Cepheid wins 1st FDA nod for point-of-care coronavirus test |

One of the most powerful engines in the United States is public-private collaboration. The symbiosis of government authority and funding along with the entrepreneurial motivation of industry leads to extraordinary results.  We saw this same occurrence. World War II when production facilities transitioned in a very short time to war output. Factories in Detroit, MI shut down automobile assembly lines to begin producing tanks, and jeeps.

Clinical laboratories and medical device manufacturers are tapping into today's high-speed broadband to accelerate testing for COVID-19.  Every great challenge mobilizes great advances in technology, production, and human interaction

The FDA has granted the use of the Cepheid  POS (point of service) for a variety of diseases, Critical Infectious Diseases such as those listed here can be tested in hospital and clinic without waiting for the return of results.

Xpert Xpress SARS-CoV-2 (EUA), Covid-19
Xpert Xpress Strep A
Xpert Xpress Flu/RSV
Xpert Xpress Flu
Xpert MTB/RIF
Xpert-EV

HOW IT WORKS

• The test, run on Cepheid's GeneXpert systems, takes about 45 minutes to deliver results. The company said there are nearly 5,000 of the automated systems currently deployed throughout the U.S., with more than 23,000 around the world.
• With point-of-care testing, FDA Commissioner Stephen Hahn said in a statement on Saturday ​results will be delivered to patients in "hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory" and will enable "patient access to more immediate results.” 
• The device, named Gene Expert System was already approved for rapid diagnostic procedures for Critical-Infectious-Diseases. 
• Xpert Xpress SARS-CoV-2 (EUA) Covid-19
• Xpert Xpress Strep A
• Xpert Xpress Flu/RSV
• Xpert Xpress Flu
• Xpert MTB/RIF
• Xpert-EV
The test, run on Cepheid's GeneXpert systems, takes about 45 minutes to deliver results. The company said there are nearly 5,000 of the automated systems currently deployed throughout the U.S., with more than 23,000 around the world.
• While tests from clinical lab networks LabCorp and Quest have significantly increased the nation's coronavirus testing capacity in recent weeks, those services require a healthcare provider to send specimens to an external facility. In addition, patients with a suspected case of COVID-19 do not receive confirmed results for at least a few days.
• Another potential advantage of Cepheid's 45-minute test is that it can use a saline wash for testing if swabs are not available, according to the company. Some labs across the country are reporting a short supply of swabs, which are needed for collecting patient samples to test for coronavirus infection, as well as reagents.​
• "The test cartridge is a complete solution containing all the necessary reagents," according to Cepheid​. "This is different from some other test kits on the market which may require additional reagents such as extraction materials."
• FDA has updated its COVID-19 diagnostic testing FAQs, which now lists the clinical labs that are offering to test, the states that have chosen to authorize labs to develop and perform tests, as well as commercial manufacturers that are distributing test kits. ​
• EMERGENCY USE AUTHORIZATION

The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. 


Coronavirus Disease 2019 (COVID-19) UPDATE

Cepheid wins 1st FDA nod for point-of-care coronavirus test | MedTech Dive: MedTech industry news

Coronavirus pandemic could last over 18 months, according to a federal plan

The next year and a half could include "multiple waves of illness."

The coronavirus pandemic could last over 18 months, according to a 100-page federal government response plan recently shared with The New York Times.

The next year and a half could include "multiple waves of illness," according to the document. "The spread and severity of COVID-19 will be difficult to forecast and characterize." 

What's more, increasing COVID-19 cases in the U.S. will mean more hospitalizations among at-risk people, which could strain the health care system, they wrote. The document, dated March 13, is marked as "unclassified" but "for Official Use Only," and "Not For Public Distribution or Release." 

In the document, officials explore responses that the government could take in response to the outbreak, including steps already taken such as shutting down schools and invoking the Defense Production Act of 1950, a law dating back to the Korean War that authorizes action to force industry to increase production of crucial equipment and supplies.

On Wednesday (March 18), President Donald Trump announced he was invoking the Defense Production Act, and two days later said he had put it into effect, according to The Washington Post.

 The plan also predicts that product shortages will occur "impacting health care, emergency services, and other elements of critical infrastructure." What's more, state and local governments, critical infrastructure and communication channels "will be stressed and potentially less reliable," the plan read. 

Another report published on Monday (March 16) by the Imperial College of London gave another grim forecast that pushed both the U.K. and the U.S. into action: Uncontrolled spread of the virus could cause up to 510,000 deaths in Britain and up to 2.2 million deaths in the U.S., according to The New York Times.

