Epigenetics company Base Genomics has launched with a team of leading scientists and clinicians with the aim of setting a new gold standard in DNA methylation detection. The company has closed an oversubscribed seed funding round of US$11 million to accelerate development of its TAPS technology, initially focusing on developing a blood test for early-stage cancer and minimal residual disease. The funding round was led by Oxford Sciences Innovation.
DNA methylation is an epigenetic mechanism involved in gene regulation and has been shown to be one of the most promising biomarkers for detecting cancer through liquid biopsy. The existing industry standard for mapping DNA methylation degrades DNA and reduces sequence complexity, however, limiting scientific discovery and clinical sensitivity. Base Genomics’ new technology, TAPS, overcomes these issues and generates significantly more information from a given sample, creating new opportunities in research and clinical application.
Dr Anna Schuh, CMO, Base Genomics, commented: “In order to realize the potential of liquid biopsies for clinically meaningful diagnosis and monitoring, sensitive detection and precise quantification of circulating tumour DNA is paramount. Current approaches are not fit for purpose to achieve this, but Base Genomics has developed a game-changing technology which has the potential to make the sensitivity of liquid biopsies a problem of the past.”
First developed at Ludwig Institute for Cancer Research Branch at the University of Oxford, TAPS is a novel chemical reaction that converts methylated cytosine to thymine under mild conditions. Unlike the industry standard technology, bisulfite sequencing, TAPS does not degrade DNA, meaning that significantly more DNA is available for sequencing. TAPS also better retains sequence complexity, cutting sequencing costs in half and enabling simultaneous epigenetic and genetic analysis.
Dr Vincent Smith, CTO, Base Genomics said: “[TAPS] has the potential to have an impact on epigenetics similar to that which Illumina’s SBS chemistry had on Next Generation Sequencing.”
Base Genomics is led by a highly experienced team of scientists and clinicians, including Dr Smith, a world-leader in genomic product development and former Illumina VP; Dr Schuh, Head of Molecular Diagnostics at the University of Oxford and Principal Investigator on over 30 clinical trials; Drs Chunxiao Song and Yibin Liu, co-inventors of TAPS at the Ludwig Institute for Cancer Research, Oxford; and Oliver Waterhouse, previously an Entrepreneur in Residence at Oxford Sciences Innovation and founding team member at Zinc VC.
Waterhouse, founder and CEO, Base Genomics, said: “The ability to sequence a large amount of high-quality epigenetic information from a simple blood test could unlock a new era of preventative medicine. In the future, individuals will not just be sequenced once to determine their largely static genetic code, but will be sequenced repeatedly over time to track dynamic epigenetic changes caused by age, lifestyle, and disease.”
Volunteer laboratory network launched in UK to expand Covid-19 testing
, /in Corona News, E-News /by 3wmediaThe UK-based Covid-19 Volunteer Testing Network launched April 9 to provide essential additional testing capacity to front-line workers. The project, started by Mike Fischer CBE, helps small laboratories convert to run critical antigen testing and identify Covid-19 cases among local healthcare workers – at no cost to Government.
The UK has thousands of small laboratories with the right equipment, personnel and processes to run Covid-19 testing. Although some of the critical RT-PCR machines in university and healthcare settings have already been requisitioned by central Government, thousands of others are currently sitting idle in small, ‘long-tail’ facilities up and down the United Kingdom.
Fischer set up SBL, a non-profit medical research laboratory in Oxfordshire, which is already running 250-500 tests a week for 10 GP surgeries in the local area.
“Although our facility is small – with just three full-time staff, two containment hoods and two real-time machines – we were quickly able to convert to Covid-19 testing using the Centre for Disease Control protocols and are now running up to 500 tests a week for the staff at 10 local GP surgeries on a same-day basis,” said Fischer.
“If other labs could join the effort we could quickly scale to providing tens of thousands of tests a day in complement to the central program.”
“If we are going to beat this pandemic, we need to employ every resource we can to make sure that our essential health care workers can go to work safely. Even at our small facility, we have been able to run up to 500 tests a week for NHS staff on a same-day basis. By creating an emergency network of volunteer laboratories like ours across the UK, we can quickly and efficiently create the capacity we need to deliver tens of thousands of additional tests every day.”
