industry news

Caris Life Sciences, a molecular profiling offerings provider, has received breakthrough device designation from the US Food and Drug Administration (FDA) for its MI Transcriptome companion diagnostic (CDx) test.

The whole transcriptome sequencing-based assay, which detects gene fusions in solid tumours, is meant to help identify patients who could benefit from treatment with specific targeted therapies.

It analyses RNA extracted from formalin-fixed paraffin embedded (FFPE) tumour tissue to detect all structural rearrangements classes such as fusions, deletions, inversions and duplications.

The in-vitro diagnostic test could also measure expression and splice variants in cancer patients.

FDA granted the breakthrough status to detect FGFR biomarkers including gene fusions in solid tumours.

The companion diagnostic can differentiate between various fusion types as well as fusions from other rearrangements.

Caris Life Sciences added that the assay has the potential to find previously uncharacterised events. This is considered useful to identify patients who may have strong response to targeted therapy.

In addition, it could offer tumour profiling data for use by qualified health care professionals.

Caris Life Sciences president and chief scientific officer David Spetzler said: “RNA-based sequencing analysis is emerging as the best method to detect clinically relevant fusions.

“MI Transcriptome CDx, which is enabled by Whole Transcriptome Sequencing, provides information on all genes that are expressed in the cancer, which allows the most complete assessment of a patient’s tumor to inform more targeted treatment.”

The company intends to file for pre-market approval of the companion diagnostic later this year.

MI Transcriptome is expected to be the first companion diagnostic to help identify patients with fusions who could be eligible for pan-cancer treatment.

Scientists at Ruhr-Universität Bochum (RUB) in Germany have developed a blood test that could help identify Alzheimer’s disease nearly eight years before the initial clinical symptoms appear.

Existing techniques detect the disease only after the formation of plaques in the brain, a stage when therapy is not effective.

Based on the information that first protein level changes by Alzheimer’s occur up to 20 years sooner, the German team developed a two-tier approach to detect the neurodegenerative disease in the blood at an early stage.

In 2016, the researchers developed a blood test that could identify the amyloid beta protein misfolding.

Even though the test was able to diagnose the disease in symptomless stages in 71% of the cases, it was considered unsuitable for clinical application because of its false positive diagnoses for 9% of the subjects.

To reduce the false positives, the new approach employs the original blood test to identify high-risk individuals followed by an additional test for tau protein, a dementia-specific biomarker.

People who test positive in the first step are subjected to the second test conducted using cerebrospinal fluid from the spinal cord, and those testing positive for both biomarkers are considered at high risk for developing Alzheimer’s.

In a study, the two-tier approach was able to correctly identify 87 out of 100 patients, with false positives in healthy subjects being three of 100.

The researchers believe that the new test offers hope for early-stage therapies.

RUB biophysics department professor Klaus Gerwert said: “Now, new clinical studies with test participants in very early stages of the disease can be launched.

“Recently, two major promising studies have failed, especially crenezumab and aducanumab – not least because it had probably already been too late by the time therapy was taken up. The new test opens up a new therapy window.”

The test has been devised as a fully automated sensor and further research is being conducted to better detect the tau protein.

This research has been published in the Alzheimer’s and Dementia: Diagnosis, Assessment and Disease Monitoring journal.

ClinSpec Diagnostics, a spinout of the University of Strathclyde in the UK, has announced the development of a new blood test to enable early identification of brain cancer.

The test is said to be inexpensive and can deliver accurate results in a short timeframe, which in turn could cut delays in referral times.

It is based on the work by University of Strathclyde researcher Matthew Baker, who devised infrared spectroscopy-based approaches to analyse blood serum for the detection of cancer.

Baker developed the diagnostic algorithm in alliance with a colleague, David Palmer.

The new blood test is believed to possess the potential to offer information on the type and severity of the cancer. Doctors can use the information to prioritise and fast-track appropriate and effective therapies.

Currently, clinical studies are being conducted in Edinburgh to accelerate the development of the technology. The blood test is expected to be available for use in UK hospitals in three to four years.

ClinSpec Diagnostics is working to create additional blood tests for other diseases, including pancreatic and prostate cancer.

Scotland Business Minister Jamie Hepburn announced a funding of £600,000 to support the company’s spinout as well as development of the brain cancer test.

Hepburn said: “The blood test demonstrates significant advancements in cancer detection methods, and will play a vital role in helping to save lives. This technology also paves the way for similar blood tests to be developed in the future for other diseases.”

Brain cancer, which is difficult to detect and diagnose, is characterised by headaches, a common symptom in multiple other health conditions that may not be life threatening.

