Chinese exports rose unexpectedly in April, bucking a
pandemic-induced economic slump that has crimped demand and disrupted
supply chains world-wide.
But economists warned that Chinese exporters may be enjoying a
temporary reprieve and they aren’t likely immune to a global downturn
that remains highly uncertain–a reality underscored by a surprise plunge
in Chinese imports.
China’s outbound shipments rose 3.5% in April compared with a year
earlier, better than the 6.6% year-over-year decline in March, data from
the General Administration of Customs showed Thursday. The result was
far better than an 18.8% year-over-year drop expected by economists
polled by The Wall Street Journal.
China’s April export figure reflected a clearing of backlogs of
delayed orders from earlier this year due to the coronavirus outbreak,
economists said. Southeast Asia, which as a bloc surpassed the European
Union and the U.S. as China’s largest export destination earlier this
year, continued to offset losses from more advanced Western economies.
Chinese officials also highlighted increased demand from countries
that signed on to Beijing’s infrastructure-and-trade project, the Belt
and Road Initiative, which are primarily clustered in Central Asia,
Africa and the Middle East.
Chinese imports, meantime, fell 14.2% last month, far sharper than
March’s 0.9% drop and the biggest decline since February 2016,
indicating rapidly weakening demand at home.
The unexpected surge in exports and drop in imports helped China’s
trade surplus balloon to $45.34 billion last month, compared with a
$19.9 billion surplus in March.
Economists, and Chinese government officials, are generally
pessimistic about China’s ability to sustain the April export strength,
particularly as the growth picture sours further in the U.S. and Europe.
“The risks and challenges for foreign trade are unprecedented,” said
Gao Feng, a spokesman for the Ministry of Commerce, in a briefing in
reference to China’s foreign trade.
Major exporters surveyed by the commerce ministry are still facing
order cancellations and delays, or are having difficulties winning new
orders and delivering products to their customers, Mr. Gao said. He said
the government would roll out targeted measures to help exporters win
new orders and help some of them sell more at home.
“While demand in emerging markets is resilient, it’s not enough to
offset declines from other major trading partners in European and the
U.S., which will feed through to weaker exports in coming months,” said
Liu Xuezhi, an economist with Bank of Communications.
Underscoring the challenges ahead, official and private surveys of
Chinese purchasing managers in April showed new export orders falling
deeper into contractionary territory.
In data released Thursday, a private gauge of China’s service-sector
activity–the Caixin services purchasing managers index–improved slightly
in April, though it remained in contraction territory, a gloomy result
that reflects quickly weakening foreign demand.
Another major cause of concern is rising geopolitical tensions
between Washington and Beijing over China’s handling of the coronavirus
outbreak.
President Trump said Wednesday he was “watching closely” to see if
China would fulfill its commitment under the “phase one” trade deal
signed earlier this year, which commits Beijing to purchasing an
additional $200 billion in U.S. goods and services over the next two
years.
The goal now appears out of reach, particularly in the wake of the
pandemic, and some economists–including Julian Evans-Pritchard, senior
China economist for Capital Economics–see rising risks that the phase
one trade deal “soon falls apart.”
Mr. Trump has hinted at levying additional tariffs on Chinese goods,
which could heighten tensions between the world’s two largest economies
at a time of great vulnerability for the global economy.
As new coronavirus cases have ebbed in China, where the first
outbreak emerged late last year, Beijing has moved to restart its
economy by reopening factories and businesses, resuming construction
projects and handing out consumer vouchers to boost spending.
However, high-frequency data shows the recovery’s pace remains slow.
Restrictions on human movement remain in place, tens of millions of
workers have lost their jobs and a cloud of uncertainty hovers over the
economic outlook.
In one recent indicator, official data showed economic activity
during a recent five-day holiday, from May 1 to May 5, fell well short
of last year’s levels, despite being a day longer.
When April data on fixed-asset investment and retail sales are
released next week, they are likely to show continued contraction,
economists polled by The Wall Street Journal have said. These economists
remain optimistic, however, that industrial production could show a
small increase from a year earlier.
Economists, investors and analysts are looking to a coming annual
legislative conclave, set to begin on May 22, for clues about the
government’s response. The legislative meeting, which will follow a
postponement of more than two months, is typically the venue where
Beijing’s leaders unveil their annual economic targets and spending
plans.
