Medical Device

Abbott (NYSE: ABT) announced today it received CE Mark for its new quantitative SARS-CoV-2 IgG (Immunoglobulin G) lab-based serology test. IgG antibody testing that gives a quantitative result (measuring the amount of antibodies) provides important insights to people as they recover from COVID-19 and helps evaluate a person's immune response to a vaccine.

Countries around the world are preparing for the authorization and the distribution of COVID-19 vaccines. As these vaccines become available, healthcare professionals and researchers will need to assess how individuals and communities are responding.

"Testing will continue to help both identify those who are infected as well as determine whether people have had a natural or vaccine-induced immune response," said John Hackett , Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "Quantitative antibody testing can help provide greater understanding of a person's immune response."

The evolution of serology testing during COVID-19

During the early months of the pandemic, Abbott launched its first COVID-19 IgG antibody blood test, which detects the nucleocapsid protein of the virus. The qualitative test continues to provide a better understanding of people's immune response to the virus, including potential duration of the recovery process. The new quantitative antibody test expands on this knowledge by determining both the presence and level (or titer) of antibodies present in the blood.

Abbott's scientists designed its quantitative assay to detect the spike protein of the virus, which plays an important part in how the virus enters the cells. As the body develops an immune response, antibodies develop and bind to the spike portion of the virus in order to block the protein and ultimately prevent infection.

Several vaccines are designed with the spike protein to trigger that same immune response. Research has also shown a correlation between rising IgG levels that target the spike protein, such as those in Abbott's quantitative test, and rising levels of neutralizing antibodies, or the specific antibodies that block infections. 1-2 Studies are underway to understand the relationship between the levels of antibodies a person has and potential immunity from the virus.

As we continue to learn more about the virus, antibody tests may help:

  • Determine and monitor a person's immune response to vaccines, including research to determine how long a response may last
  • Assess whether a person's antibody levels are a result of the body's natural response to fighting the virus, versus a vaccine-induced response
  • Evaluate an individual's level of antibodies to help determine eligibility and potency for convalescent plasma donations 3

The quantitative IgG antibody test is the latest in Abbott's broad portfolio of tests to support the global healthcare community in the fight against COVID-19. Abbott's COVID-19 test portfolio includes molecular, antigen and serology tests. These tests can help healthcare professionals detect the virus at all stages of its life cycle, including tests that are done in the lab as well as rapid tests done at the point of care.

About the SARS-CoV-2 IgG II Quant antibody test
Abbott's quantitative IgG antibody test is designed to detect levels of IgG antibodies that attach to the virus' spike protein on the virus surface in serum and plasma from individuals who are suspected to have had COVID-19, or in serum and plasma of subjects that may have been infected by SARS-CoV-2.

A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG II Quant test on its Alinity i instrument found it had 99.60% specificity (ability to exclude false positives) and 99.35% sensitivity (ability to exclude false negatives) in patients tested 15 days or more after symptoms began.

The quantitative IgG test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott is also developing a test and plans to submit for U.S. Food and Drug Administration (FDA) emergency use authorization soon.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

References:

  1. Poh CM et al. Two linear epitopes on the SARS-CoV-2 spike protein that elicit neutralizing antibodies in COVID-19 patients. Nat Commun 2020;11(1):2806. doi:10.1038/s41467-020-16638-2
  2. Keech C, et al. Phase 1–2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N Engl J Med Accepted manuscript. Published online September 2, 2020 . doi:10.1056/NEJMoa2026920
  3. Shen C, et al. Treatment of 5 critically ill patients with COVID-19 with convalescent plasma. JAMA 2020;323(16):1582-1589. doi:10.1001/jama.2020.4783

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SOURCE Abbott

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Bausch Health Provides Update Following Oral Order in XIFAXAN® Patent Litigation

-- Company to Appeal Expected Court Decision on Certain XIFAXAN® Patents –

Bausch Health Companies Inc. (NYSETSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced the U.S. District Court of Delaware issued an Oral Order in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. regarding the infringement and validity of certain U.S. Patents protecting the composition and use of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea (IBS-D) and reduction in risk of overt hepatic encephalopathy (HE) recurrence.

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IIROC Trade Resumption - BHC

Trading resumes in:

Company: Bausch Health Companies Inc.

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Thermo Fisher Scientific Reports Second Quarter 2022 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the second quarter ended July 2, 2022.

Second Quarter 2022 Highlights

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Bausch Health Companies Inc. Will Release Second-Quarter 2022 Financial Results on Aug. 9

Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") will release its second-quarter financial results on Tuesday, Aug. 9, 2022 . Bausch Health will host a conference call and live web cast at 8:00 a.m. ET to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

Conference Call Details

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Abbott Introduces Canada's First Remote Neuromodulation Patient-Care Technology, NeuroSphere Virtual Clinic, to Treat People with Chronic Pain and Movement Disorders*

  • The new system allows patients implanted with an Abbott neuromodulation device to communicate with their physician and remotely receive treatment in real time, regardless of location §

Abbott (NYSE: ABT) announces the Health Canada licencing† of NeuroSphere™ Virtual Clinic, a remote programming technology that is the first of its kind in Canada and is compatible with Abbott's suite of neuromodulation technologies. NeuroSphere Virtual Clinic has the potential to increase access to optimal treatment for patients living with chronic pain, Parkinson's disease, or essential tremors who might otherwise have difficulty receiving care from their healthcare provider due to location or being unable to travel to seek care.

Sample screen view of a patient-physician interaction on Abbott's NeuroSphere Virtual Clinic

Abbott's NeuroSphere Virtual Clinic gives patients the flexibility and comfort of receiving care anywhere § by connecting with their doctor via secure in-app video chat and an integrated remote programming feature. This feature enables clinicians to prescribe new treatment settings remotely to the patient's neurostimulation device using the clinician programmer app and a new, simple, and secure remote care connection.

In Canada , it is estimated that more than 6 million people live with chronic pain, 1 almost 100,000 people live with Parkinson's disease, 2 and almost 2 million people live with an essential tremor. 3 , 4 Many of these people who don't live close to a healthcare centre have difficulty accessing care due to the inability to see their doctor in-person. They are often challenged by the time associated with the trip, and/or the availability of a caregiver to help with their travel. In addition to the time implications, patients and caregivers may experience considerable travel-related costs and reduced employment wages. This is particularly true for those living in rural, northern, and remote parts of the country. 5

"Without alternatives to in-person programming, many of these patients may delay or forego care, particularly those who face a travel burden," said Alfonso Fasano , M.D., Ph.D., with Krembil Brain Institute at Toronto Western Hospital, part of the University Health Network. "Fortunately, innovative virtual healthcare options are changing the treatment landscape, ultimately extending care beyond clinic walls. Remote programming is an important new option that allows patients to communicate with their physicians virtually to ensure proper device settings and functionality. This brings the convenience of connected care to neurostimulation therapy, giving patients the ability to manage their therapy in a way that fits their personal needs."

NeuroSphere Virtual Clinic is compatible with the following Canadian-licensed Abbott neuromodulation devices: **

  • Proclaim™ spinal cord stimulation (SCS), for the management of chronic, intractable pain of the trunk and/or limbs
  • Proclaim dorsal root ganglion (DRG) therapy, for the management of moderate to severe chronic intractable pain of the lower limbs
  • Infinity™ deep brain stimulation (DBS) therapy, for the management of Parkinson's disease and tremor

"For more than a decade, Abbott has been evaluating the treatment hurdles neuromodulation patients faced," said Pedro Malha, vice president, neuromodulation, Abbott. "During this time, we have diligently worked to find better ways of connecting patients to their doctors. The launch of NeuroSphere Virtual Clinic in Canada exemplifies Abbott's ability to put science and innovation to work, delivering solutions to help people live their best lives."

