Roche introduces self-sampling solution for cervical cancer screening
17 JUNE | Diagnostics
Roche has introduced a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark in order to extend screening options for cervical cancer.
Screening for HPV can help identify individuals at risk of developing cervical cancer.
The solution from Roche allows patients at healthcare facilities to collect the sample needed for HPV screening in private.
The clinically validated vaginal sample is subsequently assessed on a Roche molecular instrument with the Roche cobas HPV test.
This test is indicated for routine cervical cancer screening to analyse cervical precancer and cancer risks according to professional medical guidelines.
The screening includes HPV primary screening, co-testing (or adjunctive screen) with cytology, and triage of women with abnormal cytology.
According to the test performance of the new sampling method, self-obtained vaginal specimens analysed using molecular technology were found to be adequate and offered results that were in line with clinician-collected cervical samples.
20 JUNE | Diagnostics
UNIVERSITY OF SYDNEY DEVELOPS DEVICE TO DETECT EARLY SIGNS OF HEART ATTACK
The University of Sydney’s Nano Institute and School of Biomedical Engineering biomedical engineer Dr Arnold Lining Ju is developing a new biomedical micro-device that can detect early signs of a heart attack or stroke.
Developed based on an integrated microfluidic chip, the device can detect subtle platelet changes that occur before a heart attack or stroke takes place.
A blood sample from a person’s finger is collected and analysed for platelet clotting and white cell inflammation responses.
An external operating system can immediately process the result.
The university’s research forms part of a former long-term collaboration with the Heart Research Institute Charles Perkins Centre cardiovascular research director Shaun Jackson.
17 JUNE | Diagnostics
UNIVERSITY OF EDINBURGH DEVELOPS AI TOOL TO DETECT HEART FAILURE
Researchers from the University of Edinburgh in the UK have developed a tool that uses artificial intelligence (AI) to merge patient data with blood test results for NT-proBNP heart protein levels to help doctors detect heart failure earlier.
Named CoDE-HF, the tool leverages AI to merge routinely obtained patient data with NT-proBNP test results to predict if they have suffered heart failure.
Researchers from the university and 13 other countries merged findings from 10,369 individuals with suspected acute heart failure to develop the tool, which could improve clinicians’ decisions and enhance patient care.
CoDE-HF was also highly accurate in hard-to-diagnose patient populations, such as the elderly and people with pre-existing medical conditions.
16 JUNE | M&A
BOSTON SCIENTIFIC TO PURCHASE STAKE IN M.I.TECH FOR $230M
Boston Scientific has signed a definitive agreement with Synergy Innovation to acquire its majority stake of nearly 64% in M.I.Tech in a $230m (KRW291.2bn) deal.
Under the terms of the deal, the company will acquire the stake at a purchase price of $11.24 (KRW14,500) per share, subject to closing adjustments.
Korean company M.I.Tech manufactures and distributes medical devices for endoscopic and urologic procedures.
The company developed a family of conformable, self-expanding metal stents, called HANAROSTENT, to improve patients’ quality of life.
Since 2015, Boston Scientific has been distributing these non-vascular metal stents in Japan.
The company stated that the non-vascular gastrointestinal and airway stents are used to clear occlusions or strictures in several areas of patient anatomy, including the oesophagus, biliary tree, colon, pancreatic duct and duodenum.
20 JUNE | Diagnostics
HSE UNIVERSITY RESEARCHERS ANNOUNCE NEW SENSOR TO DETECT CANCER
A research group from the Russian HSE University, Skoltech University, Moscow Pedagogical State University (MPGU) and National University of Science and Technology (MISIS) has developed a nanophotonic-microfluidic sensor that can help with cancer diagnoses.
The sensor helps to detect, monitor and assess treatment response for the disease.
The researchers found that the new hybrid sensor device can identify liquids and gases that are dissolved at low concentrations with a highly sensitive analysis.
It features nanophotonic optical sensors on a chip along with microfluidic channels on the surface of the sensor.
HSE University noted that gases or liquids pumped through the channels affect the optical radiation propagation in the highly sensitive nanophotonic devices, which changes the output’s spectral characteristics.
21 JUNE | FunDing
ELYPTA RAISES FUNDS TO DEVELOP MULTI-CANCER EARLY DETECTION TEST
Swedish diagnostics firm Elypta has raised $21m in a Series A financing round for the development of a metabolism-based multi-cancer early detection (MCED) test.
