PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China where it originated, there are 400,000 cases of coronavirus worldwide, including more than 200,000 infected by SARS-CoV-2 in the 55 sovereign states in continental Europe, where they are mourning more than 18,000 deaths.
A leap forward in testing techniques
Four countries – Italy, Spain, France and Germany – account for more than 77% of all cases seen in Europe. “We need to step up automatic testing for all suspected cases, and isolate and trace contacts in order to slow down the progression of the pandemic,” Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO), told BioWorld.
The tests currently used to detect cases of COVID-19 are based on the reverse transcription process followed by a polymerase chain reaction (RT PCR), which allows detection of the virus RNA. Using reagents that are meant for SARS-CoV-2, involve processes that slow down the turnaround. Faced with the objective of vastly increasing the number of tests, European in vitro diagnostics med-tech companies can call upon two levers: the development of faster processes that are easier to implement, and increasing the production capacity of their reagents. A race against the clock has begun, in an ultra-competitive market.
Novacyt is ramping up production capacity
Primerdesign Ltd. (Southampton, U.K.), the molecular diagnostics division of French company Novacyt SA, developed the first European CE marked test in early February. The U.S. FDA issued an emergency use authorization (EUA) on March 23 for its Genesig Real time PCR. The advantage of the Primerdesign test is that it produces a result in under two hours. Logistics and storage are made much easier thanks to its freeze-dried format.
Over the past four weeks, Primerdesign has purchased sufficient raw materials to manufacture five million COVID-19 tests. The company has ramped up its production capacity via two subcontractors in continental Europe and the U.K. Thus, on March 25, Primerdesign signed an agreement for certain contract manufacturing services with the English company Yourgene Health plc. Yourgene’s GMP (Good Manufacturing Practice) state-of-the-art manufacturing facility at Citylabs in Manchester, U.K., will be used to expand Novacyt’s production capacity for the COVID-19 test.
“The combination of these manufacturing capacities in England and on the European continent should make it possible to manufacture up to two million COVID-19 tests each month, so multiplying the initial production capacity tenfold,” Graham Mullis, CEO of Novacyt, told BioWorld.
To date, Primerdesign has fulfilled and received orders worth more than $10.6 million for its CE marked, research use only (RUO) COVID-19 tests. This would normally represent 18 months of sales revenue for this division, and already exceeds the revenue achieved by Primerdesign in 2019.
Bioméreiux is developing three COVID-19 tests
The French in vitro diagnostics company Biomérieux SA is not idle, with three tests in development aimed at responding to the COVID-19 pandemic. Firstly, on March 11, the Lyons-based group launched the real-time PCR test Sars-CoV-2 R-Gene. This first test, undergoing CE mark approval, manufactured at the Verniolle site in Ariège, France, provides a result in four to five hours. “This test can be used by analytical laboratories within their current procedures, without needing to acquire a specific platform,” said Mark Miller, executive vice president and chief medical officer at Biomérieux.
To get results faster, in under an hour, Biomérieux turned to its American subsidiary, Biofire Diagnostics LLC, specializing in molecular biology. This has allowed them to develop two tests that use Biofire Filmarray, a CE-marked multiplex PCR technique, accredited by the FDA since 2016, that integrates sample preparation, amplification and detection of pathogens in a closed system. The Biofire COVID-19 test just received emergency use authorization from the FDA, on March 23. This is under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate and high complexity tests to detect SARS-CoV-2. This fully automated test, manufactured at various production sites in Salt Lake City, is the result of a partnership with the U.S. Department of Defense. The Biofire Filmarray test requires only two minutes of processing to detect two specific SARS-CoV-2 genes. The time needed for delivering results is 45 minutes from a nasopharyngeal sample taken with a swab.
Finally, Biomérieux is also developing a new extended version of its 2 Biofire Filmarray respiratory panel (RP2.1). This new panel will include SARS-CoV-2 in addition to the 21 pathogens most frequently responsible for respiratory infections for which it already enables detection.
Roche can supply millions of tests each month
Swiss manufacturer Roche Holding AG obtained authorization to distribute its Cobas SARS-CoV-2 test in the EU on March 13, one day after the FDA EUA authorization. The new Cobas SARS-CoV-2 test is a kit that labs can run on Roche’s fully automated Cobas 6800/8800 systems. These integrated and fully automated medium and high speed molecular testing platforms were initially designed for screening blood donations, monitoring viral loads and microbiology testing.
The test analyzes nucleic acids from nasopharyngeal and oropharyngeal swab samples and compares them to genetic sequences found in coronavirus strains, including COVID-19. Once the lab starts the test, results are available in about 3.5 hours. The instruments can process up to 384 results on the Cobas 6800 system and 960 results on the Cobas 8800 system in an eight-hour shift. At the current maximum rate of production, Roche can supply millions of tests each month for the Cobas 6800/8800 instruments and the Magnapure/Lightcycler systems. “We began shipping tests to U.S. laboratories where appropriate infrastructure is in place and expect to supply about 400,000 tests a week in the U.S.,” said Nicolas Dunant, Head of Roche Group Media Relations.
Eurofins Scientific offers multiple testing solutions
Luxembourg-based Eurofins Scientific SE reported it is offering detection tests in France, Germany, the Netherlands, the U.S., Spain and Brazil. This global leader in bio-analytical testing (with a portfolio of more than 200,000 analytic methods, and 800 laboratories worldwide) is currently rolling out a standalone real-time reverse transcriptase PCR assay for qualitative detection of SARS-CoV-2, and a Target Enriched Multiplex PCR (TEM-PCR) respiratory viral panel. The results are provided same day for samples received in the morning, in other words within 12 to 18 hours from sample receipt. “Our teams are working 24 hours a day to increase production capacity,” said Gilles Martin, CEO of Eurofins Scientific. Current global capacity is more than 15,000 tests a day, split roughly equally between Europe and the U.S. “It is now expected to increase significantly by April 1, 2020, as new sites and testing methods come on line,” said Martin.