The ongoing evolution of Abbott neuromodulation technologies highlights the commitment to patient-centered research integrated with cutting-edge technologies to go beyond physical symptom relief and improve the lives of people with neurological disorders. Abbott's NeuroSphere Virtual Clinic was first launched in the United States in March 2021 .

*Neurostimulation systems for DBS are used in patients with levodopa-responsive Parkinson's disease or tremor. Please refer to the device Instructions for Use for details.

§ Anywhere with a cellular or Wi-Fi connection and sufficiently charged patient controller.

†The St. Jude Medical Clinician Programmer App and St. Jude Medical Patient Controller App used with the NeuroSphere Virtual Clinic are currently licensed.

**Certain configurations of the devices within may not have been licensed in accordance with Canadian law. Contact your local sales representative for the regulatory status of the device(s) in Canada . This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events as applicable to Canada .

About Neuromodulation
Neuromodulation is an advanced personalized treatment option often recommended for patients who suffer from chronic pain and certain movement disorders, such as Parkinson's disease and essential tremors. Abbott neuromodulation systems use a recharge-free implanted generator, and a thin wire called a lead to send mild electrical pulses to areas of the brain that cause pain or tremors. These pulses interrupt the signals responsible for these symptoms. 6

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

1 Prevalence of chronic pain among individuals with neurological conditions. Statistics Canada . Updated March 21, 2018 . Accessed on May 25, 2022 . https://www150.statcan.gc.ca/n1/pub/82-003-x/2018003/article/54921-eng.htm
2 About Parkinson's Disease. Parkinson's Canada . Accessed on May 25, 2022 . https://www.parkinson.ca/about-parkinsons/
3 Agarwal, S. (2020, July 14 ). Essential Tremor. Access on May 25, 2022 . https://www.ncbi.nlm.nih.gov/books/NBK499986/
4 Canada's population estimates: Age and sex, July 1, 2021 . Statistics Canada . Updated September 29, 2022 . Accessed May 25, 2022 . https://www150.statcan.gc.ca/n1/daily-quotidien/210929/dq210929d-eng.htm
5 Publicly funded medical travel subsidy programs in Canada . Canadian Social Work Review. Volume 34, Number 1, 2017, p. 123–139. Accessed May 24, 2022 . https://www.erudit.org/en/journals/cswr/1900-v1-n1-cswr03182/1040998ar/
6 Yu, H., & Neimat, J. (2008). The treatment of movement disorders by deep brain stimulation. Neurotherapeutics , 5, 26-36 http://dx.doi.org/10.1016/j.nurt.2007.10.072 .

Abbott Logo (PRNewsFoto/Abbott)

SOURCE Abbott

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Beckman Coulter Partners with Mass General and BARDA to Identify Severe Pediatric Infections in Emergency Departments

Beckman Coulter, global leader in advanced diagnostics, today announced that it will partner with Massachusetts General Hospital to validate the use of the novel Monocyte Distribution Width (MDW) hematology biomarker in rapid identification of children presenting with early signs of severe illness from infection.

Beckman Coulter partners with Mass General and BARDA to validate the use of the novel Monocyte Distribution Width (MDW) hematology biomarker in rapid identification of children presenting with early signs of severe illness from infection.

This pivotal, multi-center trial will receive funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. MDW is currently the only FDA-cleared blood biomarker to aid in detecting adult sepsis in the Emergency Department (ED). This current partnership aims to expand the utility of MDW as a screening tool to measure the severity of infection in children 15 years old and younger presenting with high fevers.

Approximately 25 million children under 15 visit the emergency room every year, and about one in five presents with a fever. 1 The most common cause of fever in these children is infections that can be safely treated at home; however, one out of every four pediatric hospital admissions are due to complications from infection. 2 No objective biomarker yet exists that accurately identifies children at risk of hospitalization from an excessive immune response early in the infectious course when intervention is critical, making clinical decisions in the ED on how to treat pediatric infections difficult.

