Can the US Learn From Italy, Where Antibody Test Makers Battle for a New Market? | Instant News


After eight weeks of national confinement in an attempt to defeat the deadly outbreak of COVID-19, Italy begins to tentatively reopen certain businesses and return millions of citizens to work on May 4. As part of a gradual reopening, Italian national and local authorities conducted an extensive antibody testing campaign to determine how many people might have developed immunity to the corona virus. At the same time, companies that carry out these tests – from global players Abbott Laboratories and DiaSorin to local apparel such as Diesse Diagnostica and TechnoGenetics – compete to win emerging markets for tests that detect COVID-19 antibodies in the blood.

It is not clear that all of these tests will provide very useful information. WHO already be warned oppose its use to issue so-called “immune passports” – which will allow those who test positive for COVID-19 antibodies to continue normal life – because experts still do not know how long immunity lasts, or even whether antibodies can protect from re-infection. In the absence of a vaccine, the Italian regional government uses antibody tests – also called serological or blood tests – to measure how many people have been infected and allow certain employees to return to work if the test results are positive.

One problem here, noted Dr. Antonio Giordano, founder and director of the Sbarro Institute for Cancer Research and Molecular Medicine at Temple University in Philadelphia, is not clear whether the current test can tell the difference between antibodies for SARS-CoV-2, coronaviruses that cause COVID-19, and antibodies for coronavirus that has been circulating which causes the common cold.

Facing the choice of several tests offered by dozens of different companies, the authorities struggled to decide on a coherent strategy for testing. Even worse, many tests on the market are not reliable – researchers at UC San Francisco and UC Berkeley be measured the efficacy of twelve different antibody tests and found that many kits had high false positive rates. Regulators have become increasingly cautious about certification tests: U.S. Food and Drug Administration was announced on May 4 it will ask the testing manufacturer to provide validation data within 10 working days or risk canceling their emergency authorization. In Italy, at least three regions – roughly equivalent to state A. – initially banned private laboratories from offering antibody tests to the public.

Because of the differences between these tests, Giordano suggested using only one, so at least each error would be consistent, and therefore easier to calculate. “It would be better to implement the same serological tests throughout the country, to have a better picture of the spread of the virus throughout Italy,” he said.

While the Italian territory was reopened carefully thanks to steep decreased in the new infection curve in the country, there are new cases ticked in the U.S. countries which has been reopened. On April 22, researchers at Johns Hopkins Center for Health Security was published a report calling for a national antibody testing campaign, warns that many of the tests currently available on the U.S. market. do not have validation or produce results that cannot be compared with each other. Meanwhile, the National Institute for Health has started a large-scale study that will provide antibody tests to a large portion of the US population to measure the spread of the corona virus and examine immunity.

There are several types of antibody tests that are currently used, which are different from nasal swab tests that are used to diagnose whether a person is currently infected with a virus. Two of the most widely used type An antibody test is a rapid diagnostic test, which can detect the presence of antibodies – but not quantity – in less than half an hour and usually uses blood samples from a finger prick; and laboratory-based ELISA tests, which take two to five hours and provide data on the amount of antibodies present in a patient’s blood or plasma.

A few weeks before the Italian government announced a contract on April 25 with an Illinois-based health care company, Abbott Labs for the delivery of up to 4 million antibody tests at the end of May, most of the twenty Italian local governments had advanced with their own plans to begin antibody testing. . Just like the competition built between the American governors Bid for ventilators that are badly needed in the U.S., regional officials in Italy now face a situation similar to antibody tests, forced to navigate new markets with little guidance from the national government.

In the central region of Marche, home to around 1.5 million people, Governor Luca Ceriscioli is Among the first in the country to begin antibody testing on health workers in large hospitals. Now that Italy has reopened, he is worried about what he sees as a slow response from the national government and a lack of clarity about antibody testing. “In theory, the national health institutions said a few weeks ago they would decide on the most effective test,” Ceriscioli said. Forbes. “Because this hasn’t happened yet, we decided to continue … with our own campaign. Even in an emergency, the response we need yesterday always comes a week later. “

In Lombardy, the richest and largest region in Italy and hardest hit by the virus, a battle to give antibody tests is ongoing in court. On March 25, the local government announced an ambitious campaign to test all residents who had been told to quarantine at home after reporting symptoms of COVID-19, starting on April 23. The contract for the antibody test was given to the Italian biotechnology company DiaSorin, a part owned by a billionaire Gustavo Denegri, which obtained approval for its products from European regulators and the FDA in April.

