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Covid-19 live timeline – Verdict Medical Devices

3:12 pm

Coronavirus cybersecurity: Ten tips for secure remote working

As the ongoing Covid-19 pandemic continues to affect numerous aspects of daily life, workers and employers are adapting to new ways of working.

Although social distancing and social isolation are key to slowing the spread of the virus, they have tested organisations’ infrastructure and remote working practices.

“Remote working on a scale we’ve never seen before has now become a fact of life; doing this without compromising security will be more important than ever,” says Jeremy Hendy, CEO at cybersecurity firm Skurio.

Here are ten key pieces of advice from experts from the cybersecurity industry to help organisations maintain robust security while remote working.

Read more here

2:18 pm

Astrotech develops screening instrument to detect Covid-19 infections


1:30 pm

UK government calls for rapid ambulance sanitising technology

The UK Defence and Security Accelerator (DASA) has launched an open call for rapid sanitising technology to speed up the time it takes to clean ambulances, as part of the national effort against Covid-19.

It currently takes up to 45 minutes to clean an ambulance after transporting a suspected Covid-19 patient. Some ambulance cleaning centres are a significant distance from their base or hospitals, adding strain to the already pressurised NHS as the vehicles cannot be used again until cleaning is completed.

DASA is now seeking industry help to identify rapid sanitising technology solutions that can be demonstrated in a live trial on an ambulance. Solutions must be suitable for rapid deployment to clean public sector vehicles following the transport of patients with the Covid-19 virus.

Solutions that are mobile, robust, reliable and easy to operate are of particular interest. It is hoped their deployment can extend beyond ambulances to other emergency services or potentially hospital wards. The open call lasts until 1 April 2020.

1:00 pm

$500,000 raised to expand Covid-19 testing in Nigeria

African genomics company 54gene has launched a fund to tackle the current challenges around Covid-19 testing in Nigeria.

The company initially donated $150,000 to the Nigeria Centre for Disease Control. Within 24 hours of the fund’s launch it had secured an additional $350,000 from its partners.

The money raised thus far will help increase Covid-19 testing capacity in the country by up to 1,000 additional tests a day. It will be used to buy testing instruments and the required biosafety materials such as biosafety cabinets and personal protective equipment needed to keep frontline healthcare workers safe.

54gene is also calling for the deployment of a specialised Covid-19 workforce trained in molecular diagnostics.

11:55 am

Quidel gets expanded emergency use authorisation for SARS-CoV-2 test


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The US Food and Drug Administration (FDA) has granted expanded emergency use authorisation (EUA) for Quidel’s Lyra SARS-CoV-2 Assay for the coronavirus (Covid-19) diagnosis.

The expanded EUA will enable testing with three additional thermocyclers – Applied Biosystems 7500 Standard, Roche LightCycler 480 and Qiagen Rotor-Gene Q.

The initial EUA allowed the Lyra SARS-CoV-2 assay real-time RT-PCR test to qualitatively detect nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of Covid-19 by their healthcare provider.

Recently, the Centers for Disease Control and Prevention (CDC) expanded the list of acceptable specimens to include nasal and nasal turbinate swabs.

The FDA grants EUA to enable the early availability of important diagnostic tools when there are no adequate, approved and available alternatives.

The Lyra reagents are characterised by features that allow simple transport and storage, enhanced workflow, quicker results and other benefits that positively affect the diagnostic test outcome.

The test also provides certain additional advantages, including easier set-up and faster test results compared to other tests currently on the market for the coronavirus.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests.

Meanwhile, the Lyra SARS-CoV-2 Assay received CE-Mark, allowing its market launch in Europe and other countries.

Quidel also obtained authorisation from Health Canada to market and sell the assay in Canada. The assay is currently available for sale in the US under the EUA.

11:15 am

Medopad offers Covid-specific remote patient monitoring

British healthtech company Medopad is offering support to the global healthcare sector by providing clinicians with a specialised Covid-19 version of its remote patient monitoring (RPM) platform. The technology will be available for NHS Trusts across the UK as well as global healthcare providers.

Medopad has worked with Imperial College, Guys’ and St Thomas’ NHS Foundation Trust, as well as Johns Hopkins University to create the specialist Covid-19 RPM platform. It is designed to help monitor ill and at-risk patients, enable care for chronically ill patients and provide insights into the operations of healthcare systems to help them prioritise resources and respond more effectively.

Using Medopad’s RPM app and a clinician dashboard, doctors can track patient data and symptom progression and flag patients with worsening symptoms, both inside and outside of clinical settings. Patients are able to use a corresponding mobile phone app to securely share personal health data such as temperature, respiration rate and heart rate.

Read full story here.

