Abbott Labs Has Shipped One Million Rapid Coronavirus Tests To All 50 U.S. States

Forbes

In less than a month, Abbott Laboratories has shipped more than one million of its highly touted “rapid” molecular tests for the Coronavirus strain COVID-19 to all 50 U.S. states.

The milestone is significant because it has been hailed in the ability of states across the U.S. to ramp up testing and surpass daily goals to re-opening their economies. In Illinois, for example, Gov. J.B. Pritzker Friday reported the state’s biggest volume of COVID-19 test results thus far, calling it a “very important milestone” in the battle against the virus.

The effort to get the ID NOW COVID-19 test to doctor’s offices, urgent care centers and temporary testing sites like drive-thru parking lot locations is a snapshot into the massive diagnostic effort under way in the U.S. Abbott’s ID NOW COVID-19 test can deliver “positive results in as little as five minutes and negative results in 13 minutes.”

“We have shipped more than 1 million of our rapid ID NOW tests to all 50 states, Washington DC, Puerto Rico and the Pacific Islands,” Abbott said in an update posted Friday on the company’s website. “The majority of these tests have been sent to outbreak hotspots and we’ve asked that customers prioritize frontline health care workers and first responders.”

The test, hailed by the White House and praised by commercial companies like drugstore chains CVS Health and Walgreens Boots Alliance, was granted the U.S Food and Drug Administration’s “emergency use authorization” less than a month ago amid a growing number of agency approvals for more rapid molecular “point-of-care” diagnostic tests that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour.

The FDA has escalated approvals of rapid “point-of-care” diagnostics made by other companies including Mesa Biotech and Cepheid which are also ramping up production to meet unprecedented demand.

Earlier this week, The Advanced Medical Technology Association (AdvaMed)  projected that the medtech industry will have produced more than 25 million tests by the end of April that are largely molecular testing for the live virus. AdvaMed didn’t disclose specific company names or tallies produced by certain makers.

That kind of production will be welcome to U.S. healthcare providers on the frontlines as well as a Trump White House and federal health agencies dogged by criticism for the lack of testing for Coronavirus. 

The U.S. is considered well behind other countries when it comes to the availability of testing. As of Saturday morning, the number of U.S. Coronavirus cases was set to eclipse 930,000 as the number of deaths hurtled past 50,000.

“We’re currently manufacturing 50,000 tests per day, plan to increase ID NOW manufacturing capacity to 2 million tests a month by June and are working to expand beyond that,” Abbott disclosed.

Read Forbes’ story here:
https://www.forbes.com/sites/brucejapsen/2020/04/25/abbott-labs-has-shipped-one-million-rapid-coronavirus-tests-to-all-50-us-states/?utm_campaign=forbes&utm_source=twitter&utm_medium=social&utm_term=Carrie/#598bb6127e2c

Logansport Manufacturer Gets Early Jump on Producing PPE

Kokomo Tribune

LOGANSPORT — A local manufacturer was ahead of the game when he conceived the idea of producing protective masks and face shields for those who need them during the coronavirus pandemic.

John Hopper is the owner of Hopper Development Incorporated (HDI), which was founded by Hopper’s father Robert in 1970. HDI makes products using precision plastic injection molding and offers mold building and tooling services. Hopper said over the years the company has produced many molds and tooling for different types of plastic components, though never before for any medical device.

According to Hopper, he had an eye on the COVID-19 outbreak a few months ago when the virus was really beginning to escalate in China.

“I guess I watch a lot of news,” Hopper said. “We’re paying attention to what’s going on in the world.”

Hopper recalled that in January people around the world were getting pretty concerned about the virus. He then noticed manufacturers in other parts of the world coming out with designs for various protective gear or PPE.

“There were designs for the face shields and even the respirator masks,” he said. “It was because there was a shortage and people were getting very, very nervous. And I thought well, there’s nothing stopping that virus from hitting the United States. It just made sense.”

Hopper said he examined some of the designs for the face shields and got his team at HDI together in late February to begin the process of creating a mask using their 3D printers. It was an endeavor that took several phases.

“We have four 3D printers,” he said. “We went through about a hard week of development on these face shields. We didn’t like any of the designs that were coming out of different sources.”

According to Hopper, many of the existing designs he and his team looked at used elastic, and they had heard from healthcare workers that the elastic was uncomfortable. They also noticed elastic was almost completely unavailable to order.

“We started to experiment with a design that is kind of like a heavy duty pair of sunglasses,” Hopper said. It was a tough week of design and print. We had all of our printers running constantly, making these things.”

