UNIVERSITY OF NOTTINGHAM TEAM DEVELOPS NEW PROBE FOR DISEASE DIAGNOSTICS
03 May | diagnostics
Researchers at the University of Nottingham in the UK have created an ultrasonic imaging system, which can be inserted into the human body for three-dimensional visualisation of cell abnormalities.
Presently in prototype stage, the non-invasive imaging tool called ‘phonon probe’ will be positioned on the tip of a hair-thin optical fibre.
It could be inserted into a standard optical endoscope, a thin tube with a light and camera at the end. This can be steered into the body to detect, assess and operate on cancerous lesions, as well as several other diseases.
Delivering microscopic and nanoscopic resolution images, the technology can potentially aid doctors in assessing cells in hard-to-reach body parts, such as the gastrointestinal tract. It is also expected to provide better diagnoses for various diseases, including gastric cancer and bacterial meningitis.
Scientists noted that merging optical and phonon technologies could accelerate the clinical workflow process and cut down invasive test procedures for patients.
Funded by the Engineering and Physical Sciences Research Council, the phonon probe is a compact system with a performance level that is currently achievable only in research labs with large scientific instruments, the researchers said.
The probe can be deployed in clinical settings to enhance patient care and can lower the requirement of standard fluorescent labels.
Fluorescent labels, which are chemicals used for analysing cell biology under a microscope, can harm human cells in high doses.
The team now plans to work with the Nottingham Digestive Diseases Centre and the Institute of Biophysics, Imaging and Optical Science to design various biological cell and tissue imaging applications for the development of a viable clinical tool.
03 MAy | innovation
INDIAN START-UP 30M GENOMICS DEVELOPS FIVE-SECOND DNA EXTRACTION KIT
Indian start-up 30M Genomics has developed a new technology called AmpReady for extracting DNA from biological sample in five seconds without requiring any equipment.
30M Genomics, which focuses on point-of-care genetic diagnostics, was incubated at Association for Scientific Pursuits for Innovative Research Enterprises (ASPIRE)-BioNEST at the University of Hyderabad (UoH).
A single vial of reagent, AmpReady works with addition of the recommended quantity of biological sample and mixing well for extracting DNA.
It can be used with any biological sample, including human, animal, plant or microbes.
The extracted DNA sample can be used for downstream applications such as polymerase chain reaction (PCR), quantitative PCR and isothermal assays.
03 may | testing
GUARDANT HEALTH’S BLOOD TEST PREDICTS RISK OF COLORECTAL CANCER RECURRENCE IN STUDY
Guardant Health has reported that its first blood-only liquid biopsy for detecting minimal residual disease (MRD) was able to identify stage I-IV colorectal cancer (CRC) patients with increased risk of recurrence, with greater sensitivity.
Named Guardant Reveal, the liquid biopsy test does not require tumour tissue to detect genetic information in samples, on contrary to existing standard MRD tests.
In early-stage CRC patients, the presence of circulating tumour DNA or MRD following curative intent therapy is considered a key prognostic biomarker for the recurrence of cancer.
The new test showed 91% sensitivity in detecting circulating tumour DNA by examining both genomic and epigenomic alterations of longitudinal surveillance samples in a single-center, prospective clinical study.
30 april | trials
BD TREATS FIRST SUBJECTS IN STUDY OF WAVELINQ SYSTEM FOR FISTULA CREATION
Becton, Dickinson and Company (BD) has treated the first subjects with the WavelinQ EndoAVF System in a post-market surveillance study to prove its role in arteriovenous (AV) fistula creation.
Using the WavelinQ EndoAVF System, doctors can create an AV fistula, for patients who require hemodialysis to survive, in a less invasive manner.
The system uses two thin, flexible, magnetic catheters and a burst of RF energy to make an endovascular AV fistula.
Its 4F, low profile builds anatomical fistula location options and permits extra venous wrist access points (ulnar vein or radial vein), giving expanded procedural flexibility to doctors, while aiding in lowering the risk of scarring or arm disfigurement for patients, which can be caused by open surgical AV fistula creation.
Named ‘CONNECT-AV’, the prospective, single-arm, open-label study will follow up the treated subjects for a duration of 24 months. BD plans to enrol 280 subjects in the study in the US.
The percentage of participants dialysing using successful two-needle cannulation for at least 75% of the dialysis sessions over a continuous 28-day period at six months and those maintaining primary patency at six months, will form the dual primary effectiveness endpoints of the study.
Freedom from device and procedure-related serious adverse events through 30 days will be the primary safety endpoint.
29 April | testing
UK’S MASS COVID-19 TESTING POLICY UNLIKELY TO REDUCE TRANSMISSION, SAY EXPERTS
Encouraging twice-weekly home testing for Covid-19 for all adults in England and Scotland is a misguided policy that is unlikely to reduce transmission, public health experts have warned in the BMJ.
Public health consultants Angela Raffle and Mike Gill wrote that, without training and proficiency testing for those taking and reading samples alongside a robust process ensuring appropriate actions follow a test result, “SARS-CoV-2 self-testing by asymptomatic members of the public is unlikely to reduce transmission.”
Raffle told Medical Device Network: “Some testing in asymptomatic people is of course essential, for example in an outbreak, for close contacts, in certain workplaces etc. It is the use of testing for millions of low risk people that we are questioning in our editorial.
"So the cornerstone of testing needs to be for suspected cases, their contacts, and where there is high risk, and all delivered to high quality with support for people who need to isolate.”
The academics said the cost-benefits for testing the nation twice a week are “not known” and “no plans are in place to measure them”, adding that there is no empirical data to support mass screening.
29 april | grants
HELIO HEALTH, NCC RECEIVE GRANT TO ACCELERATE LIVER CANCER TEST IN CHINA
The Ministry of Science and Technology of China has awarded a grant to Helio Health and the Chinese National Cancer Center (NCC) to expedite the development of the Helio Liver Test for early identification of hepatocellular carcinoma (HCC) or liver cancer.
Helio will collaborate with the NCC to put the grant towards a study that will assess the performance of the blood test in real-world screening settings.
The Helio Liver Test is a cell-free DNA methylation blood-based assay, which can be carried out using a simple blood draw.
The prospective study will be blind and involve around 3,000 participants in China.
It will evaluate the sensitivity and specificity of the Helio Liver Test versus existing standards of care for liver cancer detection.
It is currently enrolling participants at Jiangsu Provincial Center for Disease Control and Prevention.
The Helio Liver Test is also currently undergoing analysis in a US multi-centre, prospective trial as well as being under regulatory review for registration by the China National Medical Products Administration.
FDA GRANTS BREAKTHROUGH STATUS TO MEDTRONIC’S ABLATION CATHETER
The US Food and Drug Administration (FDA) has granted breakthrough device designation status to Medtronic’s investigational device, the Emprint ablation catheter kit.
FDA AUTHORISES NEUROLUTIONS’ STROKE PATIENT MUSCLE REHABILITATION DEVICE
The US FDA has authorised the marketing of Neurolutions’ IpsiHand Upper Extremity Rehabilitation System, which aids in rehabilitation for stroke patients with upper extremity (hand, wrist and arm) disability.
SPEEDX OBTAINS CE-IVD MARK FOR TWO-GENE SARS-COV-2 TEST
SpeeDx has received CE-IVD marking for its two-gene PlexPCR SARS-CoV-2 assay for identifying the SARS-CoV-2 virus that causes Covid-19.
Targeting the RdRp and ORF1ab conserved regions of the SARS-CoV-2 genome, the assay can detect all known circulating variants of the virus.
STRATHCLYDE SCIENTIST GETS MRC FUNDING TO DEVELOP BIO-ARTIFICIAL ARTERIES
A scientist at the University of Strathclyde in Scotland has received funding worth $523,624 (£377,000) from the UK Medical Research Council (MRC) to develop a bio-artificial artery for treating cardiovascular diseases.
The bio-artificial artery will be made using human cells and vascular matrix proteins. It will contain no synthetic materials. If successful, it could potentially be used to bypass blocked arteries in cardiovascular disease patients.
FDA GRANTS 510(K) CLEARANCE TO GETINGE’S VENTILATOR SOFTWARE OPTIONS
The US FDA has granted 510(k) clearance to Getinge’s new software options for the Servo-u and Servo-n ventilators as well as the novel Servo-u MR ventilator for the MRI room.
29 april | DEALS
NIH GRANTS FUNDING TO XTRAVA HEALTH’S COVID-19 ANTIGEN TEST
The US National Institutes of Health (NIH) has awarded a $6.2m contract to Xtrava Health to accelerate the launch of its SPERA COVID-19 antigen test.
This easy-to-use antigen test only needs shallow nasal swabs and delivers results in 15 minutes or less.
Currently, the test is being analysed in clinical trials for use in point-of-care settings.
Following these tests, the company plans to begin over-the-counter trials. Increased sensitivity will be achieved by combining the test with a smartphone app and portable digital reader.
Xtrava Health CEO Sameh Sarhan said: “We are honoured to be selected as part of the Rapid Acceleration of Diagnostics (RADx) initiative to help significantly increase the number, type and availability of Covid-19 tests, which is essential to a full reopening of the economy.
“For the point-of-care market, our ability to quickly deliver millions of easy-to-use rapid antigen tests should contribute to the overall effort, with a subsequent over-the-counter test that will further maximise the impact.”
The contract was selected as part of the RADx programme after meeting the necessary milestones and having Xtrava Health’s technology and scale-up plans examined by clinical, diagnostics industry and academic experts.
28 APRIL | APPROVALS
CLEP APPROVES BIOMARKER ASSAYS FROM EUROFINS AND TRANSPLANT GENOMICS
The New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved two non-invasive tests from Eurofins Viracor and Transplant Genomics that aid clinicians in analysing rejection status in kidney transplant recipients.
Eurofins Viracor and Transplant Genomics are part of the Eurofins Transplant Diagnostics group.
The Viracor Transplant Allograft Rejection Check donor-derived cell-free DNA test and TruGraf blood gene expression test aid health care providers in making decisions that help kidney transplant recipients achieve better long-term outcomes.
At present, invasive and expensive organ biopsy is the gold standard method of rejection diagnosis and surveillance, but it can cause additional complications for patients.
Viracor TRAC can be used to non-invasively identify rejection in renal transplant patients in the early stages.