The European Commission authorizes rapid diagnosing COVID-19 test in 15 minutes: it will reach the market in less than a month.
This week the community of Madrid has started to perform antigen tests to diagnose the coronavirus quickly thanks to the purchase of two million tests of this type from the company Abbott.
At the same time as these rapid tests were being used for the first time in Europe, another pharmaceutical company has obtained the necessary authorisation to market a new variant. This is also the American Becton Dickinson (BD), which has obtained Wednesday authorization from the European Commission to market its rapid test in all those countries that accept the CE mark.
As announced by the company, it expects to start mass marketing its product from the end of October at a production rate of 8 million test per month, which will increase to 12 million monthly in 2021. The main clients will be the health authorities of European countries.
"It's really a revolutionary element here in Europe," said Fernand Goldblat, BD's diagnostic director for Europe. The Old Continent was at the epicenter of the pandemic between April and May, and Goldblat believes that it is now going the same way, so "the need will be extremely high."
These tests based on the detection of antigens, a protein found in the surface layer of SARS-CoV-2, have been established as a valuable tool in the fight against COVID.-19 due to its low cost and its ability to detect a contagion in 15 minutes. Although scientists warn that they are not perfect.
U.S. pharmaceutical company Abbot has become the leader in the antigen testing business after being the first to receive authorization to market its tests, assuring that they had a sensitivity of more than 93% and a specificity of more than 99%.
European Commission authorizes rapid diagnosing COVID-19 test
Sensitivity refers to the ability to detect cases and specificity to the ability to differentiate them. Basically, sensitive tests generate few false negatives and specific tests give few false positives.
Industry giant Roche has also just made a similar announcement, saying it will launch an antigen test at the end of September in all markets where it can operate with the authorisation of the European Commission. The test has a sensitivity of 96.52% and a specificity of 99.68%, according to the company, which wants to produce 40 million monthly tests.
The last to obtain European authorisation has been BD, which will start marketing an antigen test with a sensitivity of 93.5% and a specificity of 99.3% at the end of October. These data differ from the sensitivity of 84% and the specificity of 100% of the U.S. label, as they come from a new clinical study that was recently submitted to the U.S. Food and Drug Administration, spokesman Troy Kirkpatrick told Bloomberg.
Becton Dickinson's Veritor system, which is the size of a mobile phone, has already been used in Europe before. "It has been widely used to detect influenza, but with the new functionality you can extend its scope to antigen testing and other respiratory viruses," commented Goldblat at the product presentation.
The U.S. pharmaceutical company is in talks with health authorities in several European countries to see where and how the solutions offered by the new BD product would fit.
The test is also available in the US market, but the BD leader did not want to clarify how the distribution of the tests between Europe and the United States will be planned, only commented that "a good part of it will arrive in Europe".
As for the price, it states that it will depend on the commitments made and the repayment environment in a given country, among other factors. The tests purchased by the community of Madrid from the company Abbot have a unit cost of 4.5 euros. In the United States, where regulators approved the trial in July, the Veritor Plus system has an average selling price of 250 euros, and the tests themselves cost around 17 euros each.
End of European Commission authorizes rapid diagnosing COVID-19 test
"We need to be taken seriously and see the potential of startups": fintechs demand the support of Spanish institutions and companies to overcome the crisis
COVID-19 has changed much of the world's routines - from the workplace to how you buy or pay. Startups, thanks to their agility, in many cases have been able to adapt so that the consequences will spill as little as possible, but their representatives are clear: they need the support of the government and large corporations to deal with this crisis.
"We need to be taken seriously and see the potential that startups have," says a panel organized by Visa Mireia Badía, CEO and founder of Grow.ly, a crowdlending platform that provides financing for SMEs and profitability for small savers equally.
The same has defended Borja Aranguren, the CEO of the flexible employee compensation platform Cobee, which criticizes the "lack of connection between companies and startups" caused by the hierarchy of large corporations.
"We need to change the culture of big corporations. Finding the person who can help you is an odyssey, " agrees Daniel Espejo, responsible in Spain for the Swedish fintech payment in installments Klarna. "How fast we evolve and grow will depend on that support."
The sandbox or test bench was approved in the Cabinet last February, but there has been no change since then. Espejo regrets that it has not been launched before, as "these tools create new ideas and new models".
"A sandbox helps innovate without being constrained by a very strict regulatory environment. If you are never allowed to do so, you cannot prove that the future is there," Aranguren argues.
The CEO of Grow.ly she was more sceptical and explained that, while it was very good as a conceptual idea, it would have to be seen how it was set in motion: how many officials assigned, what subjects they dealt with...
The implementation of this test bench would also help to form an entrepreneurial ecosystem, which is necessary to continue to grow, according to panel speakers. "Part of agility is not having to do everything yourself," Espejo insists.
Coronavirus resistant and expected to grow
The outbreak of the coronavirus was a surprise for everyone, but startups have been able to adapt to the environment thanks to their agility. Maria Benjumea, founder and president of the South Summit, also participated in the panel organized by Visa and highlighted the reaction of the fintech sector. "The' startups 'have that ability," he argues. "At all times they are identifying new opportunities."
Aranguren said that he does not believe that the situation has hampered innovation, but rather on the contrary. "Many startups were born in the other crisis and this time is similar. The entrepreneur is watching and more will be created, " he says.
Changes in almost all areas of the day to day have benefited many of these companies, especially those related to e-commerce, since as Espejo points out, half a million users have bought for the first time over the internet. "The processes that were expected to be in 5 or 10 years are being greatly accelerated."
Also, the head of Klarna in Spain points to a change in the next 5 years of the ecosystem in the financial sector, with the consumer at the center, in which services are personalized and try to return part of their time.