China’s economy shrank by 6.8% in the first quarter from a year
earlier, the first such contraction in more than four decades. Analysts
widely question whether Beijing can meet its year-end political goal of
doubling the size of the overall economy from a decade ago, a goal that
economists say requires at least 5.5% growth this year.
China has pledged to increase the fiscal deficit ratio, issue more
government bonds to fund investment and help businesses and individuals
that have been hit hard by the coronavirus.
Separately on Thursday, China’s foreign-exchange regulator said the
country’s foreign-currency reserves rose by $30.83 billion to $3.091
trillion at the end of April–the product of higher asset prices and a
weakening U.S. dollar that drove up valuation of nondollar assets.
https://www.marketscreener.com/news/China-Counters-Coronavirus-Crunch-With-a-Surprise-Rise-in-Exports-Update–30556147/
Thursday, May 7, 2020
China, U.S. trade negotiators to hold talks as early as next week
Trade negotiators from the United States and China will hold a phone
call as early as next week, Bloomberg reported on Thursday, citing
people familiar with the matter.
The call will include Chinese Vice Premier Liu He and U.S. Trade Representative Robert Lighthizer, according to the report https://bloom.bg/3dpgPyo.
The talks will be about progress in implementing a Phase 1 trade deal after U.S. President Donald Trump threatened its termination if China was not adhering to the terms, the report added.
The report comes as tensions have flared up between Washington and Beijing in recent days over the origins of the coronavirus.
The United States had earlier pledged to launch negotiations with China on a Phase 2 trade deal tackling government subsidies and thornier technology transfer issues, but there have been no efforts to start these talks since the coronavirus outbreak has locked down large parts of the U.S. economy.
https://www.marketscreener.com/news/China-U-S-trade-negotiators-to-hold-talks-as-early-as-next-week-Bloomberg–30556042/
The call will include Chinese Vice Premier Liu He and U.S. Trade Representative Robert Lighthizer, according to the report https://bloom.bg/3dpgPyo.
The talks will be about progress in implementing a Phase 1 trade deal after U.S. President Donald Trump threatened its termination if China was not adhering to the terms, the report added.
The report comes as tensions have flared up between Washington and Beijing in recent days over the origins of the coronavirus.
The United States had earlier pledged to launch negotiations with China on a Phase 2 trade deal tackling government subsidies and thornier technology transfer issues, but there have been no efforts to start these talks since the coronavirus outbreak has locked down large parts of the U.S. economy.
https://www.marketscreener.com/news/China-U-S-trade-negotiators-to-hold-talks-as-early-as-next-week-Bloomberg–30556042/
Glaxo sells $3.35 billion stake in Hindustan Unilever
GlaxoSmithKline
said on Thursday it sold its stake in Unilever’s Indian business for
$3.35 billion, which Refinitiv says is the largest block trade ever to
have been carried out in India.
The funds will help GSK in its goal of reinvigorating its drug development pipeline, having made costly bets on experimental cancer treatments and future cell and gene therapies amid sluggish revenue growth.
The 5.7% stake in Hindustan Unilever was accepted by GSK as payment for the sale of its malted drink brand and other nutrition brands to Unilever, agreed in late 2018.
The 133.77 million shares were offloaded on average for 1,905 rupees, according to a statement from GlaxoSmithKline.
Potential investors were earlier told the shares would be sold in a range of 1,850 to 1,950 rupees, which was a 3%-8%discount to Wednesday’s closing price of 2,010.20 rupees.
In the statement, GSK said it would now receive net proceeds from the Horlicks divestment of 2.9 billion pounds ($3.59 billion), up from its original expectation of 2.4 billion pounds.
It said the recent Hindustan Unilever share price gains led to the better than expected outcome.
The deal, at $3.35 billion, eclipses the previous block trade record in India when Daiichi Sankyo sold its $3.18 billion stake in Sun Pharmaceuticals in April 2015, according to Refinitiv.
On a global basis, the Glaxo block trade will be the 10th ever biggest, according to the data provider.
The largest ever block trade remains Naspers selling $9.8 billion worth of Tencent stock in Hong Kong in March 2018.
MORE DIVESTMENTS
GSK’s decision could also inject some momentum into India’s equity capital markets which have struggled in line with other major financial markets as a result of the coronavirus pandemic.
There has been $6 billion worth of equity capital market deals in India so far in 2020, down from $8.52 billion during the same time list year, according to Refinitiv.
