Tag Archives: ROCHE

For Patients Confirmed With COVID-19 – U.S. Food and Drug Administration (FDA) Has Issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 Test

Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorization to help in identifying patients at high risk of severe inflammatory response

  • FDA EUA1 now makes IL-6 testing accessible to patients in the United States to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark2
  • Interleukin 6 (IL-6) is an early indicator for acute inflammation to aid in the management of critically ill patients
  • This test is available on Roche’s cobas e analysers which are widely available around the world

 
Roche announced on June 4, 2020 that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.

The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation.“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”

“In the current pandemic, Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients,” said Tobias Herold, MD from the Emergency Department, University Hospital, LMU University Munich, Germany. “Elevated IL-6 values help us to identify patients with a high risk of upcoming respiratory failure.

Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas e® analysers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.

About Elecsys IL-6
The IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma. This assay is used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation. Under the Emergency Use Authorization in the US, this assay can be used 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. IL-6 is released by immune cells, once they are activated by virus, bacteria or other immune cells. IL-6 acts like a messenger to activate other immune cells to fight the infection. Because IL-6 is released so early during a severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible. 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 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.

About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorization for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorization and is available in markets accepting the CE mark. Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.

While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future. On 19 March, we announced the initiation of COVACTA – a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.

In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.

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] The Emergency Use Authorization (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
[2] 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.

Thanks and Appreciation To Our Guests For Joining Us On C. diff. Spores And More Season II

As Season II concludes, we wish to take this opportunity to sincerely thank each
and every guest for taking time out of their
busy schedule and joining us on Tuesday’s at
10:00a Pacific Time / 1:00p Eastern Time over the past seven months.

C. diff. Spores and More Global Broadcasting Network will be taking a break and will return to live broadcasting on  January 17th, 2017 with the Centers for Disease Control and Prevention (CDC) leading the way with our guest
Dr. Katherine Fleming-Dutra, Medical Officer, CDC’s Office of Antibiotic Stewardship.

A Prescription for Over-Prescribing: The Key to Fighting
Antibiotic Resistance

Dr. Fleming-Dutra is a medical epidemiologist with the Office of Antibiotic Stewardship in the Division of Healthcare Quality Promotion at the Centers Disease Control and Prevention (CDC).

Dr. Fleming-Dutra is a pediatrician and pediatric emergency medicine physician and has focused on infectious diseases epidemiology and antibiotic stewardship in the outpatient setting in her career at CDC.

Join Dr. Fleming-Dutra as she discusses a recent study published by the Journal of the American Medical Association, was released showing that at least 30 percent of all prescriptions written in doctors’ offices and emergency rooms are completely unnecessary. So how do we use these alarming results to transform the culture of over-prescribing Dr. Katherine Fleming-Dutra, M.D., will:

  • Give a detailed explanation of the study results, and provide an in-depth review of specific findings;
  • Highlight what CDC is doing to promote antibiotic stewardship across healthcare settings, and
  • Identify what clinicians, other health care professionals, and patients can do to improve antibiotic prescribing, therefore fighting antibiotic resistance.

 

C diff Radio Live Broadcast AND Podcasts

C. diff. Spores and More Global Broadcasting Network

  brought to you by VoiceAmerica and
sponsored by Clorox Healthcare

An educational program that is dedicated to  C. difficile Infections  and more–

 

Click On The LOGO  Above And Enjoy Listening To the Live Broadcasts In the C. diff. Spores and More Podcast Library.

 

Live Broadcast airs
on Tuesdays at:    10a PT,    11a MT,   12p CT,    1p ET

We are pleased to share  “C. diff. Spores and More ”  with you because, as advocates of  C. diff.,  we know the importance of this cutting-edge new weekly radio show  and what it means for our Foundation’s community worldwide.–

Hard Facts: Deaths and illnesses are much higher than reports have shown. Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released today, February 25, 2015, by the Centers for Disease Control and Prevention (CDC).

• More than 100,000 of these infections developed among residents of U.S. nursing homes.

Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection. Of these 29,000 – 15,000 deaths were estimated to be directly related to a
C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.


Previous studies indicate that C. diff. has become the most common microbial cause of Healthcare-Associated Infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone. Approximately
two-thirds of C. diff. infections were found to be associated with an inpatient stay in a health care facility, only 24% of the total cases occurred in patients while they were hospitalized. The study also revealed that almost as many cases occurred in nursing homes as in hospitals and the remainder of individuals acquired the
Healthcare-Associated infection, C. diff., recently discharged from a health care facility.