"Whilst our understanding of infectious diseases and their prevention is now very different compared to in 1918 [the year H1N1 influenza called the Spanish flu caused a global pandemic], most of the countries across the world face the same challenge today with COVID-19, a virus with comparable lethality to H1N1 influenza in 1918," they wrote. To combat the current pandemic, the report focuses on two major strategies: "suppression," in which steps are taken to reduce the spread of the virus; and "mitigation," in which the final spread isn't decreased but it is slowed down.

Their results suggested that population-wide social distancing would have the largest impact, and in combination with other interventions, such as home isolation of people who have COVID-19 and school closures, has the potential to rapidly reduce spread, they wrote.

"To avoid a rebound in transmission, these policies will need to be maintained until large stocks of vaccine are available to immunize the population," which could be 18 months or more, according to the Imperial College of London report. 

From all current information, our social isolation will remain in effect and slowly be relaxed in stages to measure what long term cycles may recur.  This presumption is based upon previous seasonal influenza recurrences.

At least 8 states have issued stay-at-home orders

From CNN’s Jamiel Lynch

The following states, in order of population, have issued stay-at-home orders:

• California - 39.5 million – started Thursday
• New York - 19.5 million - effective Sunday evening
• Illinois - 12.7 million – started 5 p.m. Saturday
• Ohio - 11.6 million – effective 11:59 p.m. Monday
• New Jersey - 8.9 million – started 9 p.m. Saturday
• Louisiana - 4.6 million – effective 5 p.m. Monday
• Connecticut – 3.5 million – effective 8 p.m. Monday
• Delaware – 967,171 – effective Tuesday 8 a.m.

Source

Researchers in US give first shot to person in experimental COVID-19 vaccine test, Health News, ET HealthWorld

According to a report by the Associated Press (AP), scientists at the Kaiser Permanente Washington Research Institute in Seattle begin an 'anxiously awaited testing

As coronavirus cases continue to shoot up across the globe, researchers in the US gave first shot to the first person in a test of an experimental COVID-19 vaccine on Monday.

Forty-three-year-old Jennifer Haller of Seattle, an operations manager at a tech company, received the injection inside an exam room.

Haller, the mother of two teenagers, termed it an "amazing opportunity" for her to "do something".

The said 'vaccine', codenamed mRNA-1273, was developed by the National Institutes of Health (NIH) and Massachusetts-based biotechnology company Moderna Inc.

More than 1,50,000 people have been infected worldwide by the virus which originated in China last December and has claimed the lives of over 6,500 people.

"We are team coronavirus now. Everyone wants to do what they can in this emergency," Kaiser Permanente study leader Dr. Lisa Jackson was quoted as saying on the eve of the experiment.

Jackson said that from not even knowing that coronavirus was out there to have any vaccine in testing in about two months is 'unprecedented'. She, although, said that it is not at this stage where it would be "possible or prudent" to give it to the general population.

The tests came amid worldwide attempts to develop the vaccine for the deadly virus.

However, these vaccines are unlikely to be available for widespread use anytime for 12 to 18 months, said Dr. Anthony Fauci of the NIH.

Finding a vaccine "is an urgent public health priority," Dr. Fauci was quoted as saying.

According to the AP report, most of the vaccine research underway targets a protein aptly named "spike" that studs the surface of the new coronavirus and lets it invade human cells.

Other Developments

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India declares Covid-19 a ‘Notified Disaster
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Ibuprofen vs Paracetamol: Which medicine to take in case you suspect coronavirus symptoms?
Coronavirus cases top 300,000 worldwide
All the senators are going to seek medical advice" after Rand Paul tests positive for coronavirus, Romney says
International Olympic Committee will consider rescheduling Olympics, says cancellation not on the agenda
Half of patients tested at one New York health care system yesterday were positive for Covid-19



Researchers in the US give first shot to a person in experimental COVID-19 vaccine test, Health News, ET HealthWorld:

Mapping the Coronavirus Outbreak Across the World

                           

The coronavirus outbreak is now a pandemic, the World Health Organization declared on March 11, as global confirmed cases of Covid-19 now surpass 200,000 worldwide. The outbreak has spread from the Chinese city of Wuhan in late January to countries and territories—affecting every continent except Antarctica—in the course of a month. Cases in Europe now exceed the number in China. Efforts to prevent the pneumonia-like illness from spreading further have led to shuttered cities, widespread flight cancellations and shaken financial markets.