The data showed the rate of activity in 2020 is the slowest since 2017.
In comparison, Hong Kong’s equity capital markets have seen $12.8 billion worth of activity this year.
GSK struck a deal in 2018 to fold its Indian business – whose main product is Horlicks – into Unilever’s Indian unit Hindustan Unilever in exchange for shares in the combined group.
According to GSK’s first-quarter report, it completed the Horlicks deal on April 1, receiving the 5.7% equity stake in Hindustan Unilever plus about 400 million pounds in cash.
Earlier this year, GSK launched a two-year programme to split into two entities, separating the core prescription drugs and vaccines business from an enlarged over-the-counter products business that was merged with a Pfizer unit.
It is considering more divestments to fund the costs of the separation.
Having sold travel vaccines to Bavarian Nordic for up to 955 million euros ($1.03 billion)in October last year, the British group is looking into shedding more assets, starting with a review of its prescription dermatology business with about 200-300 million pounds in annual sales.
https://www.marketscreener.com/news/GSK-sells-3-35-billion-stake-in-Hindustan-Unilever–30549900/?countview=0
The funds will help GSK in its goal of reinvigorating its drug development pipeline, having made costly bets on experimental cancer treatments and future cell and gene therapies amid sluggish revenue growth.
The 5.7% stake in Hindustan Unilever was accepted by GSK as payment for the sale of its malted drink brand and other nutrition brands to Unilever, agreed in late 2018.
The 133.77 million shares were offloaded on average for 1,905 rupees, according to a statement from GlaxoSmithKline.
Potential investors were earlier told the shares would be sold in a range of 1,850 to 1,950 rupees, which was a 3%-8%discount to Wednesday’s closing price of 2,010.20 rupees.
In the statement, GSK said it would now receive net proceeds from the Horlicks divestment of 2.9 billion pounds ($3.59 billion), up from its original expectation of 2.4 billion pounds.
It said the recent Hindustan Unilever share price gains led to the better than expected outcome.
The deal, at $3.35 billion, eclipses the previous block trade record in India when Daiichi Sankyo sold its $3.18 billion stake in Sun Pharmaceuticals in April 2015, according to Refinitiv.
On a global basis, the Glaxo block trade will be the 10th ever biggest, according to the data provider.
The largest ever block trade remains Naspers selling $9.8 billion worth of Tencent stock in Hong Kong in March 2018.
MORE DIVESTMENTS
GSK’s decision could also inject some momentum into India’s equity capital markets which have struggled in line with other major financial markets as a result of the coronavirus pandemic.
There has been $6 billion worth of equity capital market deals in India so far in 2020, down from $8.52 billion during the same time list year, according to Refinitiv.
The data showed the rate of activity in 2020 is the slowest since 2017.
In comparison, Hong Kong’s equity capital markets have seen $12.8 billion worth of activity this year.
GSK struck a deal in 2018 to fold its Indian business – whose main product is Horlicks – into Unilever’s Indian unit Hindustan Unilever in exchange for shares in the combined group.
According to GSK’s first-quarter report, it completed the Horlicks deal on April 1, receiving the 5.7% equity stake in Hindustan Unilever plus about 400 million pounds in cash.
Earlier this year, GSK launched a two-year programme to split into two entities, separating the core prescription drugs and vaccines business from an enlarged over-the-counter products business that was merged with a Pfizer unit.
It is considering more divestments to fund the costs of the separation.
Having sold travel vaccines to Bavarian Nordic for up to 955 million euros ($1.03 billion)in October last year, the British group is looking into shedding more assets, starting with a review of its prescription dermatology business with about 200-300 million pounds in annual sales.
https://www.marketscreener.com/news/GSK-sells-3-35-billion-stake-in-Hindustan-Unilever–30549900/?countview=0
TG pulls victory from the jaws of defeat
The Unity-CLL trial shows ublituximab plus umbralisib conferring an unexpected progression-free survival benefit.
With TG Therapeutics yesterday claiming victory in the Unity-CLL
trial, the study’s standing among biotech’s most curious is confirmed.
Unity-CLL had suffered numerous delays and had its focus changed after
an initial failure, but despite all this it has apparently shown a
strong progression-free survival benefit.
The result positions the combo TG tested, ublituximab plus umbralisib, to be filed by the end of 2020 for chronic lymphocytic leukaemia (CLL). The projects’ sales will depend on the absolute benefit seen, the safety profile, and how strong the Unity-CLL result was in first-line versus relapsed/refractory subjects.
