Image courtesy of Abbott

Abbott Receives FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity M System

Originally posted on Abbott.com

– Alinity m is Abbott’s new molecular lab system, which was approved by the U.S. FDA in March

– The Alinity m system is highly advanced and greatly improves speed and efficiency, running up to 1,080 tests in 24 hours

– Abbott is launching Alinity m to U.S. customers and will be making the SARS-CoV-2 test available for use under an Emergency Use Authorization

– This is Abbott’s fifth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad, reliable molecular and antibody testing during this pandemic

Abbott announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s molecular test for the novel coronavirus (COVID-19) for use on its new Alinity m molecular laboratory instrument. Abbott is in the process of launching the Alinity m system to U.S. customers.

The Alinity m system was cleared by the FDA for use with Abbott’s HCV (hepatitis C) assay in late March. Abbott is working with hospitals and health systems in the U.S. to install this new instrument, which will help keep up with the growing demand for testing.

“Molecular lab tests play a critical role in detecting the virus for COVID-19. As a leader in diagnostics, we are pushing forward to develop high-performing tests across our platforms to help combat this pandemic,” said Robert B. Ford, president and chief executive officer, Abbott. “As we continue to develop and improve our testing technologies, we want to ensure they are meeting the needs of our customers – and right now that means having reliable tests for COVID-19 on all of our diagnostic instruments.”

The Alinity m system is Abbott’s most advanced laboratory molecular instrument. It is an automated platform, which can run more tests in less time to give laboratories improved efficiency and flexibility when using the system. The Alinity m system is able to run up to 1,080 tests in 24 hours, and our m2000 RealTime system can run up to 480 tests in 24 hours.

With current systems, running different types of tests at the same time will slow down the time to results and/or volume throughput. Alinity m delivers true random access, allowing labs to run any test, any time for different types of infectious diseases while still providing results in less than two hours. This is especially critical during the COVID-19 pandemic when volume, speed and flexibility are needed.

 

 

Latest News

Syracuse University campus

News Roundup: TV Diversity, Syracuse Hire, and Segregated Training

Check out our news roundup of diversity and inclusion updates and insights from across the U.S.: Syracuse University Creates Athletics Diversity Position  While most colleges and universities around the county are making COVID-19-related cuts in regard to their athletic departments, Syracuse University has hired Salatha T. Willis as the associate athletic…

Cesar Conde

NBCUniversal Sets Ambitious 50% Diversity Goal for Women, People of Color

Cesar Conde, chairman at NBCUniversal News Group, announced a groundbreaking goal to have a 50% diverse workforce at NBCUniversal, according to Deadline. Conde, the first Latino in this role, outlined his plans in an internal video for employees on Wednesday. The ultimate goal is for NBCUniversal, No. 7 on DiversityInc’s 2020…

TIAA Launches Programs to Raise Awareness of Racial Injustice and Support Communities in Need through the “Be The Change” Initiative

On June 30, TIAA announced new virtual programs designed to raise awareness of racial injustice and support communities in need as a part of the company’s recently launched “Be the Change” initiative. One is TIAA’s “Race Against Racism,” an effort in support of The Innocence Project which included more than…

Stop TB Partnership and Johnson & Johnson, with support from USAID and The Global Fund, Announce Price Reduction for SIRTURO® (bedaquiline) for Treatment of Drug-Resistant Tuberculosis in Low- and Middle-Income Countries

Originally published on jnj.com. Joint efforts aim to accelerate scale-up of WHO-recommended all-oral treatment regimens – a transition urgently needed to help protect the health of people with drug resistant-tuberculosis who are particularly vulnerable during COVID-19 pandemic In 2020, the initiative aims to reach at least 125,000 patients and could…

Toyota, Alabama A&M and Huntsville Hospital Collaborate to Make COVID-19 Testing Easier

Originally published on pressroom.toyota.com. $100,000 grant provides free service to the community Alabama A & M University (AAMU), Huntsville Hospital and Toyota are developing a mobile health clinic initiative to provide free COVID-19 testing to underserved communities in Madison County. Launching later this year, the mobile medical clinic program has…

Sanofi and Regeneron Provide Update on Kevzara® (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients

Originally published on sanofi.com. Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo)….

TD Bank: How a PPP Loan Saved Essential Jobs for Hundreds of Frontline Healthcare Heroes Amid COVID-19

Originally published on newscenter.td.com. Yet, “it’s not about earning a paycheck” for these medical responders A hero is defined as “a person who is admired or idealized for courage, outstanding achievements or noble qualities.” Never has that word resonated more than right now, with millions of frontline responders risking their…

Boeing Dreamlifter Transports 500,000 Protective Face Masks for Utah Students and Teachers

Originally published on boeing.mediaroom.com. Partnered with the state of Utah, Atlas Air, H.M. Cole, Cotopaxi, Flexport and UPS to deliver face masks to school districts with the greatest need Boeing [NYSE: BA] today completed its 12th COVID-19 transport mission, using a Boeing Dreamlifter to bring personal protective equipment (PPE) to the United…