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Benefits of molecular biology in clinical diagnostics

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The advent of molecular biology techniques has revolutionized disease diagnosis. CLI discussed with Dr Chandrasekhar Nair from Molbio Diagnostics the benefit that these techniques have brought and how these technologies are being adapted for point-of-care use for rapid diagnosis and the benefit of rural populations.

What has the impact of molecular biology been on disease diagnosis and treatment?

Accurate and timely diagnosis of infectious diseases is essential for proper medical management of patients. Early detection of the causative agent also enables care providers to intervene in a precise rather than presumptive manner and institute adequate measures to interrupt transmission to the susceptible population in the hospital or community.
The conventional diagnostic model for clinical microbiology has been labour and infrastructure intensive and frequently requires days to weeks before test results are available. Moreover, due to the complexity and length of such testing, this service was usually directed at the hospitalized patient population. Bacterial/viral culture has been – and continues to be – the gold standard for detection. However, time taken for some pathogens to grow, coupled with the difficulty in culturing some pathogens has resulted in a demand for alterna tive techniques that would allow direct pathogen detection in clinical samples rapidly.
The application of engineering techniques to the technological revolution in molecular biology has greatly improved the diagnostic capabilities of modern clinical microbiology laboratories. In particular, rapid techniques for nucleic acid amplification and characterization combined with automation and user-friendly software have significantly broadened the diagnostic arsenal. Among the molecular techniques, applicability of PCR-based methods has gained popularity as it allows for rapid detection of unculturable or fastidious microorganisms directly from clinical samples.
Clinical laboratories are increasingly finding utility of molecular techniques in diagnosis and monitoring of disease conditions. Nucleic acid amplification tests are becoming very popular in the diagnosis and management of viral infections [hepatitis B and V viruses (HBV, HCV), human immunodeficiency virus (HIV), influenza virus, etc] because they allow determination of the viral load. In most cases, they are now considered a reference, or gold standard method for diagnostic practices such as screening donated blood for transfusion-transmitted viruses [cytomegalovirus (CMV), HIV, HCV, etc]. Another important case is the use of molecular tests for the detection of the tuberculosis (TB)-causing bacterium Mycobacterium tuberculosis (MTB). Considering the limited sensitivity of smear microscopy, coupled with the steady rise in drug-resistant MTB, rapid molecular tests appear promising.

What are the challenges of implementing molecular diagnostic techniques in developing countries?

For a long time the field of molecular diagnostics has been limited to the domain of large centralized laboratories because of its dependency on complex and expensive infrastructure, highly skilled manpower and special storage conditions. This investment has also resulted in the need for batch testing to make such facilities affordable. As a result, patients and samples need to travel long distances for a test to be conducted and results are delayed, resulting in a loss of follow-up. These factors have led to a concentration of such facilities in urban centres, and poor reach of molecular diagnostics techniques, particularly in low and middle income countries (LMICs). The poor testing rates in the current COVID-19 pandemic are evidence of such dependence on centralized facilities, limiting the ability to test on demand and take appropriate action.
The lack of timely access to good diagnostics resulting in either delayed or inaccurate diagnosis by other methods has been increasingly resulting in spread of disease and poor treatment outcomes.

How can these challenges be overcome?

We need to increase the reach of molecular diagnostics techniques. Given the economic constraints in LMICs, point-of-care technology (POCT) hold a lot of promise and several major global initiatives are devoted to providing such devices. Facilities for testing that can be deployed, set up and run quickly, at affordable costs, with minimal infrastructure requirements and training are critical to the success of the efforts to increase reach. Mobile data coverage, that exists with reasonable density in LMICs, could also be leveraged for better programme management and hotspot detection.
The success of these technologies also depend on uncompromised performance and adherence to quality standards.
Furthermore, designers of POCT devices need to focus on key user requirements which include: (1) simplicity of use; (2) robustness of reagents and consumables; (3) operator safety; and (4) easy maintainability.

What is Molbio Diagnostics doing to meet these demands?

