Dante Labs, a pioneer and leader in genomic testing, Cambridge Cancer Genomics (CCG.ai), a software developer specialising in data-driven precision oncology, and Nonacus, a provider of genetic testing products for precision medicine and liquid biopsy, have signed a collaboration agreement.
In a joint statement they said the partnership aims to build the most comprehensive and patient-centric tumour profiling service enabling improved cancer patient management, treatment and monitoring. By combining Dante Labs’ experience and capacity in delivering a sequencing service for both solid tumour and cell free circulating tumour DNA from liquid biopsies, Nonacus’ sensitive targeted pan-cancer NGS libraries, and CCG.ai’s industry leading AI powered software platform, OncOS, the companies will enable precision oncology at scale.
Improving outcomes for cancer patients means ensuring they have the right drug, at the right time to beat their cancer. This means understanding the molecular profile of the individual cancer and using that data to recommend treatments or clinical trials. Oncologists and clinical researchers will be able to send samples for processing to Dante Labs, who will use library preparation kits from Nonacus and software from CCG.ai to create a sample to report solution. If there are actionable mutations, the report will recommend the right treatments for those mutations, if there are novel or unactionable mutations, the software will also be able to match possible clinical trials. Chris Sale, CEO of Nonacus, said: “Long turn-around time and lack of clinically oriented analysis are the main obstacles to fully deliver the potential of cancer genomics to patients. This partnership will provide the flexibility and accuracy that oncology professionals need to integrate cancer genomics into the care of their patients. The COVID pandemic has increased the backlog of genetic testing for cancer, potentially leaving many suspected cancers unconfirmed and treatments delayed. Dante Labs are one of the biggest clinical sequencing hub in Europe able to process large numbers of samples in high throughput. It is our hope that by combining AI software from CCG.ai and our library preparation kits, together we will be able to process samples and provide bioinformatic analysis critical to determining the best treatment path for patients.”
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NanoPass 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.
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In response to the global COVID-19 pandemic, Beckman Coulter, a global leader in clinical diagnostics, announced 31 March that it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with IgM and IgG tests.
The assays will be designed for use on any of Beckman Coulter’s high-throughput Access family of immunoassay systems, including the Access 2 and DxI series, which can be found worldwide.
“Antibody assays play a critical role in understanding the level of immunity an individual has developed against SARS-CoV-2,” said Kathleen Orland, Senior Vice President and General Manager for Beckman Coulter’s Chemistry and Immunoassay Business. “This type of understanding could help identify those who would require a vaccine, once available, or when an infected individual could safely return to work.”
Shamiram R. Feinglass, MD, MPH, Chief Medical Officer, Beckman Coulter, added: “With the ability to assess a patient’s immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that they have had prior exposure and therefore have built an immunity to the disease. This test could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Beckman Coulter operates within the Danaher Corporation, together with a collection of the world’s leading diagnostic companies, all on the front line in the fight against coronavirus.
Once the assays are finalized, Beckman Coulter intends to achieve CE mark certification and to follow FDA’s Emergency Use Notification process.
For the latest information on the new assays, visit www.beckmancoulter.com/coronavirus
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Avacta Group, the developer of Affimer biotherapeutics and reagents, has entered into a collaboration with Integumen to evaluate recently generated Affimer reagents that bind the SARS-COV-2 spike protein for the detection of the coronavirus in waste water, to provide a real-time alert system to warn of localised COVID-19 outbreaks.
Over 60 percent of COVID-19 positive patients had gastrointestinal symptoms, such as diarrhoea, nausea and vomiting, and the SARS-COV-2 virus was found in their faecal samples. Sampling waste water from households may therefore provide an early warning system for localised outbreaks in communities.
Recently, Avacta announced that it had generated a number of highly specific Affimer reagents that detect the SARS-COV-2 virus spike protein for use in diagnostic tests and in neutralising therapies.
The collaboration with Integumen, announced 13 July, aims to evaluate some of these Affimer reagents in next-generation sensors, based on the real-time bacteria detection and alert system1 developed by Rinocloud, a subsidiary of Integumen, with the aim of integrating these sensors into Modern Water’s Microtox water contamination system to detect the coronavirus. The award-winning Microtox system, which can detect the presence of contaminating bacteria, virus and toxins, is distributed by Modern Water and has a global footprint of over 3,000 installations. The proposed Affimer sensors would be consumable items to be replaced on a roughly monthly basis.
Once initial testing of the Affimer reagents is completed over the next few weeks, validation of the sensors will be carried out using SARS-COV-2 virus samples in a containment level 3 laboratory at the University of Aberdeen. Upon successful completion of this evaluation, Integumen and Avacta will enter into a supply agreement to allow Integumen to manufacture and commercialise the waste water detection sensors globally by retrofitting into Microtox systems.
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The 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
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The new coronavirus, SARS-CoV-2, causing a disease that has been called COVID-19, was first identified in Wuhan, China in December 2019, and has been transmitted widely across the globe. This article gives a general overview of what is currently known in a fast developing situation.
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LGC has acquired The Native Antigen Company (NAC), one of the world’s leading suppliers of high quality infectious disease antigens and antibodies.
NAC is a developer, manufacturer and supplier of critical reagents to the in vitro diagnostic (IVD), pharmaceutical and academic sectors. It offers a comprehensive portfolio of native and recombinant infectious disease antigens and related products including pathogen receptors, virus-like particles and antibodies for use in immunoassay applications, vaccine development and quality control solutions. NAC was one of the first companies globally to offer antigens for SARS-COV-2 and continues to play an important role in supporting the global response to the COVID-19 pandemic.
