OPN_200314-Corona1
A lab technician Northwell Labs begins semi-automated testing for COVID-19 at Northwell Health Labs on March 11, 2020 in Lake Success, New York. An emergency use authorization to the FDA allows Northwell to move from manual testing to semi-automated. Andrew Theodorakis/Getty Images/AFP Image Credit: AFP

The US woke up to its first good coronavirus testing news in a while Friday, after weeks of hearing about nothing but delays and dangerously inadequate capacity.

The Food and Drug Administration (FDA) announced an emergency authorisation of a Roche Holding AG test that can screen patients substantially faster than existing options.

It’s good news for Roche — the approval sent shares some 7 per cent higher after a mostly down week — as well as for America’s COVID-19 response.

Once these tests are up and running, they should begin to help the US catch up on a dangerous backlog and give more people the information and care they need.

...we’re still only in the early stages of this outbreak. And we need more firepower.

- Max Nisen, Bloomberg Opinion columnist

Unfortunately, the country’s inability to test enough people for weeks has contributed to an outbreak that is likely to grow substantially in the weeks to come — and won’t be contained any time soon.

We don’t just need more lab tests; other important tools we don’t have now — including so-called "serologic tests" and "on-site diagnostics" — could play a vital role in helping to better gauge the size of the outbreak and control its spread.

SEROLOGIC TEST
Serologic diagnostics allow extensive testing of samples from people who aren’t confirmed COVID-19 cases.

Extensive testing of samples

Serologic diagnostics allow extensive testing of samples from people who aren’t confirmed COVID-19 cases.

If people have been exposed and have developed antibodies against the virus, such tests will let public health officials know.

If people have been exposed and have developed antibodies against the virus, such tests will let public health officials know.

- Bloomberg report

This is incredibly valuable information in the fight against a disease that is mild or asymptomatic in many people.

In addition to giving a better sense of how many cases we’re missing and COVID-19’s true fatality rate, it could also identify areas where it is spreading more quietly and help direct needed response.

Centres for Disease Control Director Robert Redfield recently told a Congressional committee that his agency has two tests of this type in development.

Their speedy deployment is especially crucial in the US, where there simply isn’t reliable information on where the disease is and how many people have it.

Another important step would involve moving testing capabilities out of the lab and into doctors’ offices.

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This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2, yellow, emerging from the surface of cells, pink, cultured in the lab. Also known as 2019-nCoV, the virus causes COVID-19. The sample was isolated from a patient in the U.S. On Thursday, March 5, 2020, Tennessee's Department of Health Commissioner Lisa Piercey confirmed the state's first case of the new coronavirus. (NIAID-RML via AP) Image Credit: AP

Ideally, providers should be able to order and run tests rapidly on site as they now can for viruses such as the flu instead of sending them off to an overtaxed lab.

Lowering risk of infection

An accurate and quick test of this type would mean that fewer people are left in limbo about their infection status, substantially aiding isolation, monitoring, and treatment efforts.

People could be diagnosed in a far broader array of settings, lowering the risk of further spread of infection and keeping them out of hospitals that could spend more of their time dedicated to severe cases.

A broader array of diagnostics would enable more targeted surveillance and reduce the need for blanket travel bans and other economically harmful containment measures.

FDA support and federal dollars should go to companies and labs working on such tests to get them approved and distributed quickly.

So good news for Roche and the fight against the virus, but we’re still only in the early stages of this outbreak. And we need more firepower.

— Bloomberg

Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care.

covid 19 March 14
Sources: World Health Organisation [https://bit.ly/2I9XT9q]; Johns Hopkins Center for Science and Engineering [https://bit.ly/2ILLw3z]; Worldometers.info [https://bit.ly/3aT5jdp]