Industry news
University of Washington develops new blood-clotting test
14 FEBRUARY | Diagnostics
Researchers at the University of Washington have developed a new blood-clotting test, which uses a single blood drop as well as a smartphone’s vibration motor and camera.
A plastic attachment holds a tiny cup below the smartphone camera.
This cup contains a small copper particle as well as a chemical that will start the blood clotting process when a person adds blood.
During the test, the vibration motor of the phone shakes the cup while the particle movement is monitored by the camera.
Once the clot forms, the movement slows down and then stops. For calculating the prothrombin time (PT) and international normalised ratio (INR), the phone gathers two timestamps. The first is when the user adds the blood to the cup, and the second is after the particle movement stops.
The test showed results that were similar to those commercially available for both sets of patients. Going forward, the researchers plan to work with patients to test the system in an at-home setting as well as resource-limited areas and countries.
14 FEBRUARY | Results
LUNGPACER MEDICAL INTRODUCES AEROPACE SYSTEM TO PIVOTAL STUDY
Lungpacer Medical is set to accelerate the RESCUE 3 pivotal clinical study with the introduction of the AeroPace System.
The AeroPace System stimulates the nerves that activate the diaphragm by providing repetitive exercises to rebuild muscle strength and enable independent, natural breathing.
The RESCUE 3 clinical study is using the minimally invasive diaphragm strengthening technology developed by Lungpacer to examine faster ventilator independence.
It will evaluate the device’s safety and efficacy, which will assist in seeking approvals from the US Food and Drug Administration (FDA) and other international regulators.
According to an abstract presented at the 2021 American College of Chest Physicians Annual Conference, Covid-19 patients treated with Lungpacer therapy showed earlier liberation compared to mechanical ventilation.
The therapy was also demonstrated to strengthen the diaphragm 246% more, with 128% more improvement observed in lung function, according to findings from a previous Lungpacer clinical study.
The company stated that the system works as a personal trainer for the diaphragm muscle. At present, more than 40 medical centres in France, Germany, Spain and the US are taking part in the Lungpacer therapy pivotal trial.
11 FEBRUARY | DEALS
GENETRON, HUTCHMED PARTNER TO DEVELOP DIAGNOSTIC FOR ORPATHYS IN CHINA
Genetron Health and Hutchmed (China) have signed a collaboration agreement to develop a companion diagnostic (CDx) test for Orpathys (savolitinib) in the country.
Under the terms of the deal, the companies will jointly authorise and register Genetron Health’s eight-gene lung cancer assay (Tissue) as a CDx for Orpathys, an oral, potent, and MET tyrosine kinase inhibitor (TKI).
Genetron’s assay covers the HER2, BRAF, PIK3CA, EGFR and KRAS mutations; translocations of ALK and ROS1; and MET exon 14 skipping.
The 2018 National Comprehensive Cancer Network guidelines recommended seven of these genes as biomarkers for non-small cell lung cancer (NSCLC) patients.
The next-generation sequencing (NGS)-based assay, developed using Genetron’s One-step Seq method, was approved as an in vitro diagnostic (IVD) assay by National Medical Products Administration in China in 2020.
It is claimed to be the first approved test for NSCLC that can detect RNA-based MET exon 14 skipping alterations for therapy selection and monitoring. Last year, the test obtained the CE mark and has been commercialised for use in Chinese hospitals.
14 FEBRUARY | REGULATORY
US FDA APPROVES SENSEONICS’ EVERSENSE E3 CGM SYSTEM
The US Food and Drug Administration (FDA) has approved the use of Senseonics’ Eversense E3 continuous glucose monitoring (CGM) system for periods of up to six months.
The device uses sacrificial boronic acid (SBA) technology and is claimed to be the first and only long-term implantable CGM in the world.
The latest approval allows Eversense E3, which had previously been approved for a wear time of 90 days, to be used for up to six months.
Using a single sensor, the CGM system accurately tracks the glucose levels of users.
It includes a removable smart transmitter that is kept in place with a mild silicone-based adhesive.
The E3 transmitter provides glucose values, trends and discreet on-body vibratory alerts to a mobile app.
11 FEBRUARY | DEALS
SEEGENE SIGNS COVID-19 TESTS SUPPLY DEAL WITH BRAZIL
Molecular diagnostic company Seegene has signed an agreement with the Ministry of Health of Brazil to supply four million Covid-19 tests.
The company will deliver its Covid-19 tests, as well as associated consumables, to help respond to a rapid surge of Flu A and Covid-19 infections in Brazil.
According to Seegene, more than 280,000 cases of Covid-19 a day were recently reported in the country.