This new study finds that 1 out of every 5 patients with the Healthcare-Associated Infection (HAI), C. diff., experience a recurrence of the infection and 1 out of every 9 patients over the age of 65 diagnosed with a HAI – C. diff. infection died within 30 days of being diagnosed. Older Americans are quite vulnerable to this life-threatening diarrhea infection. The CDC study also found that women and Caucasian individuals are at an increased risk of acquiring a C. diff. infection. The CDC Director, Dr. Tom Frieden, MD, MPH said, “C. difficile infections cause immense suffering and death for thousands of Americans each year.” “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

“This does not include the number of C. diff. infections taking place and being treated in other countries.”  “The  C Diff Foundation supports hundreds of communities by sharing the Foundation’s mission and  raising C. diff. awareness to healthcare professionals, individuals, patients, families,  and communities working towards a shared goal ~  witnessing a reduction of newly diagnosed C. diff. cases by 2020 .”   ” The C Diff Foundation volunteer Advocates are greatly appreciated and continue to create positive changes by sharing their time  aiding in the success of our mission “Raising C. diff. awareness ”  worldwide.

C. diff. Spores and More “ spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the
C. diff.
community and more.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower listeners worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice Head for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.

 

Take our show on the go…………..download a mobile app today

www.voiceamerica.com/company/mobileapps

 

Programming for C. diff. Spores and More  is made possible through our official Corporate Sponsor;  Clorox Healthcare

We look forward to sharing time with our worldwide listeners when we return in January, Season III. 

Until then………………

We send out get-well wishes to everyone being treated for and recovering from a C. difficile infection and all wellness draining illnesses worldwide.

“None of us can do this alone – All of us can do this together!”

June 21st Join C. diff. Spores and More #CdiffRadio Discuss the Partnership Between Laboratories and Clinical Staff For Accurate C. diff. Infection Diagnosis

 

Listen to the live broadcast from  June 21st,  2016


To access the live broadcast and Podcast Library
C. diff. Spores and More  Global Broadcasting Network
please click on the logo above *

C. diff. Spores and More,” Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:   The Partnership Between Laboratories and Clinical Staff For the Accurate Diagnosis of a C. difficile Infection.

With Our Guests:  Dr. Steven Cagas, Ph.D.,  Dr. Nathan A. Ledeboer, Ph.D, D(ABMM),
Dr. Whitney R. Buckel, PharmD, BCPS, And  Jeanine Thomas

 

Learn about the importance of laboratory testing in the identification of C. difficile Infections (CDI). We will open with an interview with Jeanine Thomas, President and Founder of the MRSA Survivors Network who is a survivor of both MRSA and C. diff. infections. She will share her healthcare journey including the role that diagnostics played. Our second guest will be Nathan A. Ledeboer, PhD, D(ABMM), Medical Director of Microbiology and Molecular Diagnostics for Wisconsin Diagnostic Laboratories and Froedtert Health. He will give an overview and comparisons between various testing technologies available to clinical laboratories today. Our third guest will be Whitney R. Buckel, PharmD, BCPS who is the Infectious Diseases and Antimicrobial Stewardship Clinical Pharmacist at Intermountain Medical Center. Whitney will share with us some important details of how nurses and doctors can support the lab by taking into account the full clinical picture before sending specimens to the lab. Our last guest, Dr. Steven Cagas, will give us a brief overview of Roche Diagnostics as well as their new cobas® Cdiff Test.

 

MORE ABOUT OUR GUESTS:

Jeanine Thomas – President/ Founder of MRSA Survivors Network, National Spokesperson for MRSA, MRSA Expert and Consultant     Ms. Thomas founded MRSA Survivors Network in early 2003 due to having been critically ill with a MRSA infection, sepsis and C. difficile. Her organization was the first in the U.S. to raise the alarm about the MRSA epidemic, healthcare-acquired infections (HAI’s) and antibiotic resistance (AMR) to state and federal health officials in the U.S.   Ms. Thomas has been designated a “Patient Safety Champion” with the World Health Organizations’ World Alliance for Patient Safety (2008 – present), past member of the Joint Commission’s Patient and Family Advisory Council (2008-2010), FDA- appointed consultant on the FDA Anti-Infective Drug Advisory Committee (2008 –present) and a member of Brookings Institution’s Antibiotic Drug Development and Antimicrobial Stewardship Council (2012 –present). WHO- appointed patient representative on developing their Hand Hygiene and Antimicrobial-resistance programs for patients (2009-2012). She is a member of the Patient, Consumer and Public Health Coalition, Washington, D.C.
Dr. Nathan A. Ledeboer, PhD, D(ABMM) 

Nathan A Ledeboer is an Associate Professor of Pathology at the Medical College of Wisconsin and the Medical Director of Microbiology and Molecular Diagnostics for Wisconsin Diagnostic Laboratories and Froedtert Health.  His research endeavors, particularly in the area developing diagnostic tools for infectious diseases, have led to more than 70 publications in peer-reviewed journals and more than 100 funded research projects.
Dr. Ledeboer is also a senior editor for the Journal of Clinical Microbiology.