The Covid-19 Volunteer Testing Network is being coordinated on an entirely voluntary basis and is looking for further labs to join the effort. “We hope existing equipment can be used in situ with qualified staff volunteering to conduct the tests. We are able to provide guidance, protocols, documentation and reporting,” Fischer added.
The Fischer Family Trust has also made £1 million in funding available to support the purchase of consumables for the tests if labs are unable to cover these.
For more information about the Covid-19 Volunteer Testing Network, visit: www.covid19-testing.org
NanoPass shares proprietary MicronJet microneedle to assist in development of a Covid-19 vaccine
, /in Corona News, E-News /by 3wmediaNanoPass is sharing its proprietary MicronJet microneedle device with leading vaccine and immunotherapy companies around the world to assist in development of a Covid-19 vaccine.
The NanoPass device targets immune cells of the skin by harnessing the skin’s potent immune system to improve vaccines and/or to dramatically reduce the dose while achieving the same immunity.
“The human skin is our first layer of defence against many infectious diseases,” says Yotam Levin, MD, CEO of NanoPass. “The skin contains specialized Dendritic Cells that process and induce strong immune responses – that’s why microneedle injections enable reduction of vaccine doses by five-fold, thereby reducing overall cost, required capacity and production time. We believe a reliable injection into the skin is critical for successful activation of broad and effective immune responses, which should be explored for most injectable vaccines.”
The company’s technology is supported by more than 55 completed/ongoing clinical studies with various vaccines and vaccine platforms, including H1N1, H5N1 and live attenuated VZV vaccine, that have shown improved immunogenicity and significant dose-sparing. Pre-clinical evidence with mRNA and DNA vaccines showed promising results.
NanoPass has previously supported US CDC in a Phase 3 infant polio vaccination trial; with ITRC on PPD skin testing; in Type 1 Diabetes immunotherapy; and supported NIAID with devices to evaluate immunogenicity of a pandemic flu vaccine; and multiple vaccine pharma.
NanoPass Technologies flagship product, the 0.6 mm MicronJet, is the first true (<1 mm) microneedle to receive FDA clearance as an intradermal delivery device for substances approved for delivery below the surface of the skin. It is supported by extensive clinical data and regulatory approvals in most major markets including the US, Europe, China and Korea.
IVD assay iAMP Covid-19 Detection Kit receives CE Mark
, /in Corona News, E-News /by 3wmediaFujirebio Europe has received the CE mark for the molecular IVD assay iAMP Covid-19 Detection Kit from its partner Atila Biosystems. The qualitative detection kit is based on real-time fluorescent reverse transcription isothermal amplification, eliminating the need for RNA extraction.
The detection kit was also granted Emergency Use Authorization by the US Food and Drug Administration on April 10.
The iAMP COVID-19 Detection Kit can be run on a Real-Time PCR PowerGene 9600 Plus or any other qPCR automate capable of measuring fluorescence in FAM/HEX channel in real-time.
The new iAMP COVID-19 molecular assay complements the existing panel of biomarkers available on the LUMIPULSE® G System for infection (PCT, Ferritin), inflammation (IL-6) and epithelial lung injury (KL-6) to predict disease severity in patients infected with SARS-CoV-2.
Products from Atila Biosystems are available through Fujirebio’s European affiliates and through a large portion of Fujirebio’s existing or new European distribution network.
For more information, visit: www.fujirebio.com/en/contact
BIOHIT supplies COVID-19 detection kits in the UK
, /in Corona News, E-News /by 3wmediaBIOHIT Healthcare is distributing test kits for the diagnosis of both current and past COVID-19 infections to help in the fight against coronavirus in the UK. The new product line includes the MutaPLEX® Coronavirus kit from Immundiagnostik AG (IDK) – a real-time RT-PCR assay to screen for infected individuals – and Epitope Diagnostics Inc’s (EDI’s) immunodiagnostic tests for IgM and IgG COVID-19 antibodies, to detect past infections.