The Truelab® Real Time Quantitative micro PCR System from Molbio Diagnostics brings PCR technology right to the point of care, at all laboratory and non-laboratory settings, primary centres, in the field, near patient – essentially at all levels of healthcare, thereby decentralizing and democratizing access to molecular diagnostics. With a large and growing menu of assays for infectious diseases, this rapid, portable technology enables early and accurate diagnosis and initiation of correct treatment right at the first point of contact. The platform is infrastructure independent and provides complete end-to-end solution for disease diagnosis. With proven ability to work even at primary health centres and with wireless data transfer capability, this game changing technology brings in a paradigm shift to the global fight in control and management of devastating infectious diseases.
Under the aegis of the Council of Scientific and Industrial Research and New Millennium Indian Technology Leadership Initiative partnership, Bigtec Labs (research and development wing of Molbio Diagnostics Pvt. Ltd.) has developed a portable and battery-operated micro PCR system that has since been extensively validated [under the Department of Biotechnology and Indian Council of Medical Research (DBT & ICMR)]. Bigtec has also developed various tests and nucleic acid preparation devices to facilitate ‘sample to result’ molecular diagnostics in resource limited settings. The micro PCR system has since been launched in India through the parent company, Molbio Diagnostics, which has its manufacturing and marketing base in Goa, India.
The system works on disease specific Truenat™ microchips for conducting a real-time PCR. The sample preparation (extraction and purification) is done on a fully automated, cartridge-based Trueprep® AUTO sample prep device. The purified nucleic acids are further amplified on the Truelab® Real Time Quantitative micro PCR System which enables molecular diagnostics for infectious diseases at the point of care.
This compact battery-operated system has single testing capability and provides sample to result within 1 hour. Hence, it enables same-day reporting and initiation of evidence-based treatment for the patient.It also has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Physicians benefit from this technology by having a definitive diagnosis, early in the infection cycle, without patients/samples having to travel extensively to centralized facilities.
The Truelab® Real Time Quantitative micro PCR System from Molbio Diagnostics is a cost-effective and sensitive device that can detect diseases accurately with high specificity. The device is battery-operated and portable. This offers the additional advantage of placing the device in almost any kind of laboratory setting, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Considering our platform’s potential to perform molecular diagnostics for infectious diseases at the point of care, India has initiated screening for COVID-19 using the Truenat™ Beta CoV test available on the Truelab® Real Time Quantitative micro PCR System. This will allow same-day testing, reporting, and initiation of patient isolation, if required – thereby reducing the risk of infection spreading while waiting for results.
The successful translation of our innovative concept into a product was made possible by Molbio’s multi-disciplinary workforce – with a constant mission to enable better medicine through precise, faster, cost-effective diagnosis at the point of care; to provide every patient access to the best healthcare through cutting edge technologies. Molbio aims to be a leading global player in the point-of-care diagnostics arena by continuing to innovate and bring new technologies for social betterment.

The company is based in India – how does this affect what you do, how is the clinical lab diagnostics industry developing in India and does it create more chances for you?

In India, we have over between 45¦000–50¦000 in vitro diagnostic laboratories – every one of which uses routine conventional diagnostic methods. Only a handful of them have adopted molecular diagnostic testing for reasons mentioned above. But this is changing with the advent of Molbio’s Truelab® platform, with regular standalone laboratories that were, up to now, outsourcing molecular testing, starting to perform the tests themselves. In the short span of a few years, Molbio has established itself as a company focused on making a significant impact in aiding infectious disease diagnostics worldwide with our extensive testing menu.
Our test range covers infectious diseases such as TB, the entire hepatitis range, High risk HPV, H1N1, along with the recent addition of tests for COVID-19, catering to a large population base and addressing diseases with a very significant global mortality percentages. Our rapid test development for Nipah virus and the leptospirosis-causing Leptospira bacteria show our commitment to neglected tropical diseases. Going forward, Molbio will continue to increase the assay range looking at the needs of the global LMIC geography.
The Truenat™ MTB and MTB-RIF tests have started playing a significant role in India’s mission to becoming TB-free by 2025. We would be happy to partner with other National TB Programmes in achieving sustainable development goals well before 2030.
Our vision has always been ‘innovate to have a real impact’ and hence Molbio will continue to bring in newer POCT platforms so that the benefits of science and technology reach the masses.
The interviewee
Dr Chandrasekhar Nair, BE, PhD, chief technical officer, Molbio Diagnostics

For further information visit Molbio Diagnostics (http://www.molbiodiagnostics.com)

