How Animal Health Innovation Enabled a Rapid and Reliable SARS-CoV-2 Diagnostic Test Kit

In the battle of fighting against COVID-19, a rapid test is crucial to understand the spread of the pandemic.

The Swiss start-up LiVET that originally developed diagnostic tests for respiratory diseases in horses has accelerated their platforms to detect COVID-19 in human samples, establishing a newly incorporated company ender diagnostics ag. Undeniably, ender is a fascinating example of how health developments can be transferred from animal health technology into human health. ender’s isothermal technology utilizes a single temperature for all the steps providing a dramatic decrease of detection time when comparing to the gold standard polymerase-chain-reaction (PCR). In addition, its 30-minute turnover platform can support a relatively small sample size, no need for waiting for a large sample size in a batch. Thus, it is flexible and efficient to operate in laboratories.

Besides the currently sold CE-marked detection kit ender LAB, the company is developing its new outstanding platforms, ender MAS and ender MOBILE, which provide much simplified steps for the sample handling and for point-of-care purpose.

As of 25 June, the cost of all coronavirus tests, including coronavirus and antibody tests, will be covered by the Swiss federal government, implying that people would be more willing to get themselves tested (source: The Federal Council). The Federal Office of Public Health (FOPH) has encouraged people to participate in prevention efforts by installing the SwissCovid app, a proximity tracing system to help in contact tracing and informing people who have spent a certain time with someone who tested positive for coronavirus.

Hand holding mobile with geoHealthApp for COVID-19 tracking

A similar app has been already launched in Switzerland in April by GeoHealthApp, a german start-up supported by HEMEX.

In an estimated 8,000 tests per day carried out in Switzerland, the need for tests is still increasing (source: thelocal.ch). A prediction model of Prof. Dirk Mohr at ETH Zurich suggests that the second pandemic wave would develop more slowly but potentially more deadly (source: Swissinfo). The good news is that it would not overload the Swiss healthcare capacity and we could better prepare in testing and tracing the population. There is no doubt that start-ups such as ender diagnostics play a pivotal role in this battle of COVID-19.

In summary, with the increased availability of advanced testing kits and tracing apps, we can now better monitor the current pandemic status in Switzerland and respond rapidly in order to prevent catastrophic local outbreaks.

HEMEX supports LiVET, ender diagnostics, and GeoHealthApp with clinical, regulatory and market access services.

For more information, see Swissinfo.ch.

Rapid COVID-19 Diagnostic Test – launched by ender diagnostics!

Swiss-based start-up ender diagnostics develops rapid molecular tests for the detection of SARS-CoV-2. The first rapid test has just been CE -certified and can now be used in laboratories worldwide.

What makes the ender LAB and subsequent ender MAS test outstanding is not just that the result is obtained within 30 minutes, but also that its accuracy is comparable to the current gold standard. The ender team has extensive experience in developing molecular biological rapid tests. 

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HEMEX supports ender’s team with clinical, regulatory and marketing services. HEMEX’s regulatory experts will support with the CE-certification of the test as an in vitro diagnostic medical device under the European In Vitro Diagnostic Regulation (IVDR). 

Why Testing for Antibodies after COVID-19 Infection

On 31 December 2019, the World Health Organization (WHO) received the first case report about pneumonia of unknown cause in Wuhan, China1. Despite draconian containment measures such as lockdown and air travel bans in many countries, as of 4 June 2020, the COVID-19 pandemic has caused more than 6.6 million infections worldwide and the death toll has reached more than 380,000 globally. The numbers are still rising in countries such as Brasil, USA and Russia, and several countries like Bulgaria are seeing signs of the emergence of a 2nd wave.

Researchers around the globe have been investigating the virus that caused the pandemic, SARS-CoV-2. Analysis on the genomic data suggests that there are several strains of the virus: Type B virus is mainly found in East Asia, while type A and C are predominantly found in America and Europe, respectively2. Notably, the SARS-CoV-2 virus exhibits significantly higher binding affinity to the human angiotensin-converting enzyme 2 (ACE2) receptor, compared to the SARS-CoV virus which caused the SARS epidemic outbreak in 20023,4. This may explain why the SARS-CoV-2 virus is much more contagious. However, it is still unknown how such difference contributes to the outbreak of different strains in certain parts of the world.

To fight against the pandemic, companies have been developing virus detection kits, which can be roughly categorized into two groups: the first type of tests uses polymerase-chain-reaction (PCR) technology to directly detect virus genome from clinical samples such as nasal swabs. This group includes ID NOW COVID-19 assay, cobas SARS-CoV-2 test, and also a reliable CE-marked rapid COVID-19 test from Ender Diagnostics5, a newly incorporated Swiss diagnostics company. The other group is the serological assay for COVID-19 antibodies in bloodstream, indicating whether an individual developed possible immunity to the virus.  

In spite of the round-the-clock effort, effective vaccines and antiviral drugs still would take months, if not years, to be developed. So far, the most practical and effective ways to combat COVID-19 are washing hands, maintaining social distancing, wearing a mask (when social distancing is not feasible), and strengthening our health systems.