The firm will deliver its Allplex SARS-CoV-2/FluA/FluB/RSV PCR assay, which has the capability to detect influenza A and B, Covid-19, and respiratory syncytial virus (RSV) in a single test.
The multiplex real-time PCR assay received approval from Health Canada under its Interim Order last month. It enables the simultaneous amplification and differentiation of respiratory symptoms.
14 FEBRUARY | RESULTS
INIVATA REPORTS POSITIVE DATA FROM RADAR LIQUID BIOPSY TEST STUDY
Inivata has announced positive results from the prospective clinical study of its RaDaR liquid biopsy test in patients with head and neck squamous cell carcinoma (HNSCC).
The Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS) study was conducted in partnership with the Ludwig Maximilian University (LMU) Klinikum, Department of Otorhinolaryngology, Head and Neck Surgery (ORL-HNS) as well as the LMU Munich, Institute of Pathology, Faculty of Medicine.
Blood samples from 17 stage III-IVB, p16-negative HNSCC patients, who received curative-intent primary surgical treatment, were collected for the LIONESS study.
These samples were tested using RaDaR for detecting circulating tumour DNA (ctDNA) for minimal residual disease (MRD) and evidence of the recurrence of the disease pre- and post-surgery.
RaDaR is a multi-tumour, personalised assay, which is designed to track up to 48 tumour-specific variants using a liquid biopsy.
The company stated that all the patients in the study had detectable ctDNA before the surgery. ctDNA was detected before disease progression in all five patients with clinical recurrence.
The remaining 12 patients had no recurrence and indicated a 100% clinical specificity of the RaDaR assay.
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.
11 FEBRUARY | DIAGNOSTICS
ABACUS DIAGNOSTICA TO LAUNCH NEW COVID-19 TEST IN EUROPE
Finnish company Abacus Diagnostica is set to launch the GenomEra SARS-CoV-2 2.0 Assay Kit, its second-generation Covid-19 test, in the European market.
The assay recently received the CE mark for in vitro diagnostic (IVD) medical devices.
The multiplex RT-qPCR test is designed for the detection of the SARS-CoV-2 virus from respiratory samples.
With 98.3% sensitivity and 99.8% specificity, the assay provides rapid PCR test results in 50 minutes.
8 FEBRUARY | DEALS
COOPERCOMPANIES TO ACQUIRE COOK MEDICAL’S REPRODUCTIVE HEALTH BUSINESS
Medical device company CooperCompanies has signed a binding agreement to buy Cook Medical’s Reproductive Health business in an $875m deal.
Under the terms of the deal, the company will pay $675m at the time of closing and a further $200m in four annual instalments of $50m each.
The Reproductive Health business of Cook Medical manufactures minimally invasive medical devices for fertility, obstetrics, gynaecology, in vitro fertilisation (IVF) and assisted reproductive technology (ART).
In brief
US FDA GRANTS 510(K) CLEARANCE TO MOTUS GI’S PURE-VU EVS SYSTEM
The FDA has granted 510(k) clearance for the commercialisation of Motus GI’s Pure-Vu EVS System. The device is designed to enhance navigation capabilities in tortuous anatomy and improve the speed of set-up. It offers enhanced cleansing capabilities and improved navigation. Motus GI plans to commercially launch the Pure-Vu EVS System in the first quarter of the year.
MEDMIRA’S COVID-19 TOTAL ANTIBODY TEST OBTAINS CE MARK
Rapid Vertical Flow diagnostics manufacturer MedMira has obtained the CE mark for its Covid-19 test, which has been designed to identify the presence of antibodies from a prior infection or following vaccination against the SARS-CoV-2 virus. MedMira will now launch the test in Europe and other countries that accept the CE mark.
AMBU RECEIVES FDA 510(K) CLEARANCE FOR ASCOPE GASTRO AND ABOX 2
Ambu has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Ambu aScope Gastro and Ambu aBox 2. aScope Gastro is said to be the company’s first, sterile single-use gastroscope with advanced imaging and design features. Its launch allows Ambu to enter the gastroscopy market, which has nearly 20 million procedures a year and typically relies on reusable endoscope systems.
COSARA’S SARAQ HEPATITIS B VIRAL LOAD KIT RECEIVES INDIA’S CDSCO APPROVAL
Co-Diagnostics’ joint venture, CoSara Diagnostics, has secured clearance from the Central Drugs Standard Control Organization (CDSCO) in India for its SARAQ Hepatitis B (HBV) Viral Load Kit. The regulatory approval allows CoSara to manufacture and sell the new real-time HBV PCR test as an in vitro diagnostic (IVD) test in the Indian market to assess the response to antiviral treatments in HBV patients.
