September 8, 2021

Volume 3 | Issue 9

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A big week for testing, from the highest federal level to schools and employers. The rate of new vaccinations has declined, while employer mandates are expanding. It has become crystal clear at the highest echelons that higher levels of testing are required to bridge the remaining gap in our public-health efforts.

Now, we all need to get on board that screening testing is for everyone, not just a punishment for being unvaccinated - we know that Delta’s high transmissibility means it can infect even the fully vaccinated. The importance of this progression in thinking cannot be overstated.  

The results of the third and final Arizona State University COVID Workplace Survey have just been released. Of note:

• 93% of companies are requiring or encouraging vaccinations 

• 70% of companies are testing all or some of their employees 

• Employees are more likely to resign when companies’ COVID mandates are too lax, not too strict: 

• 39% reported resignations because of overly restrictive polices (vaccine / masks / etc) 

• 59% reported resignations because polices were not restrictive enough or lacking 

More details in the Newsletter.

If you have not checked TestingCommons.com lately - there are now more than 2,600 tests on the market or in development around the world. 

September 8, 2021

Volume 3 | Issue 8

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An eventful two weeks - with old patterns morphing into new ones as we go back to work and back to school.  

In so many ways, numbers are so cold. They only tell part of the story - they don’t tell us about the anguish that flares in kitchens and living rooms when a positive test result or a call from a hospital arrives.  But nonetheless, to make the best decisions for the public’s health we have to understand the data.

• Cases: Now averaging 150,000 per day.

• Tests: Now averaging 1.5 million a day.  But these reported tests dramatically underestimate the number of actual tests completed, as they do not include the vast majority of antigen tests - both at home and in point-of-care systems that do not automatically get reported to state or federal health authorities. More on this in the coming weeks - but our best estimate is that those uncounted tests number 800,000 a day, bringing the total to 2.2 million.  And it is not enough.  

• Deaths: Now averaging 1,500 per day - up 91% in just these last two weeks. And it is far too many.  

More inside, including information on Mu vs. Delta, vaccinated vs. unvaccinated viral load, Pfizer vs. Moderna, and early K-12 data.

August 25, 2021

Volume 3 | Issue 7

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Good: 

- The FDA fully approved the Pfizer/BNT vaccine. No new data - but we know that it will motivate at least some vaccine-hesitant people to get vaccinated and many companies / government institutions to issue vaccine mandates.  

- Willingness to test is way up, with more than 1 million tests per day reported. Positive rate is now 13.6% nationally.  Please note that this vastly underestimates the numbers of home / OTC tests - the majority of which are rapid antigen tests. 

Bad:  

- With test willingness up, test availability is down.

- Deaths in the US have averaged over 1,000 for the last seven days.

- Delta and its sub-group, AY3, account for virtually 100% of all infections. The average person with Delta infects 7 other people.

Ugly: 

- Vaccinated people can clearly spread disease - regardless of whether they have symptoms.

- Israel is seeing their own surge despite the fact the over-80% vaccination rate country-wide.

- Kids’ “invisible immunity shield” to COVID has disappeared with the Delta variant (if it ever really existed - it may have been a figment of under-testing and asymptomatic infection all along) 

August 18, 2021

Volume 3 | Issue 6

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Where are we? 

• If we are pessimistic - Cases continue to climb; 140,000 a day average, deaths now over 650 per day, and in the last week 18% of new cases were in children. 

• If we are optimistic - The UK reopened and dropped virtually all restrictions in mid July at the height of their Delta surge, when there were 47,000 infections a day. One month later, new infections have dropped to an average of 29,000 a day. The UK is ahead of the US - 61% in the UK are fully vaxxed, and 71% have had one dose. In the US, 51% are fully vaxxed, and 61% have had one dose. 

• In the US, there is good news on testing. Reported tests are over 1 million a day compared to 1.4 million a day during the last surge, but actual tests are much higher, as most of the home / OTC tests as well as point-of-care and surveillance tests are not included in state-reported numbers. We expect testing numbers to continue to increase with more symptomatic people and more testing mandates. 

