[Ip-health] Health Policy Watch: New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader

Thiru Balasubramaniam thiru at keionline.org
Thu Mar 19 13:48:29 PDT 2020


New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible”
Says Roche Industry Leader

19/03/2020 • Elaine Ruth Fletcher & Svet Lustig

New high-throughput test technologies that can process thousands of
COVID-19 samples a day are coming online, but the CEO of Roche
Pharmaceuticals, which recently gained US FDA approval for a new
high-volume test, asserted on Thursday that “broad-based testing is simply
not feasible.”

Severin Schwan, Roche CEO, was speaking at a press conference of the
International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA), where he also serves as vice-president.

“Testing is very important to help isolate infected patients, to flatten
the curve to help health systems cope with capacity,” Schwan said. “Whilst
industry has been ramping up production, still the demand is by far
outstripping the supply. Tests should be targeted to patients at risk.
Broad-based testing is simply not feasible.”

His comments came as countries rushed to secure new tests, but gaps
appeared to be widening between different health systems’ abilities to
secure and run the diagnostics – and not always along the lines of
wealthier and poorer countries. The USA, parts of Europe, and some
countries in Latin America and Africa have been attempting to accelerate
mass testing to head off wider transmission of the virus in line with WHO
Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to
“test, test, test.”

But as the number of cases continued to grow throughout Europe, the new
virus epicentre, some of its most affluent nations,  including Switzerland
which is home to Roche, said that they are reserving tests for only
seriously ill and at risk patients, as a result of the overall shortfall in
tests, reagents or other resources.

The Canton of Berne was forced to put plans to create a “drive-in” testing
sites, imitating a successful Korean model, on hold because of the lack of
available tests, Swiss public health officials conceded in a press briefing
on Thursday.

“There has been an increase in testing, and this has stretched the
availability of tests to their limits,” said Daniel Koch, director of
communicable diseases in the Swiss Office of Public Health, in a press
conference convened by Federal authorities in Switzerland, where 3,888
cases have now been confirmed.  Speaking in a televised interview, he
added, “Initially you test as broadly as possible. But this phase is over
in Europe. It is impossible at the moment to test everyone who might have
been infected.”

Koch called upon citizens to remain secluded and avoid social contact in
order to reduce further transmission, “it’s the last moment. If everyone
doesn’t make an effort, we are going to face a catastrophe.”

He remarks came against a continued worldwide increase in infectionns by at
least 20,000 new cases overnight, mostly driven by western European
countries which are the new epidemic epicentre. Italy was now reporting
over 5,000 new cases overnight for a total of 41,035, according to national
data. Spain and Germany were reporting over 30,000 cases combined, followed
by the United States and France with about 9,415 and 9,058 cases each.

The concerns over testing also have been heightened by the recent surge of
infections in Latin America (1397), Africa (733), as well as South-East
Asia (497) where public health authorities are scrambling to contain
outbreaks, and prevent spread in mega-cities.  In Lagos, which has so far
seen only 8-12 reported cases, Nigerian officials ordered schools closed on
Thursday as a pre-emptive move.


The Swiss-based Roche has also announced plans to produce millions of
diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic

Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman
told Health Policy Watch. That includes 136 units of the larger Cobas 8800,
and 706 units of the smaller COBAS 6800, a Roche spokesperson said.  She
said that Roche would be partnering with “local affiliates as well as
customers, nonprofits, and governments” to harness that testing capacity.

The Cobas 8800, Roche’s larger automated diagnostic system, is capable of
delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a
week.  This is ten-times faster than Roche’s existing test, which runs on
their MagNA Pure 24 and the LightCycler 480 devices.

This suggests that the Cobas 8800 automated diagnostic systems alone could
more than double the USA’s current test capacity (of about 182 000 a week),
according to a scientific site monitoring COVID-19 test capacity.


In well-resourced Europe, as well, there is a growing worry that current
diagnostics tests are too expensive for the quantities now being required-
despite the fact that the main patents on reverse-transcriptase Polymerase
Chain Reaction (rt-PCR) technology have expired,

WHO has estimated the cost of currently avaialable low-throughput tests as
ranging between US$ 30-$US60.  However, some countries, such as France,
seem to be paying even more.

“It is unclear why the set price for a Covid-19 test is 135 Euros, given
that the production price is estimated at 12 Euros,” says Pauline Londeix
co-founder of the French Observatory for Medicines Transparency in a recent
post. “We are asking the [French] Minister of Health to be fully
transparent about the issues surrounding screening in order to inform the
public debate. We are asking him to implement a policy of transparency
regarding the price of diagnoses and to regulate them, as was the case with
the price of hydroalcoholic gel. Leaders in the diagnostics market exist in
France. Their production units must be requisitioned to enable us to
produce the tests we urgently need.”

In Thursday’s press conference today, Roche CEO Schwan deferred from
discussing the per-unit price of the COBAS tests.  But he asserted that
testing infrastructure and lab capacity were the real barriers – not costs.

“Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and
access. With regards to the so-called high-throughput technologies, he
said, “The problem is you need to install highly sophisticated systems in
hospitals, you need personnel to ramp up testing. The priority has been to
provide those labs with existing infrastructure. These are not tests that
you can run at home. We need educated staff for this.

“In emerging markets, we have to work with low throughput systems at this
stage,” he added.  “In parallel, we need to bring additional instruments to
labs that have infrastructure where the need is biggest so that we can
increase capacity. So cost is not the bottleneck, infrastructure and
personnel is the bottleneck.”

Still, some access advocates say that without a transparent market for
COVID-19 diagnostic prices – including high- and low-throughput
technologies, it will be difficult, if not impossible, for global health
leaders and national policymakers to rationally plan their strategies, fill
stocks and adequately respond to growing demands.

“Policymakers should have a clue what it costs to manufacture and deliver
diagnostic tests, and by that, I mean, what is the cost to suppliers,” said
Knowledge Ecology International’s Jamie Love. “Testing should be done for
lots of people and some people will need lots of tests. Prices matter.
There needs to be complete transparency of costs and prices for the whole
value chain, and this is also consistent with the 2019 World Health
Assembly Resolution on transparency.

“In an emergency like this, having accurate and relevant information is
important. I think everyone knows that, but it is surprisingly how little
we know about testing costs right now. For large scale testing, we should
see prices between $1 and $5 per test. But we are way off that now.

On a related front, where diagnostics patents have not expired, legal
battles could also threaten rapid scale-up of some technologies.

In one such example, Labrador Diagnostics last week filed a lawsuit against
BioFire Diagnostics and the French-based BioMerieux S.A. in a US District
Court in Delaware for allegedly infringing on its patents linked to its
FilmArray System. The BioFire FilmArray Pneumonia Panels System is
especially helpful for diagnosing lower respiratory infections, including
those created by COVID-19. Should Labrator’s injuction be approved, use of
these FDA-approved diagnostics to slow down the outbreak in the USA could
be seriously hindered.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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