At present, nearly 38% of patients make more than five visits to their GP before being diagnosed with brain cancer, while 62% are only identified in an emergency. This is believed to be the reason for reduced life expectancy associated with brain cancer, compared to other cancers.

Abbott has partnered with the US Department of Defense (DoD) and the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Network for a clinical trial to assess its blood test technology for concussions.

The point-of-care test is being developed to facilitate evaluation of brain injuries within minutes. It is designed to measure the GFAP and UCH-L1 proteins released into the blood stream when the brain is injured.

As part of the new trial, the partners will analyse findings from patients visiting certain trauma centres across the US.

The US Food and Drug Administration (FDA) cleared a blood test to identify brain injury within 12 hours of injury.

Abbott’s research is intended to assess individuals with suspected TBI within 24 hours of injury. Blood test results from these people will be compared with standard clinical assessments, computerised tomography (CT) scans, magnetic resonance imaging (MRI) scans and clinical outcomes.

The concussion assessment test is being devised for the next generation i-STAT Alinity system that is used by the military and hospitals to run common blood tests at point-of-care using just two to three drops of blood.

Abbott Diagnostics medical director Beth McQuiston said: “Developing a blood test for the brain takes robust, proven data and collaboration among the best minds in academia, industry and the public service sectors.

“This type of blood test could give clinicians more real-time, objective information about what’s happening to the brain, so they can make timely, accurate decisions right at the point of care.”

Over the past two decades, more than 380,000 military members have sustained TBIs. The DoD teamed up with Abbott in 2014 to create a portable blood test for assessing concussions at bedside.

US Army Medical Materiel Development Activity Neurotrauma and Psychological Health Project Management Office project manager Krista Caudle said: “Having a portable biomarker technology will give clinicians an objective measure of a soldier’s brain injury in a matter of minutes and could potentially impact the care they receive when they are evaluated and treated.”

Researchers at Odin Vision, a spinout from University College London (UCL), have developed an artificial intelligence (AI) system that will leverage space technology to help doctors identify bowel cancer.

The cloud-based system detects and characterises polyps via analysis of live colonoscopy video. This is expected to facilitate early detection and treatment of the cancer.

It is being developed under the Early Diagnosis Real-Time Healthcare System for Cancer (EARTH SCAN) project, which will utilise satellite communications along with the data compression software commonly used to operate space missions.

This space technology is set to allow use of the system globally. The project is being supported by a £1m grant from the UK Space Agency, with support from NHS England and the European Space Agency, as part of an overall £5m grant awarded in June 2018 to mark the 70th birthday of the NHS.

Odin Vision CEO Peter Mountney said: “We are moving into a new era of healthcare where AI will support doctors to identify and diagnose cancer faster and more effectively.

“The EARTH SCAN project is an exciting opportunity to use satellite technology to bring this AI support to doctors in real time. Real time support means doctors can make immediate decisions regarding treatment and patients can receive the results of their scan straight away instead of waiting weeks.”

A clinical trial is being planned to be conducted next year at University College Hospital (UCH) to test the AI system for detecting bowel cancer. Early diagnosis of the cancer is associated with 90% survival rate.

The UK Space Agency has also awarded £2m in funding to the University of Leicester, for the creation of a new mobile application intended to help patients with conditions that could be exacerbated by pollution, such as asthma.

The app will use data from Earth Observation satellites, which map regions with pollution, along with AI to suggest personalised exercise routes for these patients. It offers warnings at the local level to within 10m.

Researchers at the University of Michigan Kellogg Eye Center have demonstrated the effectiveness of a smartphone technology that combines high-quality retinal imaging with artificial intelligence (AI) to enable the early detection of diabetic retinopathy (DR).

DR is a complication of diabetes caused by high levels of blood sugar damaging the back of the eye. While it can take several years for the condition to reach a stage where it threatens a patient’s sight, when is does it can lead to permanent vision loss.

Lead author of the study and vitreoretinal surgeon Yannis Paulus said: “The key to preventing DR-related vision loss is early detection through regular screening. We think the key to that is bringing portable, easy-to-administer, reliable retinal screening to primary care doctors’ offices and health clinics.”

The team at the Kellogg Eye Center worked to develop a device which turns a smartphone into a retinal camera, known as the RetinaScope. While traditional retinal cameras are expensive, large, immobile devices which require specialist training to operate, RetinaScope is cheap and easy to use with no specialist training necessary.

RetinaScope was used to collect data from 69 adult patients with diabetes seen in the Kellogg Eye Center Retina Clinic. The images of the patients’ retinas taken after induced pupillary dilation were analysed with an AI eye screening system known as EyeArt, which graded them as referral-warranted diabetic retinopathy (RWDR) or non-referral-warranted DR.

