Industry news
VELA DIAGNOSTICS EXPANDS COVID-19 PORTFOLIO OFFERING WITH NEW ASSAYS
01 march | covid-19
Vela Diagnostics has announced the addition of two assays, ViroKey SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey SARS-CoV-2 ID RT-PCR Test, to its Covid-19 portfolio offering.
Using next-generation sequencing (NGS) technology, the genotyping assay sequences the whole SARS-CoV-2 genome, and accompanying Sentosa SQ Reporter software identifies mutations and categories them by lineage.
This process helps in the research and interpretation of the molecular epidemiology of Covid-19.
To increase the effectiveness/sensitivity of molecular diagnostics, serological assays, vaccine design, and anti-viral therapy, whole-genome sequencing is necessary. It also helps in studying routes of transmission and outbreak clusters, the World Health Organization (WHO) said.
Vela Diagnostics managing director Andreas Goertz said: “We offer a highly automated workflow, which requires less than two hours of hands-on time from sample to report generation.
“With this ease-of-use, laboratories can very quickly adopt an NGS solution that would become an important tool in this pandemic situation.”
The ViroKey SARS-CoV-2 ID RT-PCR Test (RUO) can potentially detect variants such as B.1.1.7 (UK), B.1.351 (South Africa), and P.1 (Brazil) lineages in the positive samples rapidly.
Vela Diagnostics Business Development director Scott Cassidy said: “With emerging variants like the recent B.1.526 from New York that may weaken vaccine effectiveness, the need for mutation identification becomes clear.
“We are now able to offer options for quick detection of known variants of concerns, and all future variants for better pandemic management.”
The company noted that the variant identification test can be used, along with the ViroKey SARS-CoV-2 RT-PCR Test v2.0, which has obtained the US Food and Drug Administration (FDA) emergency use authorisation (EUA), CE-IVD, and TGA approval, and HSA provisional authorisation.
Using the automated Sentosa platform, Vela’s test solutions offer a distinctive ability to leverage a single system for NGS and PCR testing in infectious disease and oncology.
01 march | Approvals
GERMANY APPROVES ROCHE’S SARS-COV-2 ANTIGEN TEST FOR AT-HOME USE
The German Federal Institute for Drugs and Medical Devices (BfArM) has granted special approval to Roche’s SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in the country.
The rapid chromatographic immunoassay is for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 in human nasal swab samples collected from the front area of the nose instead of the nasopharynx.
It demonstrated 82.5% sensitivity and 100% specificity versus RT-PCR testing in a self-testing clinical study.
Furthermore, the test showed a relative sensitivity of 91.2% for samples with a high viral load (Ct ≤30).
The test can be obtained at pharmacies without needing a prescription and carried out at home. It provides results in just 15 minutes.
Roche Diagnostics CEO Thomas Schinecker said: “The German Federal Institute for Drugs and Medical Devices’ special approval of our test provides people in Germany with a reliable option to test themselves in the comfort of their own home."
26 february | covid-19
UK OPENS NEW WALK-THROUGH COVID-19 TESTING CENTRE IN EDINBURGH
The UK Government has opened a new walk-through testing centre for Covid-19 in Niddrie, Edinburgh, Scotland.
The new facility, which has been opened in the shared car park of the Jack Kane Leisure Centre and Jack Kane Community Centre, is part of the largest network of diagnostic testing facilities set up in the UK.
The network includes seven drive-through sites, 32 walk-through sites, 42 mobile units across Scotland, along with the Glasgow Lighthouse Lab, to process the samples.
The government is providing all Covid-19 testing and test processing outside of the NHS in Scotland.
It is also providing approximately two-thirds of all daily tests in support of health services.
National Institute for Health Protection interim executive chair Baroness Dido Harding said: “Walk-through sites offer communities better access to coronavirus testing, so everyone with symptoms can get a test.
“This new site is part of our ongoing work to expand our testing network across the UK, which now has the capacity to process more than 700,000 tests a day."
25 February | regulation
US LAW FIRM WARNS OF TIGHTENING EUA REQUIREMENTS FROM FDA
US legal experts have warned that EUA requirements from the US FDA may become tighter.