NEWS CLI COMPANY

GC-MS discovery of biomarkers will allow non-invasive early disease detection by breath biopsy

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Owlstone Medical and Thermo Fisher Scientific recently announced a collaborative partnership to advance the early diagnosis of cancer and other diseases. This will involve the integration of Orbitrap gas chromatography mass spectrometry (GC-MS) instrumentation into Owlstone Medical’s Breath Biopsy platform, aiding metabolomics studies of breath samples for unique biomarkers that could translate into non-invasive, routine screening solutions for improved early diagnosis of cancer and other disease. CLI caught up with Dr Max Allsworth, Owlstone Medical, and Dominic Roberts, Thermo Fisher Scientific, to discuss how MS has benefited clinical lab diagnostics.
Mass spectrometry is an incredibly powerful technique, used increasingly in clinical lab diagnostics. How has it been of benefit in this application?
Clinical laboratories involved in both routine and research applications are under ever-increasing pressure to deliver fast results, while maintaining the highest levels of accuracy and confidence. The majority of these laboratories currently rely on targeted analytical approaches, using both gas chromatography (GC) and liquid chromatography coupled to triple quadrupole mass spectrometry (MS) instrumentation. These techniques cover the wide range of chemical classes to be monitored at the required levels of sensitivity and selectivity. However, they are limited to those compounds in the target list and they require careful optimization of acquisition parameters for each compound. High-resolution, full-scan MS using Orbitrap technology provides a solution to meet:

  • the demand for detection and quantification of a growing number of compounds;
  • retrospective analysis of samples long after data acquisition; and
  • identification and elucidation of the chemical composition and structure of unknown compounds.

While MS adoption in clinical settings has been somewhat limited to date, that is rapidly changing. A small number of MS-based assays have received United States Food & Drug Administration (U.S. FDA) clearance over the past few years in areas including microbiology pathogen identification, vitamin D quantitation, newborn screening and genetic analyses. One of the key benefits of MS adoption in clinical settings is its flexibility. The same instrumentation platform can be deployed into a wide variety of applications, being able to detect and measure protein, lipid, genomic, and the area with perhaps most clinical promise, metabolites. As a result, a broad range of laboratorydeveloped tests now exist in Clinical Laboratory Improvement Amendments (CLIA)-facilities with more being developed all the time.
One of the areas of greatest promise of MS in clinical settings is through the deployment of Breath Biopsy®. Metabolites, being the furthest downstream in biological processes, represent the most phenotypically relevant biomarkers that take into account both endogenous and external drivers of disease. Breath represents an extremely exciting approach to capturing these chemicals at very low levels with powerful implications for the early detection of disease and the effective delivery of precision medicine.
What current work is underway for developing the use of MS in the clinical lab?
GC-MS is Owlstone Medical’s core discovery technology, enabling us to explore volatile organic compounds in breath, seeking to link specific chemicals, and the changes in their levels, to specific diseases. In many metabolomics studies samples have to undergo a complex sample preparation protocol that can lead to complexity and variation if not controlled adequately. This is particularly true of liquid samples. However, as Owlstone Medical is identifying breath-based volatile biomarkers directly, sample preparation is relatively simple. By using thermal desorption to release the chemicals found in breath, which we have captured on a sorbent matrix in cartridges as part of our ReCIVA® Breath Sampler, the outflow can be directly introduced into a GC-MS system.
Owlstone Medical is focused on developing diagnostic and screening solutions in oncology (for example through LuCID, the world’s largest breath-based clinical trial for the discovery of breath-based biomarkers of early-stage lung cancer), liver disease (with whom they have partnered with the Cleveland Clinic), respiratory disease (working with AstraZeneca and GSK on asthma and COPD), and environmental exposure. In the future, once tests have been developed and launched into the market, sample analysis for a substantial portion of these tests will also be via GC-MS.

Researchers develop method for identifying aggressive breast cancer drivers

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Precision cancer medicine requires personalized biomarkers to identify patients who will benefit from specific cancer therapies. In an effort to improve the accuracy of predictions about prognosis for patients with breast cancer and the efficacy of personalized therapy, University of North Carolina Lineberger Comprehensive Cancer Center researchers have developed a method to precisely identify individual patients who have aggressive breast cancer. The new approach involves sorting and characterizing invasive breast cancer cells by epigenetic characteristics – a method that involves analysing how particular regulatory proteins interact with DNA to control their expression – as well as by how the genes are amplified or abnormally expressed. The researchers reported that they used this technique to identify potential new prognostic markers to predict distinct clinical outcomes for two major subtypes of breast cancer.

