Health Matters: COVID-19 Testing - 9 April 2020

Graphs below show how the EU5 compare in terms of daily new COVID-19 cases and deaths during April.
By 7th April, the daily new cases were very similar across the EU5.
The UK recorded its highest daily increase in cases, to-date, on 6th April (5,903).
Spain’s drop from 9,222 new cases on April 1st to 4,273 on 7th April is noteworthy.
Hopefully Italy and Germany are past their peaks. Both countries had their highest daily increase, to date, way back on March 20, and numbers. have stayed relatively consistent in April.
French cases have been fluctuating up and down.

source: finnCap, WHO

The UK reported its highest daily increase in deaths, to date, yesterday on 8th April (786).
France reported a huge sudden spike in deaths on 4th April, with 2,003 deaths, its highest to date. Deaths halved to 1,053 on the subsequent day.
Daily deaths in Italy and Spain remain relatively consistent.
Germany continues to have a very low death rate, as discussed in last week’s Health Matters.

source: finnCap, WHO

Testing, testing, testing

With lockdown fully in place and at the end of its third week, and measures in place to increase hospital beds (e.g. Nightingale Hospital) and ventilator capacity (Ventilator Challenge UK consortium), government and media attention is now focused on COVID-19 testing.

Large scale testing is key in order for us to be able to exit lockdown and return to our normal lives. Two companies, Avacta* and Omega Diagnostics *, announced collaborations to develop antigen and antibody tests, respectively. These would both be developed as strip tests (lateral flow diagnostics such as a pregnancy test) that do not require processing in the laboratory and therefore could be applied in large scale population screening situations (ie 100s of millions of tests).

Antigen Testing

This is the testing currently being carried out, and looks at whether a person currently has the virus. It is a molecular diagnostic test, based on a swab test, and using PCR technology.

30 such tests have been authorised by the FDA for COVID-19, including the test from Novacyt’s (AIM: NYCT) molecular diagnostics division, Primerdesign.

The government has reported shortages of chemical reagents needed to run these tests, as global demand for them exceed supply.

In early March, the NHS announced it would scale up daily testing capacity to 10,000, although it was struggling to reach this goal in late March

More than 10,000 people were tested in a single day for the first time on April 1.

Germany, by comparison, is testing around 70,000 people a day, and 500,000 a week.

The UK government aims to reach 100,000 tests per day by the end of April (and given that antibody tests are not ready, as discussed below, this target will be made up entirely of antigen tests). This is a big ask in our opinion, but the direction of travel, given the effort being applied through a range of consortia/partnerships, is clear.

Yesterday, Avacta* (AIM: AVCT) announced that it has entered into a collaboration with Cytiva, formerly GE Healthcare, to develop and manufacture an Affimer-based point-of-care rapid antigen test for screening of large populations to diagnose COVID-19 infections.

Suffice to say, the market opportunity for a cost-effective high volume test is significant (>$1bn). The upside, if successful is substantial, as illustrated by the c.£220m value created by Novacyt’s antigen test, boosted by the revelation that it was collaborating with the University of Cambridge and the might of GSK and AstraZeneca.

Genedrive (AIM: GDR) are also developing two antigen tests. The first can be performed on a variety of platforms already installed in many labs. GDR believes its clinically validated high throughput test format could be available in ~8 weeks, and believes it could ramp quickly to high production volumes of over 10,000 tests per hour.

GDR’s second test, will be adapted to run on the Genedrive instrument platform, to allow testing outside main hospital environments where rapid testing might be required.

A new COVID-19 diagnosis lab will be set up by AstraZeneca, GlaxoSmithKline and Cambridge University to conduct high throughput screening. No news yet on how many tests that will translate to per day

Antibody Testing

This could detect if a person had the virus in the past, and has since recovered. Antibody tests would help work out how widespread the disease has been and whether individuals, especially key workers, are safe to return to work.

Typically antibodies start developing at the time of infection, but peak 3-4 weeks after infection.

While the government was initially very optimistic that antibody tests would roll out quickly, it now does not expect to be doing antibody tests by the end of April.

In March, Mologic announced that it had been awarded a £1m grant by the UK government to develop a rapid diagnostic antibody test for COVID-19. On March 26, the company announced that it has initiated early validation of the test.

Similarly, SureScreen Diagnostics has developed a £6 antibody test which it claims is 98% accurate and works in 10 minutes ((it should be noted that it is likely that the 98% accuracy claim has not been independently validated. It is likely that the kit has only been tested in hospitals, on patients with very significant symptoms). BioSure has also developed an at-home finger prick test that takes 15 minutes.

The government states they are currently engaged with several companies and testing the quality of potential tests.

However, on 5th April, Health Secretary Matt Hancock said that none of the tests so far were yet “good enough”. Government scientists hope to work with companies to improve the performance antibody tests.

It has been claimed that the detection rate may be 50%-60%, after two weeks, especially in asymptomatic or mildly symptomatic cases.

Professor Sir John Bell and researchers at the University of Oxford say they are weeks away from solid validation, and none of the tests so far have performed well enough. “There are 100 or more such test kits from different suppliers available for identifying Covid-19 antibodies, and it is important that each of these is checked for accuracy before making them available to the public”.

Once a test is validated, it will take at least a month to be scaled up for widespread use.

Today, Omega Diagnostics* (AIM: ODX) announced it has signed a Memorandum of Understanding with three other companies in the UK (Abingdon Health, BBI Group Holding and CIGA Healthcare) and in conjunction with the University of Oxford to jointly develop and manufacture a COVID-19 point-of-care antibody test. The test will be based on an assay initially developed by Professor Sir John Bell.

No country has yet rolled out a COVID-19 antibody testing programme. However, the FDA granted Cellex an emergency use authorisation to market a rapid COVID-19 antibody test.

However its FDA labels states “results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection”. Labelling suggests that people who test negative should be checked again in a few days and positive results should be confirmed by other methods. The test provides results in 15-20 minutes.

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