10:01 am

ixlayer adapts Covid-19 clinical testing platform

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ixlayer has adapted its platform to help laboratories and healthcare systems to address the demand for rapid and increased coronavirus (Covid-19) clinical testing.

The ixlayer Covid-19 clinical testing platform already encompasses the complex security components that are time-consuming to deliver.

It is now adapted for Covid-19 specific content and user flows, enabling clinicians to quickly connect with partnering labs to deliver clinical testing for the virus.

Furthermore, the platform can support multiple labs and providers across all states while allowing physicians to connect with patients remotely using its telemedicine infrastructure.

On the platform, patients can also directly request testing by logging into the secure patient portal and completing a health screening eligibility questionnaire, which evaluates their current symptoms, recent travel and community exposure to the disease.

ixlayer CEO Pouria Sanae said: “When the World Health Organization (WHO) declared rapid and global testing was needed to address Covid-19, I knew that would present challenges. Bringing a new test online can be complicated and time-consuming without technology solutions.

“Thankfully, the ixlayer platform has been efficiently delivering precision health testing across the US using the telehealth model for several years, so we already have the needed security and infrastructure in place.”

The Centers for Disease Control (CDC) and other researchers will be able to identify trends in disease transmission as ixlayer’s Covid-19 platform collects real-time data, including demographics on positive and negative tests by age, gender and geographic location.

In addition, issues with the testing pipeline can be identified and addressed immediately if a large number of inconclusive results are present in a given area.

ixlayer evaluates and adjusts the content in the platform regularly according to, CDC and WHO guidelines.

The content can be customised for the specific needs of individual groups while maintaining the integrity of the message from leading authorities.

3:51 pm

UK coronavirus mass home testing available ‘within days’

Public Health England (PHE) has said that thousands of home testing kits for Covid-19 will be available within days, reports The Guardian.

The UK government has bought 3.5 million of the tests, which have a 15-minute turnaround for results. They will be delivered by Amazon to people self-isolating with symptoms as well as being available in pharmacies.

The tests will first be validated in Oxford to ensure they work as well as hoped. Resembling a pregnancy test, people will need to prick their finger to produce a drop of blood which the device will then analyse. The tests are antibody tests, which detect the presence of the IGM and IGG antibodies that accompany a Covid-19 infection.

2:49 pm

FDA approves emergency use of PerkinElmer Covid-19 test

The US Food and Drug Administration (FDA) has provided Emergency Use Authorisation (EUA) to PerkinElmer for its New Coronavirus RT-PCR test. Laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using the test to detect the virus that causes Covid-19.

Perkin Elmer’s RT-PCR test is an in vitro diagnostic that is available in over 30 countries worldwide.

PerkinElmer CEO Prahlad Singh said: “Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic. The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”

12:29 pm

Non-profit launches to distribute essential Covid-19 supplies

Chinese laboratories and factories have a new distribution channel of diagnostic tests and surgical masks in newly launched non-profit RapidWard.

Founded by humanitarian Milton Zhou, RapidWard volunteers are helping source and lock in production contracts with the most advanced laboratories and factories in the country. The organisation is selling its inventory of rapid diagnostic tests and surgical masks at not-for-profit, with the testing kits retailing for $12 each.

Consumers can register their interest to purchase equipment at a future date on the company’s website. The company is seeking international volunteers to expand its reach across the world.

RapidWard’s tests are CE and TUV SUD, registered with the British Medicines and Healthcare products Regulatory Authority. Their surgical masks meet all clinical specifications N95 masks have US Food and Drug Administration approval.

Milton Zhou said: “The time for action is now – the 1,000% markup, grotesque profiteering and artificial shortages that characterize the responses to date should be considered crimes against humanity at this stage in the pandemic.”

11:06 am

Covid-19 test being designed to provide diagnosis in 30 minutes

Biopharmaceutical company Heat Biologics is collaborating with the University of Miami to develop a Covid-19 point-of-care diagnostic kit.

The test will require a pharyngeal throat swab and deliver results within 30 minutes. The results appear on a paper strip in a similar fashion to a pregnancy test, with one line indicating a negative result and two lines indicating a positive result.

Current tests for Covid-19 often rely on expensive thermal cylinders that take five to six hours to produce results, or require blood draws to detect antibodies which indicate exposure.

Preliminary research suggests that the Heat Biologics test is specific to the virus which causes Covid-19 and will not cross-react to other coronavirus subtypes. Researchers also expect the test to be less expensive to produce than others currently in development, while still delivering quicker results, meaning it can be easily scaled and deployed internationally.

By using molecular recognition and amplification of the target virus, the test should allow for detection of the disease within a couple of days of exposure. Tests that detect antibodies can be less effective at these early stages as they have yet to form in the body.