“This paper describes a ground-breaking multi-omics technology to discover drivers of proliferative and invasive breast tumours,” said Xian Chen, PhD, professor in the UNC School of Medicine Department of Biochemistry & Biophysics. “We think that eventually, these tools could help doctors better predict which particular patients have a good response, or acquire resistance to treatment.” Doctors often rely on information about tumour size, whether the cancer has spread and the tumour subtype to make treatment decisions. In addition to clinical subtypes of breast cancer, researchers have discovered molecular subtypes that have been used to help make treatment decisions. However, Chen argues that existing markers do not adequately distinguish breast cancer patient sub-populations with different clinical outcomes.

“Single ‘omics’ approaches, which rely on either genomics, transcriptomics, or proteomics alone, fail to dissect the heterogeneity that contributes to individual patients’ variability in terms of their rates of tumour growth, metastasis, or susceptibility to anti-cancer therapies,” he said. “Because biomarkers are not available to distinguish distinct patient sub-populations that are either responsive or resistant to particular drugs, doctors do not have all the tools they need to predict patient response to treatment and outcomes.”
In their study, the researchers wanted to see if they could stratify patients beyond existing molecular subtypes. Their goal was to develop a method to determine which patients within a single subtype would develop resistance or invasive cancer. There are five major molecular subtypes of breast cancer, which are classified based on how genes are expressed in a tumour.

Chen and his colleagues analysed luminal breast cancer and basal-like breast cancer, which is more commonly known as triple negative breast cancer, using breast cancer samples from two large international studies, The Cancer Genome Atlas and the Molecular Taxonomy of Breast Cancer International Consortium.

To move beyond subtype for identifying exactly which patients might develop resistance, they first sorted the most invasive tumour cells in frozen tissue using a molecular probe that was able to distinguish tumour from adjacent non-malignant cells or tissue by binding to an epigenetic regulator, or a histone methylase, called G9a. This enzyme has been reported by other scientists to be abnormally upregulated in many cancer types, including breast cancer.

They then identified select proteins that were working with G9a as partners-in-crime, and worked backwards from there to identify the genetic abnormalities linked to those partner proteins in the cancer cell. They found in many instances the genes for these interactor proteins were amplified in multiple copies, or abnormally overexpressed, rather than mutated.

“Nowadays, people think somatic mutations of select genes are the primary drivers of tumorigenesis,” Chen said. “We didn’t see many mutations on our identified driver genes. We actually found the genes encoding those interactors have a high frequency amplification in breast cancer patients with poor prognosis.”

They then used this information to generate sets of genes that encoded these “interactor proteins,” and identified those linked to poor prognosis in patients. Looking ahead, Chen and his colleagues plan to determine the specificity and sensitivity of multi-omic aberrations of particular interactor gene sets as new systems biomarkers to predict cancer patient prognosis.

University of Northern Carolina

www.med.unc.edu/biochem/news/

Liquid biopsy has prognostic role in colorectal cancer and potential for guiding therapy

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Liquid biopsy is likely to play an increasing role in identifying patients with colorectal cancer (CRC) who are likely to relapse after surgery, and has potential for optimising treatment for individual patients, according to new research.

Of 805 patients in the phase III IDEA-FRANCE trial who had liquid biopsy prior to adjuvant chemotherapy for stage III CRC, 109 (13.5%) had circulating tumour DNA (ctDNA) in their blood.

In this group, two-year disease-free survival (DFS) was 64%, compared to 82% in those who were ctDNA negative.

“In this large prospective trial, we confirmed that ctDNA is an independent prognostic factor in colorectal cancer and that approximately six out of 10 patients who are ctDNA positive will remain disease-free two years after standard adjuvant chemotherapy, compared to eight out of 10 of those who are ctDNA negative,” said study author Prof Julien Taieb, Hôpital European Georges Pompidou, Paris, France.

IDEA-FRANCE also showed that six months of adjuvant treatment was superior to three months in both ctDNA positive and negative patients, and that ctDNA positive patients treated for six months had a similar prognosis to ctDNA negative patients treated for three months.