Updated March 20,2020

256,689 Confirmed cases worldwide
10,368 Deaths

Where

         Deaths           Cases

Italy 3,405 41,035
Mainland China 3,248 80,967
Iran 1,284 18,407
Spain 1,002 19,980
France 450 12,612
U.S. 206 15,973
U.K. 177 3,983
Netherlands 106 2,994
South Korea 91 8,565
Germany 49 18,607
Switzerland 43 4,176
Belgium 37 2,257
Japan 33 950
Indonesia 32 369
Philippines 18 230
Iraq 12 164
Sweden 10 1,423
Canada 10 846
Denmark 9 1,325
Greece 9 495
Diamond Princess Cruise 8 714
Algeria 8 82
Norway 7 1,742
Australia 7 709
Austria 6 2,388
Portugal 6 1,020
Brazil 6 621
Egypt 6 210
Luxembourg 5 484
Poland 5


This link includes numerous graphs and charts.

What Is Coronavirus: Mapping the Pneumonia-Like Respiratory Illness in China, Globally:

Social Distancing: This is Not a Snow Day - Ariadne Labs - Medium

 I know there is some confusion about what to do next in the midst of this unprecedented time of a pandemic, school closures, and widespread social disruption.  

Things are changing quickly as public health officials, state governments and local cities struggle to keep up with changing guidelines.  Driving this chaotic evolution is the fear of not having adequate beds, and ventilators to treat those who have life-threatening pneumonia.

Covid-19 is not influenza, as we have come to realize now that autopsies reveal the extent of pulmonary damage.  Today is March 21, 2020, just 8 days after this article, "Social Distancing: This is Not a Snow Day " was published on Medium.

Since then it has become a global pandemic spreading across Europe, Italy and the Americas with the two largest cities in the U.S. heavily impacted (New York City) and Los Angeles.

At this point there is open-ended guidance to shelter at home, most businesses are closed, theaters dark, and only take out food service.  Many parts of the country, smaller towns and rural areas may not be afflicted as yet.  Major city populations are now aware of the threat now that governments have ordered business to close.

Schools are now shuttered and the expected resumption of classes was changed from April 1st  to closed for the rest of the year.

To understand the Flattening the Curve this exhibit explains the epidemiology of pandemics.

How Much Worse the Coronavirus Could Get, in Charts (New York. Times) The article is interactive and displays the results of the timing of intervention. The bottom line is that the earlier isolation has begun the flatter the curve.








Social Distancing: This is Not a Snow Day - Ariadne Labs - Medium:

Infographic: The History of Pandemics, by Death Toll

The history of pandemics, from the Antonine Plague to the novel coronavirus (COVID-19) event, ranked by their impact on human life.

The History of Pandemics

Pan·dem·ic /panˈdemik/ (of a disease) prevalent over a whole country or the world.

As humans have spread across the world, so have infectious diseases. Even in this modern era, outbreaks are nearly constant, though not every outbreak reaches pandemic level as the Novel Coronavirus (COVID-19) has.

Today’s visualization outlines some of history’s most deadly pandemics, from the Antonine Plague to the current COVID-19 event.

A Timeline of Historical Pandemics
Disease and illnesses have plagued humanity since the earliest days, our mortal flaw. However, it was not until the marked shift to agrarian communities that the scale and spread of these diseases increased dramatically.

Widespread trade created new opportunities for human and animal interactions that sped up such epidemics. Malaria, tuberculosis, leprosy, influenza, smallpox, and others first appeared during these early years.

The more civilized humans became – with larger cities, more exotic trade routes, and increased contact with different populations of people, animals, and ecosystems – the more likely pandemics would occur.

Antoine Plague 165-180 Believed to be either smallpox or measles 5M
Japanese smallpox epidemic 735-737 Variola major virus 1M
Plague of Justinian 541-542 Yersinia pestis bacteria / Rats, fleas 30-50M
Black Death 1347-1351 Yersinia pestis bacteria / Rats, fleas 200M
New World Smallpox Outbreak 1520 – onwards Variola major virus 56M
Great Plague of London 1665 Yersinia pestis bacteria / Rats, fleas 100,000
Italian plague 1629-1631 Yersinia pestis bacteria / Rats, fleas 1M
Cholera Pandemics 1-6 1817-1923 V. cholerae bacteria 1M+
Third Plague 1885 Yersinia pestis bacteria / Rats, fleas 12M (China and India)
Yellow Fever Late 1800s Virus / Mosquitoes 100,000-150,000 (U.S.)
Russian Flu 1889-1890 Believed to be H2N2 (avian origin) 1M
Spanish Flu 1918-1919 H1N1 virus / Pigs 40-50M
Asian Flu 1957-1958 H2N2 virus 1.1M
Hong Kong Flu 1968-1970 H3N2 virus 1M
HIV/AIDS 1981-present Virus / Chimpanzees 25-35M
Swine Flu 2009-2010 H1N1 virus / Pigs 200,000
SARS 2002-2003 Coronavirus / Bats, Civets 770
Ebola 2014-2016 Ebolavirus / Wild animals 11,000
MERS 2015-Present Coronavirus / Bats, camels 850
COVID-19 2019-Present Coronavirus – Unknown (possibly pangolins)





















Infographic: The History of Pandemics, by Death Toll:

JOIN THE COCHRANE CROWD AND CONTRIBUTE TO COVID-19 KNOWLEDGE BASE

What is Cochrane?