Most Frequently Asked Questions (FAQ):

1. What is the ratio of asymptomatic patients?

Recent research suggests a significant amount (25% to 80%) of COVID-19 infected patients are mild and asymptomatic6. These patients may even not be aware that they were infected. Thus, large scale antibody testing is crucial to inform about the actual infection rates.

2. Am I protected from the COVID-19 if I already have the antibody?

The antibody test is useful in determining whether you have contracted the virus in the past. It seems likely that contracting the virus can result in immunity as seen with other viruses. Nevertheless, it remains unknown how long the protective antibody lasts with this particular coronavirus. Currently, there is no evidence that people who have recovered from COVID-19 are protected from a second infection. In addition, patients who have not fully recovered could still be contagious, hence spreading the virus to people that they interact closely with, such as their families. 

3. Why do some children develop severe symptoms?

COVID-19-associated cases in children show multisystem inflammatory syndrome (MIS-C) which features are similar to Kawasaki disease. Unfortunately, it is not known what causes MIS-C and how it affects children. There is no vigorous evidence showing how MIS-C affects children who have underlying conditions. Children with MIS-C may develop a rash, stomach/muscle pain, fever (less common in children), bloodshot eyes, exhaustion, diarrhea, or vomiting. If a child shows any of these signs and symptoms, one should seek emergency care immediately. In a report7, about 23% of COVID-19-confirmed children have underlying conditions, such as chronic lung disease, cardiovascular disease, and immunosuppression. By 10 June 2020, children (under 20) account for about 3.5% of total COVID-19 cases in Switzerland8. In general, children with COVID-19 do not have severe symptoms. Nonetheless, parents should keep monitoring their children if they show the symptoms mentioned above. The best way to fight against COVID-19 is still to prevent contracting the disease, by washing hands and maintaining social distancing.

4. Is Remdesivir effective in the treatment of COVID-19?

There are no specific drugs approved by the Food and Drug Administration to treat COVID-19 patients. Gilead, a company producing the antiviral drug Remdesivir, is conducting two phase-3 clinical trials to evaluate the safety and efficacy of the drug in patients with severe and moderate symptoms, respectively.9 One of their recent reports10 suggests that patients who are treated with Remdesivir showed significantly shortened time to recovery, about 11 days on average, comparing to 15 days in the placebo group. The primary conclusion from this study is that Remdesivir is superior to placebo in treatment of hospitalized patients with COVID-19, shedding a light on its potential to expand the number of severe cases who could benefit from it. Similar results have been reported in another clinical trial in US.

5. Is there a vaccine for the coronavirus disease? How long does it take to develop a vaccine?

Currently there is no vaccine available for SARS-CoV-2. Typically, vaccine development can take several years. With current technology using egg- and cell-based platforms and working together with regulators, it can take five to six months to become available in the best scenario of H1N1 influenza-vaccine11. Currently, multiple platforms and technologies are under development for SARS-CoV-212, targeting the S-protein of the virus or the whole virion. However, the current novel pipeline and technologies for SARS-CoV-2 have not been thoroughly tested for safety and efficacy. The SARS-CoV-2 vaccine is under its way, calling for more patience.

References:

1. https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/
2. Forster et al., 2020. PNAS. https://doi.org/10.1073/pnas.2004999117
3. Ou et al., 2020. bioRxiv. https://www.biorxiv.org/content/10.1101/2020.03.15.991844v4
4. Tai et al., 2020. Cellular & Molecular Immunology https://www.nature.com/articles/s41423-020-0400-4
5. https://enderdiagnostics.com/
6. https://www.healthline.com/health-news/50-percent-of-people-with-covid19-not-aware-have-virus
7. CDC COVID-19 Response Team: Stephanie Bialek et al., 2020. https://pubmed.ncbi.nlm.nih.gov/32271728/
8. https://covid-19-schweiz.bagapps.ch/fr-1.html
9. https://www.gilead.com/purpose/advancing-global-health/covid-19/remdesivir-clinical-trials
10. Beigel et al., 2020. The New England Journal of Medicine.https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
11. https://www.who.int/csr/disease/swineflu/notes/h1n1_vaccine_20090806/en/
12. Fatima Amanat and Florian Krammer, 2020. Cell. https://pubmed.ncbi.nlm.nih.gov/32259480/

HEMEX supports the ender diagnostics team with clinical, regulatory and marketing services. HEMEX’s regulatory experts will support with the CE-certification of the test as an in vitro diagnostic medical device under the European In Vitro Diagnostic Regulation (IVDR). 

More Info: Dr. Xiao Yu

Swiss TPH Receives Grant from BRCCH To Combat COVID-19 with Support of the M4IVD Association

Swiss TPH in Basel submitted one of eleven projects that will receive funding from the Botnar Research Centre for Child Health (BRCCH) and Fondation Botnar. This Fast Track Call for Acute Global Health Challenges (FTC) is a new initiative that supports research in three areas to respond to the global COVID-19 crisis.

Swiss TPH (Tropical and Public Health Insitute) is a world-leading institute in global health focusing on infectious and non-communicable diseases, environment, health systems and interventions.