Investors seeking answers to these questions will need to wait until the full data are presented at a medical meeting – Ash in December looks a likely venue. Sellside consensus compiled by EvaluatePharma sees the two projects generating a combined $1.7bn of revenue in 2026, though this includes some $300m from ublituximab’s separate potential use in multiple sclerosis.
High statistical significance
For now, however, TG can boast of a PFS benefit for its combo that beat the comparator cohort, Roche’s Gazyva plus chlorambucil, with a high degree of statistical significance (p<0.0001).
Though the still undisclosed absolute result is key, TG closed up 34% yesterday, with a valuation of $1.8bn, and today took the opportunity to tap the market for $60m. TG separately hopes to complete a US lymphoma filing for umbralisib monotherapy by mid-2020.
For Unity-CLL, however, the biggest mystery remains why a study that had failed to show a benefit in terms of objective response would nevertheless read out positively for PFS. If patients are progression-free it is logical to expect them to be responding, but the TG readout suggests no correlation between the two measures.
Alethia Young, an analyst at Cantor Fitzgerald, said Unity-CLL had been powered to show a 40% improvement in PFS, and the goal was for the combo to reduce risk of progression by 29% (HR=0.71). Given that this was an interim result, causing Unity-CLL to be halted early for efficacy, the actual HR should be even better, “in the neighbourhood of 0.50”, wrote Ms Young yesterday.
A separate question is how ublituximab, an anti-CD20 antibody, and umbralisib, a PI3K delta inhibitor, will compete against new regimens such as Abbvie/Johnson & Johnson’s Imbruvica and Roche/Abbvie’s Venclexta. In first-line CLL Venclexta plus Gazyva cut risk of progression versus Gazyva plus chlorambucil by 67%, while Imbruvica beat chlorambucil alone with a staggering HR=0.16.
Importantly, Unity-CLL comprised first-line as well as relapsed/refractory subjects, in a ratio of 60/40. Though TG insists that the PFS benefit was observed across both populations, the precise contribution of each will be a key datapoint to watch, and should determine the drugs’ potential labels.
PI3K first
On an analyst call yesterday TG hailed its combo as being the first to show the benefit of a PI3K delta inhibitor in front-line CLL; this mechanism, courtesy of Gilead’s ill-fated Zydelig, has become associated with toxicity, and assuming that TG’s safety data hold up this could be a key selling point.
TG also said Unity-CLL was a springboard for additional combinations, and the company’s pipeline also includes a BTK inhibitor, TG-1701.
Still, investors would be right to remain cautious until the full data are disclosed. Unity-CLL’s failure to show a remission rate benefit scuppered TG’s accelerated approval plan, and prompted a change of focus to PFS. Then the PFS readout was delayed twice, forcing the company to add an interim analysis (TG shrugs off another delay, but history is against it, March 4, 2020).
It is with this analysis that TG has, at the eleventh hour, found something positive. Whether it has struck gold will only become clear once the full data are known.
https://www.evaluate.com/vantage/articles/news/trial-results/tg-pulls-victory-jaws-defeat
The result positions the combo TG tested, ublituximab plus umbralisib, to be filed by the end of 2020 for chronic lymphocytic leukaemia (CLL). The projects’ sales will depend on the absolute benefit seen, the safety profile, and how strong the Unity-CLL result was in first-line versus relapsed/refractory subjects.
Investors seeking answers to these questions will need to wait until the full data are presented at a medical meeting – Ash in December looks a likely venue. Sellside consensus compiled by EvaluatePharma sees the two projects generating a combined $1.7bn of revenue in 2026, though this includes some $300m from ublituximab’s separate potential use in multiple sclerosis.
High statistical significance
For now, however, TG can boast of a PFS benefit for its combo that beat the comparator cohort, Roche’s Gazyva plus chlorambucil, with a high degree of statistical significance (p<0.0001).
Though the still undisclosed absolute result is key, TG closed up 34% yesterday, with a valuation of $1.8bn, and today took the opportunity to tap the market for $60m. TG separately hopes to complete a US lymphoma filing for umbralisib monotherapy by mid-2020.
For Unity-CLL, however, the biggest mystery remains why a study that had failed to show a benefit in terms of objective response would nevertheless read out positively for PFS. If patients are progression-free it is logical to expect them to be responding, but the TG readout suggests no correlation between the two measures.