Cochrane has now developed a crowdsourcing application available to anyone to report on new evidence.

What is TaskExchange?

TaskExchange connects people working in health evidence with people who have the time and skills to help.

The Covid-19 pandemic provides an opportunity. While the impact is devastating and lethal to some people, at the same time it is a tragic battleground to be examined by clinicians and scientists.  Although in the coronavirus family, this new mutation is a novel and fresh organism, which has some very different pathophysiology from ordinary and historical seasonal corona influenza.

The current protocols for prevention, diagnosis, containment, and beyond are based upon standard CDC guidelines, which have been used previously for  SARS, MERS, EBOLA, and AIDS (HIV).  We are especially fortunate that one of the members of the task force is Deborah Birx, M.D. who has a life-long interest and experience with the aforementioned epidemics.

 Corona virus-19 Cheat Sheet

Evolution of CVID-19 Pandemic

For more specific details, I suggest these links regarding Covid-19

NEJM

JAMA

BMJ

UpToDate

Cochrane Database

Internet Book of Critical Care

https://register.gotowebinar.com/register/3740452101263557388

Tracking COVID-19 IMPORTANT UPDATE

BREAKING NEWS MAYOR WILLIAM DEBLASIO GAVE AN IMPASSIONED SPEECH TO NEW YORK CITY CITIZENS EXPRESSING HIS SEVERE DISAPPOINTMENT IN THE   FEDERAL GOVERNMENT.  HE REQUESTED ASSISTANCE FROM THE FEDERAL GOVERNMENT TO MEET THE NEEDS OF NEW YORK CITY BY APRIL 2020.  HE STATED THAT SUPPLIES WOULD BE EXHAUSTED AT THAT TIME. HE EXPRESSED HIS FRUSTRATION AT THE PRESIDENT'S DELAY IN USING HIS ALREADY ESTABLISHED POWERS TO ENGAGE THE MILITARY AND THE VETERANS ADMINISTRATION HEALTH CARE SYSTEM, AS WELL AS DOD TRANSPORTATION ASSETS TO DISTRIBUTE HEALTH-RELATED MATERIALS.  DEBLASIO ALSO SAID. THE PRESIDENT HAS THE POWER TO DIRECT MANUFACTURERS TO DO WHATEVER IS NECESSARY TO MEET THE NEEDS OF THE PEOPLE, INCLUDING DIVERTING MANUFACTURING FACE MASK, SURGICAL GOWNS, AND OTHER PROTECTIVE GEAR. Major hospital and medical groups called for Congress to provide $100 billion in direct assistance to front-line healthcare workers and hospitals so they can get ready for the influx of COVID-19 patients. The letter, sent Thursday by the American Hospital Association (AHA), the American Nurses Association and the American Medical Association, comes as some healthcare systems are beginning to be overwhelmed in hot spots of COVID-19 outbreaks. “Due to expenses to treat COVID-­19 patients, hospitals are currently losing up to $1 million per day,” the letter to congressional leaders said. “This loss may increase as the outbreak spreads.”  The letter calls for immediate funding in three areas. The first is a stabilization fund that will include covering losses due to the suspension of elective services, a key moneymaker for hospitals. The fund will also help cover training on telemedicine and telehealth as well as increased costs for more healthcare staff. Hospitals should also get money for construction and retrofitting facilities to create separate areas to screen for COVID-19. Another major priority is ensuring childcare for front-line healthcare professionals. This can be done by partnering with schools or daycare centers to provide funding for childcare. “Schools have closed in numerous states, leaving many front line health care personnel with an impossible choice—caring for their children or caring for their patients—a choice that can be alleviated if Congress takes swift and comprehensive action to assist with providing childcare during this unprecedented time,” the letter said. RELATED: Physician practices told to be extra cautious in purchasing supplies from 'grey market' Congress must also provide funding for the capacity to care for mild or moderately sick COVID-19 patients at alternative care sites. “This is a crucial step in ensuring we have as much inpatient capacity as possible to respond to the sickest COVID-­19 patients,” the letter said. “Funding also may involve creating temporary structures.” The request comes after the AHA sent a separate letter to Congress asking them to include direct assistance in a financial stimulus package the White House and Congress are hammering out. Lawmakers are debating a package of nearly $1 trillion that could include direct economic assistance to every American, payroll tax holidays and economic assistance to small businesses. Providers wanted to make sure lawmakers did not forget about them in the run-up to the stimulus but did not give a direct number until its latest letter on Thursday.The biggest worry for hospitals, healthcare workers: Protective equipment In order to bring you the most comprehensive and up-to-date information relating to the pandemic, we are publishing additional stories and all of the day’s coronavirus-related news in a PM edition. If you would prefer not to receive this newsletter, you may opt-out at any time by clicking here.