Detecting the virus earlier, before many people have started to show symptoms, could play a significant role in helping to curb the spread of the disease. If a patient knows they have the disease at an earlier stage they can immediately self-isolate and bypass the risk of infecting other people while asymptomatic.

Heat Biologics CEO Jeff Wolf said: “We believe this point-of-care diagnostic will address many of the challenges facing existing tests, including time to readout and cost. We look forward to providing further updates on this platform in the near future.”

As well as the test, Heat Biologics and the University of Miami are also working together to develop a Covid-19 vaccine.

2:44 pm

AliveCor’s KardiaMobile 6L wins approval for use in Covid-19 patients


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AliveCor’s KardiaMobile 6L technology has received the US Food and Drug Administration (FDA) approval to measure QTc and detection of potentially dangerous QT prolongation in coronavirus (Covid-19) patients.

The heart rate corrected interval QTc reflects the integrity of the heart’s electrical recharging system.

Its abnormal prolongation can stem from congenital long QT syndrome, many disease states and electrolyte abnormalities. It can also be caused by several of the FDA-approved medications.

Patients with a prolonged QTc are at a risk for Torsades de Pointes that can cause sudden cardiac arrest or even sudden cardiac death (SCD).

The company noted that the drugs being used off-label to treat Covid-19 have the potential for unwanted QT prolongation and drug-induced SCD (DI-SCD) in patients.

The drugs include Hydroxychloroquine and Azithromycin.

AliveCor CEO Priya Abani said: “At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. The benefits of remote, personal ECG measurement have never been clearer.

“We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of Covid-19 during this global health emergency.”

KardiaMobile 6L is considered to be six-lead personal ECG. It helps in obtaining the patient’s QTc as a vital sign to allow rapid and safe use of the drugs.

In addition, the technology will allow ECG technicians to collect QTc without exposing them to the affected patients.

The immediate availability of the device is expected to bring down the life-threatening effects of Covid-19 drugs.

AliveCor expects to add a professional QTc monitoring service soon. It will facilitate a seamless workflow with no on-premise calculations required.

12:37 pm

NxGen MDx reports immediate launch of Covid-19 test


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US-based women’s health company NxGen MDx has reported an immediate launch of its coronavirus (Covid-19) test to combat the lack of diagnostic test availability for the virus.

The test is expected to help meet the shortfall of diagnostic capabilities in the US, which has limited the country’s ability to combat the spread of the outbreak.

NxGen MDx laboratory operations director Dr Jacqueline Peacock said: “Like the CDC-built kits, ours will be conducted on QuantStudio qPCR instrumentation and will be able to process 2000 samples per day with tests being resulted in 24-48 hours.”

Due to the rise in Covid-19 cases in the US, the lawmakers, including the US Food and Drug Administration (FDA), have called on laboratories and medical companies to expand testing capacity to fight the pandemic.

NxGen MDx CEO Alan Mack said: “Covid-19 is a global challenge and we are committed to providing people on the frontlines of this pandemic with critical tests to help ensure proper care.”

Apart from the Covid-19 diagnostic test, the company is also working to validate a 40+ respiratory pathogen panel to identify the cause of respiratory symptoms in a single test. The test is expected to be launched in July this year.

Coronavirus causes highly contagious and sometimes fatal respiratory illness in the patients.

Meanwhile, healthcare companies across the world are striving to resolve the unprecedented health crisis caused by Covid-19.

Coronavirus cases have reached 380,000 globally with more than 16,000 deaths. In the US, the positive cases have increased to 33,404 and with over 400 deaths.

11:53 am

Mylab receives approval for Covid-19 test kit


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India-based Mylab Discovery has become the first company in the country to receive approval for its coronavirus (Covid-19) diagnostic test kits, called reverse transcription polymerase chain reaction (RT-PCR) tests.

The testing kit has been commercially approved by the Indian FDA / Central Drugs Standard Control Organisation (CDSCO).

The approval is expected to help increase testing in the country.

RT-PCR kits can study 1000 samples from large labs and 200 from smaller labs.

Mylab expects to produce one lakh test kits per week and then gradually increase the production to meet the testing demands.

Mylab medical director Dr Gautam Wankhde said: “In the current lab-based testing, it takes four years for test results to come out, Mylab’s turnaround time is two and half hours.”

The kits are expected to be priced approximately INR1200.

Germany’s Altona Diagnostics has also won approval for its diagnostic kit for coronavirus.

Last week, the Drug Controller General of India (DCGI) granted a test licence to 14 private companies, including Roche Diagnostics India, to evaluate the quality of testing kits for detecting Covid-19.

Meanwhile, India is experiencing a rise in coronavirus cases. So far, 511 positive cases and nine deaths have been recorded. Most of the cases are reported in Kerala.

