industry news

Clinicians at Children’s Hospital Los Angeles have found a way to glean genetic tumour information from the aqueous humour liquid inside the eye, which could provide a novel way to biopsy retinoblastomas.

Most cancers are biopsied and studied so the medical team can design targeted treatments for patients, but this isn’t possible with retinoblastoma as the tumour is like liquid and has cells all over the eye. In the absence of molecular tests, ophthalmologists must look for anomalies in the eye and use ultrasound imaging to diagnose the disease. However, using genetic information biopsied from the aqueous humour – the liquid in the front part of the eye – clinicians may be able to make more accurate diagnoses.

This type of biopsy would also allow researchers to study the disease on a molecular level, which has led to successful new treatments for other cancers.

Retinoblastomas form in the light-detecting cells at the back of the eye, typically in children under two years of age, and can lead to blindness or eye removal.

Retinoblastoma cells also spread easily, and direct biopsy can cause relapse or spread of the disease outside of the eye.

While blood tests can also help make a retinoblastoma diagnosis, these aren’t always accurate or useful.

Children’s Hospital Los Angeles associate director of ocular oncology Dr Jesse Berry said: “It would be easier if we could get tumor information that way, but in our study there was no sign of retinoblastoma in blood samples.

“Many children actually have retinoblastoma tumors in both eyes. If we were to test the blood and find a positive result, we wouldn’t actually know which eye it was from. Instead, aqueous humor biopsies give us specific information for tumors in each eye.”

Berry’s research has also shown that genetic factors can predict treatment success for a given tumour.

Berry said: “Aqueous humor biopsy has potential to become the new standard of care for retinoblastoma. It is our best chance to diagnose and treat these patients on a molecular level.”

Cancer Research UK has announced a £56m research network to transform the UK into a global hub for radiotherapy study.

By leveraging the use of the latest techniques, such as FLASH radiotherapy and artificial intelligence (AI), the network aims to accelerate the development of advanced radiotherapy.

The network, Cancer Research UK RadNet, will bring together the Universities of Cambridge, Glasgow, Leeds, Manchester and Oxford, as well as the Cancer Research UK City of London Centre, The Institute of Cancer Research and London in partnership with The Royal Marsden NHS Foundation Trust.

Cancer Research UK chief executive Michelle Mitchell said: “Radiotherapy is a cornerstone of cancer medicine, with around 3 in 10 patients receiving it as part of their primary treatment. The launch of our network marks a new era of radiotherapy research in the UK.

“Scientists will combine advances in our understanding of cancer biology with cutting-edge technology to make this treatment more precise and effective than ever before”.

The network aims to explore flash radiotherapy, which delivers pulses of radiation in high doses within a fraction of a second so healthy tissues surrounding the tumour get less damaged compared to conventional radiotherapy.

The network will also investigate the use of proton beam therapy technique to improve cancer patients’ survival rate. The proton beam therapy emits out beams of protons, rather than photons, to kill cancer cells.

Cancer Research UK RadNet will explore different approaches to overcome hypoxia, a condition of low oxygen within tumours. Such tumours react far less to radiotherapy. Researchers aim to find methods to identify hypoxic tumours, investigating treatments to oxygenate them.

It will also study the role of cancer stem cells and why some cancers reappear despite radiotherapy.

The network aims to develop drugs for use in combination with radiotherapy.

Furthermore, the network aims to leverage AI to provide personalised treatment guided by data drawn from patients’ scans.

Cancer Research UK trustee Adrian Crellin said: “I’ve seen first-hand how successful radiotherapy can be for patients that I treat but it’s been frustrating to see the UK lagging behind other countries when it comes to prioritising research into this vital treatment.

“Cancer Research UK’s investment will overhaul radiotherapy research in the UK to bring the next generation of treatments to patients sooner.”

An open-source database of genomic variants in health and disease has been developed by Australian and North American researchers to simplify the sharing of this information between academics.

The MaveDB database stores data from multiplex assays of variant effect (MAVE) experiments, which systematically measure the impact of thousands of individual sequence variants on a gene’s function. It was developed by researchers from the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia, as well as the University of Washington in the US and the University of Toronto in Canada.

MAVE experiments provide valuable information about how genetic proteins function, how genetic variants may contribute to disease, and how to engineer synthetic versions of naturally occurring proteins that are more effective than the original protein.

Until now, MAVE data from experiments has either been uploaded to journal websites or provided on request to other researchers. This has made it hard for clinicians to access the data of other groups, or even know if a particular MAVE experiment has been carried out elsewhere in the world, hindering both collaborations and the progress of genomics research.

Walter and Eliza Hall Institute bioinformatics researcher Dr Alan Rubin said: “MaveDB makes it easier for scientists to share their datasets in a single location, using a flexible format that is applicable to multiple research fields, and enables other scientists to easily access this data to enhance their research.

