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 17, 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.