COVID-19 Communications

Dear Valued Customer,

On June 2, 2020, Roche Diagnostics received Emergency Use Authorization for the Elecsys^® IL-6 (Interleukin-6) immunoassay to further support the fight against COVID-19.

This in vitro assay uses serum and plasma to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Clinical laboratories can run the test on Roche’s cobas e 411, e 601, e 602, and e 801 analyzers. These fully-automated systems provide IL-6 test results in approximately 18 minutes. The Elecsys IL-6 is the first and only FDA reviewed IL-6 assay available in the market.

Elevated circulating concentrations of IL-6, a key mediator of inflammation, can serve as an early alarm signal of SARS-CoV-2 infection-triggered hyperinflammation, helping clinicians identify this hyperinflammatory process in severely ill COVID-19 patients. A subset of these severely ill COVID-19 patients may experience rapid deterioration and need for mechanical ventilation due to the development of Acute Respiratory Distress Syndrome (ARDS).^1,2,3,4

As COVID-19 cases resurge throughout the United States, ensuring the right patients receive the right treatment at the right time is as important as ever. The Elecsys IL-6 test enables clinicians to get timely results to help make an objective, rapid decision for ventilator resource allocation.⁵

To learn more about how IL-6, along with other biomarkers, can be used to assist in the management of critically ill COVID-19 patients and mechanical ventilation decision making, please attend one of the upcoming webinars hosted by Roche Medical and Scientific Affairs.

Sign up here

We appreciate your critical work to support the national healthcare response to COVID-19 and are honored to play a role in supporting you.

If you have any questions, please contact your Roche representative.

With gratitude and partnership,

Your Roche Diagnostics Team

<sup>- This test has not been FDA cleared or approved - This test has been authorized by FDA under an EUA for use by authorized laboratories - This test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID‑19 patients - This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb‑3(b)(1), unless the authorization is terminated or revoked sooner

References:
1. Jose RJ. (2020). Lancet Resp Med. doi: 10.1016/S2213-2600(20)30216-2
2. Mehta P, et al. Lancet. (2020). 395:1033-4
3. Herold T et al. J Allerg and Clin Immunol (2020), doi: https://doi.org/10.1016/j.jaci.2020.05.008
4. Ye Q et al J Infect (2020) doi:10.1016/j.jinf.2020.03.037
5. Elecsys IL-6 Package Insert 2020-06, V1.0; Material Numbers 05109442190 and 07027532190</sup>

Dear Valued Customer:

On May 2, 2020, Roche Diagnostics received Emergency Use Authorization for the Elecsys^® Anti-SARS-CoV-2 immunoassay.

This in vitro test uses human serum or plasma (Heparin or EDTA) and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Hospitals and reference laboratories can run the test on Roche’s cobas e 411, e 601, e 602, and e 801 analyzers. These fully-automated systems provide SARS-CoV-2 antibody test results in approximately 18 minutes.

Clinical data for this antibody test*:

• 99.81% Specificity achieved through the testing of 5272 samples:
• No cross reactivity found in 80 samples from individuals with past infection to common cold and other coronaviruses.
• 100% Sensitivity >14 days after PCR confirmation

During this global pandemic, demand for this vital serology test is certain to outpace supply. In alignment with the government, we’ll prioritize labs that can implement quickly and enable the broadest geographic reach. We’ll work to meet demand by scaling global production rapidly in an effort to expand broader access as quickly as possible.

Our teams are working around the clock to manufacture, ship and distribute the Elecsys^® Anti-SARS-CoV-2 immunoassay to customers around the globe. We appreciate your critical work to support the national healthcare response to COVID-19 and are honored to play a role in supporting you. 

If you have any questions, please contact your Roche representative.

With gratitude and partnership,

Your Roche Diagnostics Team

^{- This test has not been FDA cleared or approved;}

^{- Warning: Not for use for screening donated blood.}

^{- This test has been authorized by FDA under an EUA for use by authorized laboratories}

^{- This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.}

^{- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner}

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March 23 Business Continuity Update

As the world watches the magnitude of the COVID-19 pandemic unfold, we continue to actively manage our supply chain and are taking measures to maximize operations and employee safety.

We have activated our Business Continuity Management (BCM) plan, which includes a broad range of emergency measures that enable us to increase both our short-term and long-term capacity. Our task force meets daily.

Our manufacturing network has a global footprint with Roche plants located in China, Switzerland, Germany, South Africa and the United States. Our manufacturing site in China opened very recently and does not produce for the U.S. market, so its operations have no impact on supply in this country. Importantly, all of our manufacturing sites have detailed business continuity plans and we will execute those plans as needed in response to regional outbreaks. 

Roche business continuity plans address potential risks across multiple categories that include: 

• Essential staffing roles and levels 
• Supporting infrastructure systems and equipment 
  
• Raw material and service supplier monitoring 
• Finished goods inventory levels and distribution planning 
• Customer communication/ continuity for order management and service support 
• Production, service and supply alternatives including freight carriers, production capacity and distribution points 

U.S. Product Supply Updates

Increased demand for COVID-19 testing materials and the cobas Liat - as it relates to seasonal influenza testing - has been especially dramatic. Non-COVID-19 related product demand remains at standard levels, allowing us to better meet routine testing needs. We have increased stock levels in our broad portfolio (tissue, serum work area, point of care and molecular products) to support the continuity of supply should we face a disruption associated with the pandemic. 