“We’ve also ensured MaveDB can ‘talk’ to other databases to add an extra level of collaborative capacity. For the growing field of MAVE research this database is an important step towards open science and reproducibility by ensuring data is made available.”

Alongside MaveDB the team developed a data visualisation platform called MaveVis, which makes it easier for researchers to understand and interpret the results of MAVE experiments.

Rubin said: “MaveVis provides an immediate and consistent display for MAVE data, including valuable annotations such as protein structure information, that will accelerate collaborative research.”

The research was funded by the Brotman Baty Institute for Precision Medicine, the US National Institutes of Health, the Canadian Institutes of Health, the Lorenzo and Pamela Galli Charitable Trust, the Australian National Health and Medical Research Council and the Victorian Government.

Mental health clinics in London’s Harley Street medical district have partnered with Flow Neuroscience to offer patients the company’s deep brain stimulation treatment for depression.

Facilities including the Chelsea Psychology Clinic will now offer patients Flow’s headset as an add-on treatment in combination with traditional talking therapies and psychiatric services.

The Flow headset directs transcranial direct current stimulation (tDCS) into the dorsolateral prefrontal cortex, an area of the brain associated with cognitive skills and emotional expression where depressed patients often have reduced neural activity. The tDCS is intended to activate neurons in this area and rebalance the brain’s activity. Randomised controlled trials published in the New England Journal of Medicine and the British Journal of Psychiatry have shown that this type of tDCS had a similar impact to antidepressants but with fewer and less severe side effects in general.

tDCS has been associated with skin irritation at the site of the headset, and some patients undergoing tDCS have experienced tinnitus and nervousness. Two patients undergoing tDCS in one trial also experienced a period of mania.

Chelsea Psychology Clinic clinical director Dr Elena Touroni said: “We pride ourselves on treating mental health conditions in an integrated, therapeutic approach. With Flow’s brain stimulation headset our highly respected experts now have a new tool to treat depression and help patients overcome their mental health challenges.”

The headset is the first and only depression treatment of its kind to be approved in the UK and the EU. As well as now being deployed in select clinics, the device can be directly purchased by patients for £399.

Flow Neuroscience CEO Daniel Mansson said: “Integrating the Flow brain stimulation headset with the standard practice of treating mental health is of great benefit to the patient but also to the clinician who can now provide an effective and accessible option for the treatment of depression. We’re starting talks with the NHS to have our headset available on prescription.”

The first saliva test to detect if someone has recently taken the drug known as ‘spice’ has been developed at the University of Bath.

The saliva test can be completed on the spot and takes about five minutes. It can identify whether spice has recently been smoked, and if so which variant it has come from and how concentrated the dose was.

Spice poses a significant risk to public health, but there is currently no point-of-care test to see if someone has recently taken it. The team that developed the test hopes it can be used by health professionals to treat people suffering from adverse effects of the drug.

Many people who experience adverse effects from spice are found unconscious, incoherent or experiencing psychosis. Without being able to test for spice, a precautionary approach is often followed, which might not be the optimal course of treatment.

People undergoing temporary spice-induced psychosis may also be unnecessarily admitted to a psychiatric ward, putting pressure on already scarce NHS resources.

University of Bath senior lecturer of pharmacy and pharmacology Dr Jenny Scott said: “Detection and confirmation of spice use early on when someone is found incoherent gives a chance to start timely treatment for their symptoms. Further down the line, we can foresee the kit being used as part of a care pathway that avoids the need to hospitalise some patients if appropriate healthcare can be given where they are.”

Spice can be made from a mixture of more than 100 man-made chemicals, which is why it can be so difficult to test for. Its presence can be detected with a urine or blood sample in a laboratory, but this takes days to process and is pointless for patients needing on-the-spot care.

The research team now wants to further develop the prototype to optimise it for use in clinical settings, and hopes to be able to trial it with medical professionals within a year.

University of Bath senior lecturer of biology and biochemistry Dr Chris Pudney said: “We’ve proved the concept with a test that’s simple and very accurate. The hardware is compact and portable and the results are easy to understand. We’re working on software now, so that the user has a simple ‘one click’ way to use it.

Researchers from Florida Atlantic University’s College of Engineering and Computer Science have collaborated with the Icahn School of Medicine and the University of Rochester Medical Center to develop machine-learning algorithms to track tremors in patients suffering from Parkinson’s Disease.

Around seven to ten million people worldwide suffer from Parkinson’s, the second-most age-related neurodegenerative disorder.

The most significant problem in Parkinson’s is tremor, an involuntary movement disorder that affects the daily activities of patients.

Typically, neurologists measure the tremors using the Unified Parkinson’s Disease Rating Scale (UPDRS).

However, UPDRS is an onsite physical examination method that offers only a glimpse of the tremors that patients experience in their everyday activities.