"A sick, febrile child can be challenging to examine, and current blood tests have limited ability to predict who will progress to acute illness," states Lael Yonker , M.D., a pediatric pulmonologist at Mass General for Children, and co-investigator on this clinical trial.  "Objective tests that are readily available are needed to make sure children get the medical attention they need in a timely manner."

The utility of MDW as a biomarker in pediatric infection was first recognized by Mass General during the height of the COVID-19 pandemic, when more than 400 children a month were developing a life-threatening complication from COVID-19, now termed Multisystem Inflammatory Syndrome in Children (MIS-C).

As published in June 2022 in BMC Infectious Diseases 3 , the team found that MDW can improve the identification of children at high risk of MIS-C complication, a task that has proven challenging to clinicians. 4 Now, this team will join Beckman Coulter and BARDA to potentially expand the use of MDW in the early recognition of severe infections in children presenting to EDs.

Notably, this tool is based on routinely ordered blood tests and can be reported as an additional parameter on Complete Blood Count (CBC) results. This approach may allow ED physicians to make rapid, accurate and safe decisions about which children with infections can go home and which children with infections need to be admitted to the hospital for further treatment without subjecting patients to additional and costly testing.

"We are thrilled to be partnering with pediatricians at Mass General to investigate the utility of MDW in identifying children at risk of adverse outcomes due to infection," said Julie Sawyer Montgomery , president, Beckman Coulter. "Along with the award from BARDA, Beckman Coulter is committing additional funds to this partnership. We are invested in establishing the performance of MDW in the pediatric population and in continuing our commitment to clinical evidence for use of MDW, and other novel hematological biomarkers."

MDW is a regulatory-cleared parameter for adult patients presenting to the ED and is available as a standard component of a CBC performed on Beckman Coulter's DxH 900 and 690T hematology analyzers. The MDW parameter measures the dispersion of monocyte volume in the blood, which is altered during infection due to monocyte activation and subsequent changes in monocyte morphology. Increases in MDW indicate increases in the variability of monocyte morphology, which can indicate a progression from localized to systemic infection.

MDW provides physicians with an early indication of sepsis risk, which is especially important when a patient's symptoms are mild and alternative diagnoses are being considered. MDW is only available on Beckman Coulter platforms.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00036.

Follow and connect with Beckman Coulter via LinkedIn , Twitter , and Facebook

About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif. , it has more than 11,000 global team members.

  1. Cairns C, Kang K, Santo L. National Hospital Ambulatory Medical Care Survey: 2018 emergency department summary tables. Available from: FastStats - Emergency Department Visits (cdc.gov)
  2. Goto T, Tsugawa Y, Mansbach JM, Camargo CA Jr, Hasegawa K. Trends in Infectious Disease Hospitalizations in US Children, 2000 to 2012. Pediatr Infect Dis J . 2016;35(6):e158-e163. doi:10.1097/INF.0000000000001134
  3. Yonker LM, Badaki-Makun O, Arya P, Boribong BP, Moraru G, Fenner B, Rincon J, Hopke A, Rogers B, Hinson J, Fasano A, Lee L, Kehoe SM, Larson SD, Chavez H, Levin S, Moldawer LL, Irimia D. Monocyte anisocytosis increases during multisystem inflammatory syndrome in children with cardiovascular complications. BMC Infect Dis . 2022;22(1):563. doi: 10.1186/s12879-022-07526-9.
  4. Rosu CA, Martens AM, Sumner J, Farkas EJ, Arya P, Arauz AB, Madhavan VL, Chavez H, Larson SD, Badaki-Makun O, Irimia D, Yonker LM. Heterogeneity in the evaluation of suspected MIS-C: a cross-sectional vignette-based survey . BMC Pediatr . 2022;22(1):392. doi: 10.1186/s12887-022-03446-4.

© 2022 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2022-10652

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

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SOURCE Beckman Coulter, Inc.

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