The IDK MutaPLEX coronavirus screening assay allows the detection of SARS-CoV-2 viral RNA in a variety of biological specimens, especially nasal/throat swabs. This real time RT-PCR kit contains all the reagents, primers and dual-labelled probes required for the amplification and simultaneous differentiation of RNA from SARS-CoV-2 and other betacoronaviruses, as well as house-keeping genes designed to prevent false negative results due to insufficient sample collection or transport problems.
EDI’s Novel Coronavirus COVID-19 ELISA kits provide qualitative detection of antibodies in patient serum, indicating a past COVID-19 infection. The IgM assay provides the earliest immunodiagnostic indication of an infection, while the IgG test can be used to aid detection and provide an indication of long-term immunological response, making it particularly useful in cases where clustering is suspected or differential diagnosis is required.
These tests extend and complement BIOHIT’s repertoire of diagnostic kits for gastroenterology, aiding the evaluation of patients with both GI and upper respiratory complaints, as COVID-19 may include stomach and bowel symptoms in some cases. Inflammatory bowel disease patients being treated with immunosuppressive agents should also be considered at high risk for COVID-19, making differential diagnosis essential.
Avacta Group collaborates with Adeptrix to develop a high throughput Covid -19 antigen test
, /in Corona News, E-News /by 3wmediaUK-based Avacta Group, the developer of Affimer biotherapeutics and reagents, will collaborate with US-based Adeptrix to develop a high throughput Covid -19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS) platform.
The Affimer-based BAMS coronavirus antigen test that will provide clinicians with a significant expansion of the available testing capacity for Covid-19 infection in hospitals.
Adeptrix’s novel BAMS platform combines enrichment of the sample to improve sensitivity with the power of mass-spectrometry to improve specificity. Hundreds of samples per day can be analysed by a single technician using BAMS, exceeding the capacity of single PCR machine, making BAMS a very attractive high throughput technique for Covid-19 screening in the clinical setting.
The diagnostic test will allow hospitals around the world to utilise their existing installed base of mass spectrometers that are not currently used for Covid-19 testing, thus contributing significantly to the increase in global testing capacity. Avacta’s recently developed Affimer reagents that bind the SARS-COV-2 spike protein will be used to provide the capture and enrichment of the virus particle from the sample which could be saliva, nasopharyngeal swabs or serum.
The companies are aiming to have a BAMS test ready for clinical validation, regulatory approval and manufacturing in June. Adeptrix and Avacta are already in discussion with large-scale manufacturing partners to rapidly deploy this new high throughput test.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “We believe that the BAMS test will be hugely attractive as an adjunct to PCR testing because it uses laboratory equipment that is already in hospital labs but not currently used for Covid-19 testing so it provides incremental testing capacity.
I have made it clear that we intend to partner the SARS-COV-2 spike protein Affimer reagents with several select companies to support antigen test development on multiple diagnostic test platforms. This will contribute most effectively to the urgent need to increase antigen testing capacity globally and maximise the commercial return to Avacta. Adeptrix is one example of this and other discussions are underway. I look forward very much to further updating the market in the near future.”
Dr. Jeffrey C. Silva, Director of Product Development, Adeptrix Corporation commented: “Mass spectrometry can enhance the diagnostic utility of immunoassays, as it is capable of monitoring both existing and emerging viral strains by accurately measuring the molecular components of the virus. BAMS provides an ideal multiplexing platform to obtain higher specificity for monitoring Covid-19 infection.”
DefiniGEN launches tool to support in vitro intestinal research of Covid-19
, /in Corona News, E-News /by 3wmediaUK-based iPSC (induced pluripotent stem cells) disease modelling company DefiniGEN has identified iPSC-derived intestinal organoids that could be used to help structure in vitro studies of the biology of SARS-CoV-2 infection across cohorts of multiple patients.
While SARS-CoV-2 primarily targets the respiratory system, studies have shown that it also infects and multiplies within the intestinal epithelium. IPSC-derived organoids exhibit characteristics that closely mimic the in vivo intestinal epithelium, making them a valuable surrogate model for studying the virus.
