A little over a third of healthcare leaders and clinicians said that
access to quick, timely testing has been “extremely challenging” for
U.S. healthcare organizations, according to results of a new survey.
The survey,
conducted in April, includes responses from 522 from members of the
NEJM Catalyst Insights Council, a group of executives, clinical leaders,
and clinicians at organizations directly involved in healthcare
delivery in the U.S.
Five survey results:
1. Thirty-six percent of respondents said that access to quick,
timely testing has been “extremely challenging” for healthcare
organizations, while 8 percent said access has not been challenging or
not very challenging.
2. About 51 percent of respondents said that getting enough personal
protective equipment has been “extremely” or “very” challenging.
3. Twenty-eight percent said getting enough intensive care beds has been at least very challenging.
4. Most respondents (57 percent) said that their organization’s
leadership has responded very or extremely effectively to the COVID-19
pandemic.
5. About 21 percent of respondents said that their organization’s
external communications about COVID-19 have been “fair” or “poor.”
https://www.beckershospitalreview.com/hospital-management-administration/access-to-quick-testing-extremely-challenging-for-us-healthcare-survey-shows.html
Monday, May 4, 2020
New CMS panel seeks answers for nursing homes fighting coronavirus
CMS has created an independent commission to make recommendations for responding to the COVID-19 pandemic in nursing homes.
The commission will include clinicians, resident/patient advocates, medical ethicists, administrators, infection control and prevention professionals as well as state and local authorities, among others. It is expected to convene later this month and develop recommendations in three key areas:
● Protecting nursing home residents from COVID-19 and improving the responsiveness of care delivery
● Strengthening efforts to identify and curb COVID-19 transmission in nursing homes
● Enhancing strategies to improve infection control compliance in response to COVID-19
The panel also will focus on finding new ways to use nursing home data to allow for better coordination between federal surveyors, state and local entities and nursing homes.
https://www.beckershospitalreview.com/post-acute-care/new-cms-panel-seeks-answers-for-nursing-homes-fighting-coronavirus.html
The commission will include clinicians, resident/patient advocates, medical ethicists, administrators, infection control and prevention professionals as well as state and local authorities, among others. It is expected to convene later this month and develop recommendations in three key areas:
● Protecting nursing home residents from COVID-19 and improving the responsiveness of care delivery
● Strengthening efforts to identify and curb COVID-19 transmission in nursing homes
● Enhancing strategies to improve infection control compliance in response to COVID-19
The panel also will focus on finding new ways to use nursing home data to allow for better coordination between federal surveyors, state and local entities and nursing homes.
https://www.beckershospitalreview.com/post-acute-care/new-cms-panel-seeks-answers-for-nursing-homes-fighting-coronavirus.html
Roche takes on Abbott in Covid-19 antibody testing
Robust specificity data mark Roche’s serological test out as a major competitor.
Roche has become the latest company to gain FDA emergency use
authorisation for a Covid-19 antibody blood test, and the accuracy
claims the Swiss group makes for the assay suggest it is very
competitive with Abbott’s rival product.
Roche claims sensitivity of 100% and specificity of more than 99.8% when an individual is tested two weeks after a PCR test has diagnosed an active Covid-19 infection. This beats – though only by the slimmest margin – the figures Abbott released for its test, which was launched in the US in mid-April, without an EUA. It finally got the FDA’s buy-in last week, though it only obtained EUA last Tuesday.
The Elecsys anti-Sars-CoV-2 antibody test works on Roche’s cobas e range of analysers, more than 40,000 of which are installed around the world and which can run up to 300 tests an hour. Roche has already started shipping the test, which is also CE marked, and says it can ramp up production capacity to “high double-digit millions” per month.
The Elecsys assay is the ninth serological test to have gained an EUA from the FDA, but the quality of the evidence for their accuracy – specificity is particularly important – varies (Covid-19 antibody tests face a very specific problem, April 22, 2020).
Evidence
Roche assessed its test’s sensitivity on 204 samples from 69 symptomatic patients with a PCR-confirmed Covid-19 infection. But only 29 samples were from the 14-day time point, a smallish dataset, though to be fair the assay correctly flagged them all.
Still, specificity is the crucial point, and here the Elecsys test acquitted itself well, and in a much larger cohort. It was used to test 5,272 blood samples taken from routine diagnostic testing, blood donors, a common cold panel, and a coronavirus panel comprising 40 potentially cross-reactive samples from individuals with past infection with non-Covid-19 coronaviruses. All of these samples were obtained before December 2019 and thus could not carry the Covid-19 virus. 10 of the samples came back positive, giving a specificity of 99.81%.