FAU department of computer and electrical engineering and computer science assistant professor Behnaz Ghoraani said: “A single, clinical examination in a doctor’s office often fails to capture a patient’s complete continuum of tremors in his or her routine daily life.

“Wearable sensors, combined with machine-learning algorithms, can be used at home or elsewhere to estimate a patient’s severity rating of tremors based on the way that it manifests itself in movement patterns.”

Researchers have investigated the application of two machine-learning algorithms, gradient tree boosting and LSTM-based deep learning.

Results from the study showed that the gradient tree boosting method estimated total tremor and resting tremor sub-score with high accuracy and in majority cases with the same results determined through the UPDRS.

Patients also experienced a decline in tremors after taking medication, even in cases where results did not match with the total tremor sub-scores recorded through the UPDRS assessments.

Out of all existing UPDRS task-dependent methods and task-independent tremor estimation methods, this process is claimed to have provided the highest performance results.

Meanwhile, in a separate development, Medtronic has launched its advanced Patient Programmer technology for Deep Brain Stimulation (DBS) therapy at the Samsung Developers Conference in San Jose, California.

Berlin-based Siemens Healthineers has closed its $1.1bn acquisition of US-based Corindus Vascular Robotics.

Corindus manufactures robotic systems for minimally invasive procedures, while Siemens’ products use quality imaging before and during medical interventions to make minimally invasive treatment possible.

At a shareholders’ meeting held last week, 87.5% of its stockholders approved the acquisition.

The deal had earlier gained approval from the regulatory authorities.

Siemens Healthineers CEO Bernd Montag said: “With the completion of the acquisition, we are opening up a new field for our Advanced Therapies business, tapping into adjacent growth markets with great potential for the future. We are taking an important step forward in the upgrading phase of our 2025 strategy.”

Following the completion of the deal, Massachusetts-based Corindus has become a part of the Advanced Therapies reporting segment.

Corindus former president and CEO Mark J Toland said: “The combination of Siemens Healthineers’ strong medical technology portfolio with its digital platforms and solutions, together with Corindus’ precision robotics platform, has the potential to transform healthcare delivery so that, together, we can provide better care at lower cost.”

Toland will continue to be responsible for managing Corindus Vascular Robotics within Siemens Healthineers.

Following the acquisition, Siemens’ role in image-based minimally invasive procedures will now be complemented by robotic-assisted precision medicine.

This acquisition expands Siemens’ Advanced Therapies business, combining its cardiovascular and neuro-interventional therapy systems with Corindus’s technology for image-based minimally invasive therapies.

In August, Siemens Healthineers had signed a definitive agreement to acquire Corindus Vascular Robotics for a deal valued at $4.28 per share in cash or $1.1bn in total.

MedRhythms, a US-based digital therapeutics company, has launched its five-site randomised controlled trial (RCT) at rehabilitation hospitals and research centres to examine a post-stroke walking rehabilitation device.

This is the first product in the company’s pipeline of digital therapeutics.

This RCT will study the product’s effect on walking among a group of patients who are stroke survivors and have post-stroke walking impairments.

It is estimated that 3.5 million people in the US live with walking deficits due to chronic stroke, and this number will rise by 465,000 individuals every year.

MedRhythms aims to address this unmet medical need by developing the therapeutic.

MedRhythms co-founder and CEO Brian Harris said: “This clinical trial marks an important milestone toward MedRhythms’ mission to make this high-quality intervention available to those who need and deserve to have it.

“As this new industry grows, it is important for digital therapeutics to demonstrate efficacy with the support of rigorous clinical trials, and this RCT is an integral step in MedRhythms’ evidence generation strategy to do so.”

The clinical trial will be carried out at Shirley Ryan AbilityLab in Chicago, the Kessler Foundation in New Jersey, Mt. Sinai Hospital in New York, Spaulding Rehabilitation Hospital in Boston, and the Boston University Neuromotor Recovery Laboratory in Boston.

This study is being launched after completing a feasibility study in the target population, which took place at the Boston University Neuromotor Recovery Lab.

The company will announce the results of the feasibility study at the American Physical Therapy Association’s annual Combined Sections Meeting in February 2020 in Denver, Colorado.

MedRhythms’ Mount Sinai clinical trial site principal investigator David Putrino said: “Right now, the MedRhythms digital therapeutic technology is a novel treatment for a subset of individuals that have few, if any, effective treatment options.

“The mission of the ARC is to identify and validate novel technologies that have the potential to significantly enhance the rehabilitation of people who are recovering from brain injuries and neurological conditions, including chronic stroke. The digital therapeutics industry has the potential to transform rehabilitation and disrupt healthcare, and it is imperative for companies in this space to run full-scale, multisite RCTs like MedRhythms is doing.”