The company says their iPSC-derived intestinal organoids provide a unique in vitro system to model the human intestine. The organoids display a polarized epithelium and harbour a mixture of cell types normally present in the primary intestinal epithelium barrier in vivo, including goblet cells, Paneth cells, enterocytes, LRG5+ stem cells, and enteroendocrine cells. The organoids polarise, form crypt structures and grow villi at the apical surface, and are shown to secrete mucus in a similar manner to primary human gut tissue.
DefiniGEN points out that several studies have proven that angio-tensin-converting enzyme 2 (ACE2) expression in host cells is required for SARS-CoV-2 recognition and infection. Activity of membrane proteases such as TMPRSS2 cleaves the coronavirus’ Spike protein and facilitates the membrane fusion with the host cell. Human intestine is one of the few human tissues with high expression of both ACE2 and TMPRSS2 therefore is a good candidate to study Covid-19 and the mechanisms of the SARS-CoV-2 infection.
Additionally, DefiniGEN have a platform to generate various patient-derived intestinal models which could support population studies, using many different donors with diverse ethnic profiles.
Such studies are useful as there is growing evidence that ethnic differences are a major factor in patients showing a severe response to Covid-19.
DefiniGEN’s differentiation platform is optimized to enable successful generation of intestinal organoids from a diverse range of patients. Patient skin fibroblasts or PBMCs can first be reprogrammed to iPSC, and then differentiated to produce mature intestinal organoids which carry the original patient genetics, and so manifest a gut model specific to that donor.
For more information, visit www.definigen.com/products/intestinal/covid-19
Siemens starts worldwide shipping of total antibody test for COVID-19
, /in Corona News, E-News /by 3wmediaSiemens Healthineers announced late May that it is now shipping worldwide its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test received the CE mark and data has demonstrated 100 percent sensitivity and 99.8 percent specificity. The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.
The US FDA has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test.
Siemens says it is prepared to ramp up production as the pandemic evolves with capacity exceeding 50 million tests per month across its platforms starting in June.
The antibody test is now available on the largest installed base in the U.S. and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide. This includes the Atellica Solution immunoassay analyser, which can run up to 440 tests per hour and enables a result in just 10 minutes. By detecting both IgM and IgG antibodies, the test provides a clearer clinical picture over a longer period of time as the disease progresses.
The antibody test also is available on the company’s installed base of ADVIA Centaur XP and XPT analysers, which can test up to 240 samples per hour, with a result in 18 minutes.
Importantly, the test detects antibodies to a key spike protein on the surface of the SARS-CoV-2 virus, which binds the virus to cells with a distinct human receptor found in lungs, heart, multiple organs and blood vessels. Studies indicate that certain (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate and infect human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.
Avacta ships SARS-COV-2 Affimer reagents to Cytiva and Adeptrix for diagnostic test development
, /in Corona News, E-News /by 3wmediaAvacta Group plc, the developer of Affimer biotherapeutics and reagents, has started shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners.
The Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva based COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States.
The Affimer reagents have been manufactured by Avacta in the quantities required for test development and are being sent to Cytiva. The reagents are also being provided to Adeptrix with whom Avacta has announced that it will develop a COVID-19 laboratory test to run on hospital mass spectrometers using Adeptrix’s proprietary BAMS assay platform.
The Affimer reagents have been studied further by Avacta and this has shown that there are Affimer reagents that can work in pairs, both binding to the spike protein at the same time. This allows tests to be developed that detect both the intact virus particle and the detached spike proteins which become separated from the virus particle during the development of the COVID-19 disease, which may also be important in monitoring disease progression.
Cytiva and Avacta will now work to develop rapid test strips for the detached spike protein and for the intact virus particle. Adeptrix is working to develop a prototype BAMS test. Both of these tests will indicate whether a person has the infection at that moment.
Abingdon Health to expand manufacturing capacity on back of increased demand for rapid tests
, /in E-News /by 3wmediaAbingdon Health will expand its York headquarters in the UK, following further investment in state-of-the-art lateral flow automation. This will substantially increase in its manufacturing footprint, resulting in Europe’s largest capacity for rapid test manufacturing, according to the company.