Alethia Young, an analyst at Cantor Fitzgerald, said Unity-CLL had been powered to show a 40% improvement in PFS, and the goal was for the combo to reduce risk of progression by 29% (HR=0.71). Given that this was an interim result, causing Unity-CLL to be halted early for efficacy, the actual HR should be even better, “in the neighbourhood of 0.50”, wrote Ms Young yesterday.
A separate question is how ublituximab, an anti-CD20 antibody, and umbralisib, a PI3K delta inhibitor, will compete against new regimens such as Abbvie/Johnson & Johnson’s Imbruvica and Roche/Abbvie’s Venclexta. In first-line CLL Venclexta plus Gazyva cut risk of progression versus Gazyva plus chlorambucil by 67%, while Imbruvica beat chlorambucil alone with a staggering HR=0.16.
Importantly, Unity-CLL comprised first-line as well as relapsed/refractory subjects, in a ratio of 60/40. Though TG insists that the PFS benefit was observed across both populations, the precise contribution of each will be a key datapoint to watch, and should determine the drugs’ potential labels.
PI3K first
On an analyst call yesterday TG hailed its combo as being the first to show the benefit of a PI3K delta inhibitor in front-line CLL; this mechanism, courtesy of Gilead’s ill-fated Zydelig, has become associated with toxicity, and assuming that TG’s safety data hold up this could be a key selling point.
TG also said Unity-CLL was a springboard for additional combinations, and the company’s pipeline also includes a BTK inhibitor, TG-1701.
Still, investors would be right to remain cautious until the full data are disclosed. Unity-CLL’s failure to show a remission rate benefit scuppered TG’s accelerated approval plan, and prompted a change of focus to PFS. Then the PFS readout was delayed twice, forcing the company to add an interim analysis (TG shrugs off another delay, but history is against it, March 4, 2020).
It is with this analysis that TG has, at the eleventh hour, found something positive. Whether it has struck gold will only become clear once the full data are known.
https://www.evaluate.com/vantage/articles/news/trial-results/tg-pulls-victory-jaws-defeat
Novo’s Nash play takes shape
As semaglutide looks set to move into pivotal trials in Nash, Novo Nordisk lays out hopes for longer-term benefits.
Encouraging mid-stage results from semaglutide in Nash were a big
focus at Novo Nordisk’s quarterly results today, and the diabetes giant
looks to be gearing up for a push into phase III.
This is despite the GLP-1 agonist failing to hit the key secondary endpoint of the study, looking at fibrosis resolution; Novo seems to believe that semaglutide could improve this liver scarring over longer periods. Still, a convincing hit on the primary Nash resolution endpoint sets the drug up as a formidable competitor to other projects nearing crucial readouts, Genfit’s elafibranor in particular.
Elafibranor’s phase III Resolve-It trial, due to report in the coming weeks, is expected to use the proportion of patients achieving Nash resolution without worsening of fibrosis at 72 weeks for its primary endpoint – the same as the Novo study that was detailed today. Semaglutide hit statistical significance at all doses tested: a 42% placebo-adjusted difference in the high group provides something of a bar to beat.
Novo’s study tested once-daily injections of sema at three different doses; the drug is sold in diabetes as a once-weekly injection, branded Ozempic, and formulated for once-daily oral dosing and sold under the trade name Rybelsus.
This is despite the GLP-1 agonist failing to hit the key secondary endpoint of the study, looking at fibrosis resolution; Novo seems to believe that semaglutide could improve this liver scarring over longer periods. Still, a convincing hit on the primary Nash resolution endpoint sets the drug up as a formidable competitor to other projects nearing crucial readouts, Genfit’s elafibranor in particular.
Elafibranor’s phase III Resolve-It trial, due to report in the coming weeks, is expected to use the proportion of patients achieving Nash resolution without worsening of fibrosis at 72 weeks for its primary endpoint – the same as the Novo study that was detailed today. Semaglutide hit statistical significance at all doses tested: a 42% placebo-adjusted difference in the high group provides something of a bar to beat.
Novo’s study tested once-daily injections of sema at three different doses; the drug is sold in diabetes as a once-weekly injection, branded Ozempic, and formulated for once-daily oral dosing and sold under the trade name Rybelsus.
Novo Nordisk Q1 2020 presentation.