Adjuvant therapy was FOLFOX (folinic acid, fluorouracil and oxaliplatin) in 90% of cases.

“ctDNA testing did not predict which patients should have three or six months of adjuvant chemotherapy and there is continuing debate over the optimal type and duration of treatment for patients who are ctDNA positive, but we do now know that ctDNA is a major prognostic factor which will be very useful in stratifying patients and driving future trials of colorectal cancer,” said Taieb.

“In all subgroups, ctDNA positive patients who only had three months of adjuvant therapy had the worst prognosis,” he added.

Thirty to 50% of patients with localised CRC relapse despite primary optimal therapy, and a second study reported at the ESMO Congress 2019 investigated whether ctDNA can be used to detect minimal residual disease and identify those at risk of recurrence.

The results showed that post-surgical plasma ctDNA predicted metastatic relapse a median of 10 months before recurrence was visible on radiological scans (hazard ratio 11.33; p=0.0001).

The researchers concluded that plasma ctDNA testing opens up an opportunity for precision treatment of patients with localised CRC.

Commenting on the results of the CRC presentations, Prof Alberto Bardelli, University of Turin, Italy, said: “When patients have surgery for early stage colorectal cancer, doubts remain as to whether the disease has been completely eradicated and, as a result, patients often receive adjuvant chemotherapy. However, the IDEA-FRANCE results have shown we can now use a blood test to say whether the patient is clear or not.”
ecancerecancer.org/en/news/16682-esmo-2019-liquid-biopsy-has-prognostic-role-in-colorectal-cancer-and-potential-for-guiding-therapy

New study identifies specific obesity-related risk factors for kidney cancer

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A new study confirms the long-suspected role of obesity as a risk factor for developing renal cell carcinoma (RCC), a type of kidney cancer, and identifies several specific obesity-related factors.
These factors include multiple measures of obesity, diastolic blood pressure and fasting insulin. In contrast, the study found little evidence for an association with RCC risk for systolic blood pressure, circulating lipids, diabetes or fasting glucose.
“This study provided robust and confirmatory evidence of the important role of obesity and diastolic blood pressure as important risk factors of RCC and novel evidence of an important role of circulating insulin in the disease’s etiology,” said Spectrum Health urologist Richard Kahnoski, MD. “But further research is needed to fully understand these important relationships.”
Renal cell carcinoma is also known as hypernephroma, renal cell cancer and renal cell adenocarcinoma. According to the National Cancer Institute, in 2018 it was estimated that there were 65,340 new cases of kidney and renal pelvis cancer in the U.S. and an estimated 14,970 people died of the disease. Kidney and renal pelvis cancer are the 8th most common cancer type in the U.S., representing 3.8% of all new cancer cases.
The development of RCC has not been fully understood by researchers. An increased risk for the disease has been observed for individuals with high body mass index (BMI), and elevated blood pressure and triglycerides.  However, traditional observational studies are subject to confounding and reverse causation errors. This study used an alternative methodology commonly referred to as mendelian randomization, which allows researchers to test for a causal effect from observational data in the presence of confounding factors.
“These obesity-related factors are inherently interrelated, and traditional observational studies have not been able to determine which individual factors directly influence RCC risk and which are merely correlated with the underlying causal factor,” said Brian Lane, MD, PhD, a board-certified urologist and Betz Family Endowed Chair for Cancer Research at Spectrum Health.
“Mendelian randomization allows us to circumvent many of the limitations of traditional observational study by use of genetic proxies of suspected risk factors.”
Lane, along with Kahnoski and colleague Sabrina Noyes, provided investigative and methodological input into the study, which evaluated genetic markers from multiple centres in a genome-wide association study of 10,784 RCC patients and 20,406 control participants. The markers included obesity measures, blood pressure, lipids, type 2 diabetes, insulin and glucose, which were initially identified as instrumental variables.
Spectrum Health https://tinyurl.com/y2ac73md

Concarlo awarded patent for novel therapeutic peptide for drug-resistant breast cancer