The Indian Government is putting strict measures in place to reduce the spread of the virus. It has ordered all states in the country to impose lockdown.

This disease was first reported in Wuhan, China.

11:39 am

Roche urges international collaboration to tackle Covid-19 pandemic

Pharmaceutical giant Roche has called on governments around the world to work closely with the life sciences industry to tackle the Covid-19 pandemic.

The company has urged governments to help keep manufacturing and supply running to meet the increased worldwide demand for drugs and medical devices. It has also stressed the importance of ensuring the free flow of vital medical goods across national borders to keep manufacturing and supply running.

Roche has suggested pragmatic temporary adjustments to regulations on packaging, reviews and customs to expedite the delivery of urgently needed medical supplies as governments work together internationally to balance global needs.

Read full story here.

9:41 am

UK Government announces closure of non-essential businesses

Last night, UK Prime Minister Boris Johnson announced more stringent, semi-lockdown measures for the UK to encourage social distancing.

These included only allowing people out of their homes to shop for basic necessities, exercise once a day, any medical appointments and to go to work if absolutely necessary.

To the end of discouraging people from leaving their houses for any other reasons, the UK Government closed all non-essential shops, including clothing and electronics retail stores, hair and beauty salons, and markets, except those selling food.

The police and other relevant authorities will be given powers to enforce these social distancing rules, including issuing out fines.

10:19 pm

Global GDP may drop by 1% in 2020, says Goldman Sachs

Goldman Sachs expects global real gross domestic product to contract by about 1 per cent in 2020, a sharper economic decline than in the year following the 2008 global financial crisis.

“The coronacrisis or more precisely, the response to that crisis — represents a physical (as opposed to financial) constraint on economic activity that is unprecedented in postwar history,” the investment bank said in a note to its clients published late on Sunday according to India Today.

1:03 pm

Microsoft and Adaptive Biotechnologies partner on Covid-19 mapping

Microsoft and Adaptive Biotechnologies have announced they will leverage their existing partnership, mapping population-wide adaptive immune responses to diseases at scale, to study Covid-19.

Adaptive will open enrolment in April to collect deidentified blood samples of individuals diagnosed with or recovered from Covid-19, using a LapCorp-enabled mobile phlebotomy service. Immune cell receptors from these samples will be sequenced using Illumina platform technology and mapped to Covid-19 specific antigens, which will have been confirmed by Adaptive’s proprietary medicine platform to induce an immune response.

The immune response data derived from the initial discovery work and samples will be uploaded to an open access data portal. Using Microsoft’s hyperscale machine learning capabilities and the Azure cloud platform, the accuracy of the immune response signature will be continuously improved and updated online in real time as more trial samples are sequenced from the study.

The companies are seeking additional participation from institutions and research groups around the world to contribute blood samples to the open data initiative.

Microsoft corporate vice president of AI and research Peter Lee said: “Making critical information about the immune response accessible to the broader research community will help advance ongoing and new efforts to solve this global public health crisis, and we can accomplish this goal through our proven TCR-Antigen mapping partnership with Adaptive.”

12:30 pm

FDA takes action to increase availability of ventilators

The US Food and Drug Administration (FDA) has taken action to increase the availability of ventilators, their associated accessories and other respiratory devices to support patients with respiratory failure or difficulty breathing during the Covid-19 pandemic.

Medical device makers can now make changes to existing products more easily, such as changes to their suppliers or materials to help address manufacturing limitations or supply shortages. Manufacturers in other sectors, such as the automobile industry, will also be more easily able to repurpose their production lines to help increase supply.

Hospitals and other healthcare providers will be able to repurpose existing machines to function as ventilators, such as repurposing ventilators normally used for transporting patients in an ambulance for long-term hospital use. The FDA has also suggested that other devices, such as those used for treating sleep apnea, should be considered.

Read full story here.

7:36 pm

OECD expects economic fallout to be felt ‘for a long time to come’

Speaking to CNBC, the OECD’s secretary general, Angel Gurria, stated: “What you have is an economic effect now that, very clearly, is going to be prolonged beyond the period of the pandemic.”

“We’ll hopefully get rid of the pandemic in the next two or three months and then the question is how many unemployed (will there be), how many small and medium-sized enterprises will be in a very, very severe situation if not disappeared by that time.”

“Life, and economic activity, is not going to be normalized any time soon,” he said. “We’re going to have the impact of this crisis for a long time to come.”

11:55 am

BATM partners with Novamed for at-home Covid-19 diagnostics kit

Medical laboratory company BATM has entered into a partnership with Israeli life sciences firm Novamed for the rapid joint development of a home-use Covid-19 diagnostics kit.