The same images were also independently evaluated by two expert readers trained to recognise signs of DR.

These results were assessed alongside previously-recorded results of dilated slit-lamp fundus examinations by their treating clinicians, which had confirmed RWDR in 53 of the subjects. A silt-lamp exam is a standard diagnostic procedure, also known as a biomicroscopy, where a doctor shines a bright light into a patient’s medically dilated eye and examines it through a microscope to look for abnormalities.

The study measured two factors: whether the AI screening method was sensitive enough to detect disease, and if it was specific enough to confirm its absence.

The AI interpretation had a sensitivity of 86.8%, well above the 80% recommended for an ophthalmic screening device, and specificity of 73.3%. While one of the human image graders did achieve a significantly higher level of sensitivity at 96.2%, both had far lower specificity, at 40% and 46.7%.

Encouraged by these findings, Paulus and his team are now looking into how to improve the technology, notably seeking a way to make it work without inducing pupillary dilation in patients. They will also be seeking US Food and Drug Administration (FDA) clearance to roll out the test commercially.

“We’re focused on overcoming patients’ reluctance to seek DR screening by bringing it to them, making it easy, immediate, and available in a familiar clinical environment,” Paulus said.

Researchers from the Stanford University School of Medicine have devised a new blood test for the identification of chronic fatigue syndrome (CFS), a debilitating condition that lacks a standard diagnostic test.

CFS sufferers can often have their symptoms written off as malingering, because the diagnostic test results for organ function and blood and immune cell counts all are normal in these patients.

The new test is based on how a person’s immune cells respond to stress. It is powered by a diagnostic technology that comprises electrodes to produce electrical current, and chambers to hold blood samples containing immune cells and plasma.

In the chambers, the presence of immune cells and plasma interferes with the current and changes its flow. This change in electrical activity is directly linked to the health of the sample.

The researchers used salt to stress the samples from healthy individuals as well as patients, and compared their effect on the flow of the electrical current. A greater change in current is associated with flailing of the immune cells and plasma.

Stanford University School of Medicine biochemistry and genetics professor Ron Davis said: “We don’t know exactly why the cells and plasma are acting this way, or even what they’re doing.

“But there is scientific evidence that this disease is not a fabrication of a patient’s mind. We clearly see a difference in the way healthy and chronic fatigue syndrome immune cells process stress.”

When assessed in 20 people with chronic fatigue syndrome and 20 individuals without the disease, the new diagnostic was able to accurately identify all patients and did not flag the healthy individuals.

Currently, the team is working on validating the test in a larger population.

The diagnostic is also said to have the potential to help in identifying possible drugs for the condition.

This will be possible by exposing blood samples to therapeutics and then performing the diagnostic test, which would offer information on whether the drug candidate improved the immune cells’ response.

The researchers have started evaluating the technology’s capability to screen for potential drugs.

Steen Solution Perfusate to heSwedish medical technology firm Xvivo Perfusion has received the US Food and Drug Administration (FDA) approval for the use of its Xvivo Perfusion System with lp in lung transplant procedure.

The device is meant to temporarily ventilate, oxygenate, and pump or perfuse preservation solution through lungs that were believed to be unacceptable for transplant.

Pumping the lungs with a solution outside the human body enables a better evaluation of lung function. This helps surgeons to then decide if the lungs are viable for transplant.

Xvivo Perfusion System, which comprises a perfusion cart with mechanical and electrical components, is expected to improve access to more lungs for transplant.

FDA Division of Reproductive, Gastro-renal, Urological Devices director Benjamin Fisher said: “Sadly, too many patients on transplant lists die waiting for suitable lungs.

“Providing patients with access to safe medical devices that have the potential to be lifesaving remains a top FDA priority, and we support the development of innovative technologies that can increase the donor organ pool for transplant patients in need of suitable lungs.”

The agency’s decision was based on findings from a study that evaluated 332 sets of donor lungs assigned into three groups.

The first control group had lungs that were initially deemed suitable for transplant and were provided to 116 recipients after standard preservation.

The second group involved lungs deemed unsuitable for transplant and after being perfused with the Xvivo Perfusion System implanted into 110 recipients, while the third group were perfused with the device and were still deemed unsuitable, and not implanted.

In the control group, the one-year survival rate was 94% compared to 86.4% for the lung perfusion patients. This difference was not considered as clinically significant.

The Xvivo Perfusion System previously secured the FDA marketing authorisation in 2014 as part the humanitarian device exemption (HDE) regulatory pathway that limits its use to a maximum of 8,000 patients per year.

This latest premarket approval lifts the limit on yearly patient use.