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Concarlo Holdings has received a US patent for IpY, a novel therapeutic peptide that addresses drug-resistant breast cancer by targeting a unique cellular pathway — p27Kip1. The patent is the latest step in Concarlo’s journey to commercialize revolutionary medicines for metastatic breast cancer.
Concarlo has also announced that a new provisional patent application has been filed for modified versions of the therapeutic peptide that are believed to exhibit enhanced bioavailability. Concarlo is a Brooklyn, New York-based biotechnology innovator dedicated to developing sophisticated, targeted therapies and diagnostics in the oncology space. The IpY technology is the first to address the high incidence of drug-refractory disease that develops with currently available CDK4 inhibitor (CDK4i) treatments. Such a solution has the potential to drastically increase overall survival of breast cancer patients.
The recent introduction of CDK4i drugs, a class of medicines that directly targets the CDK4/6 pathway implicated in many malignancies, has had a significant impact on the way in which metastatic breast cancer is managed. However, such therapeutics are associated with patients transitioning to a treatment-resistant form of the condition, despite initial extended periods of remission. Backed by more than 20 years of research and development expertise, Concarlo has developed IpY and a companion diagnostic, ApY, to effectively overcome the issue of CDK4i resistance and roll out a more targeted treatment approach for optimized patient outcomes.
“Despite the clinical efficacy of CDK4 inhibitors, we’re seeing that primary or secondary resistance to therapy is presenting a significant challenge to overall survival,” said Dr. Dominique Bridon, Chief Development Officer at Concarlo. “With the IpY technology and its unique mechanism of action, we’re effectively targeting CDK4 while simultaneously inhibiting another target — CDK2 — which has been found to be a key molecular player in the development of drug resistance. In doing so, we are the first company to successfully address the CDK4i resistance issue to provide long-term durable tumour arrest. Combined with its highly specific targeting and low toxicity profile, the positive impact of this drug on the breast cancer treatment landscape is hard to understate.”
Concarlo was formed in 2016 and is supported by a team of internationally renowned experts forming its Scientific Advisory Board. To date, the company has raised more than $3.1 million to support the development, improvement, and commercialization of its IpY and ApY technologies to bring a precision medicine approach to breast cancer management. The newly issued patent for IpY and the provisional patent application for modified versions of the peptide are the first key milestones in Concarlo’s plan to build an extensive patent estate to maintain market exclusivity for its clinically relevant therapeutics.

Base Genomics launches to commercialise ground-breaking epigenetic technology

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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.”

Dutch company CytoSMART Technologies is to donate 100 mini live-cell imaging systems to researchers in high containment labs worldwide

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Labs working to combat Covid-19 will benefit from this initiative, as CytoSMART aims to reduce the huge workload currently facing researchers on projects vital to controlling the disease.
CytoSMART’s unique and compact live-cell microscope films living cell cultures without disturbing their growth or behaviour. The device operates from inside cell culture incubators and is accessible from an online environment. This enables researchers to analyse their cell cultures remotely and assess e.g. the cytopathic effect, which is caused by virus replication. Using the CytoSMART Lux2, researchers will know when to take action for the next step and harvest the virus.
“We aim to do our part to assist researchers in minimizing the time they have to spend in high-contamination labs, by providing them with remote video access to evaluate the status of their cell cultures. The video data is used to remotely monitor the cytopathic effect, this way researchers know when it’s the right time to harvest the virus.” – Joffry Maltha, CEO at CytoSMART Technologies.
According to guidelines by the CDC and the WHO, isolation and characterization of Covid-19 should be performed in BSL-3 laboratories. Performing research in Biosafety Level 3 and 4 laboratories (BSL-3 or BSL-4) means working in a highly controlled area. Many precautionary measures must be taken to ensure the safety of researchers and help prevent the diseases they are working with from spreading outside the lab. Removing and replacing the protective clothing and apparatus can be time consuming and expensive, so entering the lab should ideally only occur when absolutely necessary.
Maltha commented: “We need to help scientists who are working in BSL-3 and BSL-4 laboratories to combat Covid-19. We know that our system can help researchers in monitoring cell growth and deciding when they need to go to the high containment labs and run further experiments.