The acquisition strengthens LGC’s existing product offering to the IVD sector, which includes a range of quality assurance tools, immunoassay reagents and disease state plasma as well as probes and primers for molecular diagnostics.
“NAC is a natural fit with our clinical diagnostics business and will enable us to provide an expanded portfolio of critical reagents to our customers. NAC’s focus on infectious disease is highly complementary with our existing offer to this segment comprising controls, reference materials, MDx tools and other components,” said Michael Sweatt, Executive Vice President and General Manager, Clinical Diagnostics, LGC.
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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)
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Siemens Healthineers’s INNOVANCE assays help improve efficiencies, workflow and resource management following a COVID-19 diagnosis.
In hospitalised COVID-19 patients, elevated D-dimer levels have been found to be strongly associated with disease severity and even mortality reflecting the procoagulant status and high thrombotic risk observed in many COVID-19 patients. Therefore, the monitoring of D-dimer levels is recommended for hospitalised COVID-19 patients to stratify their thrombotic risk including testing for deep vein thrombosis and pulmonary embolism and guiding treatment over the course of the disease.
Treating COVID-19 patients with anticoagulants has been associated with improved outcomes, both in and out of the intensive care unit setting.
Accurate antithrombin measurement in COVID-19 patients undergoing anticoagulant treatment may be useful to determine the efficacy of anticoagulant therapy as antithrombin levels might be reduced.
Siemens Healthineers has a comprehensive portfolio of assays for detection and monitoring of coagulation disorders.
For more information, visit: https://www.siemenshealthineers.com/hemostasis/ innovance-reagents-for-coagulation-disorders Read more
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Molecular diagnostics is known to have superior advantages for routine detection of infectious diseases and now has a very prominent place in clinical laboratories. Based on the principle of DNA/RNA amplification, molecular diagnostic techniques help in early diagnosis of infectious diseases, providing the added edge of excellent sensitivity and specificity. However, this technique has, thus far, been limited to centralized laboratories due to dependency on complex and expensive infrastructure, highly skilled manpower, special storage conditions and a need for batch testing. This results in high turn-around time and poses major logistics challenges, such as sample degradation, contamination, report delays, etc.
Molbio Diagnostics Pvt Ltd has developed and commercialized Truelab™, a commercial point-of-care (POC) molecular diagnostics platform that uses PCR technology with Truenat test chips. Truenat™ disease-specific test chips are available for the diagnosis of 22 infectious diseases (such as TB, H1N1, dengue, HIV, hepatitis, etc) and an additional 43 diseases (such as coronavirus, MERS, etc) are in the pipeline.
The Truelab™ platform, a global first, is a compact, battery-operated system, with single testing capability and provides sample-toresult times within 1 hour. Hence, it enables same-day reporting and initiation of evidencebased treatment for the patient. Doctors 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 Truenat™ assay is rapid and affordable with minimal infrastructure requirements. Thus, placing the Truelab™ multi-disease detection system in the most remote settings will enable mass access to advanced molecular testing for people of all socio-economic backgrounds, across the globe. The device has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Additionally, a cloud-based centralized data monitoring and surveillance network can be created and linked to all devices in a region. Complete data from tests performed can be accessed, analysed and recorded in real time. Such same-day reporting of results will strengthen the healthcare systems across countries by improving effectiveness of providing treatment and quarantining of patients, thus controlling spread of communicable diseases. The device is ideal for places that do not get regular electricity, and will work well even in primary healthcare centres, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Molbio’s technology has been approved by the Indian Council of Medical Research in 2018, after 3 years of validation study across various sites in India. Internationally, the World Health Organization (WHO), after conducting a multicountry study, has released a rapid communication in January 2020 endorsing Truenat™ as an initial diagnostic test of Mycobacterium tuberculosis (MTB) and MTB-RIF (MTB rifampicin resistance) in view of its high diagnostic accuracy. The WHO has further endorsed Truenat™ for diagnosis of TB as a replacement of the less sensitive sputum smear microscopy. The performance of Truenat™ shows comparable accuracy with other WHO approved tests such as Genexpert, TB-LAMP® and line probe assay. Truenat™ will help in decentralizing and democratizing access to high quality diagnostics to millions of patients suffering from TB and other infectious diseases even at peripheral and remote settings.
At present, Truelab™ devices are installed in over 500 private laboratories, 350 government primary health centres in India and in 27 countries around the globe, extending across the continents of Asia, Africa, Europe and South America. WHO endorsement will further enable the product to be commercialized across more than 150 countries.
Truelab™ is patented across over 100 countries which enables the transition from presumptive to efficient, real-time and precise diagnosis of multiple diseases at reasonable price even in primary healthcare centres and smaller diagnostics labs, which can now deliver high-end molecular diagnostic tests.
Molbio Diagnostics is driven by the urgent need to provide world-class medical devices to enable better medicine through precise, faster, cost effective diagnosis and envisions to be a leading global player in the POC diagnostics segment by continuing to innovate and bring new technologies for social betterment.
In addition, given the current coronavirus pandemic, Molbio is pleased to announce that the Truenat™ Beta-CoV POC RT-PCR test is currently being validated through a regulatory process and is expected to be commercially available in the next couple of weeks. This rapid, portable, POC solution will enable molecular testing for COVID-19 to be performed even at the community level and will provide results within 1 hour from sampling. Read more
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