 

Dr. Whitney R. Buckel, PharmD, BCPS
Infectious Diseases/Antimicrobial Stewardship Clinical Pharmacist Intermountain Medical Center    Dr. Whitney Buckel is the Infectious Diseases/Antimicrobial Stewardship Clinical Pharmacist for Intermountain Medical Center, in Murray, Utah. She also serves as the co-chair of the Intermountain System-wide Antimicrobial Stewardship Committee, overseeing stewardship efforts across 22 hospitals. Whitney graduated from Purdue University College of Pharmacy in 2010, and completed a PGY-1 Pharmacy Practice and PGY-2 Infectious Diseases residency at The Johns Hopkins Hospital. Her research interest is in the design, implementation and outcomes of antimicrobial stewardship initiatives.

 

Dr. Steven Cagas, Ph.D.

Dr. Steven Cagas is a Scientific Affairs Manager within Medical and Scientific Affairs within the Molecular Diagnostics Division of Roche Diagnostics Corporation.  He has 5 years of industry experience at Roche.  He directly interfaces with clinicians and key opinion leaders to assist in the commercialization of products within the Roche Molecular Diagnostics portfolio.  He has spoken at several internal and external conferences as an invited speaker on various topics related to his areas of expertise.  Dr. Cagas received his Ph.D. in Microbiology and Molecular Genetics from the University of Medicine and Dentistry of New Jersey (currently Rutgers University).  His Ph.D. work focused on the study of the proteins expressed in the pathogenic fungus Aspergillus fumigatus.  He used a novel approach to identify the proteins expressed at various stages of development as well as in response to an antifungal agent with both studies leading to high impact publications.

 

C. diff. Spores and More “ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice Head for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

Programming for C. diff. Spores and More   is made possible through our official  Sponsor;  Clorox Healthcare

ROCHE cobas® C. diff. Test approved by US Food and Drug Administration (FDA)

US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas® Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens.

The cobas® Cdiff Test targets the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients. The test provides accurate information which assists clinicians in making timely treatment decisions and aids in the prevention of further infection in healthcare settings.

“Having the ability to provide a result quickly is important when supporting infection control for Clostridium difficile,” said Dr. Steve Young, Professor of Pathology, Department of Pathology UNMHSC and Tricore Reference Lab. “The cobas® 4800 System has the capability to allow for mixed batch testing of the cobas® Cdiff Test alongside testing for Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and herpes simplex virus 1 and 2*, all on one platform. We can run these assays together at least once in each shift rather than once a day, which can greatly improve laboratory efficiency, ultimately leading to better infection control and patient care.”

In a clinical trial program conducted at sites throughout the United States, the cobas® Cdiff Test demonstrated excellent performance compared to direct and enrichment toxigenic culture. The test combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps, to facilitate earlier intervention of patients suffering from

C. difficile-associated disease. Earlier intervention can also lead to more effective implementation of infection control measures, which can prevent further transmission to additional patients.

About the cobas® 4800 System
The cobas® 4800 System offers true walk-away automation of nucleic acid purification, PCR set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The expanding system menu in the U.S. currently includes the cobas® MRSA/SA Test, cobas® CT/NG Test (Chlamydia trachomatis/Neisseria gonorrhoeae), cobas® HPV Test, cobas® BRAF V600 Mutation Test, cobas® EGFR Mutation Test and cobas® KRAS Mutation Test.

“With the addition of the cobas® Cdiff Test to the cobas® 4800 System menu, Roche is able to expand the tools available to assist clinicians in the management of healthcare associated infections,” said Paul Brown, head of Roche Molecular Diagnostics. “The cobas® Cdiff Test requires less sample handling and provides laboratories with a simplified workflow, when compared to other molecular methods. It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care.”

 

To access the news article:

http://finance.yahoo.com/news/roche-receives-fda-clearance-cobas-050000123.html