Hopper said a 3D printer is not a fast machine and it took about three hours to make one frame, even though there were four machines running. Hopper then made a decision. He asked the design and tooling department to make a plastic injection mold.

“They were excited about it,” he said. “They jumped on it and built a mold in a week for these that would normally take six to eight weeks to build.”

Hopper noted that throughout the design and production process, he had some valuable feedback from a friend.

“There’s a friend of mine that’s a doctor at Logansport Memorial Hospital and he offered a couple suggestions and we made those changes immediately,” Hopper said.

When the details of the design and the production process were fleshed out, the team at HDI began producing the PPE in earnest. Hopper said he brought a laser cutting machine home to his personal workshop so he could work on cutting the clear face shield itself. He has been working every day and said his family has been helping.

“My wife gave me our dining room table so I’ve got that to use as a work space as well. So it’s worked out wonderfully you know. It’s kept us busy here at home,” Hopper said.

It seems like busy is somewhat of an understatement. Hopper noted that they have been continuously sending out shipments for weeks now.

“We’ve been making daily shipments to many medical providers,” he said. “Lately the majority have been going to Logansport Memorial Hospital and our health department. We’ve sent them to Fort Wayne. We have a constant stream going to north Indianapolis.”

Hopper also said they have been sending shields to dentists, nursing homes, and eye doctors.

Incredibly, Hopper is giving the PPE away free of charge.

“We’re not selling these,” he said. “We’re donating these to any medical provider out there who wants to feel a little safer.”

He said they are getting good feedback at HDI from providers who have been using the masks. One prominent doctor at the hospital told Hopper the mask fits better than anything else he has tried, Hopper said.

While the enthusiastic response has kept Hopper quite busy at home, he is happy to do it.

“It’s a joy knowing that our healthcare providers feel protected,” Hopper said. “It’s a tiny little thing. They have so much workload, and if it makes them feel a little bit more comfortable it is so worth it. Whatever little we can do. We have the capability to make these things, so we’re doing it.”

For information on ordering protective masks from HDI, can call their office at 574-753-6621.

Read the original story here:
https://www.kokomotribune.com/indiana/news/logansport-manufacturer-gets-early-jump-on-producing-ppe/article_34871334-c37d-57c9-afce-e1e71ee7a829.html .

Gov. Holcomb Signs Executive Order Permitting Elective Medical Procedures

INDIANAPOLIS — Governor Eric J. Holcomb today signed Executive Order 20-23 to allow health care providers and facilities to resume elective medical procedures provided they have sufficient quantities of Personal Protective Equipment (PPE) and consult the best practices and recommendations developed by their medical associations or industries.

Providers include hospital, veterinarians, dentists and others listed in Executive Order 20-22.

Click here to see the executive order: https://www.in.gov/gov/2384.htm

Click here to download public service announcements (PSAs) recorded by the state for your use: https://www.dropbox.com/sh/egf210ognxxyx4h/AADYd7E-tBn7P6gtiLSZUiVBa?dl=0

More information may be found at the ISDH website at coronavirus.in.gov and the CDC website at https://www.cdc.gov/coronavirus/2019-ncov/index.html.

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Indy Medical Mask Producer Responds to Pandemic

Inside Indiana Business

INDIANAPOLIS – A company on the west side of Indianapolis has ramped up production exponentially, serving customers around the world, in the battle against COVID-19. Pulmodyne Inc., which manufactures airway and respiratory medical devices such as masks used in conjunction with ventilators, says it is expanding into an adjacent 7,000-square-foot building, where pre-assembly work will take place.

The company also recently hired 25 temporary workers, bringing its staff to 120 people, and plans to add 50 more production employees to keep up with demand.

“Our devices are designed to avoid intubation,” says Andy Shurig, executive director of Pulmodyne.

The company ships products around the globe and saw the rapid spread of the coronavirus even before it hit the U.S. and Indiana.

“The last week of February, we saw a big spike coming from Europe, especially Italy,” says Shurig.

Once the disease hit the U.S., demand for its medical masks exploded. “We’ve seen a massive spike in sales,” says Shurig. “Our business is up 600%.”

The flu season is typically the company’s busiest time of the year. The pandemic has pushed demand for the products dramatically higher.

“In a month, we’ve doubled our output. And I’m trying to do that again in the space of another month,” says Fred Boyer, production manager for Pulmodyne.

Boyer says the company is familiar with market fluxes, but this level is unprecedented as Pulmodyne is shipping 100,000 products a month.

“We’re continuing to get very large orders today,” says Boyer. “Everyone needs it right now. The desperation is out there.”