On April 18, five days before the testing campaign would begin, a smaller Italian competitor, TechnoGenetics, filed a lawsuit in the Regional Administrative Court of Lombardy to stop it. The lawsuit targets DiaSorin and San Matteo hospitals in Pavia – a large public hospital located south of Milan that works with companies to develop and validate tests – on the grounds that the hospital has awarded DiaSorin a testing contract without an official bidding process. Three days later, a judge ruled in part in favor of TechnoGenetics, discovering that the agreement violated European rules on competition for public contracts – an accusation which DiaSorin still denied. But the court also refused to stop testing by Diasorin and set a new trial date for May 13.

“This is not a normal situation,” said CEO of TechnoGenetics, Salvatore Cincotti Forbes. “This is a time when competition must be accelerated, not reduced.”

DiaSorin, which is listed on the Milan stock exchange and recorded a net profit of $ 190 million on revenue of $ 763 million in 2019, is a giant compared to TechnoGenetics, which ended in 2019 with sales of $ 29 million. Founded in Lodi, south of Milan, in 1982, TechnoGenetics sold 80% of its shares to a Chinese company, maker of Shanghai Kehua Bio-Engineering general trade, at a price of $ 20.3 million in 2015. Regardless of the difference in size, the two companies competed to provide antibody tests in Italy and beyond – DiaSorin provides tests to Belgium, Israel and Germany as well as the Piedmont and Sicily region, while TechnoGenetics validates its rapid test kit with the Ticino canton in Switzerland and has made it available to southern Italy from Campania and Molise.

In an effort to compete with larger competitors, several smaller companies bet that offering more granular data will make their products stand out. Diesse Diagnostica Senese, a diagnostic company based in Siena, Italy, makes tests that detect three types of antibodies developed by the immune system to fight disease – IgG, IgA and IgM – unlike most other tests currently on the market, which only measure IgG and IgM.

Diesse gave 500,000 antibody tests to local authorities in Tuscany and now produces 1.2 million tests a month. The company, which has about 200 employees and was founded in 1980, withdrew 70% of its revenue from outside Italy and posted sales of $ 32 million in 2019. In May 2019, the company was fully acquired by the French health care investment company ArchiMed for about $ 32. million.

“We decided to launch a test that detected all three antibodies because the immune response to this virus is still poorly understood,” said CEO Diesse Massimiliano Boggetti. “We need important epidemiological studies to see if we can really say that those who have developed antibodies are immune.”

Since the COVID-19 pandemic began wreaking havoc in Italy in February, the country has become a sign for other countries affected in the West, offering a potential preview in the near future. Multinational companies are now making a push to enter the Italian market, trying to use the country as a stepping stone to offer their antibody tests elsewhere when demand is increasing. No company is more prominent than US giant Abbott Labs, which provides antibody tests to the Italian government and also sends kits to regional authorities in Sicily and Piedmont.

American companies beat rival offers from Italian competitors, and that launched antibody tests in the US in mid-April with plans to increase production to 2 million tests a month in June. With $ 31.9 billion income in 2019, Abbott downgraded people like DiaSorin and smaller companies to bid for testing contracts in Italy. Another major player in the global diagnostic market, pharmaceutical manufacturer Roche, released own antibody test in early May. Several Chinese companies have also entered the Italian market, conducting distribution deals with local e-commerce companies and distributors – the most productive of these newcomers, Shenzhen-based Snibe Diagnostics, giving tests to the Veneto, Piedmont and Sicily regions.

Meanwhile, the first results of the Lombardy testing campaign – on health workers and people who have been quarantined at home with symptoms of COVID-19 – are was published on April 30th. In the Seriana valley in northeast Milan, the site of a recent study displayed the virus has been circulating since late January, 62% of 1,054 people tested turned out to have the virus. After an initial period focusing on the hardest hit areas, testing is carried out be extended to the entire region on April 29.

Many of the biggest regions in Italy are also involved in their own testing campaigns of hundreds of thousands of medical staff, police, and other important workers. Some are already effective was taken on the task of organizing your own tests, working with private laboratories to publish their own list of certified antibody tests. Forbes find or obtain information from all 20 local governments in Italy about their COVID-19 testing strategy.

In the U.S., the subsequent pandemic phase can cause competition for antibody testing. The results of a limited antibody testing study, conducted by officials in the state of New York and by researchers in two states of California, have been carried out be criticized by statisticians and epidemiologists for their poor methodology. When countries begin to test more broadly, they will be confronted with a wild market, a free market that is regulated for a product that everyone wants to get.

“US. is a vast country, unlike Italy, with a different climate and heterogeneous population, “said Dr. Giordano from Temple University. “If everyone uses a different test, at that time the state must be held responsible [for testing]. The US needs to find ways to normalize data across countries. “

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