The kit is designed to allow people to test a sputum sample at home and should deliver results within a few minutes. The manufacturers anticipate that the development of the kit will take three to four months.

Following the receipt of CE certification, the parties expect the kits to be available for sale in Israel before exporting globally.

BATM CEO Dr Zvi Marom said: “We chose to partner with Novamed thanks to their many years of experience in developing excellent at-home diagnostic products. We believe that the combination of the capabilities of BATM and Novamed will result in a uniquely effective solution to address the current pandemic as well as other outbreaks in the future.”

BATM has also started shipping a new Covid-19 diagnostic kit developed by Adaltis. This kit is designed for use in medical facilities rather than at home, with the Italian market as the current focus. The manufacturers are preparing to ramp up production within the next few weeks to meet existing orders and anticipated future demand.

Clinical testing has demonstrated strong performance from the kit, which can identify if a person has Covid-19 or other coronavirus variants in under one hour using real-time polymerase chain reaction testing.

Marom said: “This is another step forward in our strategy to provide effective solutions for tackling infectious diseases. The COVID-19 outbreak has demonstrated the huge challenges that are posed by such diseases and the importance of having a comprehensive response covering rapid diagnosis and treatment.”

Cases of coronavirus continue to surge around the world, with over 252,000 cases reported and 10,000 deaths linked to the disease. Despite having around half the amount of cases, deaths in Italy have now overtaken those reported in China, where the outbreak began.

10:24 am

Avellino increases genetic test kits production for Covid-19 detection

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Avellino Lab USA has announced additional production shifts to scale up the manufacturing of the SARS-CoV-2/COVID-19 Test (AvellinoCoV2), its newly developed coronavirus (Covid-19) diagnostic.

This ultra-rapid genetic test helps clinicians diagnose Covid-19 caused by a SARS-CoV-2 virus infection by identifying and isolating the genetic markers as approved by the FDA and the CDC.

The test is considered to be in high demand among health systems, public health services and first-responders due its precision, speed and ability to detect the disease in asymptomatic patients.

To ramp up the production of AvellinoCoV2 test, company is expanding its operations into the genetic diagnostics lab as used for its AvaGen test that assesses the risk of developing keratoconus and the presence of corneal dystrophies.

In addition, the company is temporarily suspending sequencing operations of its AvaGen genetic to meet the demand for its Covid-19-test.

Avellino Group chairman Gene Lee said: “We appreciate the support from eye care professionals who are now using the AvaGen genetic test to care for their corneal patients. We understand the breakthrough importance of the AvaGen test in treating patients with complex corneal conditions.

“Avellino will restart production of the AvaGen genetic test as soon as we have fulfilled our public health obligation surrounding the coronavirus pandemic.”

The validation process for AvellinoCoV2 was completed by the company earlier this month, according to the FDA issued guidance for laboratories developing Covid-19 tests.

2:49 pm

Medtronic ramps up ventilator production to address Covid-19 pandemic


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Medical technology company Medtronic has increased the production of ventilators by more than 40% due to the global coronavirus (Covid-19) outbreak and to cater to the increase of demands of patients and healthcare systems across the world.

The company has more than 250 employees who manufacture ventilators in its Ireland facility.

Medtronic has also put in place extra manufacturing shifts and is introducing new shift patterns to bring the plant to 24/7 operation.

Ventilators play a critical role in the management of patients with a severe respiratory illness such as Covid-19. They allow patients who cannot breath effectively to rest and recover while supplying oxygen and simulating breathing.

Medtronic Minimally Invasive Therapies Group president and executive vice-president Bob White said: “Medtronic recognises the demand for ventilators in this environment has far outstripped supply. No single company will be able to fill the current demands of global healthcare systems.

“However, with all manufacturers increasing their production and through partnerships with governments, hospitals and global health organisations, Medtronic is committed to getting more ventilators into the market and to the right locations in the world to help doctors and patients dealing with Covid-19.”

The company produces high-performance ventilators for various care settings, including the acute sub-acute segments.

They include Puritan Bennett 980 (PB 980) and Puritan Bennett 840 (PB 840) that are manufactured in Galway, Ireland, and are designed for critically ill patients in high acuity setting.

Ventilator demand has significantly increased due to the coronavirus infection, which causes severe respiratory illness in patients and other symptoms such as fever and cough.

12:10 pm

Covid-19: BGI launches RT-PCR SARS-CoV-2 test for clinical use in US

BGI Genomics’ subsidiary BGI Americas has launched its Real-Time Fluorescent RT-PCR test, which detects SARS-CoV-2 virus that causes coronavirus (Covid-19), in the US for clinical use.

