PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.
Detecting antibodies is essential to identify those people who have been infected with the virus, especially those who may have been infected without showing symptoms. This test will also make it possible to priority screen highly exposed people such as health care professionals or food distribution workers, who might have developed a certain immunity and thus be able to continue or even go back to work. Serological testing is one of the keys to easing lockdown across the world. Antibody testing is one potential route to easing restrictions on movement and social distancing.
Hundreds of tests an hour and results in 18 minutes
The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2.
The test runs on Cobas E analyzers, which are already found in hundred of hospitals worldwide. These fully automated systems can provide SARS-CoV-2 test results in 18 minutes with a throughput of up to 300 tests an hour. The company said the test accurately identifies COVID-19 antibodies in the blood 100% of the time, 14 days post-infection. Specificity is also high, at more than 99.8%
According to Thomas Schineker, CEO of Roche Diagnostics, “Roche is deeply committed to supporting the global response to the COVID-19 pandemic.”
Several million tests by June 2020
Roche Diagnostics, a world-leader in in vitro diagnostics, has been working round the clock to make this high-quality antibody test available on a large scale across the world by early May. It is planning on an accelerated ramp up of monthly production, with growth reaching double digits within a month. In other words, production and delivery of a million tests a month starting in June. “We will scale production up further as soon as possible,” said Schineker.
The company confirmed Wednesday, April 22, its forecasts for revenue and profit for the year. Its Molecular Diagnosis division, which includes testing, saw its sales increase by 29%. Based on strong demand for emergency testing and testing for the new Coronavirus, the group is expecting sales growth of 4% for the whole year and growth in net profit per share. But Roche is not the only in vitro diagnostic laboratory in the race to develop their serological test. More than 150 serological tests are being evaluated worldwide.
American and Luxembourg players in the lead
On April 27, Abbott Park, Ill.-based-based Abbott Laboratories obtained CE marking for its SARS-CoV-2 IgG serological test, which boasts test specificity and sensitivity greater than 99%, 14 days and more after the onset of symptoms.
This new serology test, produced in Europe, will be carried out in the laboratory using Abbott's Architect i1000SR and i2000SR automated systems. It will then also be available on the new Alinity system. “Distribution of this reagent begins now, with the goal of supplying 4.5 million tests in France by the end of May and six million tests in the following months,” a spokesperson for Abbott told BioWorld.
Luxembourg-based Eurofins Scientific SE reported in early April, the launch of several serological in vitro diagnostic (IVD) medical devices based on enzyme-linked immunosorbent assays (ELISA) and CE marked for the detection of antibodies in patients who have been exposed to SARS- CoV-2.
French startups in the competition
In France, Alsace-based company Biosynex SA plans to mass produce “in the short term a rapid immunochromatographic serological test for detection of antibodies in the blood specific to the virus responsible for COVID-19.” From a single drop of blood, this test makes it possible to detect in 10 minutes the specific antibodies for COVID-19 which appear approximately 10 to 15 days after infection. Larry Abensur, CEO of Biosynex, said “this serological detection allows retrospective confirmation of exposure to the virus for healthy carriers or for patients with minor signs of COVID-19 infection.”
Ng Biotech SAS, another French startup located near Rennes, has launched a rapid test for SARS-CoV-2. “This test, on which we started R&D four months ago, has been clinically validated in France,” said Alain Calvo, Director of Strategic Development for Ng Biotech. This rapid test, produced in France and now CE marked, is distributed as an “all-in-one” device, single use only, incorporating a lancing device and a capillary blood collector enabling use at the patient bedside as well as self-testing, intended in this case as priority for health care workers.
As far as Asia goes, Chinese company Innovita Biological Technology Co. Ltd. has developed a test which detects IgG/IgM antibodies in 15 minutes. The Finnish company Mobidiag Oy/Ltd. has developed, in partnership with Chinese company Autobio Diagnostics Co. Ltd., who manufactures it, a blood test which detects the IgM antibodies (produced at the start of infection) and IgG, all in 15 minutes.