U.S. Service and Support Update

Our focus remains to keep customers up and running. This guiding principle drives us to prioritize our emergency service repair work. It also informs installs and planned service activities. We deploy our support personnel based on these prioritization guidelines:

1. Support use of COVID-19-related assays and other patient-critical products
2. Service calls in response to “hard-down” systems
3. New-system installations approved for adding the COVID-19 assay capability
4. New installations generally
5. Regular sales and service activities

Our task force meets daily to ensure rapid response to emerging crisis topics that may impact support. Our current strategies are intended to keep our employees safe, optimize our service and keep our customers in operation include:

• Providing credentials and documentation to service personnel to ensure emergency travel capabilities to customer sites. 
• Remote, home-based set up for all personnel not required on customer sites, including the Customer Support Center. 
• Increased stock of spare parts located regionally, including supply at alternate warehouses, including those specific to the cobas 6800/ 8800 analyzers that run the SARS-CoV-2 test.
• Dedicated toll-free line for customers who are allocated SARS-CoV-2 testing for related parts ordering. This ensures a more streamlined experience for both customers running COVID-19 related testing and those who need support for routine testing.
• Protocol for prioritization in the call center for COVID-19 customers.
• Dedicated toll-free line for healthcare providers (866-987-6243) offering general information and updates regarding COVID-19.
• Taking proactive personnel measures to increase redundancy in both our short- and long-term capacity to support customers.

We will continue to provide any updates in real time. Throughout this public health crisis, one thing is clear – the role of the lab has never been more vital.

March 19, 2020

Since the worldwide recognition of the novel coronavirus pandemic risk in January, our singular focus has been - and continues to be - to support the global response to the outbreak of COVID-19. We are working to drive the broadest geographic reach and greatest patient impact.

We moved from the idea of an accurate high-throughput test for COVID-19 to an FDA Emergency Use Authorization on our cobas SARS-CoV-2 Test in just six weeks. Less than 24 hours after receiving authorization from FDA, we shipped the first testing kits out of Indianapolis to U.S. customers during the evening of Friday, March 13. 

We’ve been working around the clock with the government and our internal global network to drive two priorities in service of public health:

1. Deliver on our commitment to ship 400,000 tests to U.S. customers each week

2. Ensure sustainable supply of materials needed to support our committed volumes in the U.S.

    

Our Allocation Strategy

We are working to ensure the greatest access for patients in the U.S. – and the rest of the world - by bringing together the nation’s public-health interests with the development and testing capacities of the private sector. In close consultation with the government we are supporting the national public health strategy by prioritizing access to:

1. Large commercial laboratories—with the necessary instruments in place—that can quickly collect, process and move samples to maximize testing capabilities and provide the widest geographic coverage. 

2. Hospitals and laboratories in geographic regions that are currently experiencing large-scale community spread of infection. 

We recognize that addressing a pandemic of this magnitude requires the contributions of all members of the healthcare community. We are pleased that the FDA is granting Emergency Use Authorization to other companies’ novel coronavirus tests to increase testing capacity for our country’s healthcare system. 

Our Path Forward 

The situation is fluid and we are adapting our strategy in real time. We monitor daily customer inventory levels and test usage. This information helps us update our allocation planning as necessary to ensure that we provide testing supplies where and when they are needed most.

Dear Valued Customer,

As you know, on Wednesday, March 11, the World Health Organization declared the COVID-19 outbreak a pandemic. As the coronavirus spreads across the world at an alarming rate, our primary concern at Roche is to help control the outbreak by providing patients access to diagnostic testing.

Since early February, Roche has been working with the U.S. Food and Drug Administration to produce a coronavirus test under Emergency Use Authorization (EUA) guidance. On March 12, 2020, we received FDA Emergency Use Authorization for the cobas^® SARS-CoV-2 Test, an in vitro diagnostic test to detect the novel virus that causes COVID-19 disease.

The new cobas^® SARS-CoV-2 Test is a kit that labs can run on Roche’s fully automated cobas® 6800/8800 systems. The test analyzes nucleic acids from nasopharyngeal and oropharyngeal swab samples and compares them to genetic sequences found in coronavirus strains, including COVID-19.

In order to ensure patients have access to the test, we worked with the Centers for Disease Control and Prevention (CDC) to develop an allocation strategy that prioritizes labs with the broadest geographic reach and highest patient impact. Consequently, a limited number of customers with the greatest ability to implement this testing, such as the ability to go live quickly and to accept samples from other sites, will initially receive tests.

At the height of a global pandemic, demand for tests is certain to outstrip supply. We’ll strive to meet the need by continuing to manufacture as many tests as possible while working closely with the CDC and other government entities to determine shifts in our allocation strategy. In the meantime, we’re committed to keeping you informed of our next steps as the situation evolves.

We’re also closely monitoring how COVID-19 affects our overall product supply. Roche’s manufacturing network has a global footprint with plants located in China, Switzerland, Germany, South Africa and the United States. Our manufacturing site in China opened very recently and does not produce for the U.S. market, so its operations have no impact on supply in this country. Importantly, all of our manufacturing sites have a Business Continuity Plan, and we will execute those plans as needed in response to regional outbreaks.

We recognize the importance of timely product shipments to you in support of your patients, and we appreciate your understanding as we continue to assess and mitigate the impact of the outbreak on our supply chain. To date, we have not experienced any supply disruptions for raw materials and all customer-specific reserves are operating at planned levels.

We appreciate your support and our shared focus on patients. Please reach out to your Roche representative if you have any questions.

With gratitude for your partnership,
Your Roche Diagnostics Team