A blog post published by Hyman, Phelps & McNamara lawyer Jeffrey Shapiro has noted that the US Center for Devices and Radiological Health (CDRH) appears to be taking steps to shed parts of its EUA caseload.
An EUA can only be issued if a product may be effective in diagnosing, treating or preventing disease, the known or potential benefits outweigh the known risks, and there is no adequate, approved or available alternative.
CDRH is increasingly declining to review EUA requests and terminating pending EUAs, on the basis that a particular EUA is not high priority or that there are already adequate supplies available on the market.
Diagnostic devices have been particularly hard hit, with the CDRH terminating pending EUA’s and declining to accept new ones for antibody serology devices for Covid-19. Key FDA figures have recently admitted that the agency’s policy of allowing antibody tests to come to market without regulatory review in the early months of the pandemic was flawed.
Polymerase chain reaction tests may still receive EUA if they have point of care indications, but CDRH has deprioritised some tests on the ground that they were only indicated for laboratory use.
25 February | testing
QUEST DIAGNOSTICS UNVEILS NEW COVID-19 TESTING SERVICE
Quest Diagnostics has unveiled a new Covid-19 semi-quantitative serology testing service that offers insight into a person’s immune response to prior SARS-CoV-2 infection or Covid-19 vaccination.
Approximately 40% of SARS-CoV-2-infected people do not experience symptoms. Serology tests can detect people who have developed antibodies that could provide protection from future infection and detect those still at risk, the US Food and Drug Administration (FDA) said.
The test service delivers a positive or negative result and a numerical result that could offer the basis for analysing relative changes in antibody blood levels.
Furthermore, it can help in evaluating blood antibody levels produced to structural proteins of the SARS-CoV-2 spike protein.
As vaccines that are currently available in the US have mRNA that encodes the spike protein, the test could show an immune response, resulting from an infection or vaccination.
24 February | technology
NHS APP COULD BE CONVERTED INTO DIGITAL COVID-19 CERTIFICATE
The UK may use the NHS app as a digital Covid-19 certificate for people to prove they have been vaccinated against or tested negative for the SARS-CoV-2 virus, according to The Times.
Despite having previously branded so-called ‘vaccine passports’ as discriminatory, it is understood that the UK government is considering allowing businesses to demand to see the app when admitting staff and customers to their premises.
The move is being considered following reports that restaurants, entertainment venues and other business are looking into third-party certification services.
Chancellor of the Duchy of Lancaster Michael Gove is leading a review into a number of options, including a revamp of NHS App that gives patients access to a range of NHS services or the NHS Covid-19 test and trace app, to display vaccination status or input the result of a recent negative test. The review is set to report by 21 June.
In brief
CUE HEALTH’S POINT-OF-CARE COVID-19 TEST OBTAINS CE MARK
Healthcare technology company Cue Health has received the CE mark for its molecular point-of-care Covid-19 test for sale and distribution in the EU. The Cue Covid-19 Test is a highly sensitive and specific nucleic acid amplification test that works on the Cue Health Monitoring System.
FDA APPROVES AGILENT’S ASSAY AS COMPANION DIAGNOSTIC FOR LIBTAYO
The US FDA has approved Agilent Technologies PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer as a companion diagnostic. Currently, the assay can be used in detecting NSCLC patients with tumour PD-L1 expression of Tumor Proportion Score greater than or equal to 50% for treatment with Libtayo.
ENLIGHT PROJECT TO DEVELOP 3D-PRINTED PANCREAS FOR DRUG TESTING
A multidisciplinary consortium of European academic centres and companies has formed to develop a living model of the pancreas to enable better testing of diabetes medication.
PERKINELMER LAUNCHES ASSAY KITS TO ADVANCE GPCR THERAPEUTICS DISCOVERY
PerkinElmer has announced the launch of new G Protein-Coupled Receptor TR-FRET Binding Assay and Beta-Arrestin kits to help advance therapeutic discovery.