Missing the key secondary endpoint – at least one stage of liver
fibrosis improvement with no worsening of Nash – is disappointing, but
then this was always a long shot given sema’s mechanism. The drug works
mainly through metabolic and endocrine pathways, and in diabetes has
been proven to promote weight loss.
This was also seen in the Nash trial, it was revealed on an analyst call this afternoon. Mads Krogsgaard Thomsen, Novo’s chief scientific officer, said “trends were positive” on the fibrosis improvement secondary endpoint, despite missing statistical significance.
Fibrosis progression endpoints did show a statistically significant and dose-dependent reduction, he added, suggesting that sema’s impact on liver scarring could be seen in longer trials.
These data “point towards a disease mechanism that has the potential to arrest progression of the disease, including fibrosis”, he said. Novo envisions gaining approval based on the Nash resolution with no worsening in fibrosis endpoint, and then continuing the study to collect a longer-term picture of the drug’s utility.
“There are good reason to believe that achievements in hard outcomes over time should be doable,” Mr Thomsen said.
Novo also seems confident that gastrointestinal tolerability issues, a known side effect of the GLP-1 agonist class, will not hold back development. Only 5% of patients in the study discontinued because of adverse events, and only two out of 90 in the high-dose group specifically for GI issues.
Moving on
Novo declined to discuss when pivotal studies might start, and with new trial starts paused because of Covid-19 this is understandable. A once-weekly dose is likely to be used, Mr Thomsen said, stressing that he was not awaiting impending results from a study testing sema in combination with two Gilead Nash projects before deciding whether to push on.
“Semaglutide looks to become a standalone and maybe an anchor drug in the future for Nash,” he said.
Such sentiments have been heard from several small Nash players in the past few years, of course, and most have come to nothing. But the diabetes giant is not known for its hyperbole, and has already set out lofty ambitions in the related obesity space.
Novo might not be the most advanced Nash player right now, but its deep experience in metabolic disease, and equally deep pockets, make it very well placed to succeed. Its next step will be keenly awaited.
This was also seen in the Nash trial, it was revealed on an analyst call this afternoon. Mads Krogsgaard Thomsen, Novo’s chief scientific officer, said “trends were positive” on the fibrosis improvement secondary endpoint, despite missing statistical significance.
Fibrosis progression endpoints did show a statistically significant and dose-dependent reduction, he added, suggesting that sema’s impact on liver scarring could be seen in longer trials.
These data “point towards a disease mechanism that has the potential to arrest progression of the disease, including fibrosis”, he said. Novo envisions gaining approval based on the Nash resolution with no worsening in fibrosis endpoint, and then continuing the study to collect a longer-term picture of the drug’s utility.
“There are good reason to believe that achievements in hard outcomes over time should be doable,” Mr Thomsen said.
Novo also seems confident that gastrointestinal tolerability issues, a known side effect of the GLP-1 agonist class, will not hold back development. Only 5% of patients in the study discontinued because of adverse events, and only two out of 90 in the high-dose group specifically for GI issues.
Moving on
Novo declined to discuss when pivotal studies might start, and with new trial starts paused because of Covid-19 this is understandable. A once-weekly dose is likely to be used, Mr Thomsen said, stressing that he was not awaiting impending results from a study testing sema in combination with two Gilead Nash projects before deciding whether to push on.
“Semaglutide looks to become a standalone and maybe an anchor drug in the future for Nash,” he said.
Such sentiments have been heard from several small Nash players in the past few years, of course, and most have come to nothing. But the diabetes giant is not known for its hyperbole, and has already set out lofty ambitions in the related obesity space.
Novo might not be the most advanced Nash player right now, but its deep experience in metabolic disease, and equally deep pockets, make it very well placed to succeed. Its next step will be keenly awaited.
FDA clamps down on Covid-19 antibody tests
Tests
from Ortho-Clinical Diagnostics and Becton Dickinson are in the danger
zone as FDA moves to pull less accurate Covid-19 kits.
So far the US FDA has granted emergency use authorisation to 10
commercially developed blood tests that are intended to assess whether a
person has developed antibodies to the novel coronavirus, and therefore
might carry some level of immunity. But the evidence backing these
disparate assays varies in quality, and some other groups are selling
tests in the US, quite legally, without providing any accuracy data at
all.