There is one last thing to remember, however, when considering the
potential of these assays to permit the reopening of businesses, offices
and schools. There is still no definite proof that the presence of
antibodies to Sars-CoV-2 does in fact confer immunity to subsequent
infection by this virus in humans.
Roche claims sensitivity of 100% and specificity of more than 99.8% when an individual is tested two weeks after a PCR test has diagnosed an active Covid-19 infection. This beats – though only by the slimmest margin – the figures Abbott released for its test, which was launched in the US in mid-April, without an EUA. It finally got the FDA’s buy-in last week, though it only obtained EUA last Tuesday.
The Elecsys anti-Sars-CoV-2 antibody test works on Roche’s cobas e range of analysers, more than 40,000 of which are installed around the world and which can run up to 300 tests an hour. Roche has already started shipping the test, which is also CE marked, and says it can ramp up production capacity to “high double-digit millions” per month.
The Elecsys assay is the ninth serological test to have gained an EUA from the FDA, but the quality of the evidence for their accuracy – specificity is particularly important – varies (Covid-19 antibody tests face a very specific problem, April 22, 2020).
Evidence
Roche assessed its test’s sensitivity on 204 samples from 69 symptomatic patients with a PCR-confirmed Covid-19 infection. But only 29 samples were from the 14-day time point, a smallish dataset, though to be fair the assay correctly flagged them all.
Still, specificity is the crucial point, and here the Elecsys test acquitted itself well, and in a much larger cohort. It was used to test 5,272 blood samples taken from routine diagnostic testing, blood donors, a common cold panel, and a coronavirus panel comprising 40 potentially cross-reactive samples from individuals with past infection with non-Covid-19 coronaviruses. All of these samples were obtained before December 2019 and thus could not carry the Covid-19 virus. 10 of the samples came back positive, giving a specificity of 99.81%.
| Accuracy figures for selected Covid-19 antibody tests | |||||
|---|---|---|---|---|---|
| Company | Test name | Date of US EUA | EU status | Sensitivity (%) | Specificity (%) |
| Cellex | Cellex qSars-CoV-2 IgG/IgM cassette rapid test | Apr 1 | Unknown | 93.8 | 95.6 |
| Ortho-Clinical Diagnostics | Vitros anti-Sars-CoV-2 total reagent pack | Apr 14 | Unknown | 83.3 | 100.0 |
| Diasorin | Liaison Sars-CoV-2 S1/S2 IgG test | Apr 24 | CE marked | 97.4 | 98.5 |
| Ortho-Clinical Diagnostics | Vitros anti-Sars-CoV-2 IgG reagent pack | Apr 24 | Unknown | 87.5 | 100.0 |
| Autobio Diagnostics | Anti-Sars-CoV-2 rapid test (IgM and IgG) | Apr 24 | Unknown | 93.0 | 100.0 |
| Abbott Laboratories | Abbott Sars-CoV-2 IgG test | Apr 26 | CE marked | 100.0 | 99.5 |
| Bio-Rad Laboratories | Platelia Sars-CoV-2 total Ab assay | Apr 29 | CE marked | 98.0 | 99.0 |
| Roche | Elecsys anti-Sars-CoV-2 antibody test | May 3 | CE marked | 100.0 | 99.8 |
| Note: All accuracy claims made by the companies. Includes only tests with FDA emergency use authorisation. | |||||
Can Gilead make remdesivir pay?
Gilead
has been rewarded handsomely, via share price gains, for its Covid-19
remdesivir work, but the potential costs should not be forgotten.
Remdesivir is out of the gate for Gilead, with emergency use
authorisation from the FDA permitting a commercial rollout of the
antiviral for Covid-19. Instead, the company has pledged to donate its
entire supply of 1.5 million doses, which will be distributed by the US
government.
Gilead is expected to profit at some point, however: how else to explain the 23% share price surge this year, adding $18bn to the group’s market cap? This implies that a huge commercial opportunity awaits, which feels premature when considering that so much remains unknown.
On the company’s earnings call last week executives said they were still unsure what any future commercial model for remdesivir might look like. But big money is at stake here: Remdesivir costs could reach $1bn this year, Gilead estimates.
“We have to have a sustainable economic model that works here, and that achieves access [and] affordability to patients around the world,” chief executive Daniel O’Day said. “But rest assured, we understand our responsibility.”