Oxford-based businesses collaborate to scale up production of SARS-CoV-2 antigens

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OXGENE and The Native Antigen Company are collaborating to scale up production of SARS-CoV-2 reagents by combining OXGENE’s proprietary Adenoviral Protein Machine Technology with The Native Antigen Company’s antigen development expertise. Together, they aim to scale their antigen manufacturing capabilities to deliver high-purity, recombinant proteins for the development of diagnostics and vaccines.
Unlike the PCR tests that are currently being used, these diagnostics will be able to confirm past infections and determine levels of immunity to SARS-CoV-2. This could be invaluable for disease modelling and public health policy, as true transmission rates and case fatality rates can be determined. These tests could also be instrumental for the diagnosis of healthcare workers who have been exposed to the virus to ensure that they have developed natural immunity before returning to work, and to help measure patient immune responses for the rapid development of a SARS-CoV-2 vaccine.
The Native Antigen Company was one of the first recognised suppliers of SARS-CoV-2 antigens in February 2020, demonstrating their ability to rapidly support the diagnostic and vaccine industries with high-quality infectious disease reagents.
OXGENE’s Protein Machine Technology allows for the scalable production of viral proteins in mammalian cells using their proprietary adenoviral expression vector. Through genetic modification, the adenovirus is ‘tricked’ into making SARS-CoV-2 proteins rather than its own, thereby harnessing the innate power of highly scalable viral protein production.
Commenting on the collaboration, Dr Ryan Cawood, Chief Executive, OXGENE, said: “Our novel Protein Machine Technology represents a significant development in the rapid and scalable generation of high-quality viral proteins. We’re delighted that by collaborating with The Native Antigen Company, we can take advantage of our technology to support the needs of researchers racing to develop much-needed diagnostics and vaccines against COVID-19.”
The Native Antigen Company’s recombinant SARS-CoV-2 antigens are produced in mammalian cells to ensure full glycosylation and proper protein folding, both of which are essential for full biological and antigenic activity. The rapid scale up production of SARS-CoV-2 antigens is critical for the development of widely available diagnostic tests.
Dr Andy Lane, Commercial Director, The Native Antigen Company, said: “We are committed to developing the highest-quality reagents in rapid response to emerging epidemic diseases. Since the start of the crisis, the demand for our COVID-19 antigens has increased significantly, and by scaling up production of these vital reagents in collaboration with OXGENE, we hope to be able to support more researchers in their critical work developing diagnostics and vaccines.”
This collaboration builds on a long-standing collegiate relationship between the two Oxford-based businesses as they work towards developing more scalable technologies for the diagnosis of disease, and the cost-effective manufacture of high-quality diagnostics and vaccines.
OXGENE and The Native Antigen Company aim to complete the first validation of this new paradigm in protein expression by May 2020, which could have a demonstrable impact on the race to develop diagnostic kits and vaccines against this virus.
For further information about The Native Antigen Company’s Coronavirus Antigens, visit: https://thenativeantigencompany.com/coronavirus-dashboard/

Scientists develop test for uncommon brain diseases

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National Institutes of Health (NIH) scientists have developed an ultrasensitive new test to detect abnormal forms of the protein tau associated with uncommon types of neurodegenerative diseases called tauopathies.  This advance gives them hope of using cerebrospinal fluid, or CSF – an accessible patient sample – to diagnose these and perhaps other, more common neurological diseases, such as Alzheimer’s disease.

Scientists have linked the abnormal deposition of tau in the brain to at least 25 different neurodegenerative diseases. However, to accurately diagnose these diseases, brain tissue often must be analysed after the patient has died. For their study, the researchers used the same test concept they developed when using postmortem brain tissue samples to detect the abnormal tau types associated with Pick disease, Alzheimer’s disease and chronic traumatic encephalopathy (CTE). They adapted the test to use CSF for the detection of abnormal tau of progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), and other less common tauopathies.

They detected abnormal tau in CSF from both living and deceased patients. In one case, the test led to a corrected diagnosis in a patient who had died from CBD, but who was initially diagnosed with PSP. The new test is called 4R RT-QuIC – which stands for 4-repeat tau protein amplified in a real-time, quaking-induced conversion process.

The researchers plan to continue evaluating the clinical performance of 4R RT-QuIC by analysing larger sets of CSF samples. One focus will be to compare test results from tauopathy patients who agree to provide CSF samples both before and after death. The scientists hope this type of evaluation will help them better understand how abnormal tau in CSF evolves during brain disease.

NIHwww.niaid.nih.gov/news-events/nih-scientists-develop-test-uncommon-brain-diseases

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