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Can The U.S. Learn From Italy, Where Antibody Test Makers Are Fighting For A New Market?

Updated: 2 days ago

Antonio Giordano forbes

After eight weeks of national lockdown in an effort to defeat a deadly outbreak of COVID-19, Italy began to tentatively reopen certain businesses and put millions of citizens back to work on May 4. As part of that gradual reopening, Italian national and local authorities are undertaking extensive antibody testing campaigns to determine how many people may have developed immunity to the coronavirus. At the same time, the companies that make these tests — ranging from global players Abbott Laboratories and DiaSorin to local outfits such as Diesse Diagnostica and TechnoGenetics — are racing to win a share of an emerging market for tests that detect COVID-19 antibodies in the blood.

It’s not clear that all of these tests will provide solidly useful information. The WHO has warned against using them to issue so-called “immunity passports” — which would allow those who test positive for COVID-19 antibodies to resume a normal life — because experts still don’t know how long immunity lasts, or even whether antibodies can protect from reinfection. In the absence of a vaccine, Italy’s regional governments are using antibody tests — also called serological or blood tests — to gauge how many residents have been infected and allow certain employees to return to work if they test positive.

One issue here, notes Dr. Antonio Giordano, the founder and director of the Sbarro Institute for Cancer Research and Molecular Medicine at Temple University in Philadelphia, is that it’s not clear whether current tests can tell the difference between antibodies for SARS-CoV-2, the coronavirus that causes COVID-19, and antibodies for the already circulating coronaviruses that cause the common cold.

Faced with the choice of multiple tests offered by dozens of different companies, authorities are struggling to decide on a coherent strategy for testing. To make matters worse, many tests on the market are unreliable — researchers at UC San Francisco and UC Berkeley measured the efficacy of twelve different antibody tests and found that many kits had high rates of false positives. Regulators have grown increasingly cautious about certifying tests: The U.S. Food and Drug Administration announced on May 4 that it would ask test manufacturers to provide validation data within 10 business days or risk having their emergency authorizations revoked. In Italy, at least three regions — roughly the equivalent of U.S. states — initially banned private laboratories from offering antibody tests to the public.

Because of this variance between tests, Giordano suggests instead using only one, so at least any errors would be consistent, and therefore easier to account for. “It would be better to apply the same serological test in the whole country, to have a better picture of the diffusion of the virus throughout Italy,” he says.

While Italian regions are cautiously reopening thanks to a steep decline in the country’s curve of new infections, new cases have ticked up in U.S. states that have already reopened. On April 22, researchers at the Johns Hopkins Center for Health Security published a report calling for a national antibody testing campaign, warning that many of the tests currently available on the U.S. market have either not been validated or produce results that can’t be compared with each other. Meanwhile, the National Institutes for Health has begun a large-scale study that would give antibody tests to a large part of the U.S. population to both gauge coronavirus spread and research immunity.

There are several types of antibody tests currently in use, which are different from the nasal swab tests used to diagnose whether someone is currently infected with the virus. The two most widely used types of antibody tests are rapid diagnostic tests, which can detect the presence of antibodies — but not the quantity — in under half an hour and typically use blood samples from a finger prick; and lab-based ELISA tests, which take two to five hours and provide data on the number of antibodies present in the blood or plasma of patients.

Weeks before the Italian government announced a contract on April 25 with Illinois-based healthcare firm Abbott Labs for the delivery of up to 4 million antibody tests by the end of May, most of Italy’s twenty regional governments had already forged ahead with their own plans to begin antibody testing. Just as competition built up between American governors bidding for much-needed ventilators in the U.S., regional officials in Italy are now facing a similar situation with antibody tests, forced to navigate a new market with little guidance from the national government.

In the central region of Marche, home to about 1.5 million people, Governor Luca Ceriscioli was among the first in the country to begin antibody testing of healthcare workers at major hospitals. Now that Italy is reopening, he is concerned by what he views as a slow response from the national government and a lack of clarity on antibody testing. “In theory, the national health institute said a few weeks ago they would decide on the most effective tests,” Ceriscioli told Forbes. “Since this still hasn’t happened, we decided to go ahead...with our own campaign. Even in an emergency, the response that we needed yesterday always arrives a week later.”

In Lombardy, Italy’s richest and largest region and the one hardest-hit by the virus, the battle to provide antibody tests is taking place in the courts. On March 25, the regional government announced an ambitious campaign to test all residents who had been told to quarantine at home after reporting COVID-19 symptoms, starting on April 23. The contract for the antibody tests was awarded to Italian biotech firm DiaSorin, part-owned by billionaire Gustavo Denegri, which obtained approval for its product from both European regulators and the FDA in April.