• Net net, we are realistic - and focus on what we can do to shorten whatever this Delta surge has in store for us. The most important issues today are getting kids back to school and adults back to the workplace.  More schools and businesses are now mandating vaccines, masks, and testing - regardless of vaccine status. 

August 11, 2021

Volume 3 | Issue 5

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Another tough week. Delta is now part of the lexicon for everyone from ages 6 to 96. Many will even start to learn the Greek alphabet, as Eta, Iota, Kappa, and Lambda have been classified as Variants of Interest by the WHO. Current focus (as we hypothesized six weeks ago) that the next Variant of Concern may be Lambda. (Epsilon is no longer considered a Variant of Interest).  

Looking for any good news, at least for those who are vaccinated: From the Kaiser Family Foundation database for the 25 US states that are tracking vaccination status of new COVID cases, only 0.01 to 0.54% of those vaccinated will have a breakthrough case, and data from COVID tracker shows that vaccinated folks remain about 25 times less likely to experience severe disease. And while (depressingly) folks with breakthrough Delta cases do carry about the same amount of virus as unvaccinated folks, they do so for a much shorter time than the unvaccinated. Even with Delta, the vaccines are still overwhelmingly doing the job they were meant to do.

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To participate in the Arizona State University Employer Survey on COVID issues in the workplace - please go to https://chs.asu.edu/diagnostics-commons/workplace-commons

August 4, 2021

Volume 3 | Issue 4

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Another tough week. 150,000 new cases today - 92,000 average over the last week - 35% of the January high.  Testing up 40% for two reasons - rise in symptomatic people and the “Vaccinate or Test" mandates are starting to take shape.  Hospitalizations up another 90% this week - now at 33% of the January high. Deaths, at 371 daily average are far too many but, thankfully, are only 9% of the January high. Virtually all hospitalizations and deaths are the unvaccinated - but - sadly - we now understand that vaccination is not a free pass. 

Schools have started to reopen, especially in the west. No official numbers yet, but informal reports indicate that interest and implementation in testing is up.  Businesses continue to reopen in person (some big tech as exceptions) with vaccine mandates. 

July 28, 2021

Volume 3 | Issue 3

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Delta continues to drive US case numbers up to 108,000 today. We saw 63,000 cases/day on average over the last week - compare that to 12,000/day on average one month ago. Test positivity rate is very high at 10%, with a slight increase in testing.  Hospitalizations are up 70%, with 97% of those in hospital unvaccinated. The only good news is that deaths are only up 6%.

• Vaccine mandates are taking hold, with the Veterans Administration, California, and New York issuing them for public workers and front-line healthcare workers. 

• 58 healthcare organizations, including the nation’s largest, issued a joint statement urging vaccination mandates.

• As strong as the mRNA vaccines are - and they are strong - breakthrough cases are rising, and some of the vaccinated folks who are infected can carry enough virus to infect others. As a result, the CDC issued a new indoor mask guidance for everyone in areas of high or substantial transmission.  

• All of this is causing increased interest in school testing. So does testing work in schools?  Just-published data from the UK compared the efficacy of quarantine vs. daily testing for close contacts.  More inside the Newsletter, but bottom line - students in the testing Intervention Group lost 40% fewer school days, and COVID-related staff absence dropped by 60% in comparison with the Quarantine Group without an elevated number of outbreaks.

July 21, 2021

Volume 3 | Issue 2

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It is the beginning of the fourth surge in the US and the concurrent rise of the Delta variant. But we're now facing yet another obstacle: test hesitancy combined with vaccine hesitancy.   

We do have some good news on vaccines: numbers are stable and up a little - at least not declining. Courts are ruling that employers and universities can maintain vaccine mandates.  