The FDA is finally doing something about this situation. On Monday it said developers would have to provide accuracy data within the next 10 days or risk their tests being pulled. Furthermore, the regulator has set out the exact standards it will require the tests to meet – and some of those on the market will not, on current evidence, make the cut.
The agency has previously not required accuracy data on a test to award an EUA – and companies do not have to obtain an EUA to sell their tests in the US anyway. Abbott, for example, obtained EUA for its antibody test on April 26, but had started selling it in the US on April 15. It is not known exactly how many antibody tests are on sale in the country, but the figure is believed to be in the hundreds.
This soft-touch approach is to change. Stating that “the careful balancing of risks and benefits has shifted from where it was in mid-March”, the agency has revised its policy and laid out the kind of evidence it needs to allow Covid-19 antibody tests to remain on sale.
Instead of sensitivity and specificity the FDA has used the terms positive and negative percent agreement (PPA and NPA). These values are calculated identically to sensitivity and specificity, but are used when the comparator test is recognised as being imperfect. In this case the best available comparator is PCR testing for coronavirus RNA, which is not currently recognised as a clinical reference standard.
Meeting the standards
In summary, the FDA states that the data backing Covid-19 antibody tests should demonstrate a minimum overall 90% PPA, equivalent to sensitivity, and overall 95% NPA, equivalent to specificity. For tests that report specifically IgM and IgG results, minimum PPAs of 70% and 90% are required for IgM and IgG respectively.
The guidance also states that clinical agreement data should be provided using at least 30 antibody-positive samples for each immunoglobulin claimed, and 75 antibody-negative samples.
The table below summarises the accuracy figures made for some of the tests known to be on sale in the US. An important caveat is that it relies on information the companies, and in some cases distributors or academic researchers, have released. The companies might well have better data that they have kept confidential – though why they would do this is unclear.
Some of the tests fail to meet the FDA’s standards for
sensitivity/PPA or specificity/NPA. One example is the test developed by
Biomedomics, which is sold by Becton Dickinson. Others fail on the
sample size on which the testing was conducted – Epitope Diagnostics’
IgG test was validated on too few samples, and CTK Biotech, for
instance, claims sufficient accuracy for its test but has not provided
the sample sizes.
There is also a separate plan for the FDA, in conjunction with the CDC and NIH, to double-check the accuracy of tests on sale in the US. This collaboration has looked at 13 tests so far, the FDA said, with the data still under review. The agency recently issued an umbrella EUA for antibody tests that complete this validation process, and will announce in future which tests have made the grade.
The question is whether the FDA will follow up on its promise to remove underperforming tests from sale in the US. If this is left as an idle threat, the agency risks being seen as toothless.
https://www.evaluate.com/vantage/articles/analysis/spotlight/fda-clamps-down-covid-19-antibody-tests
The FDA is finally doing something about this situation. On Monday it said developers would have to provide accuracy data within the next 10 days or risk their tests being pulled. Furthermore, the regulator has set out the exact standards it will require the tests to meet – and some of those on the market will not, on current evidence, make the cut.
The agency has previously not required accuracy data on a test to award an EUA – and companies do not have to obtain an EUA to sell their tests in the US anyway. Abbott, for example, obtained EUA for its antibody test on April 26, but had started selling it in the US on April 15. It is not known exactly how many antibody tests are on sale in the country, but the figure is believed to be in the hundreds.
This soft-touch approach is to change. Stating that “the careful balancing of risks and benefits has shifted from where it was in mid-March”, the agency has revised its policy and laid out the kind of evidence it needs to allow Covid-19 antibody tests to remain on sale.
Instead of sensitivity and specificity the FDA has used the terms positive and negative percent agreement (PPA and NPA). These values are calculated identically to sensitivity and specificity, but are used when the comparator test is recognised as being imperfect. In this case the best available comparator is PCR testing for coronavirus RNA, which is not currently recognised as a clinical reference standard.
Meeting the standards
In summary, the FDA states that the data backing Covid-19 antibody tests should demonstrate a minimum overall 90% PPA, equivalent to sensitivity, and overall 95% NPA, equivalent to specificity. For tests that report specifically IgM and IgG results, minimum PPAs of 70% and 90% are required for IgM and IgG respectively.
The guidance also states that clinical agreement data should be provided using at least 30 antibody-positive samples for each immunoglobulin claimed, and 75 antibody-negative samples.