On April 18, five days before the testing campaign was set to begin, a smaller Italian competitor, TechnoGenetics, filed suit in the Regional Administrative Court of Lombardy to halt it from going ahead. The lawsuit targeted DiaSorin and the San Matteo hospital in Pavia — a large public hospital located south of Milan which worked with the firm to develop and validate the tests — arguing that the hospital had awarded DiaSorin the testing contract without a formal bidding process. Three days later, a judge ruled partially in favor of TechnoGenetics, finding that the agreement violated European rules on competition for public contracts — a charge DiaSorin still denies. But the court also refused to halt the testing by Diasorin and set a new hearing date for May 13.

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

DiaSorin, which is listed on the Milan stock exchange and recorded net profits of $190 million on revenues of $763 million in 2019, is a behemoth compared to TechnoGenetics, which ended 2019 with $29 million in sales. Founded in Lodi, south of Milan, in 1982, TechnoGenetics sold an 80% stake to a Chinese firm, publicly traded diagnostics maker Shanghai Kehua Bio-Engineering, for $20.3 million in 2015. Despite their difference in size, both firms are competing to provide antibody tests in Italy and beyond — DiaSorin is delivering tests to Belgium, Israel and Germany as well as the regions of Piedmont and Sicily, while TechnoGenetics validated its rapid testing kits with the canton of Ticino in Switzerland and has provided them to the southern Italian regions of Campania and Molise.

In a bid to keep up with larger competitors, some smaller firms are betting that offering more granular data will make their product stand out. Diesse Diagnostica Senese, a diagnostics firm based in Siena, Italy, is making tests that detect three kinds of antibodies the immune system develops to fight off a disease — IgG, IgA and IgM — unlike most of the other tests currently on the market, which only measure IgG and IgM.

Diesse is providing the regional government in Tuscany with 500,000 antibody tests and is now producing 1.2 million tests a month. The firm, which has about 200 employees and was founded in 1980, pulls in 70% of its revenues from outside Italy and posted sales of $32 million in 2019. In May 2019, it was wholly acquired by French healthcare investment firm ArchiMed for about $32 million.

“We decided to launch a test which detects all three antibodies because the immune response to this virus is still poorly understood,” says Diesse CEO 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 to wreak havoc in Italy in February, the country has been something of a harbinger for other affected nations in the West, offering a potential preview of the near future. Multinational firms are now making a push to enter the Italian market, seeking to use the country as a springboard to offer their antibody tests elsewhere as demand picks up. No company has been more prominent than U.S. giant Abbott Labs, which is providing antibody tests to the Italian government and is also sending kits to regional authorities in Sicily and Piedmont.

The American firm beat out rival bids from Italian competitors, and it launched its antibody tests in the U.S. in mid-April with plans to increase production to 2 million tests a month by June. With $31.9 billion in revenue in 2019, Abbott dwarfs the likes of DiaSorin and the smaller companies bidding for testing contracts in Italy. Another major player in the global diagnostics market, the Swiss drugmaker Roche, released its own antibody test in early May. Several Chinese companies have also entered the Italian market, striking up distribution deals with local e-commerce firms and distributors — the most prolific of these new entrants, Shenzhen-based Snibe Diagnostics, is providing tests to the regions of Veneto, Piedmont and Sicily.

In the meantime, the first results from Lombardy’s testing campaign — on healthcare workers and people who had been quarantined at home with COVID-19 symptoms — were published on April 30. In the Seriana valley northeast of Milan, where a recent study showed the virus had been circulating since late January, 62% of the 1,054 people tested were found to have already had the virus. After an initial period focusing on the hardest-hit areas, testing was extended to the whole region on April 29.

Many of Italy’s largest regions are also well into their own testing campaigns on hundreds of thousands of medical staff, police officers and other essential workers. Some have effectively taken on the task of regulating the tests themselves, working with private labs to publish their own list of certified antibody tests. Forbes found or obtained information from all 20 regional administrations in Italy on their COVID-19 testing strategies.

In the U.S., the next phase of the pandemic could lead to competition over antibody tests. Results from limited antibody testing studies, carried out by officials in New York state and by researchers in two California counties, have been criticized by statisticians and epidemiologists for their poor methodology. As states begin testing more widely, they will be faced with a wild, loosely regulated market for a product that everybody wants to get their hands on.

"The U.S. is a vast country, unlike Italy, with different climates and heterogeneous populations,” says Dr. Giordano of Temple University. “If everyone uses a different test, then at that point the states will have to take responsibility [for testing]. The U.S. needs to find a way to normalize the data across the country.”

Professor Antonio Giordano, M.D., Ph.D., is the creator and head of the Sbarro Health Research Organization, located at Temple University's College of Science and Technology in Philadelphia. Stay connected with him through his various social media platforms, including Facebook, LinkedIn, Twitter, and Instagram, to receive the latest updates.

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