Unsurprisingly the company will not talk about price yet – aside from the political sensitivities of this topic, remdesivir’s real benefit is far from clear (Remdesivir results pile up, but what do they all mean?, April 30, 2020). The cost-watchdog Icer has had a stab at this topic, however, putting together models based on “cost recovery” and a traditional cost-effectiveness analysis.
They concluded that a price of $10 per 10-day dose would cover manufacturing costs – although this would require Gilead to write off its R&D investment. But a price of up to $4,500 could be considered cost-effective, Icer found, assuming a mortality benefit is confirmed and using a $50,000 quality-adjusted life year threshold.
Few in the sellside have published remdesivir models yet, but this upper price seems to be higher than many are assuming. Consensus from EvaluatePharma provides some insight; however, this average is derived from some wildly different numbers, demonstrating the lack of clarity around this opportunity.
Gilead is expected to profit at some point, however: how else to explain the 23% share price surge this year, adding $18bn to the group’s market cap? This implies that a huge commercial opportunity awaits, which feels premature when considering that so much remains unknown.
On the company’s earnings call last week executives said they were still unsure what any future commercial model for remdesivir might look like. But big money is at stake here: Remdesivir costs could reach $1bn this year, Gilead estimates.
“We have to have a sustainable economic model that works here, and that achieves access [and] affordability to patients around the world,” chief executive Daniel O’Day said. “But rest assured, we understand our responsibility.”
Unsurprisingly the company will not talk about price yet – aside from the political sensitivities of this topic, remdesivir’s real benefit is far from clear (Remdesivir results pile up, but what do they all mean?, April 30, 2020). The cost-watchdog Icer has had a stab at this topic, however, putting together models based on “cost recovery” and a traditional cost-effectiveness analysis.
They concluded that a price of $10 per 10-day dose would cover manufacturing costs – although this would require Gilead to write off its R&D investment. But a price of up to $4,500 could be considered cost-effective, Icer found, assuming a mortality benefit is confirmed and using a $50,000 quality-adjusted life year threshold.
Few in the sellside have published remdesivir models yet, but this upper price seems to be higher than many are assuming. Consensus from EvaluatePharma provides some insight; however, this average is derived from some wildly different numbers, demonstrating the lack of clarity around this opportunity.
Gilead has a fiduciary duty to its shareholders, which means that
executives will be focused on recovering its remdesivir costs. But the
risk that this might not happen cannot be ignored.
More effective treatments might emerge, or vaccines could lessen the need for remdesivir more quickly than expected. And of course there is the opportunity cost of Gilead not focusing on potentially more profitable activities.
Analysts at Baird noted that the commercial opportunity remains “ambiguous”, and are sceptical that this will be substantially more than a “goodwill enterprise” for the company. Considering that $1bn could be sunk in remdesivir this year alone, this is a pretty big slice of goodwill.
Gilead should be applauded for its efforts to find a treatment for the pandemic. And while talking about commercial models will not win it fans, calls for greater clarity from investors will soon grow louder.
https://www.evaluate.com/vantage/articles/analysis/vantage-views/can-gilead-make-remdesivir-pay
More effective treatments might emerge, or vaccines could lessen the need for remdesivir more quickly than expected. And of course there is the opportunity cost of Gilead not focusing on potentially more profitable activities.
Analysts at Baird noted that the commercial opportunity remains “ambiguous”, and are sceptical that this will be substantially more than a “goodwill enterprise” for the company. Considering that $1bn could be sunk in remdesivir this year alone, this is a pretty big slice of goodwill.
Gilead should be applauded for its efforts to find a treatment for the pandemic. And while talking about commercial models will not win it fans, calls for greater clarity from investors will soon grow louder.
https://www.evaluate.com/vantage/articles/analysis/vantage-views/can-gilead-make-remdesivir-pay
Gilead off intraday lows on WHO interest in wider use of remdesivir
Gilead Sciences (GILD +0.1%)
has rebounded off session lows, albeit on below-average volume, on the
heels of reports that the World Health Organization (WHO) plans to seek
talks with the company about wider use of remdesivir in COVID-19.
The FDA gave its emergency use nod on Friday, May 1, the first antiviral approved for the respiratory infection anywhere in the world.
https://seekingalpha.com/news/3568445-gilead-off-intraday-lows-on-who-interest-in-wider-use-of-remdesivirUnique new mutation found in coronavirus study
As the coronavirus pandemic has swept across the U.S., in addition to
tracking the number of COVID daily cases, there is a worldwide
scientific community engaged in tracking the SARS-CoV-2 virus itself.
Efrem Lim leads a team at ASU that looks at how the virus may be spreading, mutating and adapting over time.