A big factor for Pulmodyne is the supply chain. It depends on 50-70 vendors for a variety of parts to produce its masks.

“We got some great vendors and God bless them,” preached Boyer. “When this started to unfold, we didn’t know what would be considered essential.”

Pulmodyne questioned whether its suppliers from other states would be classified that way.

“We didn’t know if a company that sold “O-rings” rings would be essential. They’re essential to us,” says Boyer. “Polybags and boxes, they matter just as much as every piece of the part we’re building.”

Shurig says he’s heard from companies that Pulmodyne had previously never done business.

“Even though our volumes are out of control, sales are out of control, but we probably turned down $10 million worth of business,” says Shurig. “As much as Fred is doing a herculean effort, doubling and doubling again, we’re nowhere close to keeping up with demand.”

Boyer says the company is operating 24 hours a day. He said initially it was doing voluntary overtime. But now it’s necessary.

The veteran production manager says workers who are assembling the units are under pressure to fill orders, but they seem to understand the mission.

“Everybody what needs to be done, our role in this, how important we are. It gives us a great sense of purpose,” says Boyer. “I’ve been doing this a long, long time. And I don’t know that I if ever been more stressed, and yet more purposeful than I do right now.”

Boyer says even when the pandemic begins to wane, he expects demand will continue as governments stockpile their products for future outbreaks. For workers, that means jobs, once considered temporary, may turn into full-time positions.  

“We have orders in house to last until the end of the year,” says Boyer. “That’s been our crisis; trying to get it out quick enough.”

Read the Inside Indiana Business story here:
https://www.insideindianabusiness.com/story/42031876/indy-medical-mask-producer-responds-to-pandemic .

Roche Develops New Serology Test to Detect COVID-19 Antibodies

Roche Diagnostics
  • The new Elecsys Anti-SARS-CoV-2 serology test can support the detection of antibodies against SARS-CoV-2 in patients who have been exposed to the virus which causes COVID-19
  • The detection of these antibodies could help indicate if a person has gained immunity against the virus and inform treatment decisions
  • Roche aims to have this test available by early May, in countries accepting the CE mark1 and is actively working with the US Food and Drug Administration for an Emergency Use Authorisation2

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the development and upcoming launch of its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease.

Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms.³ Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already have developed a certain level of immunity and can continue serving and/or return to work. Once we understand more about the immunity of COVID-19, it could also help society return faster to normality.

Severin Schwan, CEO Roche Group: “Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”

The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available in laboratories around the world.

Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorisation. Roche is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.

About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.

To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs and avoiding close contact with anyone showing symptoms of respiratory illness.

About Elecsys Anti-SARS-CoV-2 serology test
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in vitro detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.⁴

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] CE-IVD marking is granted  through completion of a comprehensive technical validation and self declaration under the European Directive for In Vitro Diagnostic Medical Devices.
[2] The Emergency Use Authorisation (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies https://www.fda.gov/home
[3] Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of Covid-19 at presentation – https://www.nejm.org/doi/full/10.1056/NEJMc2009316
[4] Full specifications of the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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How to Help: COVID-19 Resources

As you can imagine, the Trump Administration has received a deluge of offers from the private and non-profit sectors to provide or produce PPE, ventilators, and other critical supplies in response to COVID-19. As a result, HHS has established a centralized platform for receiving and vetting these requests. If you or your office are interested in helping the effort to combat the spread of COVID-19, FEMA has established a website (www.fema.gov/coronavirus/how-tohelp) providing more information. Examples for the private sector include:

  • To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011)
    • This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov. Registration must be “ACTIVE” at the time of award.
  • If you have medical supplies or equipment to donate, please provide us details on what you are offering.
  • If you are a private company that wants to produce a product related to the COVID response – email nbeoc@max.gov.
  • If you are a hospital or healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health and/or emergency management agency.
  • To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011)
    • This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov. Registration must be “ACTIVE” at the time of award.
  • If you have medical supplies or equipment to donate, please provide us details on what you are offering.
  • If you are a private company that wants to produce a product related to the COVID response – email nbeoc@max.gov.
  • If you are a hospital or healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health and/or emergency management agency.
  • If you are interested in doing business with FEMA and supporting the response to COVID- 19 with your company’s non-medical goods and/or services, please submit your inquiry to the Department of Homeland Security (DHS) Procurement Action Innovative Response Team (PAIR) team at DHSIndustryLiaison@hq.dhs.gov.

For additional information please visit FEMA’s website: https://www.fema.gov/coronavirus/.  