• Trump talks drug progress amid COVID-19 pandemic, but FDA chief Hahn urges caution
• The biggest worry for hospitals, healthcare workers: Protective equipment
• With new FDA approval, Abbott sets a goal of shipping 1 million coronavirus tests per week
• Eli Lilly opens labs, plans drive-thrus to help boost Indiana's COVID-19 testing capacity
• Home telehealth and testing companies pivot to mail-in coronavirus tests
• Biopharma roundup: Merck KGaA donates Rebif for study; Medtronic, GE Healthcare boost production of supplies
• Healthcare roundup: Insurer, provider and pharma groups send demands to White House
• Providers implore Congress to give $100B in assistance to handle COVID-19
• UPDATED: Bayer donates millions of tablets of chloroquine to help in COVID-19 fight
• AbbVie’s HIV drug Kaletra stumbles in COVID-19 trial, but one analyst begs to differ
• Physician practices told to be extra cautious in purchasing supplies from 'grey market'
• Pfizer's chief medical officer lays out COVID-19 facts in social media series
• Biogen's COVID-19 woes mount as virus forces Spinraza treatment delays
• Univercells' CDMO Exothera hopes to help scale COVID-19 vaccine manufacturing

Newsletter Tool - Questex

China Says This Drug Is “Clearly Effective” Against Coronavirus

 According to Japanese media, Chinese medical authorities have found that a drug called "favipiravir" has shown promise in treating COVID-19 patients.

ACCORDING TO A NEW STUDY, IT CAN TURN CORONAVIRUS TESTS NEGATIVE IN JUST FOUR DAYS.

 The Chinese government says it has officially decided to use the Japanese-developed anti-influenza drug Avigan in treating people infected with the new coronavirus.

Zhang Xinmin, director of the National Center for Biotechnology Development, said at a news conference in Beijing on Tuesday that the drug was found to be effective in clinical trials by two medical organizations in the country.

The director said the tests were conducted in the cities of Wuhan and Shenzhen and involved 240 patients and 80 patients respectively.

He said that the tests in Wuhan found that it took an average of 2.5 days for the temperature of those who were given Avigan to return to normal. It took 4.2 days for those who weren't given the drug.

He added that patients who were given the medicine were able to get rid of their cough in an average of 4.57 days, compared with 5.98 days for those who were not given it. He added that medicine had no obvious side effects.

In tests in Shenzhen, the director said those who were given the medicine after testing positive for the virus turned negative after a median of four days, while it took a median of 11 days for those without the drug.

The trial also found that X-ray photos confirmed improvements in lung conditions in about 91 percent of the patients who were given the medicine. The number stood at 62 percent for those who weren't given it.

According to Japanese media, Chinese medical authorities have found that an antiviral drug called “favipiravir” has shown promise in treating COVID-19 patients, The Guardian reports.

“It has a high degree of safety and is clearly effective in treatment,” Zhang Xinmin, an official at China’s science and technology ministry, told reporters on Tuesday.

The drug has been used in the past to fight an outbreak of the Ebola virus in Guinea. Its developer has yet to comment on the claims made by the Chinese authorities.

The drug, known also by its market name Avigan and developed by a Japanese Fujifilm subsidiary called Fujifilm Toyama Chemical, was reportedly able to turn COVID-19 tests negative for those who were infected after just four days as part of a trial involving 240 patients from Wuhan, China, and 80 patients in Shenzhen.

Without treatment, the median time was 11 days, according to The Guardian.

The drug also appeared to improve lung condition in 91 percent of patients, compared to just 62 percent whose lung conditions improved without the drug.

But it’s far from perfect at stopping the spread of the deadly virus.

“We’ve given Avigan to 70 to 80 people, but it doesn’t seem to work that well when the virus has already multiplied,” an unnamed Japanese health ministry source told the Japanese media, as quoted by The Guardian.

China Says This Drug Is “Clearly Effective” Against Coronavirus: