs in the embryo”.