The company’s test is eligible for immediate use, according to the US Food and Drug Administration’s (FDA) recent guidance on expediting clinical testing for the virus.

An emergency use authorisation (EUA) request will be soon submitted to the FDA by the company for its SARS-CoV-2 test.

BGI Genomics is in constant discussions with the FDA about its testing data since submitting information to the agency more than a week ago.

BGI Genomics CEO Yin Ye said: “We appreciate the FDA’s move to open up the market for our diagnostic test kits. Our goal is to deploy our maximum capability to support efforts to contain the virus worldwide.

“Our technology has been put to the test on the front lines of fighting this novel coronavirus outside the US. We are now bringing rapid and accurate testing capability at scale to bolster detection efforts throughout the US and help more patients receive an accurate diagnosis.”

Following the outbreak of coronavirus in China, BGI Genomics is considered to be at the forefront of testing for SARS-CoV-2.

The company’s diagnostic test received emergency approval from China’s National Medical Products Administration (NMPA) on 26 January, followed by CE-IVD marking on 2 March.

Over 500,000 SARS-CoV-2 tests have been performed by the company in its own central laboratories in China.

Currently, its SARS-CoV-2 detection kits are distributed in more than 50 countries and regions across the world.

The company has increased its manufacturing capacity to up to 300,000 reactions per day to meet the increasing global necessity for coronavirus testing.

BGI expects the FDA’s EUA for its SARS-CoV-2 test in the near future.

11:44 am

Smart manufacturing company cuts costs for essential Covid-19 devices

Smart manufacturing company Bright Machines has announced it will enable no-cost automation for up to a year for the manufacturing of medical devices essential to the treatment of Covid-19.

Access to testing kits and an adequate supply of treatment resources for devices like ventilators and respirators is now critical. In the wake of the global Covid-19 crisis, medical device companies will now be able to use a Bright Machines Microfactory for free to expedite the production of these kinds of devices for up to 12 months.

Bright Machines Microfactories help manufacturers scale up production using modular automation, which is less reliant on human operators than a traditional assembly and inspection process.

The company also offers Bright Machines Select, a microfactory-as-a-service model which offers Software Defined Manufacturing to manufacturers while allowing them to bypass the upfront costs associated with traditional automation equipment purchasing.

Bright Machines CEO Amar Hanspal said: “As a leader of an organization that has employees in the US, Europe and Asia, many of whom were the first to get impacted by the disease and others who are now in mandatory shelter-in-place directives, I can’t help but to feel that where we can, we must help be a part of the solution.

“The most valuable and timely contribution Bright Machines can offer is removing barriers to quickly get these critical products into the hands of as many healthcare providers throughout the world as possible. And, as the part of the supply chain helping to manufacture products like these, it is our responsibility to help do so.”

The company believes that manufacturers that would otherwise have been constrained by cost, labour shortages or slow production cycles may now be better able to meet increased demand in the healthcare sector.

Shortages of ventilator valves in Italy have already spurred action from the business community, as local 3D printing companies stepped in to manufacture replacements for patients in intensive care.

11:06 am

FDA grants emergency use authorisation for Abbott’s Covid-19 test


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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s molecular test for coronavirus (Covid-19).

The molecular tests are run on the company’s m2000 RealTime System, a molecular solution with a broad range of tests.

Following the EUA, Abbott is shipping 150,000 RealTime SARS-CoV-2 tests to existing customers in the US.

Abbott chairman and CEO Miles White said: “A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it.

“I am proud of the Abbott team and what they have accomplished in such a short period of time and I want to thank the Administration and the FDA for their partnership in making this happen.”

The Abbott m2000 RealTime platform uses polymerase chain reaction (PCR) technology, which amplifies a single piece or few copies of a piece of DNA to diagnose a patient with precision and speed.

It is currently used in hospital and reference labs in many parts of the world and is said to have the ability to run high volumes of up to 470 tests in 24 hours.

Abbott said it will coordinate with health systems and government authorities to deploy additional m2000 RealTime Systems to meet the demands for Covid-19 tests.

The company will also increase the production of the tests to highest levels possible at its US manufacturing location.

Earlier this month, it received CE Mark for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system.

Meanwhile, the number of Covid-19 cases is growing around the world. The death toll has increased to 8,809 on 18 March.

5:14 pm

Covid-19: start-up that saved lives with 3D-printed valve may face legal action

Italian 3D printing start-up Isinnova has saved the lives of ten Covid-19 patients after developing a replacement ventilator valve when supplies at Chiari hospital in Brescia ran dry.

However, the firm may now be facing legal action from the manufacturer of the original part, according to Italian newspaper La Stampa.