Led by venture capital company Bonnier Ventures, the financing round also saw participation from existing investors, namely Hillclimber, Industrifonden, Norrsken VC, Chalmers Ventures, Navigare Ventures and Nina Capital.
Elypta intends to use the funds for the development and validation of blood and urine tests for MCED in asymptomatic adult patients as well as kidney cancer recurrence diagnoses.
The tests are developed using complete profiling of human glycosaminoglycans (GAGome) as biomarkers of cancer metabolism.
At present, the company has two major multicentre studies in progress, LEVANTIS-0087A for MCED and AURORAX-0087A for kidney cancer recurrence.
22 JUNE | CLINICAL TRIALS
INIVATA REPORTS POSITIVE DATA FROM BREAST CANCER ASSAY STUDY
Inivata has reported positive data from a clinical study of its RaDaR assay to detect minimal residual disease (MRD) and recurrence in high-risk hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients.
Developed using the company’s InVision platform, the RaDaR assay is a tumour-informed, personalised, sensitive technology that is used to track a set of up to 48 tumour-specific variants in cell-free DNA (cfDNA) in the blood plasma of cancer patients.
22 JUNE | Genomics
INVETECH INTRODUCES KORUS SYSTEM FOR AUTOLOGOUS CELL THERAPIES
Invetech has introduced Korus, a new closed system for autologous cell therapies, to transform the industry standards in elutriation and cell wash.
The technology uses a mild elutriation process to supply a cleaner cell population for cell therapy production processes, such as tumour-infiltrated lymphocytes (TIL), dendritic cell, chimeric antigen receptor (CAR)-T cell or induced pluripotent stem cell (IPSC)-derived therapy.
It features elutriation and cell wash using gentle counterflow centrifugation.
20 January | Covid-19
WALGREENS LAUNCHES INTERACTIVE TOOL TO TRACK COVID-19 VARIANTS
Walgreens has launched a new interactive tracking tool, the Walgreens Covid-19 Index, to advance the rapid detection of Omicron and track variant activity. It says the index can track the spread of the omicron variant within 24 to 48 hours.
The tool uses testing data from Aegis Sciences Corporation and uniquely identifies the spread of current and emerging virus variants in real-time.
The tool offers a snapshot of data for the past seven days based on positive tests analysed at more than 5,000 Walgreens locations across the nation.
According to the data collected and tracked by the tool, more than 95% of all positive cases of Covid-19 nationally are presumed to be the Omicron variant.
ENVOY MEDICAL GETS FDA IDE APPROVAL TO BEGIN ACCLAIM COCHLEAR IMPLANT TRIAL
Envoy Medical has received approval for its investigational device exemption (IDE) application from the FDA, allowing the company to carry out an early feasibility study of the Acclaim cochlear implant.
The company will conduct the single-centre study of the new fully implanted cochlear implant at the Mayo Clinic, located in Rochester, Minnesota, US.
SENSEONICS’ GLUCOSE MONITORING SYSTEM RECEIVES CE MARK
Senseonics has obtained CE mark approval for its next-generation Eversense E3 continuous glucose monitoring (CGM) System, which can be used for up to six months.
The system is intended to continually measure glucose levels in people aged 18 years and above with diabetes and can replace fingerstick blood glucose (BG) measurements to provide information for diabetes treatment decisions.
FDA GRANTS CLEARANCE FOR RICOH’S CMF AND ORTHOPAEDIC MODELLING
The FDA has granted 510(k) clearance for the Ricoh 3D for Healthcare craniomaxillofacial (CMF) and orthopaedic anatomic modelling.
An integrated, end-to-end workflow solution, Ricoh 3D for Healthcare is intended to develop, design and produce anatomic models using 3D printing technology from Stratasys.
ZAVATION MEDICAL SECURES 510K CLEARANCE FOR LUMBAR INTERBODY FUSION DEVICE
Zavation Medical Products has received 510k clearance from the US Food and Drug Administration (FDA) for its expandable lumbar interbody fusion device, eZspand Lateral.
Part of the Zavation eZspand Interbody System, the eZspand Lateral device offers an optimal fit for individual patients through expandable precision as well as continual expansion.
US FDA APPROVES MEDICALGORITHMICS’ QPATCH ECG MONITORING DEVICE
The FDA has approved Medicalgorithmics’ ECG wearable unit, Qpatch.
The new ECG wearable device has been designed to measure individual ECG signals and obtain accurate cardiac arrhythmia diagnoses from monitoring sessions of up to 15 days.