To trace the trail of the virus worldwide, Lim’s team is using a new technology called next-generation sequencing at ASU’s Genomics Facility, to rapidly read through all 30,000 chemical letters of the SARS-CoV-2 genetic code, called a genome.
Each sequence is deposited into a worldwide gene bank, run by a nonprofit scientific organization called GISAID. To date, over 16,000 SARS-CoV-2 sequences have been deposited GISAID’s EpiCoVTM Database. The sequence data shows that SARS-CoV-2 originated a single source from Wuhan, China, while many of the first Arizona cases analyzed showed travel from Europe as the most likely source.
Now, using a pool of 382 nasal swab samples obtained from possible COVID-19 cases in Arizona, Lim’s team has identified a SARS-CoV-2 mutation that had never been found before—where 81 of the letters have vanished, permanently deleted from the genome.
The study was published in the online version of the Journal of Virology.
Lim says as soon as he made the manuscript data available on a preprint server medRxiv, it has attracted worldwide interest from the scientific community, including the World Health Organization.
“One of the reasons why this mutation is of interest is because it mirrors a large deletion that arose in the 2003 SARS outbreak,” said Lim, an assistant professor at ASU’s Biodesign Institute. During the middle and late phases of the SARS epidemic, SARS-CoV accumulated mutations that attenuated the virus. Scientists believe that a weakened virus that causes less severe disease may have a selective advantage if it is able to spread efficiently through populations by people who are infected unknowingly.
Teasing apart what exactly this means is of profound interest to Lim and his colleagues. The ASU research team includes LaRinda A. Holland, Emily A. Kaelin, Rabia Maqsood, Bereket Estifanos, Lily I. Wu, Arvind Varsani, Rolf U. Halden, Brenda G. Hogue and Matthew Scotch.
The ASU virology team had been setup to perform research on seasonal flu viruses, but when the 3rd case of COVID-19 was found in an Arizona individual on January 26, 2020, they knew they had all technical and scientific prowess to rapidly pivot to examining the spread of SARS-CoV-2.
“This was the scientific opportunity of a lifetime for ASU to be able to contribute to understand how this virus is spreading in our community,” said Lim. “As a team, we knew we could make a significant difference.”
All the positive cases show that the SARS-CoV-2 viral genomes were different from each other, meaning they were independent from each other. This indicates that the new cases were not linked to the first Arizona case in January, but the result of recent travel from different locations.
In the case of the 81-base pair mutation, because it has never been found before in the GISAID database, it could also provide a clue into how the virus makes people sick. It could also form a new starting point for other scientists to develop antiviral drugs or formulate new vaccines.
SARS-CoV-2 makes accessory proteins that help it infect its human host, replicate and eventually spread from person to person. The genome deletion removes 27 protein building blocks, called amino acids, from the SARS-CoV-2 accessory protein ORF7a. The protein is very similar to the 2003 SARS-CoV immune antagonist ORF7a/X4.
The ASU team is now hard at work performing further experiments to understand the functional consequences of the viral mutation. The viral protein is thought to help SARS-CoV-2 evade human defenses, eventually killing the cell. This frees up the virus to infect other cells in a cascading chain reaction that can quickly cause the virus to make copies of itself throughout the body, eventually causing the serious COVID-19 symptoms 8-14 days after the initial infection.
Lim points out that only 16,000 SARS-CoV-2 genomes have been sequenced to date, which is less than 0.5% of the strains circulating. There are currently more than 3.5 million confirmed COVID-19 cases worldwide.
Lim’s group has teamed up with TGen, UA and Northern Arizona University to continue tracking different genetic strains of the new coronavirus. Together, the newly formed Arizona COVID-19 Genomics Union (ACGU) hopes to use big data analysis and genetic mapping to give Arizona health care providers and public policy makers an edge in fighting the growing pandemic.
Infection researchers identify starting points for SARS-CoV-2 vaccine and therapy development
Efrem Lim leads a team at ASU that looks at how the virus may be spreading, mutating and adapting over time.
To trace the trail of the virus worldwide, Lim’s team is using a new technology called next-generation sequencing at ASU’s Genomics Facility, to rapidly read through all 30,000 chemical letters of the SARS-CoV-2 genetic code, called a genome.
Each sequence is deposited into a worldwide gene bank, run by a nonprofit scientific organization called GISAID. To date, over 16,000 SARS-CoV-2 sequences have been deposited GISAID’s EpiCoVTM Database. The sequence data shows that SARS-CoV-2 originated a single source from Wuhan, China, while many of the first Arizona cases analyzed showed travel from Europe as the most likely source.