The Bresica region of Italy has been hit hard by Covid-19, and valves were urgently required so that intensive care patients could be placed on ventilators, but Chiari’s regular supplier wasn’t able to provide the devices in time.

Digital fabrication company FabLab founder Massimo Temporelli was then contacted by the editor of the Giornale di Bresica to see if the part could be 3D-printed instead.

Through a network of additive manufacturers, word eventually reached local 3D printing start-up Isinnova founder & CEO Cristian Fracassi. Fracassi delivered a 3D printer directly to the hospital and was able to redesign and produce a new valve piece within just six hours.

The valves were printed using a filament extrusion system on location at the hospital. This involved pelting plastic wire and depositing it layer-by-layer to make the final product.

More valves were later printed by another local firm, Lonati, using a polymer laser powder bed fusion process and a custom polyamide-based material. In this process, a laser is used to melt and fuse a powder together to build up layers of an object.

When Isinnova contacted the manufacturer of the original valves for blueprints it could use as replicas, the company allegedly declined the request and threatened to sue for patent infringement. Fracassi and his colleague Alessandro Ramaioli chose to move ahead anyway by measuring the valves and 3D-printing three different versions to test.

Speaking to TPI, Fracassi said: “I have lawyers who are evaluating the matter. I am not dealing with it personally because I prefer to devote myself to [the 3D designs]. There were people in danger of life, and we acted.

“We have no intention of profiting from this situation. We are not going to use the designs or product beyond the strict need that forced us to act.”

It is unclear how durable the 3D-printed valves are or whether they can be sterilised or reused. However, considering the original part retails at around $11,000 and the 3D-printed parts cost just $1 to make, manufacturing more shouldn’t be a significant difficulty.

Some commentators have criticised the actions of the engineers, as the valves were used without safety certification being acquired.

Speaking to La Stampa, Temporelli said: “When there’s no time and people are risking their lives, you can’t stop because of bureaucracy.”

Other medical facilities throughout Italy have now been in contact with the engineers regarding ventilator valve shortages.

12:59 pm

Covid-19: Todos and 3D BioMed sign test kit distribution agreement


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Vitro-diagnostics company Todos Medical has signed a non-exclusive agreement with China-based cancer precision medicine company 3D Biomedicine Science & Technology for the distribution of the latter’s coronavirus test kits in the US and Israel.

According to the agreement, Todos will distribute 3D BioMed’s 3DMed 2019-nCoV Detection Kit (COVID), 3DMed 2019-nCoV & Flu A/B Detection Kit (COVID/Flu) and its ANDiS 350 3DMed Automated Solution countertop real-time PCR machine (3D Machine).

The kits have obtained approval from the Chinese Food and Drug Administration (FDA) and also secured a CE Mark in Europe.

Currently, the company is in talks with the FDA with regards to the approval of its products in the US.

Todos chief medical advisor Jorge Leon said: “The main differentiation in the 3D BioMed offering versus other nucleic acid PCR-based testing is the influenza A and B tests combined with coronavirus testing.

“This is a clinically meaningful combination because of the extended flu season in the United States that will create additional doubt among healthcare providers regarding the cause of symptoms for patients. The fact that this will be available in one testing paradigm seems to be novel in the United States.”

3D BioMed’s technology was initially deployed in Wuhan, China, where it has been used for more than 100,000 tests.

In Chinese clinical trial, the test has demonstrated 99.3% sensitivity and 100% specificity.

The company has shipped its kit components to the Provista Diagnostics lab in Georgia.

As part of the agreement, Todos will use the lab to conduct the CLIA validation required to launch the test in the US.

Meanwhile, the US has reported more than 6,000 coronavirus cases with the death toll reaching over 100. The disease has been confirmed in all US states.

12:30 pm

FDA relaxes regulations around Covid-19 diagnostics

The US Food and Drug Administration (FDA) has relaxed the regulations around diagnostics for Covid-19 to expedite the availability of testing.

Tests developed and used by laboratories across the country can now be authorised by state Departments of Health without direct engagement from the FDA. The developers will not need to pursue an Emergency Use Authorisation (EUA) with the FDA to have their assays approved.

The FDA does not intend to object to commercial manufacturers distributing tests, or to labs using commercially developed tests prior to the granting of an EUA, under certain circumstances.

Numerous commercial manufacturers are known to be in the process of developing tests for Covid-19 with the intent to submit an EUA. The FDA does not intend to object to the distribution of these Covid-19 tests for specimen testing for 15 days between the manufacturer’s validation of the test and the granting of an EUA.

To be eligible for this non-objection the manufacturer will need to provide instructions for using the test and data about its performance on their website.