But tests are down, down, down. Even Amazon, just as they're launching a DTC COVID mail-in test, has made the decision to STOP regularly testing their own warehouse employees. Not good.  See Newsletter for more commentary. 

July 14, 2021

Volume 3 | Issue 1

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Variants 

While Delta is now the cause of the majority of US cases, we are already starting to think about the next worrisome variant.  Not enough is known about it yet, but concern is rising about Lambda (aka C37), already prevalent in South America. 

The antigen vs. PCR debate continues 

Another study shows serial antigen / rapid tests' equivalence to PCR; see inside for more details.  

June 23, 2021

Volume 2 | Issue 15

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A relatively slow week of new COVID testing-related news, with one big exception. The VALID Act was re-introduced. VALID is the Verifying Accurate and Leading-edge IVCT Development Act  VALID re-ignites the debate as to when and who could and should regulate diagnostic tests.  More inside the Newsletter. 

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For those who may have missed the TestingCommons.com Pandemic Review, the presentation is available here. In summary: there are now at least 2,418 COVID tests authorized or in development globally. More than half are available commercially in different parts of the world, and the remainder represent the next generation of COVID tests for this pandemic and maybe the groundwork for the next viral threat.

June 16, 2021

Volume 2 | Issue 14

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The news this week was all about debates on topics like:

• Which test type is best (PCR vs. Antigen)

• How to validate Antigen tests (PCR standard vs. independent standard)

• Where to test (local testing centers vs. at home)

• Where COVID-19 originated (from the wild vs. from the lab)

• When COVID-19 came to the US (2019 vs. 2020)

June 9, 2021

Volume 2 | Issue 13

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• The short, medium and long term future of COVID testing. Current testing numbers are down but the big question is what will happen in the fall with schools and businesses mostly back in-person?

• The impact of Variants of Concern.  The WHO introduced a new naming convention using the Greek Alphabet and not the countries of initial identification. The big question is the uncertainty around B.1.617.2 (now VOC Delta) - will it cause a new surge and exploit the unvaccinated? 

• School testing. The focus moves to summer camps and other programs.  We take a deeper look at the youngest learners with an update on a new testing program in pre-schools and childcare.  The big question in the education arena  is how many colleges will require vaccination? 

May 26, 2021

Volume 2 | Issue 12

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• Testing Updates: We lowered our capacity projections to reflect reduced demand, decreased interest in building new capacity as well as fewer than expected new EUAs. But innovation continues with a new technology debut in Singapore. K-12 testing scales down for spring but readies for summer and fall. Late breaking: DoD announces Coordination Hub winners - see inside. 

• COVID’s Origin: Recent analysis reveals a potential role of the Wuhan Institute of Virology and the origin of COVID. More to come as additional information emerges.

• Just in: President Biden set a 90 day deadline for a full accounting on this issue. 

• Man's Best Friend: More developments on a canine coronavirus (see inside to see what all the barking is about!)

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May 19, 2021

Volume 2 | Issue 11

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Best news: All 50 states are reporting a decrease of COVID cases.  

Biggest news: The CDC issued new and mostly relaxed guidelines on the use of masks and testing for vaccinated individuals.   

Sad news: The pandemic rages on in India with only moderate improvements in the availability of critical necessary supplies.  

News to watch: Taiwan saw an extraordinary increase in cases after 253 days without a single case. 

Surprising news: Nine members of the NY Yankees organization tested positive after vaccination. 

Late breaking news:  Today the FDA (CDR) issued a safety communication that antibody tests “should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.” 

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May 12, 2021

Volume 2 | Issue 10

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This week was full of news: 

• Good news - The US COVID death rate has fallen to 600 a day and new cases to 38,000 a day.  For comparison, the death rate is still almost double the death rate from the flu for the worst flu season in recent history.  

• Great news - The Pfizer / BioNTech vaccine is now FDA authorized for 12 to 15 year olds. With CDC’s expected authorization tomorrow - vaccinations are 

• Bad news - The WHO has designated a fourth variant of concern, B.1.617, which appears to be highly transmissible and the dominant variant in India and rapidly rising in 40 other countries. 