Now, using a pool of 382 nasal swab samples obtained from possible COVID-19 cases in Arizona, Lim’s team has identified a SARS-CoV-2 mutation that had never been found before—where 81 of the letters have vanished, permanently deleted from the genome.
The study was published in the online version of the Journal of Virology.
Lim says as soon as he made the manuscript data available on a preprint server medRxiv, it has attracted worldwide interest from the scientific community, including the World Health Organization.
“One of the reasons why this mutation is of interest is because it mirrors a large deletion that arose in the 2003 SARS outbreak,” said Lim, an assistant professor at ASU’s Biodesign Institute. During the middle and late phases of the SARS epidemic, SARS-CoV accumulated mutations that attenuated the virus. Scientists believe that a weakened virus that causes less severe disease may have a selective advantage if it is able to spread efficiently through populations by people who are infected unknowingly.
Teasing apart what exactly this means is of profound interest to Lim and his colleagues. The ASU research team includes LaRinda A. Holland, Emily A. Kaelin, Rabia Maqsood, Bereket Estifanos, Lily I. Wu, Arvind Varsani, Rolf U. Halden, Brenda G. Hogue and Matthew Scotch.
The ASU virology team had been setup to perform research on seasonal flu viruses, but when the 3rd case of COVID-19 was found in an Arizona individual on January 26, 2020, they knew they had all technical and scientific prowess to rapidly pivot to examining the spread of SARS-CoV-2.
“This was the scientific opportunity of a lifetime for ASU to be able to contribute to understand how this virus is spreading in our community,” said Lim. “As a team, we knew we could make a significant difference.”
All the positive cases show that the SARS-CoV-2 viral genomes were different from each other, meaning they were independent from each other. This indicates that the new cases were not linked to the first Arizona case in January, but the result of recent travel from different locations.
In the case of the 81-base pair mutation, because it has never been found before in the GISAID database, it could also provide a clue into how the virus makes people sick. It could also form a new starting point for other scientists to develop antiviral drugs or formulate new vaccines.
SARS-CoV-2 makes accessory proteins that help it infect its human host, replicate and eventually spread from person to person. The genome deletion removes 27 protein building blocks, called amino acids, from the SARS-CoV-2 accessory protein ORF7a. The protein is very similar to the 2003 SARS-CoV immune antagonist ORF7a/X4.
The ASU team is now hard at work performing further experiments to understand the functional consequences of the viral mutation. The viral protein is thought to help SARS-CoV-2 evade human defenses, eventually killing the cell. This frees up the virus to infect other cells in a cascading chain reaction that can quickly cause the virus to make copies of itself throughout the body, eventually causing the serious COVID-19 symptoms 8-14 days after the initial infection.
Lim points out that only 16,000 SARS-CoV-2 genomes have been sequenced to date, which is less than 0.5% of the strains circulating. There are currently more than 3.5 million confirmed COVID-19 cases worldwide.
Lim’s group has teamed up with TGen, UA and Northern Arizona University to continue tracking different genetic strains of the new coronavirus. Together, the newly formed Arizona COVID-19 Genomics Union (ACGU) hopes to use big data analysis and genetic mapping to give Arizona health care providers and public policy makers an edge in fighting the growing pandemic.
Explore further
More information:
LaRinda A. Holland et al, An 81 nucleotide deletion in SARS-CoV-2 ORF7a
identified from sentinel surveillance in Arizona (Jan-Mar 2020), Journal of Virology (2020). DOI: 10.1128/JVI.00711-20
Walmart seen generating 9% Q1 U.S. comp
Credit Suisse says it remains constructive on Outperform-rated Walmart (WMT -0.2%) as the retailer’s Q1 earnings report approaches.
Analyst Seth Sigman: “We raise our comps estimates
for 1H, although we lower EPS to reflect incremental margin pressures/
cost headwinds/ FX. Based on our work, we are more confident in sales
outlook past Q1 (incl the potential for comps to reaccelerate from the
recent Apr. trend), while we also believe that WMT will be better
positioned to navigate what could be very choppy consumer waters ahead,
and benefit med/long-term from significant share gains from the
structural changes in shopping behavior we are seeing.”
Sigman forecasts Q1 U.S. comparables sales will be
up 9.3% vs. +5.5% prior forecast and +3.5% consensus. He also says
Walmart is just starting to see a benefit from government stimulus.
https://seekingalpha.com/news/3568414-walmart-seen-generating-9-q1-u-s-comp
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