Our BinaxNOW COVID-19 Test and FreeStyle Libre 2 both honored among Best New Products.
SOURCE: Abbott
DESCRIPTION:
Knowledge is power. Especially when it comes to your health. That's why we created products to give people the information they need, when they need it most, to make the best decisions for their health — during a pandemic or not.
For their ability to empower people through knowledge, both our BinaxNOW rapid COVID-19 test and the FreeStyle Libre 2, an integrated continuous glucose monitor (iCGM) were honored with a Gold Edison Award for Best New Product.
BinaxNOW COVID-19 Ag Card
Rapid testing has been a critical tool to helping quickly identify people with COVID-19. That's why we created our BinaxNOW COVID-19 Ag Card. Unlike other antigen tests, BinaxNOW requires no equipment and gives results in 15 minutes. As a point-of-care test, it can be delivered at massive scale, so more testing can be done in more places, more frequently and with fast results.
We also needed to be able to deliver those results in a verified and secure way.
Enter our NAVICA mobile app, which delivers and displays verified test results on a mobile device, confirming a person’s COVID status easily and providing greater confidence as we re-enter everyday activities like work, school, public transportation and the like.
Overall, the combined solutions of BinaxNOW Ag Card and the NAVICA app provide:
- Rapid results in fewer than 15 minutes
- Accessibility, through testing that requires no instrumentation
- Availability, as we produce 50 million tests per month
More access to fast testing means more access to everyday activities. Technology that provides power through knowledge and helps our communities get back to the lives we've missed so dearly.
FreeStyle Libre 2 iCGM
More than 463 million people live with diabetes around the world. Managing the condition is an expensive, lifelong challenge.
Before the development of CGMs, people with diabetes relied on finger sticks throughout the day to measure their blood glucose levels. That’s painful, not discreet and poses the risk of missing dangerous high or low glucose values. The FreeStyle Libre 2 system has minute-by-minute glucose readings to catch highs or lows five minutes earlier compared to other systems1,2 — all without the need for finger sticks. †
FreeStyle Libre 2 has enhanced features like optional real-time alarms with unsurpassed 14 day accuracy4, all for a fraction of the cost of other available CGM systems. 5 To ensure accessibility, Abbott put a unique global pricing structure in place to make the FreeStyle Libre technology available to as many people as possible.
We're grateful the Edison Awards recognized the innovations found in the BinaxNOW COVID-19 test and the FreeStyle Libre 2 system for the ability to give people the knowledge they need, when they need it to make informed decisions about their health. That’s why our teams continue to innovate and develop industry-leading technologies.
References
1 International Diabetes Federation Diabetes Atlas, 9th Edition, 2019.
2 Data on file. Abbott Diabetes Care.
3 Dexcom G6 CGM User Guide.
4 Based on FDA iCGM special controls.
5 Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitors' CGM systems.
†Finger sticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
IMPORTANT SAFETY INFORMATION
FREESTYLE LIBRE 2 SYSTEM
BINAXNOW COVID-19 TEST
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.
The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.
This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The BinaxNOW COVID-19 Ag Card 2 Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. The BinaxNOW COVID-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.
The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
FREESTYLE LIBRE 2 SYSTEM
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*
WARNINGS/LIMITATIONS*: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit* www.freestylelibre.us/ for detailed indications for use and safety information.
*For full indications for use and safety information, see more here.
The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by Abbott. Other trademarks are property of their respective owners.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of the company.
KEYWORDS: NYSE:ABT, Abbott, Abbott Inc, Edison Award, BinaxNOW COVID-19 Test, FreeStyle Libre 2