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May 5, 2021

Volume 2 | Issue 9

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A relatively quiet week for COVID related issues in the US, therefore a good week to step back and provide some commentary on where we are in the US compared to the rest of the world and opine on what the near term future might hold. 

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April 28, 2021

Volume 2 | Issue 8

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This week’s newsletter is being sent now to align with the release of the Keeping Workers Well Employer Survey from Arizona State University which, with support from The Rockefeller Foundation, examines how employers are coping with the pandemic and their plans for the future. The Report, Back to the Workplace: Are we there yet? Key Insights from Employers One Year Into the Pandemic contains 

responses from 1,339 employers, 75% of which have more than 250 employees.  

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April 21, 2021

Volume 2 | Issue 7

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We're monitoring new variants and their impact on diagnostics, while also tracking a fun 4/20 themed update. 

April 14, 2021

Volume 2 | Issue 6

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A deep dive into increasing diagnostics company acquisitions by strategics. 

April 7, 2021

Volume 2 | Issue 5

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A special edition Q1 Roundup summarizes all the EUAs and EUA Amendments in Q1 and key takeaways. We also update capacity numbers to reflect recent EUAs and manufacturing updates.

March 31, 2021

Volume 2 | Issue 4

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The Rockefeller Foundation and Health Catalysts Group release the K-12 National Testing Action Program: Connecting Schools with the Nation's Leading Testing Companies to Safely Reopen, enabled by the Biden administration's $10 billion allocation to school COVID-19 testing. 

March 24, 2021

Volume 2 | Issue 3

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FDA marks some firsts with the first EUA for a COVID screening device which identifies infection through certain biomarkers and the first COVID diagnostic to receive full marketing authorization rather than an EUA. We also examine why there are so many damaging variants emerging. 

March 17, 2021

Volume 2 | Issue 2

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Capacity projections are significantly reduced to reflect reduction in demand, however we also discuss the "wild cards" that could impact capacity and the new federal investment in school testing.  

March 10, 2021

Volume 2 | Issue 1

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With increased FDA focus on home tests and home test collection kits, we explain what these different types of tests are and how many of each are on the market. 

March 3, 2021

Volume 1 | Issue 10

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Small update to capacity numbers this week, while novel strains continue to dominate the research and policy conversation and the Biden administration expands insurance coverage of COVID-19 tests. 

February 24, 2021

Volume 1 | Issue 9

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An update to capacity numbers reflects EUA's that failed to materialize in February. We also track a new FDA policy on test and variants and new investments in testing infrastructure from the Biden Administration.

February 17, 2021

Volume 1 | Issue 8

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Our commentary on CDC's new school reopening guidance and other new and noteworthy topics. ​

February 9, 2021

Volume 1 | Issue 7

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Will current vaccines will protect against emerging coronavirus strains? The good, the bad, and what we're watching. 

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February 2, 2021

Volume 1 | Issue 6

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All signs point to increased investment in at-home tests, while school reopening efforts face local resistance. 

January 26, 2021

Volume 1 | Issue 5

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Joe Biden is sworn in as President and takes immediate actions to address the pandemic. we also highlight new insights on asymptomatic COVID-19. 

January 19, 2021

Volume 1 | Issue 4

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New data emerges on variants spreading in the U.S. while central lab antigen tests show promise. 

January 12, 2021

Volume 1 | Issue 3 

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Massachusetts announces program to offer weekly, free pooled testing to all K-12 schools. Meanwhile, more field studies emerge measuring test quality.

January 5, 2021

Volume 1 | Issue 2

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New studies add detail on the real world performance of antigen tests. 

December 29, 2020

Volume 1 | Issue 1

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Tracking a big week in rapid antigen tests, with new EUAs for Abbott Binax At-Home, Ellume, and Quidel QuickVue.