The diagnostic industry in countries such as Germany, South Korea and China lead the pack on getting coronavirus tests ready for market. Researchers warn that lax EU regulations could see it become a “dumping ground” for bad tests.

The lag is striking because it mirrors the spread of the pandemic

Stuart Hogarth

Nations with high rates of coronavirus testing such as South Korea and Germany are also leading the world in commercialising COVID-19 diagnostic tests – far outstripping the domestic UK and US diagnostic industries, new research shows.

Researchers also argue that lax EU regulations for diagnostic devices could make the region a “dumping ground for poor quality tests”.

A team from the University of Cambridge’s Department of Sociology has produced what they say may be the most comprehensive global dataset of companies developing molecular diagnostic tests for COVID-19.

They found that 88% of South Korean firms working on COVID-19, and 80% of those in Germany, now have tests either on the market or ready to be rolled out. In the UK, just 54% of firms developing COVID-19 tests have a commercialised product. The US also lags behind at 67%.

China has 93 diagnostic firms working on COVID-19, the overall highest number, 90% of which have commercialised tests.

The latest analysis is available on a website set up by CancerScreen, a Cambridge research project funded by the European Research Council on the political economy of diagnostic innovation.

 “The COVID-19 testing strategies adopted by different countries are now under intense public scrutiny,” said Dr Stuart Hogarth, who leads the research.

“The UK and US have been criticised for failing to ramp up capacity compared to places such as Germany and South Korea. We can see this playing out in the global molecular diagnostics industry.”

Building on previous work, the CancerScreen team have trawled media coverage and drawn on lists of COVID-19 tests from organisations such as the Foundation for Innovative Diagnostics (FIND) and the UK National Institutes for Health Research (NIHR) Innovation Lab.

They now have 303 firms in their dataset of COVID-19 molecular diagnostics firms and their main database has increased to 830 firms.

The Asia Pacific region already dominated the global industry, with 40% of all molecular diagnostics manufacturers, compared to 29% in the US and 28% in Europe. In terms of the COVID-19 market, Asia Pacific is even more dominant, with 55% of all firms.

The region is also ahead when it comes to commercialising COVID-19 tests. In Asia Pacific 90% of firms have a test on the market, compared to 78% in Europe and 67% in the US.

“The lag is striking because it mirrors the spread of the pandemic, starting in Asia Pacific and then moving to Europe and North America,” said Hogarth. “It suggests that firms in the US and Europe could have responded more quickly when the pandemic began.”

He points out that some of the countries with an effective commercialisation response to COVID-19 diagnostic testing needs are those where there is a strong relationship between the state and manufacturing sector.

“A country like South Korea exemplifies a pattern of industrialisation in which the state directs economic development,” said Hogarth.

“Our data suggests that strong leadership by the national government plays a role in industry responsiveness, at least at the extremes of leaders and laggards,” he said.

There are also important distinctions between regions and nations when it comes to the pace and nature of regulatory approval, says Hogarth: “Although most countries have put in place fast-track emergency approval mechanisms, the European Union already had a very low barrier to market entry.”

He points out that the ‘CE-mark’ – indicating a test complies with EU regulations – is self-certified by nearly all types of diagnostic tests manufacturers: the firm simply awards itself a CE-mark.

“The lack of regulatory scrutiny makes the EU an attractive market for firms,” said Hogarth. The CancerScreen research shows there are 50% more Chinese firms with CE-marks for the EU market than actually have approval in China itself, a pattern that is almost identical in South Korea.

Some 62 firms across China, South Korea and Singapore, as well as the US, currently export CE-marked COVID-19 tests to the EU. In China, South Korea and the US, the position is reversed: most firms with approved tests are domestic.

Meanwhile, only South Korean firms have approval in South Korea, very few firms that are not Chinese have approval in China, and this trend is replicated in the US.

Last week, the New York Times reported that the UK government bought two million kits for detecting antibodies for the coronavirus from two Chinese companies, only to find them ineffective.

“If the EU is to avoid becoming a dumping ground for poor quality tests, then further action must be taken,” said Hogarth. “That is already happening at a national level, as individual member states are forced to undertake post-market evaluation to assess the quality of tests to inform their procurement decisions.”

“Over the last few days the European Commission has begun to establish a more active role as a coordinating body and I welcome that very important development.”

The CancerScreen team is now working in collaboration with FIND to gather more data on the industry response to COVID-19 and Hogarth hopes to build links with the NIHR Innovation Lab for future work.

Added Hogarth: “It is important to share resources and expertise. FIND and NIHR have the definitive lists because they have data on immunoassays, as well as molecular diagnostics, but our strength is our broader understanding of the molecular diagnostics sector that we have developed over many years.”

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