Abingdon Health is a technology-enabled lateral flow diagnostics company providing innovative rapid testing solutions to a multi-industry, global client base. The company provides specialist assay development and smartphone reader solutions alongside its lateral flow test manufacturing capacity.
The announcement of the expansion comes weeks after the UK Government announced Abingdon Health as one of the leading members of the UK Rapid Test Consortium.
Michael Hunter, Operations Director of Abingdon Health, commented: “The additional footprint and automation come at a timely moment as demand for rapid tests is growing rapidly, with the market likely to exceed US$10bn globally. Our precision automation and multi-site approach means we can adapt to meet the varying manufacturing needs of our growing global client base.”
Earlier this year, Abingdon Health announced a preliminary round of expansion in York after 90% revenue growth in 2019, thanks to new assay developments and assay manufacturing contract wins, and the introduction of its AppDx Smartphone reader software. In April 2020, growth continued with the acquisition of a new lateral flow manufacturing facility in Doncaster, UK. This latest expansion and investment in equipment comes as 2020 sees continuing high demand for Abingdon Health’s services.
Abingdon Health’s two manufacturing sites in York and Doncaster have the capacity to produce millions of rapid tests per month. This adaptable, dual-site approach provides a peace-of-mind solution that assures customers receive product consistency and a security of supply during routine scheduling and spikes in demand.
Base Genomics launches to commercialise ground-breaking epigenetic technology
, /in E-News /by 3wmediaEpigenetics company Base Genomics has launched with a team of leading scientists and clinicians with the aim of setting a new gold standard in DNA methylation detection. The company has closed an oversubscribed seed funding round of US$11 million to accelerate development of its TAPS technology, initially focusing on developing a blood test for early-stage cancer and minimal residual disease. The funding round was led by Oxford Sciences Innovation.
DNA methylation is an epigenetic mechanism involved in gene regulation and has been shown to be one of the most promising biomarkers for detecting cancer through liquid biopsy. The existing industry standard for mapping DNA methylation degrades DNA and reduces sequence complexity, however, limiting scientific discovery and clinical sensitivity. Base Genomics’ new technology, TAPS, overcomes these issues and generates significantly more information from a given sample, creating new opportunities in research and clinical application.
Dr Anna Schuh, CMO, Base Genomics, commented: “In order to realize the potential of liquid biopsies for clinically meaningful diagnosis and monitoring, sensitive detection and precise quantification of circulating tumour DNA is paramount. Current approaches are not fit for purpose to achieve this, but Base Genomics has developed a game-changing technology which has the potential to make the sensitivity of liquid biopsies a problem of the past.”
First developed at Ludwig Institute for Cancer Research Branch at the University of Oxford, TAPS is a novel chemical reaction that converts methylated cytosine to thymine under mild conditions. Unlike the industry standard technology, bisulfite sequencing, TAPS does not degrade DNA, meaning that significantly more DNA is available for sequencing. TAPS also better retains sequence complexity, cutting sequencing costs in half and enabling simultaneous epigenetic and genetic analysis.
Dr Vincent Smith, CTO, Base Genomics said: “[TAPS] has the potential to have an impact on epigenetics similar to that which Illumina’s SBS chemistry had on Next Generation Sequencing.”
Base Genomics is led by a highly experienced team of scientists and clinicians, including Dr Smith, a world-leader in genomic product development and former Illumina VP; Dr Schuh, Head of Molecular Diagnostics at the University of Oxford and Principal Investigator on over 30 clinical trials; Drs Chunxiao Song and Yibin Liu, co-inventors of TAPS at the Ludwig Institute for Cancer Research, Oxford; and Oliver Waterhouse, previously an Entrepreneur in Residence at Oxford Sciences Innovation and founding team member at Zinc VC.
Waterhouse, founder and CEO, Base Genomics, said: “The ability to sequence a large amount of high-quality epigenetic information from a simple blood test could unlock a new era of preventative medicine. In the future, individuals will not just be sequenced once to determine their largely static genetic code, but will be sequenced repeatedly over time to track dynamic epigenetic changes caused by age, lifestyle, and disease.”