HEMEX, a founding member of the M4IVD association, is proud to have contributed to this success, together with other M4IVD members University of Basel, ETH Zurich, CSEM (Centre Suisse d’Electronique et de Microtechnique), FHNW (Fachhochschule Nordwestschweiz), BioInitials AG and Effectum Medical AG.

BRCCH_Press Release_May 2020_Successful FTC_CONFIDENTIAL DRAFT

Rapid Testing For Acute COVID-19

Reliable, fast and cost effective, are the attributes of the new COVID-19 testing kits that will be launched shortly by ender diagnostics ag.

The recently incorporated Swiss start-up ender diagnostics can rely on a skilled and experienced team of scientists and entrepreneurs, developing molecular biological rapid tests for infectious diseases. The ender testing kit provides rapid and reliable results for acute COVID–19. Capable of diagnosing multiple samples at once and within just 30 minutes, their first of 3 products “ender LAB”  can diagnose several hundred samples simoultaneously,  and  will thus reduce the time needed to get a reliable diagnosis significantly.

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HEMEX supports the ender team with clinical, regulatory and marketing services. HEMEX’s regulatory experts will support with the CE-certifification of the test as an in vitro diagnostic medical device under the European In Vitro Diagnostic Regulation (IVDR). 

COVID-19 Realtime Tracking App Available in Switzerland and Germany Now

Hand holding mobile with geoHealthApp for COVID-19 tracking

The new GeoHealthApp enables users in Germany and Switzerland to determine their individual infection risk for COVID-19, thus making a pivotal contribution to reduce the spread of SARS-CoV2.

Through a traffic light system on their smartphone display, users receive information about individualized current infection risks. The information results from the frequented locations of the past 14 days as well as personal information related to symptoms. An interactive map shows areas with high infection rates, that can be avoided. The provision of personal data is voluntary and anonymous. No personal data is passed on to any third parties.

After successful launch of the Betaversion some weeks ago, GeoHealthApp today announced the launch of the app that will enable people to protect themselves more quickly and better against pandemic crises, in particular against the current COVID-19 spread.

The app is free of charge in Germany and Switzerland and can be downloaded from the App Store and the Google Play store.

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GeoHealthApp received the support from HEMEX, whose regulatory experts helped to register the software as a CE-certified medical device under the European Medical Device Regulation, and also make sure that all data are handled in full compliance with General Data Protection Regulations (GDPR).

HELP FOR SWISS STARTUPS

Today, Federal Councillor Ueli Maurer committed support for Swiss start-ups. Start-ups that need financial support should get in contact with the canton in which they are incorporated.

Maurer: “Start-ups are particularly affected by this crisis. In the coming years, it will be an advantage for Switzerland to remain competitive in innovative industries. These companies don’t need money for two to three months; they need long-tem financial security over a period of several years.

Start-ups that need support should get in contact with their canton of incorporation.The cantons know their start-ups and are therefore best placed to evaluate a company’s needs and potential. Companies that have viable ideas will be supported – a third of the sum is provided by the canton, two thirds are provided by the Federal Government. Initially, the Federal Government will make CHF 154 million available for this program. This way, we are not offering short-term relief, but we will be creating a long-term solution, based on existing laws. We are looking ahead and will use this money to replace investors who may have reduced financial capacity due to the effects of the crisis. It is also important to note that the money will flow immediately. We will be able to pay out the first amounts at the end of April.”

For the last nine years, the World Intellectual Property Organization (WIPO) has named Switzerland one of the most innovative countries in the world. Switzerland doesn’t just invest in innovation, but also generates exceptional results.

At Hemex, we welcome this decision by the Federal Council and see this decision as a very positive sign of confidence. The Federal Government has clearly recognized the seriousness of the situation, demonstrating that it understands the challenges Swiss start-ups are facing, and giving a clear signal how important it is to provide support to start-ups and foster innovation!

“Spread the App, not the Virus”

How geoHealthApp can help stop the spread of COVID-19

Friday 27th of March 2020 – GeoHealthApp GmbH, today launched a Betaversion in Germany, Switzerland, Austria, UK and USA that has the potential to help stop the spread of COVID-19!

How does it work?

People first install the app, and the phone starts recording their location anonymously. No registration is required.

If any user reports receiving a positive COVID-19 test, the app uses the location data but also Artificial Intelligence to determine who came in close contact within the previous 14 days and warn those users via an intuitive traffic light system.

If the traffic light is green, normal precautionary measures, such as social distancing or hand washing, are enough. When the yellow or red light shows, the user is alerted to be particularly careful in contact with risk groups and if necessary, take a corona test.

Additionally, the interactive map shows areas with high infection rates, so the user can avoid these areas. No contact is the best protection against infection. Please help to break the infection chain!

GeoHealthApp received the support from HEMEX, whose regulatory experts helped to register the software as a CE-certified medical device under the European Medical Device Regulation, and also make sure that all data are handled in full compliance with General Data Protection Regulations (GDPR).

GeoHealthApp is totally free of charge and can be downloaded for iPhone and Android starting next week.