NUPROBE UNVEILS PAN-CANCER NGS PANEL FOR USE ON CFDNA SAMPLES
Genomics and molecular diagnostics company NuProbe has introduced its only liquid biopsy panel, VarMap Pan-Cancer NGS Panel, which can enrich, detect, and quantitate more than 6,500 mutations and indels in 61 clinically relevant genes.
24 February | projects
GOOGLE AND ASCENSION EXPAND CARE STUDIO EHR PILOT
Google and Ascension have announced the expansion of their pilot project to launch Care Studio, a tool to help clinicians organise patients’ electronic health records (EHR).
Google and Ascension have been working with clinicians based in Nashville, Tennessee and Jacksonville, Florida, to trial the product. The pilot is now expanding to more physicians and nurses working in clinical settings.
The software is built to work alongside existing EHR systems to streamline all data about an individual patient onto one centralised platform.
Care teams are also able to see information about the same metrics, such as blood pressure or glucose levels, in one place, making it easier to understand and assess individual elements of a patient’s medical history.
The platform can be searched based on medical terminology and clinical shorthand, so that clinicians can simply type what they’re looking for into a search bar to retrieve patient record information. Prescribed medications are all organised together along with dosing and date information, alongside lab results, procedure orders, medication orders and progress notes.
In a blog post, Ascension executive vice president Eduardo Congrado said: “In current EHR systems, clinical information too often is buried in siloed records scattered across hospitals, clinics, urgent care centers, pharmacies, physician offices, labs and other sites of care, making it challenging for physicians and caregivers to efficiently deliver coordinated and precise care."
24 February | Testing
PERKINELMER UNVEILS COVID-19 TEST TO DETECT SARS-COV-2 IN SWABS
PerkinElmer has expanded its testing solutions portfolio with the launch of its new Covid-19 antigen test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens.
The PerkinElmer Covid-19 Antigen Test is a lateral flow immunoassay test for screening or diagnosing Covid-19 in asymptomatic or symptomatic people. It can deliver a positive or negative result in 15 minutes.
It is well suited for professional use point-of-care clinical and non-clinical settings such as healthcare facilities, travel hubs, businesses, and educational institutes.
According to clinical studies in symptomatic and asymptomatic individuals, including those with low viral load, the in vitro diagnostic device demonstrated more than 97% sensitivity in all NS and NP samples.
In brief
SWIFT BIOSCIENCES INTRODUCES GENE PANEL TO DETECT NEW SARS-COV-2 STRAINS
US company Swift Biosciences has launched Swift Normalase Amplicon SARS-CoV-2 S Gene Panel in an effort to accelerate the surveillance of new SARS-COV-2 strains. The new targeted gene panel covers 100% of the SARS-CoV-2 S gene, even with limited viral titers, and eradicates the need to carry out qPCR for library normalisation.
ABBOTT’S COVID-19 ANTIGEN TEST DEVICE RECEIVES CE MARK
Abbott has received CE Mark for its Panbio Covid-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing. The lateral flow assay uses nasal or nasopharyngeal swab for collecting specimens from people.
GENTEGRA TO STUDY NEW SALIVA SAMPLE COLLECTION DEVICES FOR COVID-19
US-based company GenTegra has announced a study on the development and characterisation of two novel Covid-19 saliva sample collection tube devices.
GenTegra Saliva Transport Medium (GTR-STM) and direct-into-PCR GenTegra GTR-STMdk are devices that eradicate the dilution of virus levels in saliva samples, without compromising on safety and convenience while transporting saliva samples at ambient conditions.
PERKINELMER LAUNCHES ASSAY KITS TO ADVANCE GPCR THERAPEUTICS DISCOVERY
PerkinElmer has announced the launch of new G Protein-Coupled Receptor TR-FRET Binding Assay and Beta-Arrestin kits to help advance therapeutic discovery.
AKTIIA RECEIVES CE MARK FOR 24/7 BLOOD PRESSURE MONITORING SYSTEM
Aktiia has received a CE mark for its automated blood pressure monitoring system, which the company says is the first of its kind. The Class IIa medical device is designed to gather blood pressure data 24/7, both during the day and while the wearer sleeps.