The FDA has also highlighted that it does not intend to object to the distribution and use of serologic Covid-19 tests, which identify antibodies to an infection rather than the infection itself. These are inherently less effective for diagnostic purposes, but their use will be permitted as long as serologic tests are validated, notification is provided to the FDA and warning statements are included with the test.

On 17 March, the administration issued EUAs to Hologic for its Panther Fusion SARS-COV-2 Assay and to Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

FDA commissioner of food and drugs Stephen Hahn said: “Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. We stand ready to continue to support medical products in the pipeline to fight this virus.”

1:23 pm

Cyber attacks targeting health sector surge amid Covid-19 crisis

Cyber attacks have increased by 150% in the healthcare sector over the last two months as criminals seek to take advantage of system vulnerabilities during the Covid-19 crisis, according to new industry partnership the C5 Alliance.

On 13 March, Brno University Hospital in the Czech Republic, which is responsible for running tests for Covid-19 in the country, was hit by a cyber attack that forced the hospital to shut down its IT network.

Cybersecurity investment firm C5 Capital has created an alliance of leading cybersecurity companies to tackle issues arising from the pandemic.

The C5 Alliance – which includes cyber firms such as IronNet, ITC Secure, Haven Cyber Technologies, Enveil, 4iQ and Blue Cedar – will provide hospitals, clinics and other medical facilities in the UK and Europe free access to its IronDome system.

IronDome, based on IronNet’s collective defence solution, is the industry’s first collective crowd sourcing defence product. It takes the behavioural intelligence derived from cyber anomalies and shares it across an industry sector to deliver machine-speed visibility of potential threat campaigns.

C5 Capital hopes the initiative will help ensure hospitals and clinics protect their internal systems and databases for patients, healthcare workers and volunteers. It will also enable pharmaceutical research and development facilities to safeguard their work while developing a vaccine to prevent transmission of the Covid-19 virus.

C5 Capital founder Andre Pienaar said: “Healthcare companies and organisations are facing growing threats, as seen with the NHS attacks in 2017. Now with the Covid-19 crisis they are facing an unprecedented assault from cyberattacks.

“This initiative takes immediate action in helping to protect health services in the UK and Europe in the best way possible, with the knowledge of some of the world’s best cybersecurity experts.”

The UK National Cyber Security Centre (NCSC) has said that phishing emails with links claiming to have important coronavirus-related updates are circulating, which once clicked on lead to devices being infected.

On 16 February the World Health Organisation (WHO) warned of fraudulent emails being sent by criminals posing as the WHO. Cybercriminals have also been impersonating the US Centers for Disease Control and Prevention (CDC) by creating domain names similar to the CDC’s web address to request passwords and even bitcoin donations to fund a fake vaccine.

These attempts have been seen in several countries and can lead to loss of money and sensitive data.

NCSC director of operations Paul Chichester said: “We know that cyber criminals are opportunistic and will look to exploit people’s fears, and this has undoubtedly been the case with the coronavirus outbreak.”

12:42 pm

US health network develops rapid response Covid-19 test

New Jersey-based health network Hackensack Meridian Health’s Center for Discovery and Innovation (CDI) has created a rapid response test for diagnosing Covid-19.

The developers hope this will allow for a more effective triage system in hospitals and better control the spread of the disease. More than 127,000 cases of Covid-19 have been confirmed globally, with New Jersey confirming 23 presumptive positives.

The CDI has now received preliminary Emergency Use Authorisation from the US Food and Drug Administration (FDA) to start using the test, which has also been approved by the state Department of Health.

CDI has been working on the new test since mid-January following. It combines elements of the US Centers for Disease Control and Prevention (CDC) diagnostic and the German-developed test adopted by the World Health Organisation (WHO). Its accuracy has been validated using live virus and viral RNA.

Initially, the network will be able to use the Covid-19 rapid response test on 24 patients every eight hours, with hopes to expand the use of the test throughout the region.

CDI chief scientific officer and senior vice president David Perlin said: “We believe our test could make the difference in stemming outbreaks. It’s fast and it’s accurate, and crucial hours could mean the difference in stopping the spread of this virus.”

Network officials have stressed that strict protocols will continue to be followed regarding which patients are eligible for testing. Patients cannot simply request the test if they are experiencing respiratory symptoms or believe they may have been exposed to the virus without consulting with their primary care physician.

The rollout of Covid-19 testing across the US has been heavily criticised, with faulty test kits, reliance on laboratory results and difficulty accessing tests leaving people worried the disease will spread further.

Hackensack Meridian Health chief physician executive Daniel Varga said: “Having our own test, which allows us to respond in real-time, is the crucial tool we need at the point-of-care when we need it most.”

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Help Researchers Track COVID-19 – Scientific American

Fake Facebook ads placed by Russians in 2016 received 9 times more clicks than typical ads — ScienceDaily

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