CALL OUT FOR PERSONAL PROTECTIVE EQUIPMENT AND VENTILATORS

Dear Members of Indiana’s Medical Device Industry:
Our front line health care providers are running dangerously low on equipment they desperately need in their battle with the COVID 19 virus.
Much of the immediate need centers around:

  • isolation gowns
  • face masks and shields
  • gloves
  • specimen collection devices (swabs)
  • specimen transport packages
  • hand sanitizer
  • surface disinfectant
  • ventilators

If you have access to any of these supplies, have the capacity in your companies to produce them or know somebody that does, please let us know ASAP and we will connect you to folks who can get these supplies to our health care providers that are most in need immediately.  
Thank you for your help during these unprecedented times.

Sincerely,
IMDMC

IMDMC welcomes representatives from Sichuan

This morning, representatives from IMDMC, Cook Regentec and the Indiana Economic Development Corporation, among others, welcomed members of the China Council for the Promotion of International Trade – Sichuan Council during their inaugural visit to Indiana.   

The discussion centered around Indiana’s position as a global leader in medical device manufacturing – citing robust manufacturing capabilities, university and workforce excellence, world-class global transportation access and a dynamic entrepreneurial ecosystem as leading factors in the industry’s success in our state.

We look forward to the future opportunities and discussions this meeting will provide.

IMDMC commends Indiana delegation, congressional leaders for vote suspending the medical device tax

INDIANAPOLIS – The Indiana Medical Device Manufacturers Council (IMDMC) commends lawmakers on suspending the job-killing medical device excise tax for two years. This action by Congress was part of the continuing resolution to end the government shutdown.

“The IMDMC applauds the Indiana delegation and congressional leadership for their hard work to suspend the medical device tax for two more years. The action made by lawmakers to suspend this tax allows the medical device industry to continue to invest in innovative medical technology and job growth,” said Anne Hathaway, IMDMC Executive Director. “This job-saving, tax suspension especially benefits Hoosiers because Indiana is a leader in the medical device industry as well as being home to the medical device capital of the world in Warsaw, Ind.

“This suspension is a step in the right direction and we look forward to working with policymakers over the next two years to get the tax fully repealed. A full repeal of the tax is crucial for the continuation of research and development of new products that can save and improve the lives of Hoosiers, Americans and people worldwide.”

Indiana is a leader in the medical device industry and employs more than 20,000 Hoosiers. Jobs within the medical device industry pay 41.7 percent more than the average wage in Indiana.
IMDMC is an association of medical device manufacturers and other associated companies, formed in 1991, to promote the medical device industry. By uniting Indiana medical device manufacturers, large and small, IMDMC serves to amplify the voices and convey the interests of these innovative companies before state and federal legislatures and regulatory agencies. IMDMC also offers education and training opportunities to its members as a way to network and continue to evolve with the ever-changing industry.

Change in leadership at IMDMC

INDIANAPOLIS (Nov. 1, 2017) – The Indiana Medical Device Manufacturers Council announced today that Anne Hathaway of Hathaway Strategies, will become the new executive director for IMDMC.

Kathy Heuer, former IMDMC Executive Director, announced to the board of directors in May that she would be retiring this year, and the search for new leadership then ensued. Hathaway was introduced today to IMDMC members at their annual conference.

“Anne will be a tremendous addition to our association. I am pleased to see someone who is so devoted to Indiana and our industry lead IMDMC through the next phase of our growth,” Heuer said. “IMDMC completed our new Strategic Plan a year ago, and under Anne’s leadership I believe we will be well-situated to see continued growth for both our membership and our activities.”

Tom Barnett, National Director of State Government Affairs at Roche Diagnostic, and current President of the Board of Directors for IMDMC, added “I want to thank Kathy for her leadership and dedication to IMDMC for the past three years. In the midst of this transition, I know the board is looking forward to working with Anne, as she brings fresh ideas to the table. Our members are our number one priority and with her help, we will continue to strive to provide the best in cutting-edge education within the medical device industry, along with ensuring that our members voices are heard at the local, state and national levels.”

Hathaway, a native of Illinois, has a vast background in political campaigns, association management, consulting and fundraising. She has been recognized for her innovative leadership skills while serving as the chief of staff for the Republican National Committee. Hathaway started her Indianapolis-based business, Hathaway Strategies, in 2009 and currently sits on multiple boards, including the Indiana Chamber of Commerce, the Indianapolis Chamber of Commerce and is the chair of The Julian Center Board.

“I’m honored to have the opportunity to be a part of the Indiana Medical Device Manufacturers Council,” Hathaway said. “I look forward to implementing the newly completed Strategic Plan, and promoting an industry that has a major impact on our state.”