Roche gets FDA emergency use approval for COVID-19 antibody test
04 May, 2020
Roche Holding received emergency use approval from the united states Food and Drug Administration (FDA) for an antibody test to help determine if persons have ever been infected with the coronavirus, the Swiss drugmaker said on Sunday (May 3).
Governments, businesses and individuals would like such blood tests, to greatly help them find out more about and also require had the disease, who may have some immunity and also to potentially craft ways of end lockdowns which have battered global economies.
Roche had previously pledged to create its antibody test available by early May and boost production by June to "high double-digit millions" monthly.
The Basel-based company, which also makes separate molecular tests to recognize persons with active COVID-19 infections, said its antibody test, Elecsys Anti-SARS-CoV-2, has a specificity rate around 99.8 % and sensitivity rate of 100 %.
These rates help determine if an individual has been subjected to COVID-19, the respiratory disease due to the coronavirus, and if the individual is rolling out antibodies against it.
Others including US-based Abbott Laboratories , Becton Dickinson and Co, Italy's DiaSorin have also developed tests to recognize antibodies that develop after somebody has touch the virus.
Diasorin and Abbott recently got US emergency authorisation because of their tests.
Countries have various plans to use such tests to better understand COVID-19, while also identifying those that were infected but showed only mild symptoms, or none at all.
An erroneous false-positive result could bring about the mistaken conclusion that someone has immunity.
In developing its test, Roche scrutinised some existing products for reliability before rejecting them, its chief executive, Severin Schwan, had earlier said.
Schwan said there have been about 100 such tests on offer, including finger-prick assays that give a quick result.
It declined to specify which rival tests it had studied, but said it had been not discussing tests from established testing companies.
Roche has said its antibody test requires an intravenous blood draw to look for the existence of antibodies including immunoglobulin G (IgG), which remains longer in the body, suggesting possible immunity.
As demand escalates for blood antibody tests, a range of distributors with no background or established competency in medical testing have joined experienced companies in an all-but-unregulated marketplace in the United States, according to a Reuters investigation.
The rush to acquire, advertise and discover buyers for test kits follows the FDA's decision to allow any company to market antibody tests in the united states without prior review by the agency.
This comes after the agency faced criticism that it didn't act quickly enough with diagnostic tests.
FDA has said the purpose of its policy is to provide laboratories and healthcare providers early usage of the tests, but that it'll adapt the approach as needed.
Source: www.channelnewsasia.com
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