The table below summarises the accuracy figures made for some of the tests known to be on sale in the US. An important caveat is that it relies on information the companies, and in some cases distributors or academic researchers, have released. The companies might well have better data that they have kept confidential – though why they would do this is unclear.
| Accuracy figures for selected Covid-19 antibody tests sold in the US | |||||
|---|---|---|---|---|---|
| Company | Test name | Date of US EUA | Sensitivity or PPA (%) | Specificity or NPA (%) | Meets FDA requirements? |
| Cellex | qSars-CoV-2 IgG/IgM cassette rapid test | Apr 1 | 93.8 | 95.6 | Yes |
| Ortho-Clinical Diagnostics | Vitros anti-Sars-CoV-2 total reagent pack | Apr 14 | 83.3 | 100.0 | No |
| Chembio Diagnostic System | DPP Covid-19 IgM/IgG system | Apr 14 | 93.5 | 90.2 | No |
| Diasorin | Liaison Sars-CoV-2 S1/S2 IgG test | Apr 24 | 97.4 | 98.5 | Yes |
| Ortho-Clinical Diagnostics | Vitros anti-Sars-CoV-2 IgG reagent pack | Apr 24 | 87.5 | 100.0 | No |
| Autobio Diagnostics* | Anti-Sars-CoV-2 rapid test (IgM and IgG) | Apr 24 | 93.0 | 100.0 | Yes |
| Abbott Laboratories | Abbott Sars-CoV-2 IgG test | Apr 26 | 100.0 | 99.5 | Yes |
| Bio-Rad Laboratories | Platelia Sars-CoV-2 total Ab assay | Apr 29 | 98.0 | 99.0 | Yes |
| Roche | Elecsys anti-Sars-CoV-2 antibody test | May 2 | 100.0 | 99.8 | Yes |
| Euroimmun (Perkinelmer)* | Anti-Sars-CoV-2 Elisa (IgG) | May 4 | 65.0 | 96.0 | No |
| Becton Dickinson/ Biomedomics |
Covid-19 IgM/IgG rapid test | No EUA | 88.7 | 90.6 | No |
| Creative Diagnostics | Sars-CoV-2 antibody Elisa | No EUA | 94.5 | 100.0 | Yes |
| CTK Biotech | OnSite Covid-19 IgG/IgM Rapid Test | No EUA | 96.9 | 99.4 | Unknown |
| Epitope Diagnostics | EDI Novel Coronavirus Covid-19 IgG Elisa kit | No EUA | 100.0 | 100.0 | No |
| Epitope Diagnostics | EDI Novel Coronavirus Covid-19 IgM Elisa kit | No EUA | 45.0 | 100.0 | No |
| Intec Products | Rapid Sars-CoV-2 antibody (IgM/IgG) | No EUA | 95.2 | 98.0 | Unknown |
| Nirmidas Biotech | Covid-19 (Sars-CoV-2) IgM/IgG antibody detection kit | No EUA | 81.4 | 94.4 | No |
| SD Biosensor | Standard Q Covid-19 IgM/IgG Duo | No EUA | 81.8 | 96.6 | No |
| *Accuracy figures from this paper. All other accuracy claims made by companies or distributors. Includes only tests with FDA emergency use authorisation. Source: EvaluateMedTech & company websites. | |||||
There is also a separate plan for the FDA, in conjunction with the CDC and NIH, to double-check the accuracy of tests on sale in the US. This collaboration has looked at 13 tests so far, the FDA said, with the data still under review. The agency recently issued an umbrella EUA for antibody tests that complete this validation process, and will announce in future which tests have made the grade.
The question is whether the FDA will follow up on its promise to remove underperforming tests from sale in the US. If this is left as an idle threat, the agency risks being seen as toothless.
https://www.evaluate.com/vantage/articles/analysis/spotlight/fda-clamps-down-covid-19-antibody-tests
Fever scanners coming to GM factories
General Motors (NYSE:GM) will deploy a total of 377 FLIR (NASDAQ:FLIR) scanners across 72 sites to detect workers for high temperatures before employees return to factories on May 18.
Until the coronavirus pandemic, the bulk of
thermal camera sales were for military or industrial purposes, but sales
are now booming.
FLIR CEO James Cannon said on an earnings call
yesterday that the company saw about $100M in bookings for
coronavirus-related cameras and sensors during Q1.
https://seekingalpha.com/news/3570865-fever-scanners-coming-to-gm-factories
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