New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader
Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC)

New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.”

Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president.

“Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.”

His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.”

But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources.

The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday.

“There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed.  Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.”

Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.”

He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each.

The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities.  In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move.

Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites.

Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms 

Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms.  

“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement.

The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said.  She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity.   

The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week.  This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices.

This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. 

“We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News“Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing.

USA doubles testing capacity in five days 

According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories.

Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports.  

Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. 

In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. 

“As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday.

“We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out  in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” 

Source: @Covid2019tests

Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates

Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required.  This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired,

WHO has estimated the cost of those tests as US$ 30-$US60.  However, some countries, such as France, also seem to be paying even more.

“It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” 

In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality.

In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests.  But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs.

“Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this.

“In emerging markets, we have to work with low throughput systems at this stage,” he added, saying.  “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.”

Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands.

“Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency.  

“In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now.  

In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add.

In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered.  

Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests.